Actavis UK Limited and others (Appellants) v Eli Lilly and Company

The case is Actavis UK Limited and others (Appellants) v Eli Lilly and Company (Respondent), decided by the United Kingdom Supreme Court on 12 July 2017, with the case number UKSC 48. The judgment was delivered by Lord Neuberger, President, with Lords Mance, Clarke, Sumption, and Hodge concurring.

The factual background involves pemetrexed, a chemical known for therapeutic effects on cancerous tumors but with significant toxic side effects when used alone. The patent in question, European Patent (UK) No 1 313 508, owned by Eli Lilly, disclosed that these side effects could be mitigated by administering pemetrexed disodium with vitamin B12, enabling a successful medicament marketed as Alimta since 2004. The patent claims focused on using pemetrexed disodium in medicaments combined with vitamin B12 for cancer treatment. Actavis developed products with pemetrexed diacid, pemetrexed ditromethamine, or pemetrexed dipotassium instead of pemetrexed disodium and contended that these did not infringe Eli Lilly’s patent. Eli Lilly argued that Actavis’s products infringed the patent directly or indirectly.

The main dispute was whether Actavis’s products infringed the patent claims limited to pemetrexed disodium. The lower court, Arnold J, initially found no infringement, with the Court of Appeal confirming no direct infringement but accepting indirect infringement. Eli Lilly appealed the rejection of direct infringement, and Actavis cross-appealed the finding of indirect infringement.

The Supreme Court held that Actavis’s products did directly infringe Eli Lilly’s patent in the UK and corresponding designations in France, Italy, and Spain, and dismissed Actavis’s cross-appeal on indirect infringement. The Court applied a nuanced approach to patent claim interpretation, emphasizing the Protocol on the Interpretation of Article 69 of the European Patent Convention, which calls for a balance between fair protection for patentees and legal certainty for third parties. The Court reformulated the established 'Improver' questions to determine infringement under the doctrine of equivalents, requiring that a variant achieves substantially the same result in substantially the same way, that it would be obvious to a skilled person that the variant works equivalently, and that the patentee did not intend a strict literal interpretation excluding such variants.

The Court found that although Actavis’s products did not literally fall within the claims limited to pemetrexed disodium, they were equivalent variants achieving the same therapeutic result through substantially the same means under the patent. The prosecution history limiting claims to pemetrexed disodium did not preclude the doctrine of equivalents extending protection to other pemetrexed salts or the free acid. The Court also confirmed that indirect infringement applies where the Actavis products, when dissolved in saline for administration, effectively produce pemetrexed disodium in solution.

This case clarified the application of the doctrine of equivalents in patent infringement, endorsing a purposive interpretation of patent claims that balances the literal wording with the inventive concept and the principle of equivalents. It provided guidance on how courts should approach equivalence, endorsing a more pragmatic approach whereby the skilled person assesses variants knowing the variant works, rather than speculating on outcomes without such knowledge. The decision is influential for patent law concerning pharmaceutical patents and equivalents.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi

Disclaimer: This information report is intended for informational purposes only and does not constitute legal advice.