Has Pemetrexed revived the Doctrine of Equivalence?

Has Pemetrexed revived the Doctrine of Equivalence? Abstract This article focuses on the development of claim construction and the Doctrine of Equivalence in Germany and the UK before and after the Pemetrexed-decisions in Actavis v. Eli Lilly by the respective Supreme Courts. While especially the UK decision came as a huge surprise, positive aspects can be derived from both decisions. The German court limited the applicability of the “doctrine of renunciation”, whereas the Justices of the Supreme Court of the United Kingdom seem to have made a giant leap towards their continental colleagues. I. Introduction Even on its 40th birthday, Art. 69 EPC is still one of the most controversial provisions of the EPC. This is due to the fact that this provision was and is supposed to align the British “fence-post” approach with the German “sign-post” approach to claim construction and equivalent infringement. Unsurprisingly, the result was a compromise solution which could not reach this goal.1 After the revision of the EPC ironed out an avoidable translation error2 and explicitly referred to equivalents (at least in the accompanying Protocol on the Interpretation of Art. 69 EPC), the question arose whether the member states of the EPC, especially Germany and the UK, could resolve some of their discrepancies regarding claim construction and equivalent infringement. In 2011, with the Okklusionsvorrichtung-decision,3 the (German) Federal Supreme Court seemed to have made a move towards the British when referring to the so-called “doctrine of renunciation” (in German: “Verzichtsgedanke”) considerably limiting the scope of protection and making it more difficult for patentees to argue for equivalent infringement. Now, over 5 years later, after the Pemetrexed-decisions by the Federal Supreme Court and the UK Supreme Court have been rendered, the tables have turned (again). This article focuses on the development of the Doctrine of Equivalence under German law, including the latest developments in the wake of Pemetrexed (see below under II.). However, since the German and British Pemetrexed-decisions seem to be milestones on the way to the desired goal of a harmonised patent law, the author will also elaborate on the Doctrine of Equivalence under British law antecedent to the UK Supreme Court ruling in this regard (see below under III.), before comparing and analyzing both decisions (see below under IV. and V.). II. The determination of the scope of protection under German law prior to Pemetrexed 1. Claim construction Art. 69 (1) EPC and Sec. 14 GPA stipulate that the scope of protection is determined by the claims of the patent (“primacy of the patented claims”). Thus, the claims are not only the starting point but also the basis for the determination of the scope of protection.4 Nevertheless, the specification and the drawings shall be used to interpret the patent claims. Accordingly, the Federal Supreme Court stated that claims have to be interpreted by each court independently,5 even though the principles for claim construction in infringement and nullity proceedings are the same.6 This means that e.g. a first or second instance infringement court is not bound by a claim construction taken as a basis by the Federal Supreme Court in parallel nullity proceedings. A claim construction deviating from the Federal Supreme Court is a ground for appeal in which the Federal Supreme Court would have to decide which interpretation is preferable.7 With regard to European patents, the German courts have to take parallel foreign decisions by courts of EPC member states into consideration.8 a) The specification Furthermore, the scope of protection is limited by the claims of the patent.9 In other words, the scope of protection does not extend to those teachings that are disclosed in the specification but are not reflected in the claims; i.e. the specification can only be used to interpret the claims insofar as it explains or defines the claims.10 Nevertheless, the claims are to be construed so as to avoid inconsistencies between the claims and the specification. Even though the primacy of the claims has to be respected, a claim construction that would not cover any embodiment specified in the specification is only considerable under very rare circumstances.11 However, this does not mean that all embodiments need to be covered by the claims.12 b) Dependent claims With regard to whether reference can be made to dependent claims in order to construe the main claim, the Wärmetauscher-decision by the Federal Supreme Court provides useful guidance.13 There, the court stated that these claims are usually to be regarded as mere exemplary embodiments of the invention and, thus, are generally not able to confine the scope of protection of the main claim. How far dependent claims are at all admissible for the interpretation of the main claim depends on whether further aspects have been added to the feature of the main claim in terms of a “functional improvement”. Such “functional improvements” usually allow drawing reliable conclusions about the understanding of the main claim. On the contrary, dependent claims that add additional features to the respective feature of the main claim are no basis for finding the correct interpretation. c) Functional interpretation Having said this, the claims of the patent in suit are to be construed from the viewpoint of a person skilled in the relevant art.14 In this regard, one has to take into account the priority date of the patent; i.e. the claim construction can only be based on the knowledge accessible to the person skilled in the art at that time.15 According to German case law, the person skilled in the art understands the claim features in a functional way vis-à-vis the underlying problem and solution of the patent. Hence, the claim features are not to be interpreted literally but rather functionally in the context of the technical teaching of the claims.16 However, it is generally not permissible to reduce spatial-physical, mathematical or chemical terms to their mere functions.17 The wording of these kind of features usually curtails the construction of the claims. d) Admissible documents In order to discover the functional meaning of the claim features, it is necessary to determine which documents are admissible for interpretation. As described above, according to Art. 69 (1) EPC and Sec. 14 GPA the specification and drawings are absolutely crucial for establishing the technical teaching of the claims. Nevertheless, in some occasions useful guidance can be drawn from the (pre-grant and post-grant) prosecution history. aa) Admissibility of the pre-grant prosecution history The pre-grant prosecution file is generally not part of the admissible material for interpretation of the claims since the file is neither listed in Art. 69 (1) EPC nor Sec. 14 GPA.18 There is only one exception with regard to statements made during examination by the patentee or the examiner. While these statements cannot be used as the sole basis for the interpretation, it is permissible to regard these as indications for the understanding of the person skilled in the art and thus, as indications for the correct interpretation.19 Whether or not the patent application publication or earlier (granted) versions of the patent in suit can be used to interpret the claim features has not yet been up for decision by the Federal Supreme Court. Nevertheless, where the claims cannot be reasonably put into relation with the specification, reference can be made to the “history of the claims” to check whether the claims cover embodiments deviating from or falling short of the specification.20 However, the Federal Supreme Court has indicated that earlier versions of the patent can be consulted to find out whether the amendments of the claim were executed to distinguish the patent from prior art.21 If this is the case, there will be good reasons to assume a limitation of the scope of protection. Otherwise (i.e. the claims have been amended for formal reasons or the reasons are not apparent), the amendments do not give grounds for a limitation of the scope of protection. Additionally, at least according to the Higher Regional Courts of Düsseldorf and Karlsruhe, the patent as granted is an admissible document for the interpretation of the patent as amended after opposition. This is because the patent as granted is part of the admissible material for interpretation according to Art. 69 (1) EPC and Sec. 14 GPA.22 bb) Admissibility of the post-grant prosecution history Statements during the opposition or nullity proceedings are much more important if the patentee has made declarations limiting the scope of protection and this limitation was the reason why the patent was maintained and the defendant of the infringement proceedings has also been party to the opposition or nullity proceedings. While in principle the scope of protection is not limited by those statements, the defendant can raise the objection of unlawful exercise of a right according to s. 242 German Civil Code in the infringement proceedings if the attacked embodiment would not be covered by the limitations.23 Additionally, the reasons of the parallel opposition or nullity decision are expert statements that have to be considered by the infringement court but are not binding24 unless the patent has been amended, in which case the reasons for the decision dealing with the amended patent claims replace the respective parts of the original specification (if the specification has not been amended).25 2. Doctrine of Equivalence If the attacked embodiment does not literally infringe the patent, the question arises whether and to which extent the scope of protection extends to equivalents. The first