Actavis v Eli Lilly explained
The UK Supreme Court (UKSC) has issued a landmark Judgment in which the test for direct infringement of a patent by equivalents has been reformulated.
Eli Lilly & Company (“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 for the treatment of cancer. An Actavis group of companies (“Actavis”) sought declarations of non-infringement for its proposed products which used (1) pemetrexed diacid, (2) pemetrexed ditromethamine or (3) pemetrexed dipotassium rather than pemetrexed disodium. Actavis sought these declarations for the UK, French, Spanish and Italian designations of Lilly’s patent.
At first instance, Arnold J held that none of the Actavis products would directly or indirectly infringe Lilly’s patent in respect of the four jurisdictions. The Court of Appeal partially allowed Lilly’s appeal, holding that there would be indirect infringement in the four jurisdictions, but agreed with Arnold J that were would not be direct infringement. Lilly thus appealed to the UKSC on the issue of direct infringement, and Actavis cross-appealed on indirect infringement.
The appeal to the UKSC highlights the issue of the correct approach to the interpretation of patent claims, and the requirement of the European Patent Convention 2000 (EPC) to account for equivalents. Furthermore, the Judgment considers the extent to which the prosecution history of a patent can be used when determining its scope.
In this Judgment the UKSC overturned the decisions of the High Court and Court of Appeal, holding that the Actavis products would directly infringe Lilly’s patent in the UK, France, Italy and Spain. Actavis’ cross-appeal was dismissed, meaning that if its products would not directly infringe, they would indirectly infringe as held by the Court of Appeal.
New Test for Infringement
Lord Neuberger considered Article 69(1) EPC, and Articles 1 and 2 of the Protocol to Article 69, which together provide the basis for interpreting the scope of protection of a patent claim. Article 69(1) EPC states that the extent of protection conferred by a European patent application shall be determined by the claims (and that the description and drawings shall be used to interpret the claims). Neuberger’s interpretation of Article 1 of the Protocol to Article 69 is that the scope of protection afforded to a patentee is not to be limited by the literal meaning of the claims. His interpretation of Article 2 of the Protocol to Article 69 is that there can be a difference between the interpreted scope of a claim and the scope of protection afforded by it, and when considering the scope of protection equivalents must be taken into account.
Having reviewed the relevant case law, which included the well-known cases of Catnic, Improver, Kirin-Amgen and the Improver-Protocol questions, the UKSC went on to state that the issue of whether an item directly infringes a patent is best approached by addressing two questions through the eyes of the notional addressee (i.e. the person skilled in the relevant art), specifically:
- Does the item infringe any of the claims as a matter of normal interpretation; and if not,
- Although the item may be characterised as a variant, does it nonetheless infringe because it varies from the invention in a way which is immaterial?
If the answer to either question is “yes”, there is an infringement; otherwise there is not.
With regard to question 1, Lord Neuberger considered that according to normal principles of interpretation the Actavis products would not infringe the patent.
Lord Neuberger considered that question 2 should be answered by referring to expert evidence and facts, and that the Improver questions, which have been referred to for guidance as to whether a variant should fall within the scope of a patent claim, were useful. Nevertheless, he has reformulated these questions 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 strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?
On answering yes, yes and no to the above three questions, the UKSC held that the Actavis products would directly infringe Lilly’s patent, and considered that the Court of Appeal had not placed enough weight on Article 2 of the Protocol to Article 69 and too much weight on the words of the claim.
The new test for direct infringement by equivalents will in some cases significantly broaden the scope of protection afforded to a patent claim.
The UKSC commented that reference to the prosecution history of a case would only be appropriate in limited circumstances, which did not apply in this case.
This is clearly a landmark decision with wide-ranging implications. We will consider these in detail in a follow-up discussion article.Return to Articles