Reap what you sow!—But what about SPC squatting?

Reap what you sow!—But what about SPC squatting? Abstract The authors Jens Schovsbo and Timo Minssen are both Professors of Law at the Center for Information and Innovation Law (CIIR), University of Copenhagen, Denmark. Ulla Callesen Klinge is a European Patent Attorney and Partner at Inspicos P/S, as well as PhD Fellow at CIIR. This article Despite an avalanche of recent court decisions on the European system for supplementary protection certificates (SPCs), the issue of third-party SPC applications—also known as ‘SPC squatting’—has never been sufficiently clarified. Considering the ambiguous stipulations in the SPC Regulations, as well as the practical and theoretical significance of this issue, the lack of judicial guidance is problematic. It is important to address such situations for the sake of legal certainty and in order to enable companies to make strategic decisions. SPC squatting also involves a crucial debate about the rationales underlying the SPC system and the question whether such activities are compatible with the very goals of the Regulations. This article provides an overview on the legal status quo with regard to SPC squatting and discusses whether—and if so, to what extent—such practices should be considered legitimate. 1. Introduction The year 2017 was without any doubt a very important year for the European regulatory framework for supplementary protection certificates (SPCs). It marked the completion of two formal reviews of the European SPC system that might result in substantial legislative changes further down the road. After all, these studies not only evaluated the legal aspects of the SPCs in the EU,1 but also studied the economic impact of SPCs, pharmaceutical incentives and rewards in Europe.2 They are the first reviews the Commission has undertaken of either the Medicinal Products SPC Regulation, which entered into force in 1993 (the Regulation),3 or of the Plant Protection Products SPC Regulation,4 which entered into force in 1997.5 Notwithstanding their age, neither regulation has ever been modified in any considerable way, except to take account of EU enlargement, and on only one occasion substantively, by the somewhat peculiar legislative technique of stating in a recital to the latter regulation that some of its provisions had the effect of amending certain aspects of the earlier one and introducing paediatric extension provisions.6 This is surprising in view of the vague wording in the regulations that has resulted in a ‘turbulent adolescence’ of the legislative framework and considerable legal uncertainties.7 Meanwhile, the Court of Justice of the European Union (CJEU) has tried to address the ambiguities in the legislation in numerous references for preliminary rulings from national courts. However, by trying to fill the legal vacuum left by the regulations, the CJEU’s decisions and the application of these by the national courts have in turn resulted in additional questions that have left the area rather murky and difficult to oversee.8 Within this grey zone, some of the typical questions examined by the national courts and the CJEU decisions concern: (i) the definition of ‘product’ under the Regulation;9 (ii) the meaning of the phrase ‘protected by a basic patent’;10 (iii) the approach to cases where a single basic patent protects more than one ‘product’, or where one ‘product’ is covered by multiple basic patents;11 and (iv) the interpretation of the concepts of ‘valid authorization’ and ‘first authorization’.12,13 However, one particular issue that is of some practical relevance and touches upon the foundational principles on which the SPC system is based has not been explicitly mentioned in the aforementioned Commission tenders. It concerns the question whether the European legislative framework for SPCs allows for third-party SPC applications. These are applications by patentees for a certificate where the patentee does not rely on a marketing authorization (MA) obtained by himself or by someone related to him (eg by cooperation or licence), but on a marketing authorization obtained by a non-related third party. Typically, such SPC applications are submitted without any prior authorization from such third parties. Such a situation can occur since there is no explicit provision in the Regulation that requires the consent of the MA owner to the use of its MA by a patentee in order apply for an SPC. It appears, therefore, that these situations, where the interests of MA owners and the patentees differ, were simply not contemplated at the time when the Regulation was drafted.14 To prohibit such practices might enable MA holders to prevent patent holders from obtaining an SPC or at least to force the patent holder to apply for their own MAs and thus to suffer the costs associated with that (including duplicating experiments involving humans). This could be seen as being in direct contradiction to recital 2 of the Medicinal Regulation of continuing improvement in public health. On the other hand, allowing patent holders to apply for SPCs without having suffered the costs of obtaining an MA would appear to be inviting free-riding from patent holders. This would be problematic in light of the objective of the SPC to provide for a protection of patent holders which is ‘adequate’ to offset their costs in obtaining an MA (recital 9). How to deal with such third party SPC applications, which often are also referred to as SPC squatting or SPC piggybacking, is, therefore, a significant issue both from a practical and a theoretical/doctrinal perspective. It is important to address such situations, not only for the sake of legal certainty and in order to enable companies to make strategic decisions. It also involves a crucial debate about the very rationale underlying the SPC system and the question whether such activities would necessarily undermine the goals of the Regulation, or whether it should be allowed for under specific circumstances and on a case-by-case basis. Interestingly, both the CJEU and national courts have been (indirectly) confronted with these issues and have acknowledged the importance of clarifying the legal status of such situations. But unfortunately—and as we will elaborate further below—neither has directly addressed it with sufficient clarity. Hence, it can only be hoped that the entities15 entrusted with conducting the legal and economic Commission studies on the SPC system will carefully consider the following question: Does, or should, Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (the Regulation) allow a patent holder to obtain a supplementary protection certificate on the basis of a marketing authorization, which has been granted to a third party who is not related to the patent holder? This article intends to provide a first legal analysis and discussion of this inquiry. We start out by providing a brief overview of the applicable legal framework that applies to the European SPC system and explain how far the vague language in the current Regulation has led to interpretational difficulties and legal uncertainties (2). We then analyse the European status with regard to third-party SPC applications in more detail (3) by illustrating how the CJEU and national European courts have dealt with third-party SPCs in their case law. We explain how the issues emerged in the CJEU’s decision in C-181/95 Biogen (3.1) and give a chronological account of subsequent case law by the CJEU and national courts (3.2). These comprise decisions illustrating the CJEU’s general reliance on a teleological interpretation of the Regulation (3.2.1), as well as CJEU and national case law that (mostly indirectly) considered the third-party issue (3.2.2). This will allow us to summarize the rather elusive status quo of European case law and to provide some take-aways (3.2.3). Next, we will turn to other jurisdictions and look at how the US and Japanese patent systems deal with patent term extensions and the third-party issue (4). Although the US and Japanese systems for patent term extensions are not directly comparable with the European SPC framework, they have considered similar questions which are interesting to compare with the European situation. This will provide enough fodder for discussing how we should go forward in Europe and what we need to consider in further developing European doctrines on third-party SPCs (5). In developing our discussion and recommendations we will inter alia refer to the rationale underlying the European system for SPC protection and the positions that have been taken in European scholarly writing on the third-party SPC issues with a special focus on the UK, German and Nordic literature. Finally, we will complete the article with some concluding remarks (6). 2. The European rules on SPCs and their background An SPC provides for an extension of the protection offered by an existing patent for a medicinal product for which an MA has been granted. Thus, an SPC presupposes two steps before the application for the SPC is made: (i) a granted patent relating to medicinal product and (ii) an issued MA. Normally, both steps are initiated by the same undertaking (ie the patent holder). In the following, however, we focus on the situation where the MA (ie the second step) has been obtained by a third party but is nonetheless relied upon by the patent holder in fulfilling its obligations regarding the application for a certificate. This could arise in situations where a (possibly minor) company has obtained a patent, but is unable to fund the costs necessary for carrying out the investigations leading to a MA. In such a situation, there will normally be a licence agreement between the patent holder and the MA holder, and the patent holder should thus be able to apply for an SPC based upon his/her own patent and an MA of the licensee. Such a situation seems to be unproblematic. However, it becomes more problematic if no such licensing or other agreement between the patent holder and the MA holder exists and the patent holder and MA holder are completely unrelated. The duration of the extension by the SPC depends on the time which elapses between the date on which the application for the basic patent was filed and the date of the first marketing authorization minus 5 years. The maximum period for SPC protection is five years, providing a possible maximum period of protection of a total of 15 years for the product which is the subject of the SPC.16 As has already been hinted at, the SPC rules depend on and go hand in hand with the patent provisions, which allow for the patenting of ‘products’ that can be used as pharmaceuticals and satisfy the patentability requirements.17 The problem which the SPC Regulation seeks to address is related to the conditions for placing medicinal products on the market. Obtaining an MA for originally developed pharmaceuticals is costly in terms of direct costs in testing and documentation and so on. It is also—and primarily—costly in terms of time, since the product cannot be marketed as a medicinal product until the MA has been obtained. As the patent system works by enabling the patent holder to reap its reward on the market, the period of time in which the holder of the patent can enjoy exclusivity is crucial.18 The purpose of the SPC system is thus to provide for an adequate protection period for the product by extending the period of patent exclusivity for a period of time which reflects the period in which the medicinal product was awaiting authorization to be put on the market. Since the certificate is based on the combination of a patent and an MA, the scope of protection is defined in accordance with the MA (and not only the patent) (Article 4). The SPC system aims to supplement the patent system by providing for a separate stimulus for companies to invest in the resources necessary for obtaining MAs. In this way, it is based on two assumptions: (i) that obtaining an MA for patented products is beneficial for society and (ii) that incentivizing companies to invest in obtaining such authorizations does not automatically flow from the patent exclusivity but requires a special set of mechanisms. In particular, it is not the purpose of the Regulation to provide patent holders in the pharmaceutical field with an extra level of protection. On the contrary, the idea is to ‘re-establish a sufficient period of effective protection of the basic patent’19 and to guarantee ‘laboratories working to develop medicinal products a level of protection equal to that enjoyed by research in other industries’.20 Finally, it should be noted that the European legislator deliberately chose a regulation for the SPC system, which is the most binding form of ‘EU legislation’ available. The Preamble provides the following remarks in this regard: (7) A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the functioning of the internal market. (8) Therefore, the provision of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary. A regulation is therefore the most appropriate legal instrument. 3. Analysis of the third-party SPC issue in Europe The central question for the following is whether the Regulation allows for third-party applications, that is, applications for a certificate where the patent holder does not rely on an MA obtained by himself but on an authorization obtained by an unrelated third party. The legal framework for determining, whether or not this is possible is established by the Regulation. According to its Article 6 ‘the certificate shall be granted to the holder of the basic patent or his successor in title’ (emphasis added). It is thus clear that only the patent holder may apply for a certificate. However, to determine which conditions that patent holder must fulfil, one needs to consult Article 3 which states the following: A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application: (a)   the product is protected by a basic patent in force; (b)  a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate; (c)  the product has not already been the subject of a certificate; (d)   the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product. As it can be seen, Article 3(b) clearly states that an MA must be provided in support for the (patent holder’s) application for the certificate. This provision does, however, not make it clear by whom the MA should have been obtained.21 3.1 The third-party issue emerges in Biogen These questions were touched upon in the observation made by Advocate General Fennelly in his Opinion in Biogen: […] the text of the Regulation applies simply to a simple situation, in which basic research, product development, production and marketing are vertically integrated: where the holder of the patent or patents relating to a medicinal product, the marketing of which has been authorized in a Member State, is also the holder of the relevant marketing authorization.22 In particular, the Advocate General then pointed out that the Regulation is silent on the relationship between the holder of the basic patent and the holder of the MA. The Advocate General ascribed this fact, as a second point, to: the implicit assumption on the part of the draughtsman that they would be concentrated in the hands of a single undertaking. It is, in effect, the legislative failure to advert to the possible divergent ownership of patents and marketing authorisations that creates the problem in the present case.23 Hence, the Regulation presupposes that the patent holder and the holder of the MA is one and the same legal entity. We concur with the view expressed by the Advocate General. We do not think, however, that pointing this assumption out in itself solves the issue of third-party claiming. In that regard it should be recalled that the protection offered by the Regulation is conceptually different from patent protection, since