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Abstract The authors Nicole Jadeja is a patent litigation partner in the Intellectual Property team at Fieldfisher LLP. Hannah Smith-Willis is an associate in the team and Heidi Hurdle a senior professional support lawyer. This article This article analyses the key points of the landmark UK Supreme Court decision in Actavis v Eli Lilly.1 In taking a position contrary to the High Court and Court of Appeal, holding that a claim to pemetrexed disodium covers other pemetrexed salts and the free acid, the Supreme Court issued a decision that will have far-reaching ramifications on patent infringement assessments. The authors discuss how the Supreme Court has struck a balance between rewarding patentees for their contribution to the art, by protecting them against the ‘unscrupulous copyist’2 and the public interest in promoting competition. The article also considers the implications of introducing a doctrine of equivalents into UK patent law and the Supreme Court’s approach to using the prosecution history as an aid to determining the scope of patent protection. The facts of this case will now be familiar to many: Lilly’s Patent EP (UK) 1 313 508 (the Patent) claims the use of the compound pemetrexed disodium in combination with vitamin B12 to inhibit tumour growth. This combination, which reduces the known toxic effects of using anti-folates (of which pemetrexed disodium is one) in the treatment of cancer, has been marketed by Lilly under the brand name Alimta since 2004. The issue considered in these proceedings is whether Actavis’s proposed generic product, in which the active ingredient would be pemetrexed diacid, pemetrexed dipotassium or pemetrexed ditromethamine, would infringe Lilly’s patent in the UK, as well as in France, Italy and Spain. The High Court originally granted Actavis a declaration of non-infringement in each of these jurisdictions. The Court of Appeal agreed that there was no direct infringement but concluded that Actavis’s products would indirectly infringe the patent. In this final chapter, Lilly appealed the Court of Appeal’s decision that there was no direct infringement, whilst Actavis cross-appealed the finding that there would be indirect infringement. For the first time, the Supreme Court considered the requirement of the European Patent Convention (EPC) 2000 to take account of so-called ‘equivalents’ in determining the scope of protection of patent claims. It also set out the circumstances in which the prosecution history of a patent may be of use in determining the scope of protection. The decision of the Supreme Court The Supreme Court (with Lord Neuberger giving the principal judgment) unanimously allowed Lilly’s appeal and concluded that Actavis directly infringed the patent. It also unanimously dismissed Actavis’s cross-appeal on the basis that, if dealings in the products did not directly infringe, they would indirectly infringe as held by the Court of Appeal. Direct infringement The question of non-literal infringement was at the heart of this case. Lord Neuberger began by going back to basics on the principles of claim construction and scope of protection. In reviewing Article 69 EPC and the Protocol thereto, he noted that when determining the scope of protection of a patent, a balance needs to be struck between on the one hand the strict, literal meaning of the words of the claim and, on the other, the claims serving only as mere guidelines. The Protocol confirms3 that the correct approach is a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties. It also explicitly requires due account to be taken of equivalents when determining the scope of protection.4 Lord Neuberger concluded that patent infringement was best approached by first addressing two questions (to be considered through the eyes of the notional addressee of the patent): Does the variant infringe any of the claims as a matter of normal interpretation; and, if not, Does the variant nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial? If the answer to either question is ‘yes’, there is an infringement; otherwise, there is not. This is in contrast to the single-step approach taken by Lord Hoffmann in Kirin-Amgen5 and which Lord Neuberger cautioned against for effectively conflating the issue of interpretation (raised by question 1) with the scope of protection (raised by question 2). Lord Neuberger’s view is that having a single, conflated or compound issue will raise only the issue of interpretation, which is wrong in principle. Drawing on examples of door lintels from Catnic and epilators from Improver, Lord Neuberger explained that, whilst normal principles of interpretation could accommodate scenarios where an item is not precisely 90 degrees to another item (as was the angle of the allegedly infringing support member in Catnic), they could never result in a slotted rubber rod being within the expression ‘helical metal spring’ (as per the facts in Improver), which was wrong. Applying question 1, according to normal principles of interpretation it was clear that Actavis’s products, containing alternative salt forms of pemetrexed or the free acid, could not fall within the expression ‘pemetrexed disodium’ in claim 1. The second question involves not