Supplementary Protection Certificates

Paris Court of Appeal reverses case law in Dana Farber vs. INPI

In a recent ruling, the Paris Court of Appeal has reversed the previous case law in France on supplementary protection certificates. The court overturned the decision of the INPI, which had rejected Dana Farber's application for an SPC for the cancer drug avelumab.

10 June 2022 by Konstanze Richter

The Paris Court of Appeal overturned the decision of the INPI, which had rejected Dana Faber's application for an SPC for the active ingredient avelumab, which helps to block the development of cancer cells. ©Kateryna_Kon/ADOBE STOCK

Avelumab is a monoclonal antibody used in immunotherapy for a number of cancer therapies. In 2000, Dana Farber Research Institute filed a patent relating to the discovery of new molecules, the B7-4 proteins (later called PD-L1). In this patent, the applicant described the function of these proteins. They are useful for modulating the immune response, leading to a new way of treating cancer.

EP 1 210 424 B1, entitled “New B7-4 Molecules and Their Uses”, also claims antibodies that can bind with said proteins.

Basis for avelumab

Based on Dana Farber’s patent, Merck developed its drug Bavencio with the active ingredient avelumab. It helps to block the development of cancer cells. Merck patented this invention in 2009.

In 2017, the Darmstadt-based pharmaceutical company received a number of approvals for marketing its drug in the US and EU. For example, for treating metastatic Merkel cell carcinoma (a form of skin cancer), as well as metastatic urothelial carcinoma and advanced renal cell carcinoma.

SPC only for Merck

In November 2017, Dana Farber filed for a supplementary protection certificate (SPC) covering avelumab. In the SPC application the institute mentions its basic patent EP 424 and also refers to the marketing authorisation granted to Merck for Bavencio, with avelumab as the active ingredient.

Merck had received an SPC for its patent developed on the basis of Dana Farber’s discovery. However, the INPI denied Dana Farber an SPC in February 2021 on the grounds that the application did not meet the requirements of Article 3(a) of Regulation No. 469/2009.

According to the INPI, Dana Farber’s patent contains no indication that the product is specifically identifiable by a person skilled in the art at the priority date. Additionally, the patent office argued that EP 424 does not specifically relate to avelumab. Furthermore, it said the product, subject of the SPC, was developed after the filing date of the basic patent application, following an autonomous inventive step.

The office added that the objective of the SPC regulation is to allow the granting of a certificate under the basic patent protecting the active ingredient of a new medicine. It does not aim to allow the granting of a patent constituting the starting point of the subsequent development of active ingredients.

Reversing French case law

Subsequently, Dana Farber appealed against the INPI decision (case ID: 21/08514). The research institute maintains that avelumab is protected by patent EP 424 within the meaning of Article 3(a) of the Regulation as interpreted by the case law of the CJEU.

In particular, the judgments Eli Lilly (C-493/12), Teva (C-121/17) and Royalty Pharma (C-650-17) contain the principle that the product may be claimed in an exclusively functional manner. The judges followed this view. As a result, the Court of Appeal’s ruling clears the way for an SPC on EP 424.

For the first time, the judges did not follow the previously established case law in France. This often interpreted the CJEU judgments to the detriment of the appellants. For example, in spring 2021, the Paris Court of Appeal ruled in favor of INPI, which had denied SPCs to several pharmaceutical companies based on the CJEU ruling in the Royalty Pharma case.

First of many

Dana Farber retained the Paris team of Simmons & Simmons partner Francois Jonquères for the Court of Appeal proceedings. In addition, he is also representing the company in proceedings against INPI concerning other SPCs. Jonquères called on the lawyers of Teytaud & Saleh as specialists for proceedings before the Court of Appeal. Simmons & Simmons regularly cooperates with the firm in appeals. Patent attorney Claire Bernstein of Gevers & Ores assisted in technical matters.

Francois Jonquères, Simmons & Simmons, patent litigation

Francois Jonquères

From Dana Farber’s legal department, Steve Caltrider, Chief IP Counsel of the Institute was involved. He joined Dana Farber after retiring from Eli Lilly. He had worked at the latter for 34 years, becoming VP and general patent counsel in 2019. Christian Helbig from the Swiss patent attorney firm Wagner & Helbig, as well as DeAnn Smith and Peter Sullivan from the US firm Foley Hoag, also supported the team.

INPI was represented by its in-house counsel Virginie Landais.

For Dana-Farber Cancer Institute
Simmons & Simmons (Paris): François Jonquères (partner); associate: Sabine Borny
Teytaud-Saleh (Paris): François Teytaud, Nada Saleh (attorneys specialised in appeal procedures) (public knowledge)
Gevers & Orès (Paris): Claire Bernstein (patent attorney)

In-house (Paris): Virginie Landais (public knowledge)

Court of Appeal, Paris, 1st chamber
Isabelle Douillet (presiding judge), Françoise Barutel, Deborah Bohee