they are intended to stimulate investments in two different directions. That is to say, that even though the two systems share the same general goal of furthering pharmaceutical research, they aim specifically at different parts of the pharmaceutical value chain and channel exclusivity in different directions. The patent system seeks to reward the invention of products which have the potential to be used as medicines and rewards the disclosure of these products at a very early stage of development. In contrast, the SPC system seeks specifically to reward the work required to develop these potential products into medicinal products that are effective and safe in order to be placed on the market. Therefore, allowing the patent holder to apply for an SPC in a situation where that patent holder has not suffered any losses in time and has not made any investments in research in relation to the use of the invention is arguably problematic as seen in light of the purpose of the SPC system. Following this kind of reasoning, one’s status of being a ‘patent holder’ does not by itself confer a right to apply for the certificate. That status has to be earned separately through the application for the MA. After all, the patent holder has already been incentivized once via the patent system and any additional protection should only be provided for in return of a loss in time and costs suffered in obtaining the MA. Allowing the patent holder the possibility of extending protection without having suffered the corresponding losses would seem to be inviting rent-seeking behaviour. On the other hand, a literal interpretation of the wording of Article 3 arguably opens for certificates based on third-party MAs. Since Article 6 simply refers to ‘the patent holder’ and no limitations are contained in Article 3(b) it would seem that a patent holder could apply even if the MA has not been obtained by him or her. Further, one could support such a reading by pointing out that if the patent holder (who is the only one who may apply for a certificate) cannot rely on an existing MA, it would have to perform its own clinical trials in order to obtain its own MA. This would duplicate the process and increase costs which would end up being paid by the consumers anyway. Furthermore, requiring the conduct of performing unnecessary clinical tests would hardly be acceptable from an ethical point of view. There is thus a discrepancy between a literal interpretation of the wording and the purpose of the Regulation. The next step is to analyse how the CJEU and national courts have dealt with this issue in the ensuing case law. 3.2 Subsequent case law of the CJEU and national courts It is well known that the CJEU can and does rely on the background and purpose of EU legislation as a means for interpretation. As will be demonstrated below, the CJEU has also relied on these techniques in its interpretation of the rules in the Regulation. As mentioned before, national courts have brought the interpretation of the Regulation before the CJEU in a rather high number of cases.24 We will just refer to some of the most recent decisions below. It is, however, important to keep in mind that the great number of cases suggests that the system established by the Regulation is characterized by a rather high degree of legal uncertainty. This is also underlined by the fact that most of the cases have dealt with some of the basic requirements in Article 3 of the Regulation and not least the basic requirement in litra (a) that the product must be ‘protected by a basic patent in force’. 3.2.1 The CJEU’s reliance on a teleological interpretation of the Regulation In the aforementioned Biogen, the CJEU took the reason for the protection offered by the certificates25 as the starting point for its analysis and, furthermore, relied on the ‘scheme and objectives of the Regulation’ (para 39) in its interpretation. In AHP Manufacturing the CJEU affirmed the purposive (teleological) approach to be taken by stating that ‘[n]ext, the Court observes that the second sentence of Article 3(2) of Regulation No 1610/96 must be interpreted not solely on the basis of its wording, but also in the light of the overall scheme and objectives of the system of which it is a part.’26 The same style of interpretation was adopted in Medeva.27 In this judgment, the court also noted ‘that Regulation No 469/2009 establishes a uniform solution at European Union level by creating a SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State. It thus aims to prevent the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the European Union and thus directly affect the establishment and functioning of the internal market’ (para 24). As far as the concrete interpretation is concerned, the court referred inter alia to the fundamental objective of the Regulation (to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health) (para 30) and to the ‘reason given for the adoption of that regulation’ (ie, the fact that the period of effective protection under the patent is insufficient to cover the investment put into pharmaceutical research and the regulation thus seeks to make up for that insufficiency by creating a SPC for medicinal products) (para 31). The reliance of the CJEU in Medeva on the object and purpose of the Regulation clearly reflected the approach of Advocate General Trstenjak, who had emphasized the importance (indeed the ‘necessity’ see para 74) of a teleological interpretation to complement the literal interpretation: 79. Nevertheless, it is in my view clear that the result of the literal interpretation of Articles 1 to 3 of Regulation No 469/2009, according to which, in the case of medicinal products with multiple active ingredients only part of which is the subject-matter of a patent, no supplementary protection certificates can be granted, is not compatible with the objectives of Regulation No 469/2009. 88. The literal interpretation of Articles 1 to 3 of Regulation No 469/2009 must therefore be complemented by a teleological interpretation which ensures that the rules on supplementary protection certificates contained in those provisions can also be fully effective in respect of medicinal products in which the combination of active ingredients is only partly the subject-matter of a patent. (emphasis added)28 Thereby, the court clearly stressed the importance of the Regulation’s objective. It also demonstrated its general interest in making sure that the rules are not being used in ways which in practice run counter to the objectives of the Regulation.29 3.2.2 The third-party issue at the CJEU and the national courts The CJEU has not explicitly ruled on the third-party issue but touched upon it in the aforementioned Biogen case in 1997 and then again in Eli Lilly in 2013. However, in the meantime a few national decisions have dealt with the question. Below we will present these cases in a chronological order. 3.2.2.1 Biogen (1997) In Biogen the CJEU remarked that ‘the holder of a marketing authorisation may not obstruct the exercise of the right referred to in Article 6 of the Regulation’ (para 32). This remark related to a situation where an application for a certificate had been submitted by someone other than the holder of the MA (in casu a licensee of the patent). The issue before the court concerned the formal requirements regarding applications for certificates and the court made it clear that the Regulation does not require the holder of the MA (ie, the licensee) to provide the patent holder with a copy of the authorization and also that the holder of an MA (ie, the licensee) cannot prevent the patent holder from applying for a certificate by not providing him with the original authorization.30 As is clear from the above, the Biogen case involved two parties who were related (by a licensing agreement). The character of the relationship between the parties may constitute an important aspect in the development of future practices, see below. It was not, however, clear how or indeed whether the decision of the CJEU was affected by the fact that there was a contractual relationship between the parties. Furthermore, the court was not asked to address the substantive issue whether the patent holder was in fact in a position to apply. In our opinion, one cannot rely on this decision as having decided that issue. The CJEU merely did what it was supposed to do and answered the questions posed to it from the national court and those questions did not address the issue of the validity of third-party applications. If the court had intended the decision to deal exhaustively with all issues regarding the relationship between the holder of a basic patent and the holder of and MA—and to thus go beyond the questions posed—one would have expected the court to have made it clear that it did so. However, there is nothing to suggest this. In other words, the wider potential consequences of the decision of the CJEU in the Biogen case were probably not immediately realized for mainly two reasons: (i) it concerned two parties that were a licensor and a licensee and (ii) the main finding (with great significance for practitioners) lay in its holding that a product could be protected by more than one SPC. 3.2.2.2 Stallergenes AG v Dutch Patent Office (2009) Rather surprisingly, it took more than 10 years before the third-party issue and its implications were considered by a national court. In an obiter dictum, the District Court of The Hague rejected for other reasons an application for an SPC by a patentee based on an MA granted to a competitor.31 Importantly, however, the Dutch court also observed that since the patentee was not the owner of such an MA it could not be argued that the patentee had been delayed in getting a return on its investment through the time taken to secure the MA. As this was the rationale for the Regulation, the grant of an SPC to it would not conform with the purpose of the Regulation. The court found that: […] in order to encourage pharmaceutical research, the Regulation is designed to offer compensation to manufacturers of medicinal products for the period that elapses between the filing of the patent application and the grant of the marketing authorisation by extending the period of protection. It is an established fact that the plaintiff does not have a marketing authorisation for a medicinal product that is based on [the patent in suit]. This means that it cannot be said that the possibility of recouping the investments made in the patent has been delayed by a procedure to obtain a marketing authorisation. For that reason, granting an SPC to the plaintiff would not be in conformance with the objective of the Regulation. (emphasis added).32 3.2.2.3 Novartis Pharmaceuticals Limited v Medimmune Limited (2012) In the UK, the High Court of Justice has also touched upon the issue in a number of decisions. In Novartis Pharmaceuticals Limited v Medimmune Limited Mr Justice Arnold said in an obiter dictum at para 61 under the headline ‘A point not taken’ that: As noted above, in the present case the SPC is based upon a product obtained by means of an allegedly infringing process and upon a marketing authorisation obtained by an alleged infringer of the Patent. It might be thought that it was not the purpose of the Regulation to enable a patent owner to obtain an SPC in such circumstances, since the owner has not been delayed in getting the product to market by the need to get a marketing authorisation, and therefore no extension to the term of the patent is needed to compensate him for that delay. Counsel for MedImmune accepted that it was not clear from the judgment of the Court of Justice in Case C-181/95 Biogen Inc v SmithKline Biologicals SA [1997] ECR I-386 that this was permissible. Nevertheless, counsel for Novartis made it clear that Novartis was not taking this point.33 (emphasis added) Moreover, Justice Arnold explicitly noted that ‘the wider potential consequences of the decision of the CJEU in the Biogen case were thus not immediately recognised, perhaps because it concerned two parties that were not wholly unconnected.’34 Soon afterwards, much the same issue arose in the English courts in Eli Lilly v Human Genome Sciences although on this occasion the point was indeed taken and thus had to be addressed. 3.2.2.4 Eli Lilly v Human Genome Sciences (2012) In Eli Lilly v Human Genome Sciences35 Mr Justice Warren considered the CJEU decision in Biogen (above) in some detail and the difficulty of applying the sort of test floated in Novartis (above). He concluded that the holder of a basic patent was entitled to make an application for an SPC in reliance on an MA granted to a third party having no connection of any sort with that patentee. He stated in para 62 and 105 that: 62. I therefore conclude that the answer to the third party SPC issue is that the holder of a basic patent can make an application for an SPC in reliance on an MA granted to a third party having no connection of any sort with that holder. I do not consider that there is any real doubt about this such as would justify a reference to the CJEU if this were the only matter to be referred. […] 105. Dealing with the third party SPC issue first, I doubt very much that it would be appropriate at any stage for this court to make a reference if that issue stood alone. I regard the answer to that issue as sufficiently clear to be decided at this level without a reference. However, it does not stand alone, but stands with the Specification issue. The answer to that can only be provided after a preliminary ruling from the CJEU. If this court is to make, or were ever to make, a reference in these proceedings on the Specification issue, it would be entirely appropriate and sensible for the third party SPC issue to be referred at the same time in order to obtain a definitive ruling which will be of importance, not only in the present case, but generally. […] (emphasis added) It was, therefore, not the opinion of Mr Justice Warren that the third-party SPC issue could never be referred to the CJEU, but rather that it was not necessary to do so in the circumstances of that first instance case. This notion is supported by Mr Justice Warren’s later remarks in his decision in Eli Lilly and Company v Human Genome Sciences (para 5): In saying what I did [in para 62 quoted above], we did not mean to say that the point was necessarily acte clair, but we regarded the point as sufficiently clear to allow me, this court of first instance, to decline to make a reference, something for which a court of this level is discretionary.36 However, Justice Warren then made a reference to the CJEU, for another reason, which reached the CJEU in Eli Lilly in 2013. 3.2.2.5 The CJEU in Eli Lilly (2013) In this case, which was decided on 12 December 2013, the CJEU was once again asked to interpret the wording of Article 3, litra a, that the product must be ‘protected by a basic patent in force’.37 More concretely the CJEU was asked to decide whether a patent lived up to the requirement in Medeva (above) that the active ingredient has to be specified in the wording of the claims of the basic patent relied on in support of the SPC application (para 28). The CJEU stated, amongst other things, that: 41. Moreover, it should be recalled that the SPC is designed simply to re-establish a sufficient period of effective protection of the basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of that patent, which is intended to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for the patent was filed and the date on which the first MA in the European Union was granted. [….] 