merely identifying what the words of a claim mean but whether the scope of protection should extend beyond that meaning. Lord Neuberger held that this approach would comply with the EPC 2000 as it squarely raised the principle of equivalents. In addressing this question, Lord Neuberger revisited in detail the three Improver6 questions (introduced by Lord Hoffmann in 1990 as a tool to assessing possible infringement by a variant) and considered the application of similar tests adopted in other EPC jurisdictions. After looking at each in turn, Lord Neuberger concluded that the Improver questions should be re-formulated as follows: 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, ie the inventive concept revealed by 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 such a reader of the patent have concluded that the patentee nonetheless intended strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention? To establish infringement where there is no literal infringement, a patentee would have to show that the answer to the first two questions is ‘yes’ and the answer to the third is ‘no’. The most significant changes put forward by Lord Neuberger are the re-formulation of question 2 and the revised application of question 3. The modified questions, which favour the patentee, allowed the Supreme Court to come to different answers to those reached by the High Court and Court of Appeal, leading to the conclusion that Actavis’s products would directly infringe the patent. In respect of each of the reformulated Improver questions, the court gave the following provisional conclusions: Question 1 – This should be answered ‘yes’. There is no doubt that Actavis’s products all involve a medicament containing a pemetrexed anion and vitamin B12, and, therefore, achieve substantially the same result in substantially the same way as the invention. Question 2 – This should also be answered ‘yes’. Armed with the knowledge that Actavis’s products achieve substantially the same result as the invention, it would be obvious to the skilled person that those products achieved that result in substantially (or in this case, precisely) the same way as pemetrexed disodium. Question 3 – This should be answered ‘no’. It was very unlikely that the notional addressee would have concluded that the patentee intended to exclude all pemetrexed salts, other than pemetrexed disodium, from the scope of protection. Use of prosecution history Actavis argued that the prosecution file showed that the EPO had rejected Lilly’s broader claims, first to ‘antifolates’ as a general class, and subsequently to ‘pemetrexed’ (which the EPO considered to be a reference to the diacid form). Lilly ultimately limited the claim to pemetrexed disodium only. Actavis argued, therefore, that the scope of protection should be limited to pemetrexed disodium. The issue for the Supreme Court to decide was whether this limitation during prosecution could be taken into account and, if so, whether it altered the provisional conclusion that there was direct infringement. Lord Neuberger considered that the UK courts should adopt a sceptical, but not absolutist, attitude to a suggestion that the contents of the prosecution file of a patent should be referred to when considering a question of interpretation or infringement. Recourse to the prosecution file will only be appropriate in limited circumstances, particularly if: (i) the point at issue is truly unclear if the reader is confined to the specification and claims of the patent, and the contents of the file unambiguously resolve the point or (ii) it would be contrary to the public interest for the contents of the file to be ignored. The court concluded that, in this case, the contents of the file did not justify departing from its provisional conclusion. Indirect infringement Having reached a positive conclusion on direct infringement, the Supreme Court only briefly addressed indirect infringement by rejecting Actavis’s arguments and confirming the Court of Appeal’s finding that Actavis’s products would indirectly infringe to the extent Actavis knew, or it was obvious in the circumstances, that ultimate users would dilute its pemetrexed products in saline prior to administration. Analysis of the Supreme Court’s decision And so the Improver questions live to see another day. But, the re-formulated questions raise many issues. Some old challenges remain. Some new challenges are foreseeable. Do we now have a true doctrine of equivalents and, if so, how far-reaching are the implications? The Improver questions have featured in English patent law since 1990,7 when Lord Hoffmann distilled the principles set out in the Catnic case8 in 1982 to three key considerations. Said to be just guidelines they have, nevertheless, been applied in many cases to determine whether or not someone has made an immaterial variation to an invention which should not be allowed to escape infringement. Whilst a first for the Supreme Court, this is in fact the second time the highest court in England and Wales has had to consider the Improver questions. Lord Hoffmann scrutinized them in Kirin-Amgen9 in 2004, rejecting the approach of Lord Neuberger, who had considered them at first instance. By an interesting twist of fate, Lord Neuberger has