key decision by the Federal Supreme Court regarding the Doctrine of Equivalence was the Formstein-decision.26 The court stated that, according to Art. 69 (1) EPC (in connection with the Protocol on the Interpretation of Art. 69 EPC), the scope of protection extends beyond the wording of the claims to equivalent embodiments. Accordingly, the assessment of infringement is to be conducted in two steps. First, the infringement court has to assess whether the attacked embodiment literally infringes the patent in suit. If this is excluded, the courts have to secondly assess equivalent infringement. According to the Formstein-decision, the decisive question is whether the person skilled in the art solves the underlying problem with the same means based on the invention as protected by the claims. Over time, the court has further refined this test in its Schneidmesser-decisions.27 According to this three-step-test (the so-called Schneidmesser-Questions) an attacked embodiment is equivalently infringing the patent in suit if the modified means have the same effect, are obvious and parity is achieved: “Same effect” Do the modified means have objectively the same effect as the means specified in the claim based on the underlying problem and solution of the patent? “Obviousness” Would the person skilled in the art have come up with the modified means on the priority date without any particular (i.e. inventive) considerations on the basis of his expert knowledge? “Parity” Are those considerations conducted by the person skilled in the art in order to arrive at the modification based on the meaning of the teaching in the claims? As can easily be seen, the major difference between the Formstein-test and the Schneidmesser-Question is the additional requirement of parity. If all questions are confirmed, the infringement court would assume infringement under the Doctrine of Equivalence. a) Same effect In assessing “same effect”, it is decisive what effect the patented means – individually and collectively – has on the solution of the underlying problem.28 The underlying problem follows from what is achieved by the invention in light of the patent claims.29 Accordingly, it is not sufficient for the attacked embodiment (as a whole) to have essentially the same effect on the solution to the underlying problem. Rather, the modified means (individually) has to achieve the same effect as the corresponding (literally unfulfilled) patented means.30 Likewise, any potentially additional benefit of the patented means not having an effect on the solution does not have to be achieved by the corresponding modified means.31 In this regard, the Federal Supreme Court has stated that so-called Swiss-type claims are directed to a specific use and not to the manufacture. Hence, different effects on the preparation or manufacture are irrelevant.32 b) Obviousness Regarding “obviousness”, the decisive factor is whether an inventive step would be needed to come up with the modified means, in which case equivalence would have to be denied.33 However, it is sufficient if the modified means are detectable by the person skilled in the art. Likewise, the modified means do not have to be the most obvious means.34 Just because the modified means were unknown to the person skilled in the art at the priority date (see above under II. 1. c) does not automatically mean that the person skilled in the art required inventive considerations to come up with those means. In these cases, the assessment depends on whether the general technical progress “just fell into the lap” of the potential infringer. Hence, a hypothetical test for obviousness has to be conducted asking whether the person skilled in the art would have come up with the modified means on the priority date without any particular (i.e. inventive) considerations on the basis of his expert knowledge, hypothetically assuming that these means would have been available at the priority date.35 c) Parity Regarding “parity”, the person skilled in the art has to align his considerations with the claimed teaching so that he is able to identify the modified means as equivalent.36 This means the person skilled in the art must recognize the modified means as having essentially the same effect as the technical teaching as claimed (and not as disclosed since the protected teaching is confined to the claims).37 For this, the person skilled in the art must not rely on his expert knowledge but rather only on the patent (respectively, the patent claims). Accordingly, the modified means collectively have to be an equivalent solution to the claimed teaching.38 This does not mean that the specification must direct the person skilled in the art to the modified means.39 Notably, “parity” cannot be denied on the basis that the patentee has deliberately chosen a certain wording of the respective claim feature and, thus, has committed himself to a certain (restricted) claim interpretation. This kind of “commitment” is not able to determine the question of parity positively or negatively.40 However, “parity” is denied in case of a so-called selective invention. Here, certain embodiments are excluded from the scope of protection if these are disclosed or detectable but for whatever reasons the reader of the patent has to assume that these embodiments are not supposed to be protected (so-called “doctrine of renunciation”).41 Hence, the considerations of the person skilled in the art also have to be in line with the selective invention at hand. Accordingly, if the specification discloses several embodiments of which only one has been included in the claims, the scope of protection does not generally extend to the other, non-included, embodiments.42 Nevertheless, a claim directed at a specific chemical compound, when the specification merely discloses the class of chemical compounds, is not necessarily regarded a selective invention. This is due to the fact that the person skilled in the art would usually need further information to individualize the other members of the chemical class.43 The Federal Supreme Court has stated that the basic rule regarding selective inventions – namely, the disclosure or detectability – is restricted to the content of the specification itself. A detectability merely based on information in the specification would not render an invention a selective invention, since the detectability is anyway a requirement to assume equivalence.44 In this regard, earlier versions of the patent might give useful guidance.45 d) The Formstein-objection However, the scope of protection under the Doctrine of Equivalence is limited if the embodiment equivalently infringing the patent in suit is anticipated or obvious from the prior art.46 This is due to the fact that the scope of protection must not be extended to embodiments being covered by prior art. After raising this objection, the infringement court has to assess whether the attacked embodiment is indeed not patentable in light of the prior art. Accordingly, the Formstein-objection is an exception to the rule that German infringement courts do not have jurisdiction to assess the patentability.47 3. Interim conclusion It is very welcome to see that the Federal Supreme Court has clarified many legal issues regarding claim construction. First, the fact that the Federal Supreme Court has highlighted in many recent cases the requirement to (independently) construe the patent claims shows that the court expects infringement courts as well as the Federal Patent Court to put increasing emphasis on claim construction. Additionally, until recently, it has been unclear if and how dependent claims can be used to construe the main claim. The Wärmetauscher-decision48 provides very useful guidance in this regard. Although it is not (yet) quite clear how the “doctrine of renunciation” as outlined in Okklusionsvorrichtung49 can be aligned with Pemetrexed50 (see below in detail), it is very welcome to see the Federal Supreme Court opening the door for equivalent infringement once again. Unfortunately, however, the Federal Supreme Court seems to shy away from principally deciding whether and to what extent the prosecution file can be used for claim construction. There have been a couple of cases in which the court has missed the opportunity to issue decisions of principle in this regard.51 On the contrary, one has the impression that the court is in each case desperately looking for reasons why a decision in this regard can still be left open. III. The approach to claim construction and equivalence by UK courts prior to Pemetrexed 1. House of Lords in Catnic Components Ltd v. Hill & Smith Ltd (“Catnic”)52 In Catnic (only decided under domestic law without any reference to Art. 69 EPC), the House of Lords made it clear that there is only “a single cause of action”. Besides, the House of Lords developed the test for assessing whether the person skilled in the art “would understand that strict compliance with a particular descriptive word or phrase in a claim was intended by the patentee to be an essential requirement (…) so that any variant would fall outside the monopoly claimed (…)”. 2. Patents Court in Improver Corp. v. Remington Comsumer Products Ltd (“Improver”)53 This test was subsequently picked up by the Patents Court in the Improver-judgment. Although the court made it clear that this test is applicable in case the attacked embodiment “fell outside the primary, literal or a contextual meaning of a descriptive word or phrase in the claim (‘a variant’)”, the question was still whether or not the attacked embodiment “was nevertheless within its language as properly interpreted”. The Patents Court reformulated the test and accordingly, the following questions are to be asked with regard to variants: Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no – Would this (i.e. that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. If yes – Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim. a) The first two questions Although the first two questions cannot reasonably be answered without reference to the patent in suit, these questions are of factual nature. Accordingly, these questions are supposed to serve as a factual basis for interpreting the patent specification. b) The third question The third question, finally, concerns the construction of the claims. For this, the court made it clear that the first two questions are not exclusive. 