43. In the light of the objective of Regulation No 469/2009, the refusal of an SPC application for an active ingredient which is not specifically referred to by a patent issued by the EPO relied on in support of such an application may be justified – in circumstances such as those in the main proceedings and as observed by Eli Lilly – where the holder of the patent in question has failed to take any steps to carry out more in-depth research and identify his invention specifically, making it possible to ascertain clearly the active ingredient which may be commercially exploited in a medicinal product corresponding to the needs of certain patients. In such a situation, if an SPC were granted to the patent holder, even though – since he was not the holder of the MA granted for the medicinal product developed from the specifications of the source patent – that patent holder had not made any investment in research relating to that aspect of his original invention, that would undermine the objective of Regulation No 469/2009, as referred to in recital 4 in the preamble thereto.38 (emphasis added) The CJEU thereby touched upon the issue of third-party applications but this was not explicitly addressed since the national court did not refer questions on the third party SPC issue. However, the Eli Lilly decision, paras 41–3, seems to indicate as a general principle that in order to be able to rely on SPC protection, the patent holder needs to have carried out in-depth research and identified his invention specifically, making it possible to ascertain clearly the active ingredient which may be commercially exploited in a medicinal product corresponding to the needs of certain patients and have made investments in research relating to that aspect of his original invention which has provided the basis for the MA. The decision is thus based on the view expressed above that the purpose of the SPC system is to compensate for research aimed at turning patented inventions into medicinal products. 3.2.3 Summing up: Remaining ambiguities On several occasions, the CJEU has stressed the importance of not relying solely on a literal interpretation of the Regulation. Instead, the court has emphasized the significance of a teleological interpretation which takes into account of the purpose of the Regulation. Unfortunately, however, the CJEU has not decided explicitly on the issue of third party applications. The reliance of the court on arguments based on the objective and purpose of the Regulation and its willingness to engage in a teleological interpretation clearly suggest that the CJEU would not rely solely on a literal interpretation of the regulation in order to decide whether third-party applications are permissible. The legislator’s choice of a regulation and the need to achieve the highest degree of coherence and uniformity at the EU level would even accentuate the CJEU’s interest in dealing with issues of legal uncertainty. This line of reasoning has also been confirmed by Eli Lilly. Even though the CJEU was not asked explicitly to consider the issue of third-party applications, this decision would seem to support that the CJEU would engage in a teleological interpretation if it were to decide on this issue. Yet it is obvious that the current situation is rather ambiguous and that a direct decision of the CJEU on this particular issue would hence be very much welcomed. The need to address the persisting ambiguities is exacerbated by the fact that none of the national decisions discussed above have addressed the issue of third-party applications directly and that their persuasive effect for that reason is limited. The relevant statements in the national decisions selected for our studies indicate that the question whether the Regulation allows applicants to rely on third-party MAs or not has not been answered clearly in the case law we know of. Moreover, it also seems clear that there are contradicting views between courts in different jurisdictions. Before we embark on a discussion and present the views expressed in the literature, we briefly sketch out how other jurisdictions have dealt with similar issues. Again, we do not intend to engage in detailed comparative studies but only to add to the discussion of the specific issue of third-party applications under the EU rules. 4. How do other jurisdictions deal with similar issues? A number of other countries around the world provide for protection regimes with similar goals as the EU’s SPC, that is, to stimulate companies specifically to invest in obtaining an MA by supplementing the patent system. The various models vary and some countries extend the term of the patent itself, whereas others, such as the EU’s SPC system, provide for a separate system of exclusivity. The patent term extension systems we have examined limit the availability to apply to patent holders and also require the existence of an MA. However, the issue of third-party SPCs has been dealt with differently around the world. In some jurisdictions patent term extension based on unrelated third parties’ MAs seems not to be possible at all. For instance, in the US the patent holder must submit, together with the application for patent term extension, a ‘brief description of the activities undertaken by the applicant during the applicable regulatory review period with respect to the approved product and the significant dates applicable to such activities’.39 Furthermore, according to 37 CFR 1.730 ‘If the applicant for patent term extension was not the marketing applicant before the regulatory agency, then there must be an agency relationship between the patent owner and the marketing applicant during the regulatory review period. To show that such an applicant is authorized to rely upon the activities of the marketing applicant before the Food and Drug Administration or the Department of Agriculture, it is advisable for the applicant for patent term extension to obtain a letter from the marketing applicant specifically authorizing such reliance’ (emphasis added).40 Thus, in the US there must be a so-called agency relationship between the patent owner and the marketing applicant, and patent term extension without the consent of an unrelated third party’s MAs seems not to be possible. In Japan, in order to apply for patent term extension the patentee, or the exclusive licensee(s) or registered non-exclusive licensee(s) of the patent must be the MA holder and ‘is required to have obtained the disposition’ designated by the Cabinet Order under Article 67(2) (67-3(1)(ii)) of the Patent Act.41 Similar restrictions seem to exist in Korea, where the patentee, or his/her exclusive or non-exclusive licensee must be the MA holder.42 Hence, neither the US nor Japan and Korea seem to allow patent holders to rely on applications for MAs from third parties who are not related to the patent holder. 5. Discussion and recommendations It appears that no clear position has emerged in neither EU, nor national practice, nor in international legislation on the issue of third-party applications. This ambiguity is also reflected in the legal literature. The question has been dealt with very sparsely in the German, English and Nordic literature we have examined. Most of the authors we have investigated have not discussed the matter in any great detail but rather seem to be making the point in passing that Article 3(b) does not limit the authorization in any way (eg, to one which has been obtained by the applicant). Regarding the Nordic countries, Stenvik states that ‘it does not matter whether the proprietor [ie, the patent holder] himself is working the invention which is protected by the basic patent or not’ and ‘it is not a condition that the applicant is the beneficiary of the marketing authorisation’.43 A similar view is expressed by Lindgreen, Schovsbo and Thorsen, who point out that ‘the Regulation has not made it a condition that the marketing authorization has been issued to the applicant [of the certificate].’44 Dethlefsen remarks that ‘[t]here is no explicit requirement in the Regulation that the party who applies for a certificate does so in understanding with the party that has acquired the authorisation (if that is another party). The purpose of the Regulation, however, dictates that there should be a relation between the two “right holders”: the certificate after all is a compensation to the one who has spent the (most) time and money on the marketing authorisation.’45 As for the UK, Terrell on the Law of Patents refers to the Biogen case and states that: ‘it is clear from the decision of the European Court of Justice in [Biogen] that the basic patent and the marketing authorisation may be held by different people and this is no bar to the grant of the certificate.’46 However, it is then stressed that the Biogen case was one in which the MA holder was a licensee under the patent. On the other hand, it was also inherent in the case that the MA holder was not interested in the patent holder (Biogen) obtaining a certificate prolonging the exclusivity of Biogen and ‘the court’s decision permitting Biogen to obtain a certificate in any event necessarily shows that a patent holder does not need the consent of the holder of the relevant marketing authorisation to obtain a certificate.’47 Terrell also points to the (undecided) question of whether a patent holder may obtain a certificate based on an MA from a MA holder having no license and being infringing the basic patent. Terrell refers to both the Biogen and the Eli Lilly case and states that ‘[t]here is nothing in the terms of the Regulations which requires the holder of the marketing authorisation to be a licensee at all. Clearly the scheme was not set up contemplating that patent holders would seek supplementary protection certificates to cover other people’s products but the logic of the Biogen case would support such an application.’48 Similar findings can also be detected in major German patent commentaries, such as Benkhard49 and Busse,50 who highlight that only the patent holder shall have the right to apply for an SPC and that it follows from C-181/95 Biogen that the ownership of the SPC and the MA may differ. Klaus Grabinsky in Benkhard further concludes from Biogen that a patent holder that has received an SPC but not the MA, may prevent the MA holder to use the SPC, whereas the same patent holder will in turn be hindered from making use of the SPC due to lack of an MA.51 Yet, neither commentary provides a more detailed discussion of the wider policy implications of third-party applications. The issue is, however, discussed in some more detail by Brückner.52 This author takes also as his starting point that a certificate may be obtained on the basis of a third party’s MA.53 He points out that Article 6 does not ‘permit the conclusion that it is a precondition that the holder of the basic patent must also be the holder of the marketing authorization’.54 Brückner, however, does not stop here. He continues to discuss the pros and cons of such a reading. He points out that such a situation entails advantages (notably by keeping the number of clinical trials down) and that the Regulation does not provide an obligation to actively use a protection certificate. On the other hand, it also provides for disadvantages by not allowing the holder of the MA to recover his costs55 generally implies a risk of abuse. According to this author, opening for third-party applications becomes problematic ‘if such an applicant uses a protection certificate in order to interfere with the holder of the marketing authorisation by prohibiting him from using the product covered by the authorisation. Such a conduct ultimately inhibits the research activities of innovative enterprises.’56 The risk of abuse is reiterated regarding the case of so-called ‘passive protection certificates’. By this the author means situations where ‘the application has been based on another’s marketing authorisation and where the applicant has no marketing authorisation of his own for the product’.57 According to Brückner, the rules would seem to allow for a certificate in this situation but he goes on to point out that ‘the situation becomes problematic … if an enterprise that has acquired a marketing authorisation at huge expense is prevented from making use of this marketing authorisation by a third party who himself/herself became placed in a position by this marketing authorisation to obtain a protection certificate that he/she now can use against the holder of the authorisation.’58 Further, according to Brückner, the Regulation was created to provide companies a compensation for the loss of effective patent life caused by the performance of clinical studies and a ‘company, which did not incur such a loss of effective patent duration, does not need such a compensation’.59 Furthermore, it is stated that ‘[i]n such a case, he can only use the protection certificate destructively.’ In the Introduction, the author states that ‘[a] careful eye must be kept on the development of this problem [connected with the passive protection certificates.’60,61 We have quoted Brückner at some length in order to point out that this author, despite his initial remark that the rules apparently allow for reliance on someone else’s MA, would seem to find such a reading of the rules to be sometimes problematic and—according to our reading of Brückner—also uncertain. Furthermore, we find the general point expressed by Brückner that the ‘destructive’ use of certificates beyond the purpose of the Regulation may affect the interpretation to have been supported by the CJEU in the above mentioned Georgetown University. In this judgment, the CJEU indicated that it would take into account whether a specific interpretation would encourage ‘circumvention tactics’ as an argument against such an interpretation. Avoiding such tactics is generally considered as beneficial and, as a general principle, it is expected to also apply to the question of third-party applications.62 On this basis, it would seem to us to be fair to summarize the position in the literature as seemingly being supportive of applications based on a third party’s MA, but also that this position is not without important qualifications. Eventually it will fall on the CJEU to decide whether or not the current rules allow for patent holders to rely on third-party applications. We submit that in deciding this issue the CJEU should continue down the path it has established in the previous judgments in this area and conduct an analysis which emphasizes the purpose of the SPC system. Secondly, it should accept that the facts of these cases differ and leave the courts of the EU states with the flexibility to engage in a case-by-case analysis in the grey areas and in particular to deal with issues of misuse. Regarding the first point (ie, the purpose of the SPC system), the reference in Article 6 to the patent holder or his successor is based on the assumption that since it would normally be the holder of the basic patent who has also obtained the MA that holder should be able to apply for an SPC in consideration for those ‘extra’ losses. In other words, the recognition of the ‘patent holder’ as being competent to apply for an SPC does not hinge on the applicant’s status of being a ‘patent holder’. Instead, to be competent to apply some connection must be established between the applicant and the holder of the MA. As seen from such a perspective, allowing the patent holder to apply for an SPC in a situation where that party has not suffered any losses and has not made any investments in research in relation to the use of the invention which has formed the basis of the MA, would seem to be openly against the purpose of the Regulation; the basic quid pro quo is missing. We suggest, however, that even if the patent holder has not itself obtained the MA, there might be reasons to allow the patent holder to rely on a third party’s application in some instances. Since the specific purpose of the SPC system is to incentivize companies that have invested in obtaining MAs it is basically for the holder of the MA to decide how to obtain that benefit. For this reason, MA holders should obviously be able to grant permission to patent holders to rely on their MAs. In this way, the holder of the MA receives compensation in lieu of its investment. We also suggest that some contractual arrangements could arguably be expected to normally include an implicit licence for the patent holder to rely on an MA. If no connection exists between the patent holder and the holder of the MA, courts should normally not find patent holders to be competent to apply.63 We find such a reading to be supported by the gist of the remarks in Eli Lilly—that the applicant for an SPC should have carried out in-depth research and identified his invention specifically making it possible to ascertain clearly the active ingredient which may be commercially exploited in a medicinal product corresponding to the needs of certain patients—and have made investments in research relating to that aspect. This would seem to present an appropriate yardstick against which to measure the effort needed for the patent holder to be able to rely on the MA. Also this position appears to be in line with the rules in the US and Japan. 