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Eli Lilly v Actavis: Widening the Scope of Patent Protection

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About The Author

Connor Griffith (Joint Editor-in-Chief)

Connor is a law graduate from the University of Nottingham with a particular interest in intellectual property and corporate law. He recently completed the LPC and is waiting to begin his training contract with a large national firm. Outside the law, he enjoys stand-up comedy and horror books.

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A collision is happening between creativity and protecting IP.

Edward Felten

The recent case of Eli Lilly v Actavis [2017], decided by the Supreme Court earlier this month, has resulted in significant attention being drawn to the practice area of intellectual property. Indeed, hidden in the case – underneath intimidating compounds such as pemetrexed disodium and ditromethamine – lies the potential for an upheaval of how patent applications themselves are to be interpreted.

For this reason, Eli Lilly is a hugely important case. It appears to widen the scope of all patents to provide better protection against competing inventions that achieve substantially the same result as the original in substantially the same way, known as ‘equivalents’. Through this, the Supreme Court seems to have adopted a wider purposive approach to interpreting the language of patents, a choice which is both admirable and worrying.

The Story So Far

The case began in 2012, following global pharmaceutical company Actavis’ request for declarations of non-infringement in relation to Eli Lilly Ltd’s European Patent (the Patent) for ‘Alimta’: a freeze-dried powder which, when reconstituted and diluted with saline, can be administered to patients for the treatment of lung cancer by using pemetrexed disodium in combination with B12 and folic acid.

In April 2014, Eli Lilly alleged direct and indirect infringement of the Patent by Actavis. It argued that pemetrexed dipotassium, pemetrexed diacid and pemetrexed ditromethamine – the products in respect of which Actavis had sought declarations of non-infringement in 2012 – would either be directly within the scope of the claim based on equivalence, or would indirectly infringe when sold in lyophilised form (by constituting an essential means for putting the invention into effect when reconstituted and/or diluted with saline).

At first instance, Arnold J held that none of Actavis’ proposed products would infringe the Patent as Eli Lilly’s patent only extended to pemetrexed disodium. Eli Lilly appealed to the Court of Appeal, where it was found that while there was no direct infringement of the Patent due to the fact that Actavis’ competing product comprised the use of dipotassium as opposed to disodium,  an indirect infringement would occur when medical practitioners dilute it with saline, which contains sodium ions.

Eli Lilly then appealed to the Supreme Court regarding finding of no direct infringement, whereas Actavis cross-appealed on the basis that no indirect infringement should have been found. The Supreme Court, led by Lord Neuberger, unanimously held on 12 July 2017 that Actavis’ product would directly and indirectly infringe the Patent in the UK, France, Italy and Spain. The real matter of interest for present purposes is the finding of direct infringement.

The Supreme Court’s Judgment

Examining the Past Law

Section 60(1) of the Patents Act 1977 holds that the question of whether a product directly infringes an earlier patent requires consideration of the Protocol on the Interpretation of Article 69 European Patent Convention 2000 (EPC 2000). This, in summary, provides that:

  • The scope of protection afforded to a patentee is not to be limited by the literal meaning of the wording used in the claims, but is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.
  • For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.

As noted by the Supreme Court in Eli Lilly at [34], how far one can go outside the wording of a claim to enable the patentee to enjoy protection against products or processes which are not within the ambit of the actual language used has been discussed by three significant cases:

  • Catnic Components v Hill & Smith [1982] RPC 183

Here, Lord Diplock adopted a purposive approach. This considered whether persons, with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive word or phrase was intended by the patentee to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked.

  • Improver v Remington [1989] RPC 69

Here, Hoffmann J formulated ‘Protocol Questions’ which are outlined below.

  • Kirin-Amgen v Hoechst Marion Roussel [2005] RPC 169

Here, Lord Hoffmann (as he had become) expressed concerns about an equivalence approach to interpreting a patent. He felt it would make it difficult to determine 'where its limits should be drawn'. Instead, his Lordship opted to 'adopt a principle of construction which actually gave effect to what the person skilled in the art would have understood the patentee to be claiming', and found that Article 69 of the EPC 2000 'firmly shuts the door on any doctrine which extends protection outside the claims'.

A Change of Approach

In the present case, however, the Supreme Court adopted a balanced approach between the previous methods. This involved two distinct issues being examined:

  • Does the variant (the latter product) 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?

An answer of ‘yes’ to either of these questions will result in the finding of an infringement. In creating such an approach, Lord Neuberger stated that Lord Hoffmann’s analysis in Kirin-Amgen v Hoechst Marion Roussel [2005] 'conflated' these issues and thereby ran the risk of steps being skipped. Therefore, he argued that different tests must be adopted for the two separate issues.

It was made clear that, in the present case, there was no infringement under question (1) as Actavis’ products could 'in no sensible way' fall under the definition of “pemetrexed disodium” – this demonstrates that (1) adopts a strictly literal approach to the matter.