now had the opportunity to grapple with the questions again. What features of the questions have survived Lord Neuberger’s (second) scrutiny? Question 1 Instead of asking whether the variant has a material effect on the way the invention works, we must now consider if the variant achieves ‘substantially the same result in substantially the same way’ as the invention, that is, the inventive concept revealed by the patent. This introduces wording borrowed from ‘equivalence’ principles applied in other jurisdictions (notably the Netherlands and the USA). Whilst not substantially different from the previous iteration of this question (whether the variant has a material effect on the way the invention works), the changes have clearly been motived by a desire to be more aligned to the approach to equivalents taken in other jurisdictions. The old challenges posed by this question remain. Disputes over the level of generality at which you define the invention and what ‘substantially the same’ means in practice are foreseeable and already being discussed. Question 2 Matters become increasingly interesting when considering the re-formulation of question 2. The significant change with this question is that the notional skilled person now has the benefit of hindsight, in that they are assumed to know at the priority date that the variant works, or at least ‘achieves substantially the same result’ as the invention. Prior to this decision, the skilled person would have had to work out for themselves whether the variant works at all, which Lord Neuberger considered imposed too high a burden on the patentee and therefore failed to provide adequate protection. Indeed, the lower courts in this case held that the skilled person would not know which other pemetrexed salts would have acceptable properties for use as a medicament, despite also finding that it would be a routine exercise to find out. The introduction of hindsight into this question removes the need for the skilled person to make any assessment as to what result the variant achieves, leaving them only to answer whether it is achieved in substantially the same way as the invention. With the benefit of hindsight, this question now enables the skilled person to take account of technical developments and knowledge acquired after the priority or even the publication date of the patent. Does this imply that the scope of protection of the patent increases as knowledge in a particular field increases? Or perhaps the scope of protection remains constant, but the skilled person’s knowledge of what variants would fall within that scope will change? In either case, it is challenging to see how this provides reasonable certainty for third parties. We could also be faced with a scenario where an inventive variant (which would not invalidate the patent if it had been prior art at the priority date) could nevertheless be deemed to infringe the patent. This is an interesting proposition—driving a gulf between considerations of validity and infringement and is perhaps why Lord Neuberger acknowledged that it is less likely that an inventive variant would fall within the scope of protection of the patent. Interestingly, this amendment to question 2 is not new. It was proposed by Lord Neuberger (at first instance) and rejected (on appeal) by Lord Hoffmann back in 2004. Lord Hoffmann preferred to accept that the Improver questions might not be helpful when new technology has developed since the priority date. Question 3 Changes to the third question appear, on the face of it, to be less significant. However, the Supreme Court has given guidance as to how the question should be applied and, in so doing, it has come to a different outcome from the Court of Appeal (as well as suggesting that the outcome in Improver may have been different based on this approach). Lord Neuberger considered that the Court of Appeal, in trying to follow Lord Hoffmann’s guidance in Kirin-Amgen, had placed too much emphasis on the words of the claims and normal interpretation. On the question of scope of protection, he said that it may well be necessary to depart from the language of the claim and consider whether the variant is an ‘essential’ part of the invention (as opposed to an ‘essential’ part of the product/process of which the inventive concept is part). Again, Lord Neuberger has imbued the notional addressee with knowledge he would have at the date of infringement when considering whether the patentee nevertheless intended that strict compliance with the literal meaning of the claim was an essential requirement of the invention. Patent prosecution history The Supreme Court also tackled the issue of whether it is appropriate to consult the prosecution history of the patent to determine the scope of protection, as well as whether the prosecution history in this particular case justified altering the provisional conclusion that Actavis infringed. On the first, more general question, Lord Neuberger confirmed that the prosecution file should not generally play a role in establishing construction apart from cases where, for example, truly unclear language was used or disregarding the prosecution file would be contrary to the public interest. One of the main arguments against consulting the file has centred