6. Conclusions It is not uncommon in the pharmaceutical industry that different therapeutic products and processes developed by different companies build upon earlier patent protected products or processes.64 This may deter companies from investing in research to develop new medicinal products for fear that non-related patent holders rely on their MAs to obtain an SPC. Given the rapid scientific advances in biomedical medicine, it is further likely that situations will increase in the development of biologics, such as in the field of life-saving therapies based on mono- and polyclonal antibodies. In light of the growing practical relevance, achieving clarity with regard to third-party SPC applications is more important than ever. An appropriate approach should ensure that innovative companies are not discouraged from investing in the clinical development of new medicines for fear of the patentee engaging in SPC squatting. In the absence of unambiguous legislation on this issue, different strategies for MA holders have been suggested, including receiving a licence from the SPC holder or delaying the application for an MA until the patent has expired.65 We agree that, while such solutions may sometimes work to solve concrete situations, there is a need for establishing a clear legislative starting point for deciding on the issue of third-party SPCs. Since there should be no money for nothing and no SPCs for free, we have argued that as a default rule the best solution is probably to not allow for third-party applications. However, a caveat needs to be added. We believe that sometimes patent holders should indeed be allowed to ‘piggyback’ on MAs obtained from third parties. We, furthermore, think that the current rules provide for the necessary leeway for the courts (notably the CJEU) to get it right. Whereas this is comforting, it is at the same time highly unsatisfactory. Obviously, the legislation should not allow for applications of the rules in counterproductive ways. The protection offered by SPCs should, just like any other IPR, be sustainable and defendable and not extend beyond the point of justification. The current legal regime includes a risk of harm to an area of central societal interest. The long-term solution, therefore, is to amend the provisions and the emerging unitary patent system should provide the appropriate forum for the necessary debates. In this way, our contribution suggests yet another reason for that long overdue revision of the SPC system, which because of its complexity must involve all stakeholders. In that regard, we welcome the European Commission’s recent announcement of a review of options to modernize the SPC regulations and ‘Bolar’ research exemptions. Hopefully, the forthcoming results of the ongoing Commission studies on the SPC and pharmaceutical innovations system will provide the necessary high-quality input for this review.66 Footnotes 1 Cf Call for tenders: Study 559/PP/GRO/IMA/15/15153 on the legal aspects of the supplementary protection certificates in the EU, available at: <http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=8847> (accessed 28 August 2017). 2 Cf Call for tenders: Study 590/PP/GRO/SME/16/F/121 on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe, available at: <http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=9044&lang=en> (accessed 10 June 2017). 3 Council Regulation (EEC) no 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, OJ L 182/1–5, 2 July 1992, as amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 1 December 2006 on medicinal products for paediatric use, OJ L 378, 27 December 2006; see also: Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products, OJ L 152, 16 June 2009. 4 Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, OJ L 198/30, 8 August 1996. 5 Cf Trevor Cook, ‘Squatters’ Rights: The Problem with Third Party SPCs’ (2016) Life Science Intellectual Property Review, available at: <http://www.lifesciencesipreview.com/article/squatters-rights-the-problem-with-third-party-spcs> (accessed 28 August 2017). 6 Ibid. 7 Frantzeska Papadopoulou, ‘Supplementary Protection Certificates: Still a Grey Area?’, JIPLP (2016), at 372. 8 Cook, above n. 5. 9 Notably CJEU: Judgment in Massachusetts Institute of Technology, C-431/04, ECLI:EU:C:2006:291, and CJEU: Order in Glaxosmithkline Biologicals SA, Glaxosmithkline Biologicals, Niederlassung der SmithKline Beecham Pharma GmbH & Co. KG, v Comptroller General of Patents, Designs and Trade Marks, C-210/13, ECLI:EU:C:2013:762. 10 Notably CJEU: Judgment in Medeva BV v Comptroller General of Patents, Designs and Trade Marks, C-322/10, ECLI:EU:C:2011:773, CJEU: Judgment in Eli Lilly and Company Ltd v Human Genome Sciences Inc, C-493/12, ECLI:EU:C:2013:835 and CJEU: Judgment in Actavis Group PTC EHF and Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG, C-577/13, ECLI:EU:C:2015:165. 11 Notably CJEU: Judgment in Biogen Inc. v Smithkline Beecham Biologicals SA, C-181/95, ECLI:EU:C:1997:32, and CJEU: Judgment in Georgetown University v Octrooicentrum Nederland, C-484/12, ECLI:EU:C:2013:828. 12 Notably CJEU: Judgment in Farmitalia Carlo Erba Srl, C-392/97, ECLI:EU:C:1999:416, and CJEU: Judgment in Arne Forsgren v Österreichisches Patentamt, C-631/13, ECLI:EU:C:2015:13. 13 See generally Papadopoulou, above n. 7, at 373. See also Massimo Scuffi, ‘Supplementary Protection Certificates: The Evolution of European Case Law on the Terms of Patent Extension and the Scope of Protection’, available at: <https://www.epo.org/law-practice/legal-texts/official-journal/2015/etc/se5/p105.html> (accessed 10 August 2017). 14 Ibid. 15 The entities entrusted with the SPC studies are the Max Planck Institute for Innovation and Competition (regarding the legal framework) and Copenhagen Economics (regarding the economic impact of SPCs and other incentives in the pharmaceutical sector). For further information, see: <http://thespcblog.blogspot.dk/2017/06/max-planck-institute-spc-survey.html and http://www.lml.law.cam.ac.uk/news/Liddell-expert-board-economic-impact> (accessed 10 June 2017). 16 Cf Article 13. By way of example: The basic patent expires on 1 July 2020 if the patent application was filed on 1 July 2000 (a 20-year term). If the first authorization to place the product on the EU market was 1 July 2008, then the patent protection will be extended until 1 July 2023 (2020 + (8-5 years)). 17 Ie, novelty, inventive step and industrial applicability, see European Patent Convention Article 52 which is compatible with the international baseline found in TRIPS Article 27. 18 Eg, Erika Fisher Lietzan, ‘The Drug Innovation Paradox’ (7 April 2017). University of Missouri School of Law Legal Studies Research Paper No. 2017-12. Available at SSRN: <https://ssrn.com/abstract=2948604> (accessed 28 December 2017). 19 Eli Lilly, above n. 10, para 41. 20 Proposal for the Regulation, COM(90) 101 final – SYN 255 at point 4. See also and in the same vein recital 3 of the Regulation which calls for pharmaceutical companies to receive ‘sufficient protection’ to encourage research in medicinal products, recital 4 where it is stated that without a certificate the protection under the patent would not be sufficient to cover the investment put into the research, and recital 5 where it is said that without protection to cover the time gap pharmaceutical research would be ‘penalised’. 21 According to Article 8(1)(b) and (c) applications should contain ‘copies’ of the MA. As pointed out by Cook, above n. 5, even though this language would seem to provide MA owners with some level of control of the use of ‘their’ MAs one cannot after Biogen (below) deduct anything from these provisions regarding the third-party issue. 22 CJEU: Opinion in Biogen v SmithKline Beecham Biologicals, C-181/95, ECLI:EU:C:1996:370, para 29. 23 Ibid at para 43. 24 In particular those listed above, nn. 9–12. 25 Ie, the insufficient duration of the effective protection under the patent to cover the investment put into the pharmaceutical research, para 26. 26 CJEU: Judgment in AHP Manufacturing v Bureau voor de Industriele Eigendom, C-482/07, ECLI:EU:C:2009:501, para 30. 27 CJEU: Judgment in Medeva BV v Comptroller General of Patents, Designs and Trade Marks, C-322/10, ECLI:EU:C:2011:773. 28 CJEU: Opinion in Medeva BV v Comptroller General of Patents, Designs and Trade Marks, C-322/10, ECLI:EU:C:2011:476 29 Similar observations have been made in CJEU: Judgment in Georgetown University and Others v Comptroller General of Patents, Designs and Trade Marks, C-422/10, EU:C:2011:776, paras 24 and 29 (referring to the ‘fundamental objective of Regulation No 469/2009 [which] is to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health’); CJEU: Judgment in Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents, C-130/11, EC:C:2012:489, paras 22 and 23; Eli Lilly, above, n. 9 paras 41 and 42 (‘As stated in recital 4 in the preamble to Regulation No 469/2009, the purpose of that additional period of exclusivity is to encourage research and, to that end, it is designed to ensure that the investments put into such research are covered’); CJEU: Judgment in Actavis Group PTC EHF and Actavis UK Ltd v Sanofi, C-443/12, EC:C:2013:833, paras 31, 40 and 41 (‘the basic objective of Regulation No 469/2009 is to compensate for the delay to the marketing …’ (para 41); and CJEU: Judgment in Georgetown University v Octrooicentrum Nederland, C-484/12, EC:C:2013:828, para 31. In the latter decision the court also remarked that any interpretation of the Regulation which pursued objectives not covered by the purpose of the Regulation could ‘give rise to circumvention tactics, entailing additional costs which may discourage innovation …’. 30 The problem at issue has subsequently become obsolete since the relevant MA documents are now available online. 31 District Court of The Hague: Judgment of 4 November 2009, AWB 08/9394 OCT95, Stallergenes AG v Dutch Patent Office. 32 Ibid. 33 High Court of Justice Chancery Division Patents Court: Judgment of 10 February 2012 Novartis Pharmaceuticals Limited v Medimmune Limited, [2012] EWHC 181 (pat). 34 Ibid. 35 High Court of Justice Chancery Division Patents Court: Judgment of 3 August 2012 Eli Lilly v Human Genome Sciences, [2012] EWHC 2290 (Pat). 36 High Court of Justice Chancery Division Patents Court: Judgment of 10 October 2012, Eli Lilly and Company v Human Genome Sciences, [2012] EWHC 2857 (Pat). 37 Eli Lilly, above n. 10. 38 Ibid. 39 35 U.S.C. 156, (d), (D), emphasis added. 40 See <https://www.uspto.gov/web/offices/pac/mpep/s2752.html> (accessed 25 August 2017). 41 See the wording of the Japanese Patent Act at <http://www.wipo.int/wipolex/en/text.jsp?file_id=188310>, and further at <https://www.jpo.go.jp/iken_e/pdf/patent_utilty_20150325/08.pdf> (bothaccessed 28August2017) (emphasis added). 42 Section 91(2) cf Section 90 of the Korean Patent Act, <http://www.kipo.go.kr/upload/en/download/PATENT%20ACT_201308.pdf> (accessed 28 August 2017). 43 Are Stenvik, Patentrett, 3rd edn (Cappelen, Oslo, 2013), p. 333 (original in Norwegian: ‘Det er uten betydning om innehaveren [dvs. patenthaveren] selv utnytter den oppfinnelse som er vernet ved basispatentet eller ikke’, and ‘Det er ikke noe vilkår at søkeren er innehaver av markedsføringstillatelsen’) (emphasis in original). 44 Nicolai Lindgreen, Jens Schovsbo and Jesper Thorsen, Patentloven med kommentarer (DJØF Publishing, Copenhagen, 2012), p. 528, original in Danish: ‘Det er … ikke i forordningerne gjort til en betingelse, at markedsføringstilladelsen er udstedt til certifikatansøgeren …’. 45 Peter Dethlefsen, ‘Supplerende beskyttelsescertifikater for lægemidler’ (1993) Nordiskt Immaterieelt Rättskydd 19-231, 222, original in Danish: ‘Der er ikke noget udtrykkeligt krav efter forordningen om, at den, der søger certifikatet, gør det i forståelse med den, der har opnået markedsføringstilladelsen (hvis det er en anden). Formålet med forordningen tilsiger imidlertid, at der bør være en forbindelse mellem de to “rettighedshavere”: certifikatet er jo en kompensation til den, der har brugt (mest) tid og penge på markedsføringstilladelsen.’ 46 The Hon Mr Justice Colin Birss; Andrew Waugh, QC; Tom Mitcheson, QC; Douglas Campbell, QC; Justin Turner, QC; Tom Hinchliffe, QC in Terrell on the Law of Patents 18th edn, (Sweet & Maxwell, London, 2017), at 6-57 to 6-60. 47 Ibid. 48 Ibid. 49 Klaus Grabinski, ‘Ergänzende Schutzzertifikate’, in Benkhard, Patentgesetz, 11. Auflage, § 16 a PatG, Rdnr. 40 (C.H. Beck, Munich, 2015). 50 Franz Hacker, ‘Ergänzendes Schutzzertifikat’, in Busse, Patentgesetz, 8. Auflage, 2016, Anh § 16 a, Rdnr. 99-100 (De Gruyter, Berlin, 2016). 51 Klaus Grabinski, above n. 50: ‘Demnach ist es möglich, dass der Inhaber des Schutzzertifikats dem (personenverschiedenen) Inhaber der Genehmigung die Benutzung des Schutzzertifikats zwar untersagen kann, er aber an der Ausübung des eigenen Schutzzertifikats wegen Fehlens einer arzneimittel- oder pflanzenschutzrechlichen Genehmigung gehindert ist.’ 52 Christopher Brückner, Ergänzende Schutzzertifikate mit pädiatrischer Laufzeitverlängerung (Supplementary Protection Certificates with Paediatric Extension of Duration), Kommentar 2. Auflage (Carl Heymanns Verlag, Cologne, 2015). 53 Above SPC Art. 6, marginal number 41-78, where he relies on Biogen/SmithKline to have ‘opened up the possibility of acquiring a protection certificate with another’s marketing authorisation’ (ibid, marginal number 41). 54 Ibid, art. 6, marginal number 42. 55 Ibid, marginal number 47. 56 Ibid, marginal number 50. 57 Ibid, marginal number 57. 58 Ibid, marginal number 58 (emphasis added). 59 Ibid, marginal number 70. See also marginal number 71 where it is, furthermore, stated that ‘[t]he possibility of obtaining a passive protection certificate, however, also permitted constellations that are extremely dubious and conflict with the intentions of the Medicinal Regulation’ (emphasis added). 60 Ibid, marginal number 72. 61 Ibid, marginal number 55. 62 At para 31. 63 Similarly Tom Carver, ‘SPCs – a Reward for Someone Else’s Investment’, CIPA Journal, 44(1) (January 2015), 14, 18. 64 Ibid. 65 Ibid. 66 Cf David Pountney and Andrew Hutchinson, ‘The European Commission Announces a Review of Options to Modernise the SPC Regulations and “Bolar” Research Exemptions’, available at: <http://www.elexica.com/en/legal-topics/intellectual-property/280217-european-commission-announces-review-to-modernise-spc-regulations-patent-research-exemptions> (accessed 20 July 2017). © The Author(s) 2018. Published by Oxford University Press. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Intellectual Property Law & Practice Oxford University Press