3. House of Lords in Kirin-Amgen Inc. v. Hoechst Marion Roussel Ltd (“Amgen”)54 About 15 years later, the House of Lords had to decide the Amgen case. There, the House of Lords came to the conclusion that the approach taken in Catnic was one of “purposive construction”. Hence, the decisive point is how the person skilled in the art would understand the wording of the claims. Consequently, the House of Lords clearly was of the opinion that Art. 69 EPC “firmly shuts the door on [the doctrine of equivalence]”. Accordingly, the “purposive construction” gave “effect to the requirements of the Protocol” with the Improver-Questions merely to be used as guidelines for application with regard to equivalents. 4. Interim conclusion Especially after Amgen, it was clear that the UK did not accept a separate Doctrine of Equivalence in the absence of a literal infringement. However, the House of Lords has also stated that equivalent embodiments could be covered by a purposively constructed claim. Nevertheless, it seems fair to say that on the one hand the Germans favoured the patentee focussing on a fair protection for the patentee, the British, on the other hand, focussed on legal certainty for third parties apparently shifting their favour towards the users of the patent. While both approaches seemed to be in line with Art. 69 EPC, they were nonetheless still not at all aligned with each other.55 IV. The Pemetrexed-decisions by the Federal Supreme Court and the UK Supreme Court Over the last years, Eli Lilly and Actavis have been disputing, inter alia before German and UK courts, whether Actavis’ medicaments infringe Eli Lilly’s pemetrexed patent. The decision by the Federal Supreme Court has been rendered on 14 June 2016, over a year before the UK Supreme Court issued its decision (on 12 July 2017). 1. The background of the dispute In short, the background is as follows. Eli Lilly is the proprietor of a patent claiming the use of pemetrexed disodium together with vitamin B12 for cancer treatment. Pemetrexed belongs to the chemical class of antifolates. Other than a general remark that all antifolates are suitable for use in the patented invention, the specification only refers to “Pemetrexed Disodium”. One of Actavis’ proposed products comprised the use of pemetrexed dipotassium together with vitamin B12 for cancer treatment. 2. The decision by the Federal Supreme Court56 According to settled German case law, equivalent infringement is possible if a literal infringement can be excluded (see above). a) Literal infringement The Federal Supreme Court found that a literal infringement of the patent claim by way of using Pemetrexed Dipotassium instead of Pemetrexed Disodium is excluded. Especially a functional interpretation of the claim is not indicated due to the fact that in this case the claim is to be interpreted narrowly. First, a functional interpretation is generally not suitable in the case of a chemical compound. Secondly, the wording of the specification is consistent with the wording of the claim (since the specification generally refers to “Pemetrexed Disodium”). In this regard, statements by the patentee and the examiner during examination strengthened this interpretation. Since these statements have only been given the same weight as textbooks, the appellate court was right to use these as indications for the correct interpretation. b) Equivalent infringement However, the Federal Supreme Court disagreed with the appellate court which had also excluded an equivalent infringement due to the lack of fulfilment of the third Schneidmesser-Question. The Higher Regional Court of Dusseldorf has stated that the disclosure of a class of chemical compounds leads to a detectability of all members of this class. Since the specification points out that the invention can be fulfilled with all antifolates, reference must be made to the Okklusionsvorrichtung-decision by the Federal Supreme Court.57 Accordingly, due to the fact that detectability leads to a so-called selective invention, there is no room for “parity” and, thus, there is no room for infringement based on the doctrine of equivalence. Hence, the Higher Regional Court did not have to evaluate the other two Schneidmesser-Questions.The Federal Supreme Court did not assume a selective invention due to the fact that a mere detectability based on information given in the specification is not sufficient. Additionally, a selective invention on the basis of prior versions of the patent can only be assumed if the claims have been concretised in order to distinguish the claim from prior art. Since this was not the case, the Federal Supreme Court did not have to decide whether prior version can be consulted for interpretation at all. Finally, just because a functional interpretation is not suitable with regard to the question of literal infringement, this does not mean that an equivalent infringement is not available. Accordingly, the Federal Supreme Court made it clear that an exact scientific definition used in the claims is not sufficient to deny that a modification is based on the meaning of the teaching of the claims. Since the Federal Supreme Court can make factual findings only under very narrow circumstances, the case was referred back to the appellate court since further factual findings are needed to answer the other two Schneidmesser-Questions. 3. The decision by the UK Supreme Court58 After making reference to previous UK case law on this topic (see above), the UK Supreme Court did not follow Lord Diplock’s uniform approach in Catnic.59 Accordingly, the question of infringement is to be addressed by two issues: Does the variant infringe any of the claims as a matter of normal interpretation? If not, does the variant nonetheless infringe because it varies from the invention in a way of ways which is or are immaterial? Hence, the courts, first, have to assess infringement under “normal” (or literal) interpretation and if this is excluded, issue (2) “squarely raises the principle of equivalents”. a) Normal (or literal) infringement The UK Supreme Court denied normal infringement because “‘pemetrexed disodium’ means that particular salt, and no other salt”. b) Equivalent infringement With regard to equivalent infringement, the UK Supreme Court referred to the so-called Improver-Questions60 but decided that these questions needed to be amended. To better understand the amendments, both set of questions are contrasted with each other: The original Improver-Questions  The reformulated Improver-Questions  Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim.  Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?  Would this (i.e. that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim.  Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?  Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim.  Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?  The original Improver-Questions  The reformulated Improver-Questions  Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim.  Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?  Would this (i.e. that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim.  Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?  Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim.  Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?  aa) The first question Regarding the first question, the Supreme Court found that more emphasis should be put on the problem underlying the invention (i.e. the inventive concept). Hence, unlike in the original version, question one is not just about the factual background. bb) The second question According to the UK Supreme Court, the second question should be asked “on the assumption that the notional addressee knows that the variant works to the extent that it actually does work”. Otherwise, the burden on the patentee would be too high, since the person skilled in the art would be required to figure that out. However, it would in many cases be impossible for a skilled person to predict whether any particular variant would work. Additionally, it does not matter whether variants have only been developed after the priority date. The second revised Improver-Question does also not necessarily have to be denied (although this is very likely) if the variation represents an inventive step. Subject to the effect of the prosecution history (see below under c)), the Supreme Court did not have any doubts to confirm the first two questions. cc) The third question Finally, with regard to the third question, not only the language of the claim is important but also the specification and the knowledge and expertise of the addressee. Additionally, the fact that a variant is not covered by the language of the claim is not sufficient to deny this question. Furthermore, it is to be asked whether the respective feature of the claim is an “essential” part of the invention which means that it does not have to be an “essential” part of the whole protected product. Lastly, it is sufficient if the variant was obvious at the date of infringement. Regarding the third question, the UK Supreme Court concluded that the reason why the claims were limited was that pemetrexed