Case Analysis: Sandoz And Teva v Bristol Myers Squibb ' Court Of Appeal

• Law Firm: Dehns
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Patent, Trials & Appeals & Compensation
• Author: Mr Paul Harris
• Published date: 16 May 2023

Plausibility after Warner-Lambert and G2/21

Summary

The 'patent bargain' is sacrosanct in any patent system ie the monopoly reward for the patentee disclosing his/her invention to the world for use after the bargain ends. With many pharma companies researching solutions for the same medical problems, there is pressure to file as early as they can, and obtain that monopoly on the next 'blockbuster' drug.

Doing so early runs the risk that what is claimed in the application as the technical contribution to the art, may not have sufficient support in terms of experimental or other data. The issue is then whether there is an inventive step disclosed or if the patent specification is sufficient. This is where the issue of 'plausibility' raises its head.

Notwithstanding the majority decision of the Supreme Court on the issue of plausibility in Warner-Lambert Co LLC v Generics (UK) Ltd [2018] UKSC 56, BMS sought to argue that a claim to a single compound should be assessed differently to the test applied to those for second medical use.

Lord Justice Arnold's detailed consideration of the law, particularly his views on the (apparent) divergence between Warner-Lambert and the Enlarged Board of Appeal's decision in G2/21 is an essential read for pharmaceutical companies, and the timing of claiming to have invented a drug.

Sandoz and Teva v Bristol-Myers Squibb [2023] EWCA Civ 472

Case background

BMS obtained a patent for lactam-containing compounds as a factor Xa inhibitor, which reduce the risk of blood clots and treat thromboembolic disorders. BMS subsequently obtained a SPC. Sandoz and Teva sought to invalidate the patent (and so the SPC) on the basis that the patent disclosed no inventive step or was insufficient, on the basis of plausibility. It was accepted that the date for assessing plausibility was the date of the original application. The closest prior art was an international application called WO 131, which was 326 pages long, and revealed various nitrogen containing heterobicycles as factor Xa inhibitors.

The parties agreed who the skilled person/team was, and their common general knowledge ('CGK'). At the priority date, it was CGK that testing for potency of possible drug candidates could be achieved by off-the-shelf assays, and that the values of concentration and effectiveness (IC50 /Ki) must be in the nanomolar range: the 1-10 ?M range was known not to be potent enough.

BMS' Application set out detailed descriptions of preferred embodiments by...