Reap what you sow!—But what about SPC squatting?

Loading next page...
 
/lp/ou_press/reap-what-you-sow-but-what-about-spc-squatting-QS7ctzKSqV
Publisher
Oxford University Press
Copyright
© The Author(s) 2018. Published by Oxford University Press. All rights reserved.
ISSN
1747-1532
eISSN
1747-1540
D.O.I.
10.1093/jiplp/jpx229
Publisher site
See Article on Publisher Site

Abstract

Abstract The authors Jens Schovsbo and Timo Minssen are both Professors of Law at the Center for Information and Innovation Law (CIIR), University of Copenhagen, Denmark. Ulla Callesen Klinge is a European Patent Attorney and Partner at Inspicos P/S, as well as PhD Fellow at CIIR. This article Despite an avalanche of recent court decisions on the European system for supplementary protection certificates (SPCs), the issue of third-party SPC applications—also known as ‘SPC squatting’—has never been sufficiently clarified. Considering the ambiguous stipulations in the SPC Regulations, as well as the practical and theoretical significance of this issue, the lack of judicial guidance is problematic. It is important to address such situations for the sake of legal certainty and in order to enable companies to make strategic decisions. SPC squatting also involves a crucial debate about the rationales underlying the SPC system and the question whether such activities are compatible with the very goals of the Regulations. This article provides an overview on the legal status quo with regard to SPC squatting and discusses whether—and if so, to what extent—such practices should be considered legitimate. 1. Introduction The year 2017 was without any doubt a very important year for the European regulatory framework for supplementary protection certificates (SPCs). It marked the completion of two formal reviews of the European SPC system that might result in substantial legislative changes further down the road. After all, these studies not only evaluated the legal aspects of the SPCs in the EU,1 but also studied the economic impact of SPCs, pharmaceutical incentives and rewards in Europe.2 They are the first reviews the Commission has undertaken of either the Medicinal Products SPC Regulation, which entered into force in 1993 (the Regulation),3 or of the Plant Protection Products SPC Regulation,4 which entered into force in 1997.5 Notwithstanding their age, neither regulation has ever been modified in any considerable way, except to take account of EU enlargement, and on only one occasion substantively, by the somewhat peculiar legislative technique of stating in a recital to the latter regulation that some of its provisions had the effect of amending certain aspects of the earlier one and introducing paediatric extension provisions.6 This is surprising in view of the vague wording in the regulations that has resulted in a ‘turbulent adolescence’ of the legislative framework and considerable legal uncertainties.7 Meanwhile, the Court of Justice of the European Union (CJEU) has tried to address the ambiguities in the legislation in numerous references for preliminary rulings from national courts. However, by trying to fill the legal vacuum left by the regulations, the CJEU’s decisions and the application of these by the national courts have in turn resulted in additional questions that have left the area rather murky and difficult to oversee.8 Within this grey zone, some of the typical questions examined by the national courts and the CJEU decisions concern: (i) the definition of ‘product’ under the Regulation;9 (ii) the meaning of the phrase ‘protected by a basic patent’;10 (iii) the approach to cases where a single basic patent protects more than one ‘product’, or where one ‘product’ is covered by multiple basic patents;11 and (iv) the interpretation of the concepts of ‘valid authorization’ and ‘first authorization’.12,13 However, one particular issue that is of some practical relevance and touches upon the foundational principles on which the SPC system is based has not been explicitly mentioned in the aforementioned Commission tenders. It concerns the question whether the European legislative framework for SPCs allows for third-party SPC applications. These are applications by patentees for a certificate where the patentee does not rely on a marketing authorization (MA) obtained by himself or by someone related to him (eg by cooperation or licence), but on a marketing authorization obtained by a non-related third party. Typically, such SPC applications are submitted without any prior authorization from such third parties. Such a situation can occur since there is no explicit provision in the Regulation that requires the consent of the MA owner to the use of its MA by a patentee in order apply for an SPC. It appears, therefore, that these situations, where the interests of MA owners and the patentees differ, were simply not contemplated at the time when the Regulation was drafted.14 To prohibit such practices might enable MA holders to prevent patent holders from obtaining an SPC or at least to force the patent holder to apply for their own MAs and thus to suffer the costs associated with that (including duplicating experiments involving humans). This could be seen as being in direct contradiction to recital 2 of the Medicinal Regulation of continuing improvement in public health. On the other hand, allowing patent holders to apply for SPCs without having suffered the costs of obtaining an MA would appear to be inviting free-riding from patent holders. This would be problematic in light of the objective of the SPC to provide for a protection of patent holders which is ‘adequate’ to offset their costs in obtaining an MA (recital 9). How to deal with such third party SPC applications, which often are also referred to as SPC squatting or SPC piggybacking, is, therefore, a significant issue both from a practical and a theoretical/doctrinal perspective. It is important to address such situations, not only for the sake of legal certainty and in order to enable companies to make strategic decisions. It also involves a crucial debate about the very rationale underlying the SPC system and the question whether such activities would necessarily undermine the goals of the Regulation, or whether it should be allowed for under specific circumstances and on a case-by-case basis. Interestingly, both the CJEU and national courts have been (indirectly) confronted with these issues and have acknowledged the importance of clarifying the legal status of such situations. But unfortunately—and as we will elaborate further below—neither has directly addressed it with sufficient clarity. Hence, it can only be hoped that the entities15 entrusted with conducting the legal and economic Commission studies on the SPC system will carefully consider the following question: Does, or should, Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (the Regulation) allow a patent holder to obtain a supplementary protection certificate on the basis of a marketing authorization, which has been granted to a third party who is not related to the patent holder? This article intends to provide a first legal analysis and discussion of this inquiry. We start out by providing a brief overview of the applicable legal framework that applies to the European SPC system and explain how far the vague language in the current Regulation has led to interpretational difficulties and legal uncertainties (2). We then analyse the European status with regard to third-party SPC applications in more detail (3) by illustrating how the CJEU and national European courts have dealt with third-party SPCs in their case law. We explain how the issues emerged in the CJEU’s decision in C-181/95 Biogen (3.1) and give a chronological account of subsequent case law by the CJEU and national courts (3.2). These comprise decisions illustrating the CJEU’s general reliance on a teleological interpretation of the Regulation (3.2.1), as well as CJEU and national case law that (mostly indirectly) considered the third-party issue (3.2.2). This will allow us to summarize the rather elusive status quo of European case law and to provide some take-aways (3.2.3). Next, we will turn to other jurisdictions and look at how the US and Japanese patent systems deal with patent term extensions and the third-party issue (4). Although the US and Japanese systems for patent term extensions are not directly comparable with the European SPC framework, they have considered similar questions which are interesting to compare with the European situation. This will provide enough fodder for discussing how we should go forward in Europe and what we need to consider in further developing European doctrines on third-party SPCs (5). In developing our discussion and recommendations we will inter alia refer to the rationale underlying the European system for SPC protection and the positions that have been taken in European scholarly writing on the third-party SPC issues with a special focus on the UK, German and Nordic literature. Finally, we will complete the article with some concluding remarks (6). 2. The European rules on SPCs and their background An SPC provides for an extension of the protection offered by an existing patent for a medicinal product for which an MA has been granted. Thus, an SPC presupposes two steps before the application for the SPC is made: (i) a granted patent relating to medicinal product and (ii) an issued MA. Normally, both steps are initiated by the same undertaking (ie the patent holder). In the following, however, we focus on the situation where the MA (ie the second step) has been obtained by a third party but is nonetheless relied upon by the patent holder in fulfilling its obligations regarding the application for a certificate. This could arise in situations where a (possibly minor) company has obtained a patent, but is unable to fund the costs necessary for carrying out the investigations leading to a MA. In such a situation, there will normally be a licence agreement between the patent holder and the MA holder, and the patent holder should thus be able to apply for an SPC based upon his/her own patent and an MA of the licensee. Such a situation seems to be unproblematic. However, it becomes more problematic if no such licensing or other agreement between the patent holder and the MA holder exists and the patent holder and MA holder are completely unrelated. The duration of the extension by the SPC depends on the time which elapses between the date on which the application for the basic patent was filed and the date of the first marketing authorization minus 5 years. The maximum period for SPC protection is five years, providing a possible maximum period of protection of a total of 15 years for the product which is the subject of the SPC.16 As has already been hinted at, the SPC rules depend on and go hand in hand with the patent provisions, which allow for the patenting of ‘products’ that can be used as pharmaceuticals and satisfy the patentability requirements.17 The problem which the SPC Regulation seeks to address is related to the conditions for placing medicinal products on the market. Obtaining an MA for originally developed pharmaceuticals is costly in terms of direct costs in testing and documentation and so on. It is also—and primarily—costly in terms of time, since the product cannot be marketed as a medicinal product until the MA has been obtained. As the patent system works by enabling the patent holder to reap its reward on the market, the period of time in which the holder of the patent can enjoy exclusivity is crucial.18 The purpose of the SPC system is thus to provide for an adequate protection period for the product by extending the period of patent exclusivity for a period of time which reflects the period in which the medicinal product was awaiting authorization to be put on the market. Since the certificate is based on the combination of a patent and an MA, the scope of protection is defined in accordance with the MA (and not only the patent) (Article 4). The SPC system aims to supplement the patent system by providing for a separate stimulus for companies to invest in the resources necessary for obtaining MAs. In this way, it is based on two assumptions: (i) that obtaining an MA for patented products is beneficial for society and (ii) that incentivizing companies to invest in obtaining such authorizations does not automatically flow from the patent exclusivity but requires a special set of mechanisms. In particular, it is not the purpose of the Regulation to provide patent holders in the pharmaceutical field with an extra level of protection. On the contrary, the idea is to ‘re-establish a sufficient period of effective protection of the basic patent’19 and to guarantee ‘laboratories working to develop medicinal products a level of protection equal to that enjoyed by research in other industries’.20 Finally, it should be noted that the European legislator deliberately chose a regulation for the SPC system, which is the most binding form of ‘EU legislation’ available. The Preamble provides the following remarks in this regard: (7) A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the functioning of the internal market. (8) Therefore, the provision of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary. A regulation is therefore the most appropriate legal instrument. 3. Analysis of the third-party SPC issue in Europe The central question for the following is whether the Regulation allows for third-party applications, that is, applications for a certificate where the patent holder does not rely on an MA obtained by himself but on an authorization obtained by an unrelated third party. The legal framework for determining, whether or not this is possible is established by the Regulation. According to its Article 6 ‘the certificate shall be granted to the holder of the basic patent or his successor in title’ (emphasis added). It is thus clear that only the patent holder may apply for a certificate. However, to determine which conditions that patent holder must fulfil, one needs to consult Article 3 which states the following: A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application: (a)   the product is protected by a basic patent in force; (b)  a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate; (c)  the product has not already been the subject of a certificate; (d)   the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product. As it can be seen, Article 3(b) clearly states that an MA must be provided in support for the (patent holder’s) application for the certificate. This provision does, however, not make it clear by whom the MA should have been obtained.21 3.1 The third-party issue emerges in Biogen These questions were touched upon in the observation made by Advocate General Fennelly in his Opinion in Biogen: […] the text of the Regulation applies simply to a simple situation, in which basic research, product development, production and marketing are vertically integrated: where the holder of the patent or patents relating to a medicinal product, the marketing of which has been authorized in a Member State, is also the holder of the relevant marketing authorization.22 In particular, the Advocate General then pointed out that the Regulation is silent on the relationship between the holder of the basic patent and the holder of the MA. The Advocate General ascribed this fact, as a second point, to: the implicit assumption on the part of the draughtsman that they would be concentrated in the hands of a single undertaking. It is, in effect, the legislative failure to advert to the possible divergent ownership of patents and marketing authorisations that creates the problem in the present case.23 Hence, the Regulation presupposes that the patent holder and the holder of the MA is one and the same legal entity. We concur with the view expressed by the Advocate General. We do not think, however, that pointing this assumption out in itself solves the issue of third-party claiming. In that regard it should be recalled that the protection offered by the Regulation is conceptually different from patent protection, since they are intended to stimulate investments in two different directions. That is to say, that even