disodium was the “salt on which the experiments described in the specification had been carried out”. However, there was no indication that other pemetrexed salts should be excluded from the scope of protection. c) The effect of the prosecution history In principle, the UK Supreme Court agreed with the careful German approach. Accordingly, reference to the prosecution file shall be appropriate where either the point at issue is truly unclear if one confines oneself to the specification and claims of the patent, and the contents of the file unambiguously resolve the point, or it would be contrary to the public interest for the contents of the file to be ignored. As the court was able to construe the patent claims (see above under aa) and bb)), alternative (1) was not at issue. Alternative (2) would only be applicable in a case “where the patentee had made it clear to the EPO that he was not seeking to contend that his patent, if granted, would extend its scope to the sort of variant which he now claims infringes”. Hence, if statements of the patentee during examination regarding the scope of protection are contrary to his assertions during infringement proceedings, reference to the prosecution history should be admissible. However, the UK Supreme Court did not find any grounds for such contradicting statements. Accordingly, Actavis was found to infringe Eli Lilly’s pemetrexed patent equivalently. V. Conclusion Both courts recognize that there is room for equivalent infringement in the absence of literal (or normal) infringement; hence, a twofold assessment is to be conducted. In this regard, the UK Supreme Court seems to have made a giant leap towards Germany by refraining from the uniform “purposive construction”.61 Additionally, both courts have developed similar requirements that need to be fulfilled when assessing an equivalent infringement: The reformulated Improver-Questions  The Schneidmesser-Questions  Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?  Do the modified means have objectively the same effect as the means specified in the claim based on the underlying problem and solution of the patent?  Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?  Would the person skilled in the art have come up with the modified means on the priority date without any particular (i.e. inventive) considerations on the basis of his expert knowledge?  Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?  Are those considerations conducted by the person skilled in the art in order to arrive at the modification based on the meaning of the teaching in the claims?  The reformulated Improver-Questions  The Schneidmesser-Questions  Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?  Do the modified means have objectively the same effect as the means specified in the claim based on the underlying problem and solution of the patent?  Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?  Would the person skilled in the art have come up with the modified means on the priority date without any particular (i.e. inventive) considerations on the basis of his expert knowledge?  Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?  Are those considerations conducted by the person skilled in the art in order to arrive at the modification based on the meaning of the teaching in the claims?  The first Schneidmesser-Question searching for the “same effect based on the underlying problem” comes very close to the revised first Improver-Question searching for the “same result in substantially the same way as the invention, i.e. the inventive concept”. Additionally, the second Schneidmesser-Question is also very similar to the second revised Improver-Question. The only difference is that German case law denies an equivalent infringement if the variant required an inventive step (while the UK Supreme Court did not see any reason for this kind of absolutism). Nevertheless, the UK Supreme Court made it clear that “the German version of the second test will (…) usually produces the same result as the reformulated second [Improver] question.” Furthermore, the third Schneidmesser-Question as well as the third revised Improver-Question both look at the teaching of the claims and not at the teaching of the overall product or process. Finally, both courts only allow very limited reference to the prosecution file. Nonetheless, the UK Supreme Court seems to have a clearer approach to making references to the prosecution file. While the German Federal Supreme Court is generally not accepting any such reference (subject to exceptions not yet defined), the UK court has at least started to consider the circumstances under which reference to the prosecution file is admissible. In this regard, German case law does not offer great legal certainty (see above under II. 3.). Having said this, it is still very welcome to see that the highest courts of two of the most important patent jurisdictions in Europe seem to approach the question of equivalence very similarly. While the German case has not been finally disposed, subsequent preliminary injunction proceedings before the Higher Regional Court of Munich62 give reasons to believe that both jurisdictions are moving in the same direction regarding the Doctrine of Equivalence. Footnotes 1 Cf. the Epilady-cases litigated inter alia in Germany and the UK. 2 The English original of Art. 69 EPC 1973 spoke of “the terms of the claims”, which was translated into German as “Inhalt der Patentansprüche” and into French as “la teneur des revendications” (literally, however, both translations do not refer to the “terms” but rather to “the content of the claims”). Now, Art. 69 EPC 2000 simply refers to the “claims”. 3 Federal Supreme Court, GRUR 2011, 701 – Okklusionsvorrichtung. 4 Federal Supreme Court, GRUR 2004, 1023 – bodenseitige Vereinzelungseinrichtung. 5 Federal Supreme Court, GRUR 2010, 602 – Gelenkanordnung. 6 Federal Supreme Court, GRUR 2004, 47 – blasenfreie Gummibahn I. 7 Federal Supreme Court, GRUR 2015, 972 – Kreuzgestänge. 8 Federal Supreme Court, GRUR 2010, 950 – Walzenformgebungsmaschine; Federal Supreme Court, GRUR 2015, 199 – Sitzplatznummerierungseinrichtung. 9 Federal Supreme Court, GRUR 1987, 626 – Rundfunkübertragungssystem. 10 Federal Supreme Court, GRUR 2011, 701 – Okklusionsvorrichtung. 11 Federal Supreme Court, GRUR 2015, 159 – Zugriffsrechte. 12 Okklusionsvorrichtung, above, n 10. 13 Federal Supreme Court, GRUR 2016, 1031 – Wärmetauscher. 14 Federal Supreme Court, GRUR 2006, 131 – Seitenspiegel. 15 Higher Regional Court of Düsseldorf, docket-no. I-2 U 5/14 – Partikel-Auffangvorrichtung. 16 Federal Supreme Court, GRUR 1999, 909 – Spannschraube. 17 Federal Supreme Court, GRUR 2016, 921 – Pemetrexed. 18 Federal Supreme Court, GRUR 2002, 511 – Kunststoffrohrteil; cf. Federal Constitutional Court, NJW 2011, 842. 19 Federal Supreme Court, NJW 1997, 3377 – Weichvorrichtung II; Pemetrexed, above n 17. 20 Federal Supreme Court, GRUR 2015, 875 – Rotorelemente with further references. 21 Pemetrexed, above n 17. 22 Higher Regional Court of Düsseldorf, GRUR-RS 2014, 21715 – Verschleißteil; Higher Regional Court of Karlsruhe, GRUR-RS 2014, 17797 – Zugriffskanal. 23 Federal Supreme Court, NJW 1997, 3377 – Weichvorrichtung II. 24 Federal Supreme Court, GRUR 1998, 895 – Regenbecken. 25 Federal Supreme Court, GRUR 2007, 778 – Ziehmaschinenzugeinheit. 26 Federal Supreme Court, GRUR 1986, 803 – Formstein. 27 Federal Supreme Court, GRUR 2002, 515 – Schneidmesser I; Federal Supreme Court, GRUR 2002, 519 – Schneidmesser II. 28 Federal Supreme Court, GRUR 2015, 361 – Kochgeschirr. 29 Federal Supreme Court, GRUR 2010, 602 – Gelenkanordnung. 30 Higher Regional Court of Düsseldorf, docket-no. I-2 U 40/16 – Druckmaschine. 31 Federal Supreme Court, GRUR 2012, 45 – Diglycidverbindung; Higher Regional Court of Munich, docket-no. 6 U 3039/16 – Pemetrexed Tromethamin. 32 Pemetrexed, above n 17. 33 Federal Supreme Court, GRUR 1994, 597 – Zerlegvorrichtung für Baumstämme. 34 Higher Regional Court of Munich, docket-no. 6 U 3039/16 – Pemetrexed Tromethamin. 35 Higher Regional Court of Düsseldorf, docket-no. I-2 U 5/14 – Partikel-Auffangvorrichtung. 36 Pemetrexed, above n 17. 37 Kunststoffrohrteil, above n 18. 38 Federal Supreme Court, GRUR 2007, 91 – Pumpeinrichtung. 39 Federal Supreme Court, GRUR 2014, 852 – Begrenzungsanschlag. 40 Federal Supreme Court, GRUR 2016, 1254 – V-förmige Führungsanordnung. 41 Pemetrexed, above n 17; Federal Supreme Court, GRUR 2012, 45 – Diglycidverbindung; Federal Supreme Court, GRUR 2011, 701 – Okklusionsvorrichtung. 42 Okklusionsvorrichtung, above n 10. 43 Pemetrexed, above n 17, with reference to Federal Supreme Court, GRUR 2009, 382 – Olanzapin. 44 Ibid. 45 See above under item 1. a). 46 Federal Supreme Court, GRUR 1986, 803 – Formstein. 47 Federal Supreme Court, GRUR 2003, 550 – Richterausschluss. 48 Federal Supreme Court, GRUR 2016, 1031 – Wärmetauscher. 49 Okklusionsvorrichtung, above n 10. 50 Pemetrexed, above n 17. 51 See above under II. 1. d). 52 [1982] RPC 183, 242. 53 [1990] FSR 181. 54 [2005] RPC 9. 55 K Grabinski, ‘,,Schneidmesser” versus ,,Amgen”' GRUR 2006, 714. 56 Pemetrexed, above n 17. 57 Okklusionsvorrichtung, above n 10. 58 [2017] UKSC 48. 59 [1982] RPC 183, 242. 60 [1990] FSR 181. 61 Cf. K Grabinski, ‘,,Schneidmesser” versus ,,Amgen”' GRUR 2006, 714 who regarded the “purposive construction” followed by the UK courts at that time as one of the major differences between Germany and the UK. 62 Higher Regional Court of Munich, docket-no. 6 U 3039/16 – Pemetrexed Tromethamin. © The Author(s) 2018. Published by Oxford University Press. All rights reserved. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Intellectual Property Law & Practice Oxford University Press

Has Pemetrexed revived the Doctrine of Equivalence?

