Cour de Cassation, France, fr-A16-21638_20180516 ; The Government of the United States of America / Directeur de l’INPI – 16 May 2018
The legal issue concerned Article 3c of Regulation No 469/2009 which provides that a SPC shall be granted for a product if, in the Member State in which the application is submitted and at the date of that application, the product has not already been the subject of a SPC.
The case proceeded as follows. The European Patent No. EP 0 662 132 was granted to The Government of the United States. This granted patent covers “protein recombinant HPV 16 recombinant papilloma virus capsids”, for the diagnosis, prophylaxis and therapy of viral infections.
The Government of the United States holds also a marketing authorization (MA) No EU / 1/04/419/001 for a vaccine marketed under the name Gardasil®, the active ingredient of which is an L1 protein of papillomavirus human type 16 (HPV-16).
Based on this patent and this marketing authorization, The Government of the United States obtained the SPC No. 07C0020.
Later, The Government of the United States applied for the granting of a second SPC based on another marketing authorization on the proprietary medicinal product Cervarix®, but based on the same European Patent No. EP 0 662 132.
The applicant stated that the product concerned by the second SPC application differed from that targeted by the first SPC since “its culture using other host cells and generating a C-terminally truncated form of the L1 protein”.
However, the Director General of the National Institute of Industrial Property (INPI) and Court of appeal of Paris (fr-15-12234_20160412 ; 12 April 2016, darts-347-364-D-fr) rejected this request on the grounds that a SPC had already been issued for the same product according to Article 3c of Regulation No 469/2009.
The french supreme Court just upheld these previous decisions. The Court concludes that if the holder of a patent obtains a first SPC relating to an active ingredient (HPV-16) on the basis of a first marketing authorization (for Gardasil), the wording of Article 3c of Regulation No 469/2009 precludes that holder from obtaining, on the basis of that same patent, another SPC relating to the very same product (HPV-16) on the basis of a subsequent MA for another medicinal product which also contains HPV-16.
The Court of Cassation specified that the Court of Appeal correctly held that the rights conferred by the SPC are delimited by the basic patent. Here, the basic patent covered a protein used in the composition of each of the pharmaceutical specialties in question, it is right that it inferred that a SPC having already been issued on the basis of that patent, no other could not be, it is of little importance that the request made for this purpose is based on a second marketing authorization obtained specifically for the drug Cervarix®, since the L1 protein of HPV 16 used in the composition of the two drugs was the same.
This french case law is not in contradictory with ECJ guidelines which stipulated in C-484/12 (University Georgetown, ECJ, 12/12/2013, darts-478-129-B) that for an holder of a patent, who had obtained a first SPC relating to an active ingredient on the basis of a first marketing authorization, Article 3c of Regulation No 469/2009 does not preclude that holder from obtaining, on the basis of that same patent, another SPC if the product that is the subject of the second SPC application relates to a different product even if the latter falls within the limits of the protection conferred by said patent…