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France – Rejection of a second SPC for a biological medicinal product

Cour de cassation, Commercial Chamber, 16 May 2018, No. 16-21638

The French Cour de cassation upholds the Paris Court of Appeal’s decision to reject an SPC application for a biological medicinal product which was based on the same patent as a first SPC but on a different market authorization.

The Government of the United-States of America (USA) owns a French Supplementary Protection Certificate (SPC) for a first vaccine against various types of cancer, based on its European patent covering “Self-assembling recombinant HPV16 papillomavirus capsid proteins“.

On the basis of the same patent, the Government of the USA applied for a SPC on a second vaccine, for which it has obtained a distinct market authorization. The HPV16 protein used in the second vaccine is obtained from insects instead of yeast and, as a result, is a truncated version of the one used in the first vaccine.

This SPC application was rejected by the French patent office (INPI) and the Paris Court of Appeal on the ground that the product is already the subject of a SPC.

The Cour de cassation (French Supreme Court) upholds these decisions and confirms that the Government of the USA cannot obtain a SPC for the first vaccine, on the ground of Articles 3, 4 and 5 of European Regulation (EEC) No. 1768/92.

The Court considered in substance that the second vaccine and the first vaccine are the same product within the meaning of this Regulation.

It pointed out that the rights conferred by a SPC are defined by the basic patent. In the Court’s view, the basic patent covers a protein which is found in each of these drugs, and the existence of a specific market authorization for the second vaccine is not relevant since “the L1 protein of HPV 16 contained in both drugs is the same“.

The applicant’s argument that the proteins used in each vaccine have different pharmaceutical properties due to their structural and functional differences (one protein is truncated) did not convince the Court.

The Court noted that the basic patent claimed all self-assembling recombinant capsid proteins of papillomavirus HPV16, without any precision as to their genotype or production technique, and notably to the influence of the different culture methods on this genotype.

While the market authorizations of each vaccine mention their different production techniques, they do not refer to a structural difference between both proteins either.

Therefore, the Cour de cassation decides that the Government of the United-States’ SPC application covers a product which is already the subject of a SPC, in violation of Article 3(c) of Regulation No. 1768/92.