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Oxford University Press
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© The Author(s) 2018. Published by Oxford University Press. All rights reserved.
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1747-1532
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1747-1540
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10.1093/jiplp/jpx238
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Abstract

Abstract This article focuses on the development of claim construction and the Doctrine of Equivalence in Germany and the UK before and after the Pemetrexed-decisions in Actavis v. Eli Lilly by the respective Supreme Courts. While especially the UK decision came as a huge surprise, positive aspects can be derived from both decisions. The German court limited the applicability of the “doctrine of renunciation”, whereas the Justices of the Supreme Court of the United Kingdom seem to have made a giant leap towards their continental colleagues. I. Introduction Even on its 40th birthday, Art. 69 EPC is still one of the most controversial provisions of the EPC. This is due to the fact that this provision was and is supposed to align the British “fence-post” approach with the German “sign-post” approach to claim construction and equivalent infringement. Unsurprisingly, the result was a compromise solution which could not reach this goal.1 After the revision of the EPC ironed out an avoidable translation error2 and explicitly referred to equivalents (at least in the accompanying Protocol on the Interpretation of Art. 69 EPC), the question arose whether the member states of the EPC, especially Germany and the UK, could resolve some of their discrepancies regarding claim construction and equivalent infringement. In 2011, with the Okklusionsvorrichtung-decision,3 the (German) Federal Supreme Court seemed to have made a move towards the British when referring to the so-called “doctrine of renunciation” (in German: “Verzichtsgedanke”) considerably limiting the scope of protection and making it more difficult for patentees to argue for equivalent infringement. Now, over 5 years later, after the Pemetrexed-decisions by the Federal Supreme Court and the UK Supreme Court have been rendered, the tables have turned (again). This article focuses on the development of the Doctrine of Equivalence under German law, including the latest developments in the wake of Pemetrexed (see below under II.). However, since the German and British Pemetrexed-decisions seem to be milestones on the way to the desired goal of a harmonised patent law, the author will also elaborate on the Doctrine of Equivalence under British law antecedent to the UK Supreme Court ruling in this regard (see below under III.), before comparing and analyzing both decisions (see below under IV. and V.). II. The determination of the scope of protection under German law prior to Pemetrexed 1. Claim construction Art. 69 (1) EPC and Sec. 14 GPA stipulate that the scope of protection is determined by the claims of the patent (“primacy of the patented claims”). Thus, the claims are not only the starting point but also the basis for the determination of the scope of protection.4 Nevertheless, the specification and the drawings shall be used to interpret the patent claims. Accordingly, the Federal Supreme Court stated that claims have to be interpreted by each court independently,5 even though the principles for claim construction in infringement and nullity proceedings are the same.6 This means that e.g. a first or second instance infringement court is not bound by a claim construction taken as a basis by the Federal Supreme Court in parallel nullity proceedings. A claim construction deviating from the Federal Supreme Court is a ground for appeal in which the Federal Supreme Court would have to decide which interpretation is preferable.7 With regard to European patents, the German courts have to take parallel foreign decisions by courts of EPC member states into consideration.8 a) The specification Furthermore, the scope of protection is limited by the claims of the patent.9 In other words, the scope of protection does not extend to those teachings that are disclosed in the specification but are not reflected in the claims; i.e. the specification can only be used to interpret the claims insofar as it explains or defines the claims.10 Nevertheless, the claims are to be construed so as to avoid inconsistencies between the claims and the specification. Even though the primacy of the claims has to be respected, a claim construction that would not cover any embodiment specified in the specification is only considerable under very rare circumstances.11 However, this does not mean that all embodiments need to be covered by the claims.12 b) Dependent claims With regard to whether reference can be made to dependent claims in order to construe the main claim, the Wärmetauscher-decision by the Federal Supreme Court provides useful guidance.13 There, the court stated that these claims are usually to be regarded as mere exemplary embodiments of the invention and, thus, are generally not able to confine the scope of protection of the main claim. How far dependent claims are at all admissible for the interpretation of the main claim depends on whether further aspects have been added to the feature of the main claim in terms of a “functional improvement”. Such “functional improvements” usually allow drawing reliable conclusions about the understanding of the main claim. On the contrary, dependent claims that add additional features to the respective feature of the main claim are no basis for finding the correct interpretation. c) Functional interpretation Having said this, the claims of the patent in suit are to be construed from the viewpoint of a person skilled in the relevant art.14 In this regard, one has to take into account the priority date of the patent; i.e. the claim construction can only be based on the knowledge accessible to the person skilled in the art at that time.15 According to German case law, the person skilled in the art understands the claim features in a functional way vis-à-vis the underlying problem and solution of the patent. Hence, the claim features are not to be interpreted literally but rather functionally in the context of the technical teaching of the claims.16 However, it is generally not permissible to reduce spatial-physical, mathematical or chemical terms to their mere functions.17 The wording of these kind of features usually curtails the construction of the claims. d) Admissible documents In order to discover the functional meaning of the claim features, it is necessary to determine which documents are admissible for interpretation. As described above, according to Art. 69 (1) EPC and Sec. 14 GPA the specification and drawings are absolutely crucial for establishing the technical teaching of the claims. Nevertheless, in some occasions useful guidance can be drawn from the (pre-grant and post-grant) prosecution history. aa) Admissibility of the pre-grant prosecution history The pre-grant prosecution file is generally not part of the admissible material for interpretation of the claims since the file is neither listed in Art. 69 (1) EPC nor Sec. 14 GPA.18 There is only one exception with regard to statements made during examination by the patentee or the examiner. While these statements cannot be used as the sole basis for the interpretation, it is permissible to regard these as indications for the understanding of the person skilled in the art and thus, as indications for the correct interpretation.19 Whether or not the patent application publication or earlier (granted) versions of the patent in suit can be used to interpret the claim features has not yet been up for decision by the Federal Supreme Court. Nevertheless, where the claims cannot be reasonably put into relation with the specification, reference can be made to the “history of the claims” to check whether the claims cover embodiments deviating from or falling short of the specification.20 However, the Federal Supreme Court has indicated that earlier versions of the patent can be consulted to find out whether the amendments of the claim were executed to distinguish the patent from prior art.21 If this is the case, there will be good reasons to assume a limitation of the scope of protection. Otherwise (i.e. the claims have been amended for formal reasons or the reasons are not apparent), the amendments do not give grounds for a limitation of the scope of protection. Additionally, at least according to the Higher Regional Courts of Düsseldorf and Karlsruhe, the patent as granted is an admissible document for the interpretation of the patent as amended after opposition. This is because the patent as granted is part of the admissible material for interpretation according to Art. 69 (1) EPC and Sec. 14 GPA.22 bb) Admissibility of the post-grant prosecution history Statements during the opposition or nullity proceedings are much more important if the patentee has made declarations limiting the scope of protection and this limitation was the reason why the patent was maintained and the defendant of the infringement proceedings has also been party to the opposition or nullity proceedings. While in principle the scope of protection is not limited by those statements, the defendant can raise the objection of unlawful exercise of a right according to s. 242 German Civil Code in the infringement proceedings if the attacked embodiment would not be covered by the limitations.23 Additionally, the reasons of the parallel opposition or nullity decision are expert statements that have to be considered by the infringement court but are not binding24 unless the patent has been amended, in which case the reasons for the decision dealing with the amended patent claims replace the respective parts of the