though the two systems share the same general goal of furthering pharmaceutical research, they aim specifically at different parts of the pharmaceutical value chain and channel exclusivity in different directions. The patent system seeks to reward the invention of products which have the potential to be used as medicines and rewards the disclosure of these products at a very early stage of development. In contrast, the SPC system seeks specifically to reward the work required to develop these potential products into medicinal products that are effective and safe in order to be placed on the market. Therefore, allowing the patent holder to apply for an SPC in a situation where that patent holder has not suffered any losses in time and has not made any investments in research in relation to the use of the invention is arguably problematic as seen in light of the purpose of the SPC system. Following this kind of reasoning, one’s status of being a ‘patent holder’ does not by itself confer a right to apply for the certificate. That status has to be earned separately through the application for the MA. After all, the patent holder has already been incentivized once via the patent system and any additional protection should only be provided for in return of a loss in time and costs suffered in obtaining the MA. Allowing the patent holder the possibility of extending protection without having suffered the corresponding losses would seem to be inviting rent-seeking behaviour. On the other hand, a literal interpretation of the wording of Article 3 arguably opens for certificates based on third-party MAs. Since Article 6 simply refers to ‘the patent holder’ and no limitations are contained in Article 3(b) it would seem that a patent holder could apply even if the MA has not been obtained by him or her. Further, one could support such a reading by pointing out that if the patent holder (who is the only one who may apply for a certificate) cannot rely on an existing MA, it would have to perform its own clinical trials in order to obtain its own MA. This would duplicate the process and increase costs which would end up being paid by the consumers anyway. Furthermore, requiring the conduct of performing unnecessary clinical tests would hardly be acceptable from an ethical point of view. There is thus a discrepancy between a literal interpretation of the wording and the purpose of the Regulation. The next step is to analyse how the CJEU and national courts have dealt with this issue in the ensuing case law. 3.2 Subsequent case law of the CJEU and national courts It is well known that the CJEU can and does rely on the background and purpose of EU legislation as a means for interpretation. As will be demonstrated below, the CJEU has also relied on these techniques in its interpretation of the rules in the Regulation. As mentioned before, national courts have brought the interpretation of the Regulation before the CJEU in a rather high number of cases.24 We will just refer to some of the most recent decisions below. It is, however, important to keep in mind that the great number of cases suggests that the system established by the Regulation is characterized by a rather high degree of legal uncertainty. This is also underlined by the fact that most of the cases have dealt with some of the basic requirements in Article 3 of the Regulation and not least the basic requirement in litra (a) that the product must be ‘protected by a basic patent in force’. 3.2.1 The CJEU’s reliance on a teleological interpretation of the Regulation In the aforementioned Biogen, the CJEU took the reason for the protection offered by the certificates25 as the starting point for its analysis and, furthermore, relied on the ‘scheme and objectives of the Regulation’ (para 39) in its interpretation. In AHP Manufacturing the CJEU affirmed the purposive (teleological) approach to be taken by stating that ‘[n]ext, the Court observes that the second sentence of Article 3(2) of Regulation No 1610/96 must be interpreted not solely on the basis of its wording, but also in the light of the overall scheme and objectives of the system of which it is a part.’26 The same style of interpretation was adopted in Medeva.27 In this judgment, the court also noted ‘that Regulation No 469/2009 establishes a uniform solution at European Union level by creating a SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State. It thus aims to prevent the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the European Union and thus directly affect the establishment and functioning of the internal market’ (para 24). As far as the concrete interpretation is concerned, the court referred inter alia to the fundamental objective of the Regulation (to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health) (para 30) and to the ‘reason given for the adoption of that regulation’ (ie, the fact that the period of effective protection under the patent is insufficient to cover the investment put into pharmaceutical research and the regulation thus seeks to make up for that insufficiency by creating a SPC for medicinal products) (para 31). The reliance of the CJEU in Medeva on the object and purpose of the Regulation clearly reflected the approach of Advocate General Trstenjak, who had emphasized the importance (indeed the ‘necessity’ see para 74) of a teleological interpretation to complement the literal interpretation: 79. Nevertheless, it is in my view clear that the result of the literal interpretation of Articles 1 to 3 of Regulation No 469/2009, according to which, in the case of medicinal products with multiple active ingredients only part of which is the subject-matter of a patent, no supplementary protection certificates can be granted, is not compatible with the objectives of Regulation No 469/2009. 88. The literal interpretation of Articles 1 to 3 of Regulation No 469/2009 must therefore be complemented by a teleological interpretation which ensures that the rules on supplementary protection certificates contained in those provisions can also be fully effective in respect of medicinal products in which the combination of active ingredients is only partly the subject-matter of a patent. (emphasis added)28 Thereby, the court clearly stressed the importance of the Regulation’s objective. It also demonstrated its general interest in making sure that the rules are not being used in ways which in practice run counter to the objectives of the Regulation.29 3.2.2 The third-party issue at the CJEU and the national courts The CJEU has not explicitly ruled on the third-party issue but touched upon it in the aforementioned Biogen case in 1997 and then again in Eli Lilly in 2013. However, in the meantime a few national decisions have dealt with the question. Below we will present these cases in a chronological order. 3.2.2.1 Biogen (1997) In Biogen the CJEU remarked that ‘the holder of a marketing authorisation may not obstruct the exercise of the right referred to in Article 6 of the Regulation’ (para 32). This remark related to a situation where an application for a certificate had been submitted by someone other than the holder of the MA (in casu a licensee of the patent). The issue before the court concerned the formal requirements regarding applications for certificates and the court made it clear that the Regulation does not require the holder of the MA (ie, the licensee) to provide the patent holder with a copy of the authorization and also that the holder of an MA (ie, the licensee) cannot prevent the patent holder from applying for a certificate by not providing him with the original authorization.30 As is clear from the above, the Biogen case involved two parties who were related (by a licensing agreement). The character of the relationship between the parties may constitute an important aspect in the development of future practices, see below. It was not, however, clear how or indeed whether the decision of the CJEU was affected by the fact that there was a contractual relationship between the parties. Furthermore, the court was not asked to address the substantive issue whether the patent holder was in fact in a position to apply. In our opinion, one cannot rely on this decision as having decided that issue. The CJEU merely did what it was supposed to do and answered the questions posed to it from the national court and those questions did not address the issue of the validity of third-party applications. If the court had intended the decision to deal exhaustively with all issues regarding the relationship between the holder of a basic patent and the holder of and MA—and to thus go beyond the questions posed—one would have expected the court to have made it clear that it did so. However, there is nothing to suggest this. In other words, the wider potential consequences of the decision of the CJEU in the Biogen case were probably not immediately realized for mainly two reasons: (i) it concerned two parties that were a licensor and a licensee and (ii) the main finding (with great significance for practitioners) lay in its holding that a product could be protected by more than one SPC. 3.2.2.2 Stallergenes AG v Dutch Patent Office (2009) Rather surprisingly, it took more than 10 years before the third-party issue and its implications were considered by a national court. In an obiter dictum, the District Court of The Hague rejected for other reasons an application for an SPC by a patentee based on an MA granted to a competitor.31 Importantly, however, the Dutch court also observed that since the patentee was not the owner of such an MA it could not be argued that the patentee had been delayed in getting a return on its investment through the time taken to secure the MA. As this was the rationale for the Regulation, the grant of an SPC to it would not conform with the purpose of the Regulation. The court found that: […] in order to encourage pharmaceutical research, the Regulation is designed to offer compensation to manufacturers of medicinal products for the period that elapses between the filing of the patent application and the grant of the marketing authorisation by extending the period of protection. It is an established fact that the plaintiff does not have a marketing authorisation for a medicinal product that is based on [the patent in suit]. This means that it cannot be said that the possibility of recouping the investments made in the patent has been delayed by a procedure to obtain a marketing authorisation. For that reason, granting an SPC to the plaintiff would not be in conformance with the objective of the Regulation. (emphasis added).32 3.2.2.3 Novartis Pharmaceuticals Limited v Medimmune Limited (2012) In the UK, the High Court of Justice has also touched upon the issue in a number of decisions. In Novartis Pharmaceuticals Limited v Medimmune Limited Mr Justice Arnold said in an obiter dictum at para 61 under the headline ‘A point not taken’ that: As noted above, in the present case the SPC is based upon a product obtained by means of an allegedly infringing process and upon a marketing authorisation obtained by an alleged infringer of the Patent. It might be thought that it was not the purpose of the Regulation to enable a patent owner to obtain an SPC in such circumstances, since the owner has not been delayed in getting the product to market by the need to get a marketing authorisation, and therefore no extension to the term of the patent is needed to compensate him for that delay. Counsel for MedImmune accepted that it was not clear from the judgment of the Court of Justice in Case C-181/95 Biogen Inc v SmithKline Biologicals SA [1997] ECR I-386 that this was permissible. Nevertheless, counsel for Novartis made it clear that Novartis was not taking this point.33 (emphasis added) Moreover, Justice Arnold explicitly noted that ‘the wider potential consequences of the decision of the CJEU in the Biogen case were thus not immediately recognised, perhaps because it concerned two parties that were not wholly unconnected.’34 Soon afterwards, much the same issue arose in the English courts in Eli Lilly v Human Genome Sciences although on this occasion the point was indeed taken and thus had to be addressed. 3.2.2.4 Eli Lilly v Human Genome Sciences (2012) In Eli Lilly v Human Genome Sciences35 Mr Justice Warren considered the CJEU decision in Biogen (above) in some detail and the difficulty of applying the sort of test floated in Novartis (above). He concluded that the holder of a basic patent was entitled to make an application for an SPC in reliance on an MA granted to a third party having no connection of any sort with that patentee. He stated in para 62 and 105 that: 62. I therefore conclude that the answer to the third party SPC issue is that the holder of a basic patent can make an application for an SPC in reliance on an MA granted to a third party having no connection of any sort with that holder. I do not consider that there is any real doubt about this such as would justify a reference to the CJEU if this were the only matter to be referred. […] 105. Dealing with the third party SPC issue first, I doubt very much that it would be appropriate at any stage for this court to make a reference if that issue stood alone. I regard the answer to that issue as sufficiently clear to be decided at this level without a reference. However, it does not stand alone, but stands with the Specification issue. The answer to that can only be provided after a preliminary ruling from the CJEU. If this court is to make, or were ever to make, a reference in these proceedings on the Specification issue, it would be entirely appropriate and sensible for the third party SPC issue to be referred at the same time in order to obtain a definitive ruling which will be of importance, not only in the present case, but generally. […] (emphasis added) It was, therefore, not the opinion of Mr Justice Warren that the third-party SPC issue could never be referred to the CJEU, but rather that it was not necessary to do so in the circumstances of that first instance case. This notion is supported by Mr Justice Warren’s later remarks in his decision in Eli Lilly and Company v Human Genome Sciences (para 5): In saying what I did [in para 62 quoted above], we did not mean to say that the point was necessarily acte clair, but we regarded the point as sufficiently clear to allow me, this court of first instance, to decline to make a reference, something for which a court of this level is discretionary.36 However, Justice Warren then made a reference to the CJEU, for another reason, which reached the CJEU in Eli Lilly in 2013. 3.2.2.5 The CJEU in Eli Lilly (2013) In this case, which was decided on 12 December 2013, the CJEU was once again asked to interpret the wording of Article 3, litra a, that the product must be ‘protected by a basic patent in force’.37 More concretely the CJEU was asked to decide whether a patent lived up to the requirement in Medeva (above) that the active ingredient has to be specified in the wording of the claims of the basic patent relied on in support of the SPC application (para 28). The CJEU stated, amongst other things, that: 41. Moreover, it should be recalled that the SPC is designed simply to re-establish a sufficient period of effective protection of the basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of that patent, which is intended to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for the patent was filed and the date on which the first MA in the European Union was granted. [….] 