No end to Dana Farber’s SPC dispute with Dutch and French patent offices

For several years, Dana Farber has sought to obtain three SPCs for novel antibody-based cancer therapies in France and the Netherlands. In October 2017, the cancer research institute applied for SPCs for three specific antibodies interrupting the PD-1/PD-L1 pathway: atezolizumab, durvalumab and avelumab. All three are based on basic patent EP 1 210 424 B1.

Dana Farber filed EP 424 in 2000, relating to the discovery of new molecules called B7-4 proteins (later known as PD-L1). The patent described the function of these proteins in modulating the immune response, leading to a new way of treating cancer. The basic patent expired in August 2020.

Meanwhile, Dana Farber had concluded non-exclusive licence agreements with AstraZeneca, Merck and Roche for the commercialisation of antibodies and medicinal products. Roche developed atezolizumab and sells it under the brand name Tecentriq, while Merck sells avelumab under the brand name Bavencio. AstraZeneca developed durvalumab and sells it under Imfinzi. The granting of the SPCs is economically important for Dana Farber if it wants to continue generating licence income from the three pharmaceutical companies.

New SPC case law

The District Court The Hague has now refused to grant the three SPCs. Dutch judges Hans van Walderveen, G.P. Kleijn and Marjolein Visser ruled in favour of the Dutch Patent Office (case IDs: SGR 22/1518 OCT95 (avelumab); SGR 22/1517 OCT95 (atezolizumab); SGR 22/1516 OCT95 (durvalumab)).

The judges concluded that avelumab, atezolizumab and durvalumab are not considered specifically identifiable at the priority date from the basic patent EP 428 and therefore do not meet the requirements and the Teva/Gilead test of Article 3(a). This decision marks the first time a Dutch court has interpreted the standard of ‘specifically identifiable’ for Article 3(a) of the SPC regulation, set out by the CJEU in cases C-121/17 (Teva/Gilead) and C-650/17 (Royalty Pharma).

The court had suspended proceedings to await decisions of the CJEU in two further referral proceedings. In its judgment in joined cases C-119/22 and C-149/22 Merck Sharp & Dohme, the CJEU held that the product must fall under the invention covered by the patent, even in cases where the patent claims expressly mention the product.

Dana Farber can now appeal against the decisions to the Dutch Council of State. This court is responsible for appeals in such administrative law proceedings, but rarely hears cases concerning the granting of patents or SPCs. According to experts, the court rarely overrules the lower court in SPC cases. However, in the event of ambiguities regarding the interpretation of EU law, it must likely involve the CJEU.

Dana Farber has not yet lodged any appeals, but these are generally expected due to the economic significance of the SPCs. The research institute has also embarked on the long march through the courts in parallel French proceedings.

Different outcome in France

Dana Farber had also applied for the SPCs in France, which the French Patent Office rejected for similar reasons as in the Netherlands. However, regarding avelumab, the Court of Appeal overturned the decision of the INPI in May 2022.

In January 2024, the Supreme Court, applying the criteria laid down by the CJEU, dismissed the INPI’s appeal. According to the judges, EP 424 did indeed protect the human monoclonal antibody avelumab. Even though the basic patent does not expressly mention it, the court found that a person skilled in the art could specifically identify this through known routine tests (case ID: 22-18.374).

Regarding the SPC for atezolizumab, the French Supreme Court agreed with the assessment by the lower court and INPI that atezolizumab was not specifically identifiable in EP 424. According to sources, the Paris Court of Appeal has not yet decided on the grant of the SPC for durvalumab.

Taylor Wessing for Dana Farber

The case is also likely to be of some significance for the Dutch Taylor Wessing patent team, as this is the first time it has represented the research institute together with Belgian lawyers. The firm has previously acted for Dana Farber in other jurisdictions.

Taylor Wessing partners Wim Maas from Eindhoven and Christian Dekoninck from Brussels lead the team. Both are currently highly active in UPC proceedings, Maas for clients such as Ericsson and Abbott, Dekoninck also for Abbott. But it is Eindhoven-based counsel Margot van Gerwen who plays a central role coordinating the cases. Associate Maxime de Jong is also part of the team.

On the patent attorney side, Dana Farber relies on Mark Jolink from Dutch firm EP&C.

On behalf of the Dutch Patent Office, Martijn de Lange led the proceedings. He is a patent and SPC examiner at the office and was joined in the oral hearing by legislative lawyers Susanne Kantas and Jeroen Meewisse. The latter is patent examiner and legal adviser but also a technically qualified judge at the Unified Patent Court.