original specification (if the specification has not been amended).25 2. Doctrine of Equivalence If the attacked embodiment does not literally infringe the patent, the question arises whether and to which extent the scope of protection extends to equivalents. The first key decision by the Federal Supreme Court regarding the Doctrine of Equivalence was the Formstein-decision.26 The court stated that, according to Art. 69 (1) EPC (in connection with the Protocol on the Interpretation of Art. 69 EPC), the scope of protection extends beyond the wording of the claims to equivalent embodiments. Accordingly, the assessment of infringement is to be conducted in two steps. First, the infringement court has to assess whether the attacked embodiment literally infringes the patent in suit. If this is excluded, the courts have to secondly assess equivalent infringement. According to the Formstein-decision, the decisive question is whether the person skilled in the art solves the underlying problem with the same means based on the invention as protected by the claims. Over time, the court has further refined this test in its Schneidmesser-decisions.27 According to this three-step-test (the so-called Schneidmesser-Questions) an attacked embodiment is equivalently infringing the patent in suit if the modified means have the same effect, are obvious and parity is achieved: “Same effect” Do the modified means have objectively the same effect as the means specified in the claim based on the underlying problem and solution of the patent? “Obviousness” Would the person skilled in the art have come up with the modified means on the priority date without any particular (i.e. inventive) considerations on the basis of his expert knowledge? “Parity” Are those considerations conducted by the person skilled in the art in order to arrive at the modification based on the meaning of the teaching in the claims? As can easily be seen, the major difference between the Formstein-test and the Schneidmesser-Question is the additional requirement of parity. If all questions are confirmed, the infringement court would assume infringement under the Doctrine of Equivalence. a) Same effect In assessing “same effect”, it is decisive what effect the patented means – individually and collectively – has on the solution of the underlying problem.28 The underlying problem follows from what is achieved by the invention in light of the patent claims.29 Accordingly, it is not sufficient for the attacked embodiment (as a whole) to have essentially the same effect on the solution to the underlying problem. Rather, the modified means (individually) has to achieve the same effect as the corresponding (literally unfulfilled) patented means.30 Likewise, any potentially additional benefit of the patented means not having an effect on the solution does not have to be achieved by the corresponding modified means.31 In this regard, the Federal Supreme Court has stated that so-called Swiss-type claims are directed to a specific use and not to the manufacture. Hence, different effects on the preparation or manufacture are irrelevant.32 b) Obviousness Regarding “obviousness”, the decisive factor is whether an inventive step would be needed to come up with the modified means, in which case equivalence would have to be denied.33 However, it is sufficient if the modified means are detectable by the person skilled in the art. Likewise, the modified means do not have to be the most obvious means.34 Just because the modified means were unknown to the person skilled in the art at the priority date (see above under II. 1. c) does not automatically mean that the person skilled in the art required inventive considerations to come up with those means. In these cases, the assessment depends on whether the general technical progress “just fell into the lap” of the potential infringer. Hence, a hypothetical test for obviousness has to be conducted asking whether the person skilled in the art would have come up with the modified means on the priority date without any particular (i.e. inventive) considerations on the basis of his expert knowledge, hypothetically assuming that these means would have been available at the priority date.35 c) Parity Regarding “parity”, the person skilled in the art has to align his considerations with the claimed teaching so that he is able to identify the modified means as equivalent.36 This means the person skilled in the art must recognize the modified means as having essentially the same effect as the technical teaching as claimed (and not as disclosed since the protected teaching is confined to the claims).37 For this, the person skilled in the art must not rely on his expert knowledge but rather only on the patent (respectively, the patent claims). Accordingly, the modified means collectively have to be an equivalent solution to the claimed teaching.38 This does not mean that the specification must direct the person skilled in the art to the modified means.39 Notably, “parity” cannot be denied on the basis that the patentee has deliberately chosen a certain wording of the respective claim feature and, thus, has committed himself to a certain (restricted) claim interpretation. This kind of “commitment” is not able to determine the question of parity positively or negatively.40 However, “parity” is denied in case of a so-called selective invention. Here, certain embodiments are excluded from the scope of protection if these are disclosed or detectable but for whatever reasons the reader of the patent has to assume that these embodiments are not supposed to be protected (so-called “doctrine of renunciation”).41 Hence, the considerations of the person skilled in the art also have to be in line with the selective invention at hand. Accordingly, if the specification discloses several embodiments of which only one has been included in the claims, the scope of protection does not generally extend to the other, non-included, embodiments.42 Nevertheless, a claim directed at a specific chemical compound, when the specification merely discloses the class of chemical compounds, is not necessarily regarded a selective invention. This is due to the fact that the person skilled in the art would usually need further information to individualize the other members of the chemical class.43 The Federal Supreme Court has stated that the basic rule regarding selective inventions – namely, the disclosure or detectability – is restricted to the content of the specification itself. A detectability merely based on information in the specification would not render an invention a selective invention, since the detectability is anyway a requirement to assume equivalence.44 In this regard, earlier versions of the patent might give useful guidance.45 d) The Formstein-objection However, the scope of protection under the Doctrine of Equivalence is limited if the embodiment equivalently infringing the patent in suit is anticipated or obvious from the prior art.46 This is due to the fact that the scope of protection must not be extended to embodiments being covered by prior art. After raising this objection, the infringement court has to assess whether the attacked embodiment is indeed not patentable in light of the prior art. Accordingly, the Formstein-objection is an exception to the rule that German infringement courts do not have jurisdiction to assess the patentability.47 3. Interim conclusion It is very welcome to see that the Federal Supreme Court has clarified many legal issues regarding claim construction. First, the fact that the Federal Supreme Court has highlighted in many recent cases the requirement to (independently) construe the patent claims shows that the court expects infringement courts as well as the Federal Patent Court to put increasing emphasis on claim construction. Additionally, until recently, it has been unclear if and how dependent claims can be used to construe the main claim. The Wärmetauscher-decision48 provides very useful guidance in this regard. Although it is not (yet) quite clear how the “doctrine of renunciation” as outlined in Okklusionsvorrichtung49 can be aligned with Pemetrexed50 (see below in detail), it is very welcome to see the Federal Supreme Court opening the door for equivalent infringement once again. Unfortunately, however, the Federal Supreme Court seems to shy away from principally deciding whether and to what extent the prosecution file can be used for claim construction. There have been a couple of cases in which the court has missed the opportunity to issue decisions of principle in this regard.51 On the contrary, one has the impression that the court is in each case desperately looking for reasons why a decision in this regard can still be left open. III. The approach to claim construction and equivalence by UK courts prior to Pemetrexed 1. House of Lords in Catnic Components Ltd v. Hill & Smith Ltd (“Catnic”)52 In Catnic (only decided under domestic law without any reference to Art. 69 EPC), the House of Lords made it clear that there is only “a single cause of action”. Besides, the House of Lords developed the test for assessing whether the person skilled in the art “would understand that strict compliance with a particular descriptive word or phrase in a claim was intended by the patentee to be an essential requirement (…) so that any variant would fall outside the monopoly claimed (…)”. 