43. In the light of the objective of Regulation No 469/2009, the refusal of an SPC application for an active ingredient which is not specifically referred to by a patent issued by the EPO relied on in support of such an application may be justified – in circumstances such as those in the main proceedings and as observed by Eli Lilly – where the holder of the patent in question has failed to take any steps to carry out more in-depth research and identify his invention specifically, making it possible to ascertain clearly the active ingredient which may be commercially exploited in a medicinal product corresponding to the needs of certain patients. In such a situation, if an SPC were granted to the patent holder, even though – since he was not the holder of the MA granted for the medicinal product developed from the specifications of the source patent – that patent holder had not made any investment in research relating to that aspect of his original invention, that would undermine the objective of Regulation No 469/2009, as referred to in recital 4 in the preamble thereto.38 (emphasis added) The CJEU thereby touched upon the issue of third-party applications but this was not explicitly addressed since the national court did not refer questions on the third party SPC issue. However, the Eli Lilly decision, paras 41–3, seems to indicate as a general principle that in order to be able to rely on SPC protection, the patent holder needs to have carried out in-depth research and identified his invention specifically, making it possible to ascertain clearly the active ingredient which may be commercially exploited in a medicinal product corresponding to the needs of certain patients and have made investments in research relating to that aspect of his original invention which has provided the basis for the MA. The decision is thus based on the view expressed above that the purpose of the SPC system is to compensate for research aimed at turning patented inventions into medicinal products. 3.2.3 Summing up: Remaining ambiguities On several occasions, the CJEU has stressed the importance of not relying solely on a literal interpretation of the Regulation. Instead, the court has emphasized the significance of a teleological interpretation which takes into account of the purpose of the Regulation. Unfortunately, however, the CJEU has not decided explicitly on the issue of third party applications. The reliance of the court on arguments based on the objective and purpose of the Regulation and its willingness to engage in a teleological interpretation clearly suggest that the CJEU would not rely solely on a literal interpretation of the regulation in order to decide whether third-party applications are permissible. The legislator’s choice of a regulation and the need to achieve the highest degree of coherence and uniformity at the EU level would even accentuate the CJEU’s interest in dealing with issues of legal uncertainty. This line of reasoning has also been confirmed by Eli Lilly. Even though the CJEU was not asked explicitly to consider the issue of third-party applications, this decision would seem to support that the CJEU would engage in a teleological interpretation if it were to decide on this issue. Yet it is obvious that the current situation is rather ambiguous and that a direct decision of the CJEU on this particular issue would hence be very much welcomed. The need to address the persisting ambiguities is exacerbated by the fact that none of the national decisions discussed above have addressed the issue of third-party applications directly and that their persuasive effect for that reason is limited. The relevant statements in the national decisions selected for our studies indicate that the question whether the Regulation allows applicants to rely on third-party MAs or not has not been answered clearly in the case law we know of. Moreover, it also seems clear that there are contradicting views between courts in different jurisdictions. Before we embark on a discussion and present the views expressed in the literature, we briefly sketch out how other jurisdictions have dealt with similar issues. Again, we do not intend to engage in detailed comparative studies but only to add to the discussion of the specific issue of third-party applications under the EU rules. 4. How do other jurisdictions deal with similar issues? A number of other countries around the world provide for protection regimes with similar goals as the EU’s SPC, that is, to stimulate companies specifically to invest in obtaining an MA by supplementing the patent system. The various models vary and some countries extend the term of the patent itself, whereas others, such as the EU’s SPC system, provide for a separate system of exclusivity. The patent term extension systems we have examined limit the availability to apply to patent holders and also require the existence of an MA. However, the issue of third-party SPCs has been dealt with differently around the world. In some jurisdictions patent term extension based on unrelated third parties’ MAs seems not to be possible at all. For instance, in the US the patent holder must submit, together with the application for patent term extension, a ‘brief description of the activities undertaken by the applicant during the applicable regulatory review period with respect to the approved product and the significant dates applicable to such activities’.39 Furthermore, according to 37 CFR 1.730 ‘If the applicant for patent term extension was not the marketing applicant before the regulatory agency, then there must be an agency relationship between the patent owner and the marketing applicant during the regulatory review period. To show that such an applicant is authorized to rely upon the activities of the marketing applicant before the Food and Drug Administration or the Department of Agriculture, it is advisable for the applicant for patent term extension to obtain a letter from the marketing applicant specifically authorizing such reliance’ (emphasis added).40 Thus, in the US there must be a so-called agency relationship between the patent owner and the marketing applicant, and patent term extension without the consent of an unrelated third party’s MAs seems not to be possible. In Japan, in order to apply for patent term extension the patentee, or the exclusive licensee(s) or registered non-exclusive licensee(s) of the patent must be the MA holder and ‘is required to have obtained the disposition’ designated by the Cabinet Order under Article 67(2) (67-3(1)(ii)) of the Patent Act.41 Similar restrictions seem to exist in Korea, where the patentee, or his/her exclusive or non-exclusive licensee must be the MA holder.42 Hence, neither the US nor Japan and Korea seem to allow patent holders to rely on applications for MAs from third parties who are not related to the patent holder. 5. Discussion and recommendations It appears that no clear position has emerged in neither EU, nor national practice, nor in international legislation on the issue of third-party applications. This ambiguity is also reflected in the legal literature. The question has been dealt with very sparsely in the German, English and Nordic literature we have examined. Most of the authors we have investigated have not discussed the matter in any great detail but rather seem to be making the point in passing that Article 3(b) does not limit the authorization in any way (eg, to one which has been obtained by the applicant). Regarding the Nordic countries, Stenvik states that ‘it does not matter whether the proprietor [ie, the patent holder] himself is working the invention which is protected by the basic patent or not’ and ‘it is not a condition that the applicant is the beneficiary of the marketing authorisation’.43 A similar view is expressed by Lindgreen, Schovsbo and Thorsen, who point out that ‘the Regulation has not made it a condition that the marketing authorization has been issued to the applicant [of the certificate].’44 Dethlefsen remarks that ‘[t]here is no explicit requirement in the Regulation that the party who applies for a certificate does so in understanding with the party that has acquired the authorisation (if that is another party). The purpose of the Regulation, however, dictates that there should be a relation between the two “right holders”: the certificate after all is a compensation to the one who has spent the (most) time and money on the marketing authorisation.’45 As for the UK, Terrell on the Law of Patents refers to the Biogen case and states that: ‘it is clear from the decision of the European Court of Justice in [Biogen] that the basic patent and the marketing authorisation may be held by different people and this is no bar to the grant of the certificate.’46 However, it is then stressed that the Biogen case was one in which the MA holder was a licensee under the patent. On the other hand, it was also inherent in the case that the MA holder was not interested in the patent holder (Biogen) obtaining a certificate prolonging the exclusivity of Biogen and ‘the court’s decision permitting Biogen to obtain a certificate in any event necessarily shows that a patent holder does not need the consent of the holder of the relevant marketing authorisation to obtain a certificate.’47 Terrell also points to the (undecided) question of whether a patent holder may obtain a certificate based on an MA from a MA holder having no license and being infringing the basic patent. Terrell refers to both the Biogen and the Eli Lilly case and states that ‘[t]here is nothing in the terms of the Regulations which requires the holder of the marketing authorisation to be a licensee at all. Clearly the scheme was not set up contemplating that patent holders would seek supplementary protection certificates to cover other people’s products but the logic of the Biogen case would support such an application.’48 Similar findings can also be detected in major German patent commentaries, such as Benkhard49 and Busse,50 who highlight that only the patent holder shall have the right to apply for an SPC and that it follows from C-181/95 Biogen that the ownership of the SPC and the MA may differ. Klaus Grabinsky in Benkhard further concludes from Biogen that a patent holder that has received an SPC but not the MA, may prevent the MA holder to use the SPC, whereas the same patent holder will in turn be hindered from making use of the SPC due to lack of an MA.51 Yet, neither commentary provides a more detailed discussion of the wider policy implications of third-party applications. The issue is, however, discussed in some more detail by Brückner.52 This author takes also as his starting point that a certificate may be obtained on the basis of a third party’s MA.53 He points out that Article 6 does not ‘permit the conclusion that it is a precondition that the holder of the basic patent must also be the holder of the marketing authorization’.54 Brückner, however, does not stop here. He continues to discuss the pros and cons of such a reading. He points out that such a situation entails advantages (notably by keeping the number of clinical trials down) and that the Regulation does not provide an obligation to actively use a protection certificate. On the other hand, it also provides for disadvantages by not allowing the holder of the MA to recover his costs55 generally implies a risk of abuse. According to this author, opening for third-party applications becomes problematic ‘if such an applicant uses a protection certificate in order to interfere with the holder of the marketing authorisation by prohibiting him from using the product covered by the authorisation. Such a conduct ultimately inhibits the research activities of innovative enterprises.’56 The risk of abuse is reiterated regarding the case of so-called ‘passive protection certificates’. By this the author means situations where ‘the application has been based on another’s marketing authorisation and where the applicant has no marketing authorisation of his own for the product’.57 According to Brückner, the rules would seem to allow for a certificate in this situation but he goes on to point out that ‘the situation becomes problematic … if an enterprise that has acquired a marketing authorisation at huge expense is prevented from making use of this marketing authorisation by a third party who himself/herself became placed in a position by this marketing authorisation to obtain a protection certificate that he/she now can use against the holder of the authorisation.’58 Further, according to Brückner, the Regulation was created to provide companies a compensation for the loss of effective patent life caused by the performance of clinical studies and a ‘company, which did not incur such a loss of effective patent duration, does not need such a compensation’.59 Furthermore, it is stated that ‘[i]n such a case, he can only use the protection certificate destructively.’ In the Introduction, the author states that ‘[a] careful eye must be kept on the development of this problem [connected with the passive protection certificates.’60,61 We have quoted Brückner at some length in order to point out that this author, despite his initial remark that the rules apparently allow for reliance on someone else’s MA, would seem to find such a reading of the rules to be sometimes problematic and—according to our reading of Brückner—also uncertain. Furthermore, we find the general point expressed by Brückner that the ‘destructive’ use of certificates beyond the purpose of the Regulation may affect the interpretation to have been supported by the CJEU in the above mentioned Georgetown University. In this judgment, the CJEU indicated that it would take into account whether a specific interpretation would encourage ‘circumvention tactics’ as an argument against such an interpretation. Avoiding such tactics is generally considered as beneficial and, as a general principle, it is expected to also apply to the question of third-party applications.62 On this basis, it would seem to us to be fair to summarize the position in the literature as seemingly being supportive of applications based on a third party’s MA, but also that this position is not without important qualifications. Eventually it will fall on the CJEU to decide whether or not the current rules allow for patent holders to rely on third-party applications. We submit that in deciding this issue the CJEU should continue down the path it has established in the previous judgments in this area and conduct an analysis which emphasizes the purpose of the SPC system. Secondly, it should accept that the facts of these cases differ and leave the courts of the EU states with the flexibility to engage in a case-by-case analysis in the grey areas and in particular to deal with issues of misuse. Regarding the first point (ie, the purpose of the SPC system), the reference in Article 6 to the patent holder or his successor is based on the assumption that since it would normally be the holder of the basic patent who has also obtained the MA that holder should be able to apply for an SPC in consideration for those ‘extra’ losses. In other words, the recognition of the ‘patent holder’ as being competent to apply for an SPC does not hinge on the applicant’s status of being a ‘patent holder’. Instead, to be competent to apply some connection must be established between the applicant and the holder of the MA. As seen from such a perspective, allowing the patent holder to apply for an SPC in a situation where that party has not suffered any losses and has not made any investments in research in relation to the use of the invention which has formed the basis of the MA, would seem to be openly against the purpose of the Regulation; the basic quid pro quo is missing. We suggest, however, that even if the patent holder has not itself obtained the MA, there might be reasons to allow the patent holder to rely on a third party’s application in some instances. Since the specific purpose of the SPC system is to incentivize companies that have invested in obtaining MAs it is basically for the holder of the MA to decide how to obtain that benefit. For this reason, MA holders should obviously be able to grant permission to patent holders to rely on their MAs. In this way, the holder of the MA receives compensation in lieu of its investment. We also suggest that some contractual arrangements could arguably be expected to normally include an implicit licence for the patent holder to rely on an MA. If no connection exists between the patent holder and the holder of the MA, courts should normally not find patent holders to be competent to apply.63 We find such a reading to be supported by the gist of the remarks in Eli Lilly—that the applicant for an SPC should have carried out in-depth research and identified his invention specifically making it possible to ascertain clearly the active ingredient which may be commercially exploited in a medicinal product corresponding to the needs of certain patients—and have made investments in research relating to that aspect. This would seem to present an appropriate yardstick against which to measure the effort needed for the patent holder to be able to rely on the MA. Also this position appears to be in line with the rules in the US and Japan. 