Eli Lilly reigns Supreme
13 July 2017
The long running patent dispute between Actavis and Eli Lilly (Lilly) has now reached its zenith, with the UK Supreme Court decision issued 12th July (see here). The Supreme Court allowed Lilly’s appeal and held that Actavis’ products directly infringe Eli Lilly’s patent in the United Kingdom, France, Italy and Spain. This momentous decision has important things to say about equivalents, reformulates the historic “Improver” questions, and comments on the relevance of the prosecution history.
To recap briefly, the case concerns Lilly’s patent relating to the use of the anti-cancer drug pemetrexed disodium (marketed as Alimta®) in combination with vitamin B12. In 2014 at the UK High Court, Actavis sought declarations of non-infringement in relation to the UK, French, Italian and Spanish designations of Lilly’s European patent. The High Court ruled that Actavis’ pemetrexed dipotassium product did not infringe Lilly’s patent directed to the use of pemetrexed disodium either directly or indirectly and that Actavis was therefore entitled to the Declarations of Non-Infringement (DNIs) sought, as we reported here.
In the next round, the Court of Appeal agreed that there was no direct infringement, but reversed the decision of the High Court in relation to indirect infringement. In particular they found that dealings in pemetrexed diacid, dipotassium and ditromethamine by Actavis would constitute indirect infringement because each of Actavis’ active ingredients would be dissolved and/or diluted in saline (a source of abundant sodium ions) before administration to the patient. We reported this here.
Overturning both the High Court and Court of Appeal decisions, the Supreme Court allowed Lilly’s appeal and held that Actavis’ products directly infringe the patent. In addition, the Supreme Court dismissed Actavis’ cross-appeal on the basis that if its products did not directly infringe, they would indirectly infringe to the extent held by the Court of Appeal, i.e. when the product is dissolved or diluted in saline.
This case comes down to whether or not Lilly’s claim to the use of pemetrexed disodium covers Actavis’ salt variants. The Supreme Court posed the questions:
(i) does the variant infringe any of the claims as a matter of normal interpretation; and, if not, (ii) 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 issue is “yes”, there is an infringement; otherwise, there is not.
In taking a somewhat new approach, Lord Neuberger went to some lengths to point out that interpreting the claim is a different step from determining the scope of protection, and that the two should not be conflated, as he considered has happened in the previously influential Kirin-Amgen case.
The clear answer to question (i) is that Actavis’ salt variants do not fall within the meaning of Lilly’s claim using normal interpretation.
In Lord Neuberger’s judgment issue (ii) involves not merely identifying what the words of a claim would mean in their context to the notional addressee, but also considering the extent, if any, to which the scope of protection afforded by the claim should extend beyond that meaning.
The legal background for this reasoning is Article 69 EPC and its Protocol for Interpretation, the most relevant section of which directly addresses the question of equivalents with the guidance that “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.”
There is, of course, a long history of UK courts considering the scope of patent protection, and this was helpfully summarised in the judgment. Lord Neuberger concluded that the Improver questions provide helpful assistance but can be enhanced, particularly the second question which asks whether or not the fact that the variant has no material effect on the way the invention works would have been obvious to an expert in the field. Diverging with the Court of Appeal finding, the Supreme Court considered this to be unduly burdensome on the patentee as it requires the expert (rather than the patentee) to figure out for himself whether the variant would work. The Supreme Court therefore reformulated the Improver questions as follows:
i) 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?
ii) 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?
iii) 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?
In order to establish infringement in a case where there is no literal infringement, a patentee would have to establish that the answer to the first two questions was “yes” and that the answer to the third question was “no”.
This represents a significant shift in approach, meaning that variants which relate to developments that have occurred since the priority date could still be found to infringe, possibly even when the variant is itself patentable.
Application of the reformulated questions ultimately led to Lilly being successful in its argument that Actavis’ salt variants fell within the essence of the teaching and claim of the patent.
This judgment is good news for patentees who can now expect that non-material variations are more likely than before to be within the scope of patent protection under the reformulated Improver questions than they were previously.
With this new approach, perhaps the Supreme Court had an eye on an increasing need for a pan-European means for assessing patent infringement, a need which will become ever more important as the planned unitary patent system approaches. In any event, the decision seems to herald increased harmonisation for the patent courts of major European jurisdictions, which can only be a good thing.
Prosecution History Relevance
Taking a step back to consider this issue, at the High Court the prosecution history was considered to assist in ensuring that the patentee did not accept narrow claims during prosecution and subsequently argue for a broad construction of those claims for the purpose of infringement. This approach was rejected at the Court of Appeal, which concluded that it is not necessary to go to the prosecution history to arrive at a conclusion when one can get there, straightforwardly, by reading the claims in light of the specification.
In the Supreme Court decision Lord Neuberger concludes that it is appropriate for the UK courts to 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. His guidance is that reference to the file would only be appropriate where:
(i) 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 (ii) it would be contrary to the public interest for the contents of the file to be ignored.
This decision clarifies the situation that arguments and amendments made before grant are relevant to interpretation of the claims in infringement proceedings only in specific limited circumstances.
Dr Nicholas Jones
Life Sciences & Chemistry Group
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© Withers & Rogers LLP, July 2017