Actavis v Eli Lilly – Summary of Supreme Court Decision of 12 July 2017

Background

Lilly is the proprietor of a patent that claims the use of pemetrexed disodium in the manufacture of a medicament for use in combination with vitamin B12 (and, optionally, folic acid) for the treatment of cancer. Actavis sought declarations of non-infringement for its proposed products which used (i) pemetrexed diacid, (ii) pemetrexed ditromethamine, or (iii) pemetrexed dipotassium in place of pemetrexed disodium. Actavis sought such declaration in respect of the UK, French, Spanish and Italian designations of Lilly's patent. The ability of the English courts to grant such declarations in respect of the foreign designations had been confirmed earlier in this action.

The High Court held that none of the Actavis products would directly or indirectly infringe the patent in the UK, France, Italy and Spain. The Court of Appeal allowed Lilly's appeal in respect of there being indirect infringement of the patent in each jurisdiction. Both parties were given permission to appeal to the UKSC.

Judgment

The UKSC concluded that as a matter of ordinary language, it is clear that the only type of pemetrexed compound to which the patent claims expressly extends is pemetrexed disodium. The question that the UKSC then had to consider was how far one can go outside the wording of a claim.

The UKSC reviewed the relevant case law of the UK and other Convention states. In relation to the UK, those cases were the well-known cases of Catnic, Improver and Kirin-Amgen and the Improver/Protocol questions that arose from those cases. The UKSC has stated that the problem of infringement is best approached by addressing the following two issues:

1. Does the variant infringe any of the claims as a matter of normal interpretation; and, if not,
2. 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 of those questions is "yes" then there is infringement, otherwise there is not. The decision states that issue 1 self-evidently raises a question of interpretation, whereas issue 2 raises a question which would normally have to be answered by reference to the facts and expert evidence. The UKSC then criticises the approach taken in Catnic, Improver and Kirin-Amgen for effectively conflating the two issues and indicates that characterising the issue as a single question of interpretation is wrong in principle.

The UKSC went on to explain that treating issue 2 as one of interpretation will lead to a risk of wrong results in patent infringement cases and it will also lead to a risk of confusing the law relating to interpretation of documents. Accordingly, issue 2 is said to involve not merely identifying what the words in the 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.

Applying this new approach to the facts of this case, the UKSC confirmed that, in relation to the first issue, there was no doubt that the Actavis products do not infringe the patent as in no sensible way can pemetrexed diacid, pemetrexed ditromethamine or pemetrexed dipotassium be said to fall within the expression "pemetrexed disodium". However, it is the second issue that posed more difficulties of principle to the UKSC namely, what is it that makes a variation "immaterial"? While acknowledging that the Improver questions provided helpful assistance in answering that question, the UKSC has undertaken a critical explanation of questions 1 and 3 but has also reformulated question 2.

In relation to the first Improver question, the UKSC has now said that the emphasis of that question on how "the invention" works should involve the court…