More difficulty was encountered in relation to question (2). As the matter was similar to previous approaches by the courts, Lord Neuberger adopted the above-mentioned Protocol Questions identified by Hoffman J in Improver v Remington [1989] RPC 69, but with some reformulation. For reference, the original Protocol Questions are as follows:

  • Does the variant have a material effect upon the way the invention works? If no, the variant is outside the claim.
  • 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 that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim. If no, the patentee was intending the word or phrase to have a figurative meaning.

Lord Neuberger stated the first question was 'generally satisfactory' and so left it untouched. The second question – on the other hand – he described as imposing 'too high a burden on the patentee … given that it requires the addressee to figure out for himself whether the variant would work'. The third question was deemed 'an acceptable test', provided that it is 'properly applied'; on this, he made subtle points concerning the extent to which 'language of the claim' should be interpreted and what is meant by the 'essential requirement of the invention'.

Following such comments, the Supreme Court provided its own reformulated version of the Protocol Questions, making it clear that they are 'guidelines, not strict rules'. The new approach is 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, i.e. 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 the strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?

There will be a direct infringement where the patentee demonstrates that the answer to the first two questions is ‘yes’ and the answer to the third is ‘no’.

Following consideration of the above questions, the Supreme Court found the Actavis products did directly infringe the Patent. Under the first question, there could be no doubt that the products achieve substantially the same result in the same way. As to the second question, it seemed clear that the notional addressee of the Patent would appreciate that each of the Actavis products would work in precisely the same way as pemetrexed disodium when included in a medicament with vitamin B12, and that investigation of whether pemetrexed free acid, pemetrexed ditromethamine or pemetrexed dipotassium worked would be a purely routine exercise.

The third question is of most interest. The Court of Appeal had considered that the notional addressee 'would understand that the patent was clearly limited to the disodium salt, and did not extend to diacid or the dipotassium or ditromethamine salts'. However, the Supreme Court believed that by doing so, the Court of Appeal had wrongly adopted 'an approach which places too much weight on the words of the claim and not enough weight on Article 2 of the Protocol'.

This criticism has been echoed extra-judicially by Laddie J, who notes that the House of Lords' approach in Kirin-Amgen v Hoechst Marion Roussel [2005] (from which the Court of Appeal in Eli Lilly drew inspiration) wrongly conflates the issue of interpretation with the issue of scope of protection. In fact, such an error can be seen in Floyd LJ's assertion that 'there is no obvious leeway as a matter of language for giving it a broad as opposed to a narrow construction'. Indeed, as Lord Neuberger – by way of a counter to Floyd LJ's point – wondered, 'if one cannot depart from the language of the claim when considering those questions, what is the point of the questions in the first place?'

Therefore, the Supreme Court ultimately held that the addressee of the Patent would understand that the reason why the claims were limited to disodium salt was because that was the only pemetrexed salt on which the experiments described in the specification had been carried out. As a result, it did not follow that the patentee did not intend any other pemetrexed salts to infringe: such an approach would confuse the disclosure of the specification of a patent with the scope of protection afforded by its claims.

For these reasons, it was concluded by Lord Neuberger – with whom the rest of the Supreme Court agreed – that there was a direct infringement of the Patent.

Comment

The exact implications of this decision are yet to be seen, though it clearly demonstrates an acceptance by the Supreme Court that the scope of patents should be widened so as to protect against equivalent inventions. This move narrows the gap between the domestic approach and those taken by the wider EU community, where an infringement will be found when the two products have the same purpose behind them.

Furthermore, it shows a much clearer resemblance to the doctrine of equivalents in the US, which considers whether the infringing product (i) performs substantially the same function (ii) in substantially the same way (iii) to yield substantially the same result. The American approach, however, only applies to individual aspects of a product instead of the claim concerning the competing products as a whole, as is the case in Eli Lilly. Therefore, the Supreme Court has gone even further in lowering the bar for finding infringements.

The extent to which the UK courts will consider the purpose behind rival products is uncertain. However, it now appears likely that there will not be an infringement where the rival product achieves the same result as the original but does so in only a similar way, on the grounds that this provides an alternative for consumers which, while perhaps taking inspiration from the original product, does not necessarily copy. Herein lies the difficulty with purposive approaches: as required by Article 1 of the Protocol on the Interpretation of Article 69 of the European Patent Convention 2000 and repeatedly reiterated by the Supreme Court in Eli Lilly (see [51], [53] and [61]), a balance must be struck between achieving fair protection for the patent proprietor and a reasonable degree of certainty for third parties.

Conclusion

It could be argued that adopting a purposive approach to interpreting patents goes beyond what is fair, because it means that original inventions could be found to cover future creations that the original inventors may not have even contemplated. It is submitted, however, that this risk is certainly justifiable: protection for an invention should not be disregarded simply because the literal wording of the claim does not cover every conceivable angle that competitors could target.

Inventors deserve protection for their work, and the possibility of losing such protection simply because there exists an ambiguous meaning that could be used to form the basis of a legal challenge is hardly appealling. Of course, a balance must be struck between where it is appropriate to extend interpretations of patents and where competitors should be given the opportunity to enter the market. This balance will be where the difficulty lies in cases that follow Eli Lilly. For now, the legal world can only wait to see how subsequent cases unfold.

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Tagged: Commercial Law, IP, Intellectual Property, Property Law, Supreme Court

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