Life sciences case law update

Regulatory

No presumption of confidentiality in documents submitted to the European Medicines Agency

Two cases bolstered the tough position of the European Medicines Agency (EMA) in the area of disclosure of regulatory filings. In the first case, two Merck group companies objected to the release to an undisclosed third party of a series of toxicology test reports filed to support an application for approval of a veterinary medicine (MSD Animal Health v EMA (C-178/18)). In the second, an Irish pharmaceutical company objected to the disclosure of the main clinical study report supporting the conditional approval of its product on the basis of unmet medical need (PTC Therapeutics v EMA (C-175/18)). Underlining the core EU objective of achieving transparency in the activities of EU public bodies, the CJEU upheld disclosure in each case except where specific passages meriting special treatment could be identified.

Conflict between French cannabidiol restrictions and the free movement of goods rules

An ongoing French case, currently before the European court, considers whether French legislation prohibiting the sale of products derived from hemp plants other than fibre and seeds is contrary to the EU Treaty rules on free movement of goods (BS, CA (C-663/18)). The product, an e-cigarette, contains cannabidiol – a derivative of hemp plants that is not illegal under anti-narcotics legislation. However, conflicting French legislation meant that importers of cannabidiol from the Czech Republic were criminally liable. On referral to the European Court, the Advocate General’s opinion concluded that the French law was subject to review in light of the free movement rules. Any perceived advantages in terms of protecting human health would have to be justified and proportionate.  A final ruling is expected later this year.

Competition law

Pay-for-delay and patent settlement agreements

In January 2020, the European Court (the CJEU) ruled in the long-running pay-for-delay case concerning blockbuster antidepressant paroxetine. This litigation relates to settlement agreements in patent infringement litigation. While competition authorities recognise the generally positive effect of settling disputes, concerns were raised over payments made to generic producers, and restrictions on the generic producers’ ability to enter the market or seek revocation of relevant patents. In addition, settlement agreements that form part of a wider strategy to restrict competition can amount to abuse of a dominant position. (Generics (UK) v CMA, C-307/18) Further rulings in this area are expected in the ongoing Lundbeck (C-591/16) and Servier (C-176/19, C-201/19) cases.

Collusion and price fixing

In March 2020, The Competition and Markets Authority fined suppliers of a tricyclic antidepressant, nortriptyline, to a large pharmaceutical wholesaler. The CMA found that, rather than competing, the suppliers had divided the market between them and colluded to fix quantities and prices. The decision is under appeal. (Nortriptyline investigation: anti-competitive agreement and conduct.)

Excessive pricing

Also in March, the Court of Appeal upheld a finding by the Competition Appeal Tribunal that the CMA had incorrectly analysed a situation involving alleged abuse of a dominant position on the UK market for phenytoin sodium capsules (an important anti-epilepsy drug). Heavy fines had been issued by the CMA for charging unfair prices that bore no reasonable relation to the economic value of the medicine. The CMA will now reconsider the case. (The Competition and Markets Authority v Flynn Pharma [2020] EWCA Civ 339).

Patents and SPCs

Overbroad claims

Balancing broad claims with adequate disclosure and experimental data remains a hot topic.  Following on from the 2018 decision of the UK Supreme Court in Warner-Lambert v Generics ([2018] UKSC 56) recent rulings focus on whether broadly cast claims are valid. In Akebia Therapeutics v Fibrogen ([2020] EWHC 866 (Pat)), for example, the High Court examined the validity of a series of patents claiming enzyme inhibitors for use in the treatment of anaemia.  One claim of the patents under review defined the relevant compounds by reference to a chemical formula that covered 10183 possibilities. The judge concluded that it was simply not plausible that all or substantially all of the compounds within the structural definition had therapeutic efficacy. Experimental data supporting five compounds would justify claims to a wider group than just these, but certainly not the whole claimed class. Making and testing potentially suitable compounds would have been a research project in itself and the claim was not valid.

Errors in SPC paperwork

A decision of the UK Court of Appeal on Supplementary Protection Certificates (SPCs) demonstrates the importance of efficient administration. The patent owner, Genentech, had tasked an external organisation with management of SPC payments. Due to an oversight, the full fee was not paid at the outset as required under UK law. This meant that the SPC providing valuable protection for ranibizumab (the active ingredient of Lucentis) expired two years early. The Court of Appeal refused an application to correct the mistake. (Genentech v Comptroller General [2020] EWCA Civ 475)

Essentially biological processes

For those operating in the agritech space, the recent decision of the European Patent Office Enlarged Board of Appeal in the Pepper case (G3/19) marks a new direction, with a narrowing of the scope of patentability for the products of biological processes.

The European Patent Convention Article 53(b) excludes plant or animal varieties, or essentially biological processes for the production of plants or animals, from patentability. Earlier rulings had deemed this exclusion to apply only to essentially biological processes themselves, and not the products of these processes. The EBA, however, considered it appropriate to adopt a new interpretation. The exclusion is now to be understood as “extending to products exclusively obtained by means of an essentially biological process or if the claimed process feature defines an essentially biological process”. Plant variety rights are still available for new plant varieties but this is generally recognised to be a weaker form of protection.

If you would like to discuss how these rulings might affect your business, get in touch with one of our life sciences team.