6. Conclusions It is not uncommon in the pharmaceutical industry that different therapeutic products and processes developed by different companies build upon earlier patent protected products or processes.64 This may deter companies from investing in research to develop new medicinal products for fear that non-related patent holders rely on their MAs to obtain an SPC. Given the rapid scientific advances in biomedical medicine, it is further likely that situations will increase in the development of biologics, such as in the field of life-saving therapies based on mono- and polyclonal antibodies. In light of the growing practical relevance, achieving clarity with regard to third-party SPC applications is more important than ever. An appropriate approach should ensure that innovative companies are not discouraged from investing in the clinical development of new medicines for fear of the patentee engaging in SPC squatting. In the absence of unambiguous legislation on this issue, different strategies for MA holders have been suggested, including receiving a licence from the SPC holder or delaying the application for an MA until the patent has expired.65 We agree that, while such solutions may sometimes work to solve concrete situations, there is a need for establishing a clear legislative starting point for deciding on the issue of third-party SPCs. Since there should be no money for nothing and no SPCs for free, we have argued that as a default rule the best solution is probably to not allow for third-party applications. However, a caveat needs to be added. We believe that sometimes patent holders should indeed be allowed to ‘piggyback’ on MAs obtained from third parties. We, furthermore, think that the current rules provide for the necessary leeway for the courts (notably the CJEU) to get it right. Whereas this is comforting, it is at the same time highly unsatisfactory. Obviously, the legislation should not allow for applications of the rules in counterproductive ways. The protection offered by SPCs should, just like any other IPR, be sustainable and defendable and not extend beyond the point of justification. The current legal regime includes a risk of harm to an area of central societal interest. The long-term solution, therefore, is to amend the provisions and the emerging unitary patent system should provide the appropriate forum for the necessary debates. In this way, our contribution suggests yet another reason for that long overdue revision of the SPC system, which because of its complexity must involve all stakeholders. In that regard, we welcome the European Commission’s recent announcement of a review of options to modernize the SPC regulations and ‘Bolar’ research exemptions. Hopefully, the forthcoming results of the ongoing Commission studies on the SPC and pharmaceutical innovations system will provide the necessary high-quality input for this review.66 Footnotes 1 Cf Call for tenders: Study 559/PP/GRO/IMA/15/15153 on the legal aspects of the supplementary protection certificates in the EU, available at: <http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=8847> (accessed 28 August 2017). 2 Cf Call for tenders: Study 590/PP/GRO/SME/16/F/121 on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe, available at: <http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=9044&lang=en> (accessed 10 June 2017). 3 Council Regulation (EEC) no 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, OJ L 182/1–5, 2 July 1992, as amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 1 December 2006 on medicinal products for paediatric use, OJ L 378, 27 December 2006; see also: Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products, OJ L 152, 16 June 2009. 4 Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, OJ L 198/30, 8 August 1996. 5 Cf Trevor Cook, ‘Squatters’ Rights: The Problem with Third Party SPCs’ (2016) Life Science Intellectual Property Review, available at: <http://www.lifesciencesipreview.com/article/squatters-rights-the-problem-with-third-party-spcs> (accessed 28 August 2017). 6 Ibid. 7 Frantzeska Papadopoulou, ‘Supplementary Protection Certificates: Still a Grey Area?’, JIPLP (2016), at 372. 8 Cook, above n. 5. 9 Notably CJEU: Judgment in Massachusetts Institute of Technology, C-431/04, ECLI:EU:C:2006:291, and CJEU: Order in Glaxosmithkline Biologicals SA, Glaxosmithkline Biologicals, Niederlassung der SmithKline Beecham Pharma GmbH & Co. KG, v Comptroller General of Patents, Designs and Trade Marks, C-210/13, ECLI:EU:C:2013:762. 10 Notably CJEU: Judgment in Medeva BV v Comptroller General of Patents, Designs and Trade Marks, C-322/10, ECLI:EU:C:2011:773, CJEU: Judgment in Eli Lilly and Company Ltd v Human Genome Sciences Inc, C-493/12, ECLI:EU:C:2013:835 and CJEU: Judgment in Actavis Group PTC EHF and Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG, C-577/13, ECLI:EU:C:2015:165. 11 Notably CJEU: Judgment in Biogen Inc. v Smithkline Beecham Biologicals SA, C-181/95, ECLI:EU:C:1997:32, and CJEU: Judgment in Georgetown University v Octrooicentrum Nederland, C-484/12, ECLI:EU:C:2013:828. 12 Notably CJEU: Judgment in Farmitalia Carlo Erba Srl, C-392/97, ECLI:EU:C:1999:416, and CJEU: Judgment in Arne Forsgren v Österreichisches Patentamt, C-631/13, ECLI:EU:C:2015:13. 13 See generally Papadopoulou, above n. 7, at 373. See also Massimo Scuffi, ‘Supplementary Protection Certificates: The Evolution of European Case Law on the Terms of Patent Extension and the Scope of Protection’, available at: <https://www.epo.org/law-practice/legal-texts/official-journal/2015/etc/se5/p105.html> (accessed 10 August 2017). 14 Ibid. 15 The entities entrusted with the SPC studies are the Max Planck Institute for Innovation and Competition (regarding the legal framework) and Copenhagen Economics (regarding the economic impact of SPCs and other incentives in the pharmaceutical sector). For further information, see: <http://thespcblog.blogspot.dk/2017/06/max-planck-institute-spc-survey.html and http://www.lml.law.cam.ac.uk/news/Liddell-expert-board-economic-impact> (accessed 10 June 2017). 16 Cf Article 13. By way of example: The basic patent expires on 1 July 2020 if the patent application was filed on 1 July 2000 (a 20-year term). If the first authorization to place the product on the EU market was 1 July 2008, then the patent protection will be extended until 1 July 2023 (2020 + (8-5 years)). 17 Ie, novelty, inventive step and industrial applicability, see European Patent Convention Article 52 which is compatible with the international baseline found in TRIPS Article 27. 18 Eg, Erika Fisher Lietzan, ‘The Drug Innovation Paradox’ (7 April 2017). University of Missouri School of Law Legal Studies Research Paper No. 2017-12. Available at SSRN: <https://ssrn.com/abstract=2948604> (accessed 28 December 2017). 19 Eli Lilly, above n. 10, para 41. 20 Proposal for the Regulation, COM(90) 101 final – SYN 255 at point 4. See also and in the same vein recital 3 of the Regulation which calls for pharmaceutical companies to receive ‘sufficient protection’ to encourage research in medicinal products, recital 4 where it is stated that without a certificate the protection under the patent would not be sufficient to cover the investment put into the research, and recital 5 where it is said that without protection to cover the time gap pharmaceutical research would be ‘penalised’. 21 According to Article 8(1)(b) and (c) applications should contain ‘copies’ of the MA. As pointed out by Cook, above n. 5, even though this language would seem to provide MA owners with some level of control of the use of ‘their’ MAs one cannot after Biogen (below) deduct anything from these provisions regarding the third-party issue. 22 CJEU: Opinion in Biogen v SmithKline Beecham Biologicals, C-181/95, ECLI:EU:C:1996:370, para 29. 23 Ibid at para 43. 24 In particular those listed above, nn. 9–12. 25 Ie, the insufficient duration of the effective protection under the patent to cover the investment put into the pharmaceutical research, para 26. 26 CJEU: Judgment in AHP Manufacturing v Bureau voor de Industriele Eigendom, C-482/07, ECLI:EU:C:2009:501, para 30. 27 CJEU: Judgment in Medeva BV v Comptroller General of Patents, Designs and Trade Marks, C-322/10, ECLI:EU:C:2011:773. 28 CJEU: Opinion in Medeva BV v Comptroller General of Patents, Designs and Trade Marks, C-322/10, ECLI:EU:C:2011:476 29 Similar observations have been made in CJEU: Judgment in Georgetown University and Others v Comptroller General of Patents, Designs and Trade Marks, C-422/10, EU:C:2011:776, paras 24 and 29 (referring to the ‘fundamental objective of Regulation No 469/2009 [which] is to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health’); CJEU: Judgment in Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents, C-130/11, EC:C:2012:489, paras 22 and 23; Eli Lilly, above, n. 9 paras 41 and 42 (‘As stated in recital 4 in the preamble to Regulation No 469/2009, the purpose of that additional period of exclusivity is to encourage research and, to that end, it is designed to ensure that the investments put into such research are covered’); CJEU: Judgment in Actavis Group PTC EHF and Actavis UK Ltd v Sanofi, C-443/12, EC:C:2013:833, paras 31, 40 and 41 (‘the basic objective of Regulation No 469/2009 is to compensate for the delay to the marketing …’ (para 41); and CJEU: Judgment in Georgetown University v Octrooicentrum Nederland, C-484/12, EC:C:2013:828, para 31. In the latter decision the court also remarked that any interpretation of the Regulation which pursued objectives not covered by the purpose of the Regulation could ‘give rise to circumvention tactics, entailing additional costs which may discourage innovation …’. 30 The problem at issue has subsequently become obsolete since the relevant MA documents are now available online. 31 District Court of The Hague: Judgment of 4 November 2009, AWB 08/9394 OCT95, Stallergenes AG v Dutch Patent Office. 32 Ibid. 33 High Court of Justice Chancery Division Patents Court: Judgment of 10 February 2012 Novartis Pharmaceuticals Limited v Medimmune Limited, [2012] EWHC 181 (pat). 34 Ibid. 35 High Court of Justice Chancery Division Patents Court: Judgment of 3 August 2012 Eli Lilly v Human Genome Sciences, [2012] EWHC 2290 (Pat). 36 High Court of Justice Chancery Division Patents Court: Judgment of 10 October 2012, Eli Lilly and Company v Human Genome Sciences, [2012] EWHC 2857 (Pat). 37 Eli Lilly, above n. 10. 38 Ibid. 39 35 U.S.C. 156, (d), (D), emphasis added. 40 See <https://www.uspto.gov/web/offices/pac/mpep/s2752.html> (accessed 25 August 2017). 41 See the wording of the Japanese Patent Act at <http://www.wipo.int/wipolex/en/text.jsp?file_id=188310>, and further at <https://www.jpo.go.jp/iken_e/pdf/patent_utilty_20150325/08.pdf> (bothaccessed 28August2017) (emphasis added). 42 Section 91(2) cf Section 90 of the Korean Patent Act, <http://www.kipo.go.kr/upload/en/download/PATENT%20ACT_201308.pdf> (accessed 28 August 2017). 43 Are Stenvik, Patentrett, 3rd edn (Cappelen, Oslo, 2013), p. 333 (original in Norwegian: ‘Det er uten betydning om innehaveren [dvs. patenthaveren] selv utnytter den oppfinnelse som er vernet ved basispatentet eller ikke’, and ‘Det er ikke noe vilkår at søkeren er innehaver av markedsføringstillatelsen’) (emphasis in original). 44 Nicolai Lindgreen, Jens Schovsbo and Jesper Thorsen, Patentloven med kommentarer (DJØF Publishing, Copenhagen, 2012), p. 528, original in Danish: ‘Det er … ikke i forordningerne gjort til en betingelse, at markedsføringstilladelsen er udstedt til certifikatansøgeren …’. 45 Peter Dethlefsen, ‘Supplerende beskyttelsescertifikater for lægemidler’ (1993) Nordiskt Immaterieelt Rättskydd 19-231, 222, original in Danish: ‘Der er ikke noget udtrykkeligt krav efter forordningen om, at den, der søger certifikatet, gør det i forståelse med den, der har opnået markedsføringstilladelsen (hvis det er en anden). Formålet med forordningen tilsiger imidlertid, at der bør være en forbindelse mellem de to “rettighedshavere”: certifikatet er jo en kompensation til den, der har brugt (mest) tid og penge på markedsføringstilladelsen.’ 46 The Hon Mr Justice Colin Birss; Andrew Waugh, QC; Tom Mitcheson, QC; Douglas Campbell, QC; Justin Turner, QC; Tom Hinchliffe, QC in Terrell on the Law of Patents 18th edn, (Sweet & Maxwell, London, 2017), at 6-57 to 6-60. 47 Ibid. 48 Ibid. 49 Klaus Grabinski, ‘Ergänzende Schutzzertifikate’, in Benkhard, Patentgesetz, 11. Auflage, § 16 a PatG, Rdnr. 40 (C.H. Beck, Munich, 2015). 50 Franz Hacker, ‘Ergänzendes Schutzzertifikat’, in Busse, Patentgesetz, 8. Auflage, 2016, Anh § 16 a, Rdnr. 99-100 (De Gruyter, Berlin, 2016). 51 Klaus Grabinski, above n. 50: ‘Demnach ist es möglich, dass der Inhaber des Schutzzertifikats dem (personenverschiedenen) Inhaber der Genehmigung die Benutzung des Schutzzertifikats zwar untersagen kann, er aber an der Ausübung des eigenen Schutzzertifikats wegen Fehlens einer arzneimittel- oder pflanzenschutzrechlichen Genehmigung gehindert ist.’ 52 Christopher Brückner, Ergänzende Schutzzertifikate mit pädiatrischer Laufzeitverlängerung (Supplementary Protection Certificates with Paediatric Extension of Duration), Kommentar 2. Auflage (Carl Heymanns Verlag, Cologne, 2015). 53 Above SPC Art. 6, marginal number 41-78, where he relies on Biogen/SmithKline to have ‘opened up the possibility of acquiring a protection certificate with another’s marketing authorisation’ (ibid, marginal number 41). 54 Ibid, art. 6, marginal number 42. 55 Ibid, marginal number 47. 56 Ibid, marginal number 50. 57 Ibid, marginal number 57. 58 Ibid, marginal number 58 (emphasis added). 59 Ibid, marginal number 70. See also marginal number 71 where it is, furthermore, stated that ‘[t]he possibility of obtaining a passive protection certificate, however, also permitted constellations that are extremely dubious and conflict with the intentions of the Medicinal Regulation’ (emphasis added). 60 Ibid, marginal number 72. 61 Ibid, marginal number 55. 62 At para 31. 63 Similarly Tom Carver, ‘SPCs – a Reward for Someone Else’s Investment’, CIPA Journal, 44(1) (January 2015), 14, 18. 64 Ibid. 65 Ibid. 66 Cf David Pountney and Andrew Hutchinson, ‘The European Commission Announces a Review of Options to Modernise the SPC Regulations and “Bolar” Research Exemptions’, available at: <http://www.elexica.com/en/legal-topics/intellectual-property/280217-european-commission-announces-review-to-modernise-spc-regulations-patent-research-exemptions> (accessed 20 July 2017). © The Author(s) 2018. Published by Oxford University Press. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)

Journal

Journal of Intellectual Property Law & PracticeOxford University Press

Published: Jan 23, 2018

There are no references for this article.

You’re reading a free preview. Subscribe to read the entire article.


DeepDyve is your
personal research library

It’s your single place to instantly
discover and read the research
that matters to you.

Enjoy affordable access to
over 18 million articles from more than
15,000 peer-reviewed journals.

All for just $49/month

Explore the DeepDyve Library

Search

Query the DeepDyve database, plus search all of PubMed and Google Scholar seamlessly

Organize

Save any article or search result from DeepDyve, PubMed, and Google Scholar... all in one place.

Access

Get unlimited, online access to over 18 million full-text articles from more than 15,000 scientific journals.

Your journals are on DeepDyve

Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.

All the latest content is available, no embargo periods.

See the journals in your area

DeepDyve

Freelancer

DeepDyve

Pro

Price

FREE

$49/month
$360/year

Save searches from
Google Scholar,
PubMed

Create lists to
organize your research

Export lists, citations

Read DeepDyve articles

Abstract access only

Unlimited access to over
18 million full-text articles

Print

20 pages / month

PDF Discount

20% off