around Lord Hoffmann’s statement that ‘life is too short’ and that it would place an undue burden on third parties to have to read the prosecution file to aid construction; the irony here is that scrutiny of the prosecution file will be required in any event in order to determine whether either of these exceptions apply. In reality, potential infringers, lawyers and patent attorneys will undoubtedly analyse the prosecution file in greater detail now, but to what effect remains to be seen. The principle adopted by Lord Neuberger is still far removed from the principle of ‘file wrapper estoppel’ applied in other jurisdictions. The infamous Festo Corp. v Shoketsu10 and more recent Intendis GmbH v Glenmark Pharmaceuticals11 litigations demonstrate that, in the USA, disclaiming certain subject matter during prosecution can operate as a bar to an infringement claim under the doctrine of equivalents. Despite the UK Supreme Court introducing a doctrine of equivalents to extend the scope of protection, the decision confirms that the UK is not introducing a counterbalance in the form of a general principle of file wrapper estoppel. In this case, Lord Neuberger did not consider that the exchanges between the EPO and Lilly during prosecution justified departing from his finding of infringement. Lilly made narrowing amendments during prosecution and Actavis sought to prevent Lilly from ‘reclaiming’ patent scope that had been surrendered. It is clear that the context of the amendment will be key to whether this argument succeeds; the amendment here was to overcome an intermediate generalization objection and added subject matter, rather than to avoid a key piece of prior art. Added matter objections therefore appear less likely to derail an infringement claim as it is still open to argue that the scope covered by the claim is an equivalent. The Supreme Court’s intention is clearly that reliance on the prosecution file will only be appropriate in limited circumstances (in contrast to the position in the USA and some other jurisdictions). In practice, we anticipate potential infringers may seize this opportunity to try to place more reliance on the prosecution file, but it remains to be seen whether anything other than a definitive statement that something is outside the claims could be used as a defence to infringement. The conclusion of the Supreme Court has already been heavily debated and appears not to have been followed in a later decision handed down by the Court of Milan, which forms part of the wider battle over Lilly’s pemetrexed product. Here, the limitation to ‘pemetrexed disodium’ during prosecution was considered a ‘clear delineation of patent protection’ and therefore the patent did not cover the alternative pemetrexed salt form at issue in the case. Whilst the Italian proceedings involved different parties,12 the decision clearly sits at odds with the UK Supreme Court decision, which found infringement of the Italian designation of Lilly’s patent in the UK proceedings. Lord Neuberger’s attempt at harmonizing the scope of protection across Europe therefore appears to have encountered a shaky start. So, what does all this mean in practice? The Supreme Court has attempted to align the UK’s position on equivalents to those in Europe and the USA by firmly introducing a doctrine of equivalents into UK law. Expressly having post-priority knowledge about the variant will shift the infringement analysis from negative to positive in many scenarios, as happened in this case. Critics of the doctrine say that it will now be difficult to delineate the boundaries of the extent of protection, providing greater protection to the patentee at the expense of legal certainty for third parties. The decision is certainly pro-patentee and it will now be easier for patent owners to succeed in an action for direct infringement than it was before. Patentees who previously decided against asserting a patent based on a narrow claim may now wish to reconsider their position and reassess their chances of sufficiently broadening their claim scope to cover a potential infringer. Likewise, companies who have developed what they think are safe ‘work arounds’ should revisit just how safe these variations are. Footnotes 1 [2017] UKSC 48. 2 Per Lord Hoffmann, [2005] RPC 9 at 37, quoting Jackson J in Graver Tank & Manufacturing Co Inc v Linde Air Products Co 339 US 605, 607 (1950). 3 Article 1 of the Protocol on the Interpretation of Article 69 EPC. 4 Ibid, Article 2. 5 Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 9. 6 Improver Corp v Remington Consumer Products Ltd [1990] FSR 181. 7 Improver Corpn v Remington Consumer Products Ltd [1990] FSR 181. 8 Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183. 9 Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 9. 10 Festo Corporation v Shoketsu Kinzoku Kogyo Kabushiki Co Ltd (Supreme Court, 28 May 2002). 11 Intendis GmbH v Glenmark Pharmaceuticals Inc., USA, No. 15-1902 (Federal Circuit, 16 May 2016). 12 Fresenius Kabi Oncology Plc and Ors v Eli Lilly & Company and Ors (N.R.G. 54470/2016). © 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 of Intellectual Property Law & Practice – Oxford University Press
Published: Feb 2, 2018
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