2. Patents Court in Improver Corp. v. Remington Comsumer Products Ltd (“Improver”)53 This test was subsequently picked up by the Patents Court in the Improver-judgment. Although the court made it clear that this test is applicable in case the attacked embodiment “fell outside the primary, literal or a contextual meaning of a descriptive word or phrase in the claim (‘a variant’)”, the question was still whether or not the attacked embodiment “was nevertheless within its language as properly interpreted”. The Patents Court reformulated the test and accordingly, the following questions are to be asked with regard to variants: Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no – Would this (i.e. that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. If yes – Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim. a) The first two questions Although the first two questions cannot reasonably be answered without reference to the patent in suit, these questions are of factual nature. Accordingly, these questions are supposed to serve as a factual basis for interpreting the patent specification. b) The third question The third question, finally, concerns the construction of the claims. For this, the court made it clear that the first two questions are not exclusive. 3. House of Lords in Kirin-Amgen Inc. v. Hoechst Marion Roussel Ltd (“Amgen”)54 About 15 years later, the House of Lords had to decide the Amgen case. There, the House of Lords came to the conclusion that the approach taken in Catnic was one of “purposive construction”. Hence, the decisive point is how the person skilled in the art would understand the wording of the claims. Consequently, the House of Lords clearly was of the opinion that Art. 69 EPC “firmly shuts the door on [the doctrine of equivalence]”. Accordingly, the “purposive construction” gave “effect to the requirements of the Protocol” with the Improver-Questions merely to be used as guidelines for application with regard to equivalents. 4. Interim conclusion Especially after Amgen, it was clear that the UK did not accept a separate Doctrine of Equivalence in the absence of a literal infringement. However, the House of Lords has also stated that equivalent embodiments could be covered by a purposively constructed claim. Nevertheless, it seems fair to say that on the one hand the Germans favoured the patentee focussing on a fair protection for the patentee, the British, on the other hand, focussed on legal certainty for third parties apparently shifting their favour towards the users of the patent. While both approaches seemed to be in line with Art. 69 EPC, they were nonetheless still not at all aligned with each other.55 IV. The Pemetrexed-decisions by the Federal Supreme Court and the UK Supreme Court Over the last years, Eli Lilly and Actavis have been disputing, inter alia before German and UK courts, whether Actavis’ medicaments infringe Eli Lilly’s pemetrexed patent. The decision by the Federal Supreme Court has been rendered on 14 June 2016, over a year before the UK Supreme Court issued its decision (on 12 July 2017). 1. The background of the dispute In short, the background is as follows. Eli Lilly is the proprietor of a patent claiming the use of pemetrexed disodium together with vitamin B12 for cancer treatment. Pemetrexed belongs to the chemical class of antifolates. Other than a general remark that all antifolates are suitable for use in the patented invention, the specification only refers to “Pemetrexed Disodium”. One of Actavis’ proposed products comprised the use of pemetrexed dipotassium together with vitamin B12 for cancer treatment. 2. The decision by the Federal Supreme Court56 According to settled German case law, equivalent infringement is possible if a literal infringement can be excluded (see above). a) Literal infringement The Federal Supreme Court found that a literal infringement of the patent claim by way of using Pemetrexed Dipotassium instead of Pemetrexed Disodium is excluded. Especially a functional interpretation of the claim is not indicated due to the fact that in this case the claim is to be interpreted narrowly. First, a functional interpretation is generally not suitable in the case of a chemical compound. Secondly, the wording of the specification is consistent with the wording of the claim (since the specification generally refers to “Pemetrexed Disodium”). In this regard, statements by the patentee and the examiner during examination strengthened this interpretation. Since these statements have only been given the same weight as textbooks, the appellate court was right to use these as indications for the correct interpretation. b) Equivalent infringement However, the Federal Supreme Court disagreed with the appellate court which had also excluded an equivalent infringement due to the lack of fulfilment of the third Schneidmesser-Question. The Higher Regional Court of Dusseldorf has stated that the disclosure of a class of chemical compounds leads to a detectability of all members of this class. Since the specification points out that the invention can be fulfilled with all antifolates, reference must be made to the Okklusionsvorrichtung-decision by the Federal Supreme Court.57 Accordingly, due to the fact that detectability leads to a so-called selective invention, there is no room for “parity” and, thus, there is no room for infringement based on the doctrine of equivalence. Hence, the Higher Regional Court did not have to evaluate the other two Schneidmesser-Questions.The Federal Supreme Court did not assume a selective invention due to the fact that a mere detectability based on information given in the specification is not sufficient. Additionally, a selective invention on the basis of prior versions of the patent can only be assumed if the claims have been concretised in order to distinguish the claim from prior art. Since this was not the case, the Federal Supreme Court did not have to decide whether prior version can be consulted for interpretation at all. Finally, just because a functional interpretation is not suitable with regard to the question of literal infringement, this does not mean that an equivalent infringement is not available. Accordingly, the Federal Supreme Court made it clear that an exact scientific definition used in the claims is not sufficient to deny that a modification is based on the meaning of the teaching of the claims. Since the Federal Supreme Court can make factual findings only under very narrow circumstances, the case was referred back to the appellate court since further factual findings are needed to answer the other two Schneidmesser-Questions. 3. The decision by the UK Supreme Court58 After making reference to previous UK case law on this topic (see above), the UK Supreme Court did not follow Lord Diplock’s uniform approach in Catnic.59 Accordingly, the question of infringement is to be addressed by two issues: Does the variant infringe any of the claims as a matter of normal interpretation? If not, does the variant nonetheless infringe because it varies from the invention in a way of ways which is or are immaterial? Hence, the courts, first, have to assess infringement under “normal” (or literal) interpretation and if this is excluded, issue (2) “squarely raises the principle of equivalents”. a) Normal (or literal) infringement The UK Supreme Court denied normal infringement because “‘pemetrexed disodium’ means that particular salt, and no other salt”. b) Equivalent infringement With regard to equivalent infringement, the UK Supreme Court referred to the so-called Improver-Questions60 but decided that these questions needed to be amended. To better understand the amendments, both set of questions are contrasted with each other: The original Improver-Questions  The reformulated Improver-Questions  Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim.  Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?  Would this (i.e. that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim.  Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?  Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim.  Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?  The original Improver-Questions  The reformulated Improver-Questions  Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim.  Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?  Would this (i.e. that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim.  Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?  Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim.  Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?  aa) The first question Regarding the first question, the Supreme Court found that more emphasis should be put on the problem underlying the invention (i.e. the inventive concept). Hence, unlike in the original version, question one is not just about the factual background. bb) The second question According to the UK Supreme Court, the second question should be asked “on the assumption that the notional addressee knows that the variant works to the extent that it actually does work”. Otherwise, the burden on the patentee would be too high, since the person skilled in the art would be required to figure that out. However, it would in many cases be impossible for a skilled person to predict whether any particular variant would work. Additionally, it does not matter whether variants have only been developed after the priority date. The second revised Improver-Question does also not necessarily have to be denied (although this is very likely) if the variation represents an inventive step. Subject to the effect of the prosecution history (see below under c)), the Supreme Court did not have any doubts to confirm the first two questions. cc) The third question Finally, with regard to the third question, not only the language of the claim is important but also the specification and the knowledge and expertise of the addressee. Additionally, the fact that a variant is not covered by the language of the claim is not sufficient to deny this question. Furthermore, it is to be asked whether the respective feature of the claim is an “essential” part of the invention which means that it does not have to be an “essential” part of the whole protected product. Lastly, it is sufficient if the variant was obvious at the date of infringement. Regarding the third question, the UK Supreme Court concluded that the reason why the claims were limited was that pemetrexed disodium was the “salt on which the experiments described in the specification had been carried out”. However, there was no indication that other pemetrexed salts should be excluded from the scope of protection. c) The effect of the prosecution history In principle, the UK Supreme Court agreed with the careful German approach. Accordingly, reference to the prosecution file shall be appropriate where either the point at issue is truly unclear if one confines oneself to the specification and claims of the patent, and the contents of the file unambiguously resolve the point, or it would be contrary to the public interest for the contents of the file to be ignored. As the court was able to construe the patent claims (see above under aa) and bb)), alternative (1) was not at issue. Alternative (2) would only be applicable in a case “where the patentee had made it clear to the EPO that he was not seeking to contend that his patent, if granted, would extend its scope to the sort of variant which he now claims infringes”. Hence, if statements of the patentee during examination regarding the scope of protection are contrary to his assertions during infringement proceedings, reference to the prosecution history should be admissible. However, the UK Supreme Court did not find any grounds for such contradicting statements. Accordingly, Actavis was found to infringe Eli Lilly’s pemetrexed patent equivalently. V. Conclusion Both courts recognize that there is room for equivalent infringement in the absence of literal (or normal) infringement; hence, a twofold assessment is to be conducted. In this regard, the UK Supreme Court seems to have made a giant leap towards Germany by refraining from the uniform “purposive construction”.61 Additionally, both courts have developed similar requirements that need to be fulfilled when assessing an equivalent infringement: The reformulated Improver-Questions  The Schneidmesser-Questions  Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?  Do the modified means have objectively the same effect as the means specified in the claim based on the underlying problem and solution of the patent?  Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?  Would the person skilled in the art have come up with the modified means on the priority date without any particular (i.e. inventive) considerations on the basis of his expert knowledge?  Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?  Are those considerations conducted by the person skilled in the art in order to arrive at the modification based on the meaning of the teaching in the claims?  The reformulated Improver-Questions  The Schneidmesser-Questions  Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?  Do the modified means have objectively the same effect as the means specified in the claim based on the underlying problem and solution of the patent?  Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?  Would the person skilled in the art have come up with the modified means on the priority date without any particular (i.e. inventive) considerations on the basis of his expert knowledge?  Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?  Are those considerations conducted by the person skilled in the art in order to arrive at the modification based on the meaning of the teaching in the claims?  The first Schneidmesser-Question searching for the “same effect based on the underlying problem” comes very close to the revised first Improver-Question searching for the “same result in substantially the same way as the invention, i.e. the inventive concept”. Additionally, the second Schneidmesser-Question is also very similar to the second revised Improver-Question. The only difference is that German case law denies an equivalent infringement if the variant required an inventive step (while the UK Supreme Court did not see any reason for this kind of absolutism). Nevertheless, the UK Supreme Court made it clear that “the German version of the second test will (…) usually produces the same result as the reformulated second [Improver] question.” Furthermore, the third Schneidmesser-Question as well as the third revised Improver-Question both look at the teaching of the claims and not at the teaching of the overall product or process. Finally, both courts only allow very limited reference to the prosecution file. Nonetheless, the UK Supreme Court seems to have a clearer approach to making references to the prosecution file. While the German Federal Supreme Court is generally not accepting any such reference (subject to exceptions not yet defined), the UK court has at least started to consider the circumstances under which reference to the prosecution file is admissible. In this regard, German case law does not offer great legal certainty (see above under II. 3.). Having said this, it is still very welcome to see that the highest courts of two of the most important patent jurisdictions in Europe seem to approach the question of equivalence very similarly. While the German case has not been finally disposed, subsequent preliminary injunction proceedings before the Higher Regional Court of Munich62 give reasons to believe that both jurisdictions are moving in the same direction regarding the Doctrine of Equivalence. Footnotes 1 Cf. the Epilady-cases litigated inter alia in Germany and the UK. 2 The English original of Art. 69 EPC 1973 spoke of “the terms of the claims”, which was translated into German as “Inhalt der Patentansprüche” and into French as “la teneur des revendications” (literally, however, both translations do not refer to the “terms” but rather to “the content of the claims”). Now, Art. 69 EPC 2000 simply refers to the “claims”. 3 Federal Supreme Court, GRUR 2011, 701 – Okklusionsvorrichtung. 4 Federal Supreme Court, GRUR 2004, 1023 – bodenseitige Vereinzelungseinrichtung. 5 Federal Supreme Court, GRUR 2010, 602 – Gelenkanordnung. 6 Federal Supreme Court, GRUR 2004, 47 – blasenfreie Gummibahn I. 7 Federal Supreme Court, GRUR 2015, 972 – Kreuzgestänge. 8 Federal Supreme Court, GRUR 2010, 950 – Walzenformgebungsmaschine; Federal Supreme Court, GRUR 2015, 199 – Sitzplatznummerierungseinrichtung. 9 Federal Supreme Court, GRUR 1987, 626 – Rundfunkübertragungssystem. 10 Federal Supreme Court, GRUR 2011, 701 – Okklusionsvorrichtung. 11 Federal Supreme Court, GRUR 2015, 159 – Zugriffsrechte. 12 Okklusionsvorrichtung, above, n 10. 13 Federal Supreme Court, GRUR 2016, 1031 – Wärmetauscher. 14 Federal Supreme Court, GRUR 2006, 131 – Seitenspiegel. 15 Higher Regional Court of Düsseldorf, docket-no. I-2 U 5/14 – Partikel-Auffangvorrichtung. 16 Federal Supreme Court, GRUR 1999, 909 – Spannschraube. 17 Federal Supreme Court, GRUR 2016, 921 – Pemetrexed. 18 Federal Supreme Court, GRUR 2002, 511 – Kunststoffrohrteil; cf. Federal Constitutional Court, NJW 2011, 842. 19 Federal Supreme Court, NJW 1997, 3377 – Weichvorrichtung II; Pemetrexed, above n 17. 20 Federal Supreme Court, GRUR 2015, 875 – Rotorelemente with further references. 21 Pemetrexed, above n 17. 22 Higher Regional Court of Düsseldorf, GRUR-RS 2014, 21715 – Verschleißteil; Higher Regional Court of Karlsruhe, GRUR-RS 2014, 17797 – Zugriffskanal. 23 Federal Supreme Court, NJW 1997, 3377 – Weichvorrichtung II. 24 Federal Supreme Court, GRUR 1998, 895 – Regenbecken. 25 Federal Supreme Court, GRUR 2007, 778 – Ziehmaschinenzugeinheit. 26 Federal Supreme Court, GRUR 1986, 803 – Formstein. 27 Federal Supreme Court, GRUR 2002, 515 – Schneidmesser I; Federal Supreme Court, GRUR 2002, 519 – Schneidmesser II. 28 Federal Supreme Court, GRUR 2015, 361 – Kochgeschirr. 29 Federal Supreme Court, GRUR 2010, 602 – Gelenkanordnung. 30 Higher Regional Court of Düsseldorf, docket-no. I-2 U 40/16 – Druckmaschine. 31 Federal Supreme Court, GRUR 2012, 45 – Diglycidverbindung; Higher Regional Court of Munich, docket-no. 6 U 3039/16 – Pemetrexed Tromethamin. 32 Pemetrexed, above n 17. 33 Federal Supreme Court, GRUR 1994, 597 – Zerlegvorrichtung für Baumstämme. 34 Higher Regional Court of Munich, docket-no. 6 U 3039/16 – Pemetrexed Tromethamin. 35 Higher Regional Court of Düsseldorf, docket-no. I-2 U 5/14 – Partikel-Auffangvorrichtung. 36 Pemetrexed, above n 17. 37 Kunststoffrohrteil, above n 18. 38 Federal Supreme Court, GRUR 2007, 91 – Pumpeinrichtung. 39 Federal Supreme Court, GRUR 2014, 852 – Begrenzungsanschlag. 40 Federal Supreme Court, GRUR 2016, 1254 – V-förmige Führungsanordnung. 41 Pemetrexed, above n 17; Federal Supreme Court, GRUR 2012, 45 – Diglycidverbindung; Federal Supreme Court, GRUR 2011, 701 – Okklusionsvorrichtung. 42 Okklusionsvorrichtung, above n 10. 43 Pemetrexed, above n 17, with reference to Federal Supreme Court, GRUR 2009, 382 – Olanzapin. 44 Ibid. 45 See above under item 1. a). 46 Federal Supreme Court, GRUR 1986, 803 – Formstein. 47 Federal Supreme Court, GRUR 2003, 550 – Richterausschluss. 48 Federal Supreme Court, GRUR 2016, 1031 – Wärmetauscher. 49 Okklusionsvorrichtung, above n 10. 50 Pemetrexed, above n 17. 51 See above under II. 1. d). 52 [1982] RPC 183, 242. 53 [1990] FSR 181. 54 [2005] RPC 9. 55 K Grabinski, ‘,,Schneidmesser” versus ,,Amgen”' GRUR 2006, 714. 56 Pemetrexed, above n 17. 57 Okklusionsvorrichtung, above n 10. 58 [2017] UKSC 48. 59 [1982] RPC 183, 242. 60 [1990] FSR 181. 61 Cf. K Grabinski, ‘,,Schneidmesser” versus ,,Amgen”' GRUR 2006, 714 who regarded the “purposive construction” followed by the UK courts at that time as one of the major differences between Germany and the UK. 62 Higher Regional Court of Munich, docket-no. 6 U 3039/16 – Pemetrexed Tromethamin. © The Author(s) 2018. Published by Oxford University Press. All rights reserved.

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Journal of Intellectual Property Law & PracticeOxford University Press

Published: Mar 1, 2018

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