S.A. Ethypharm v. Alkermes Pharma Ireland Limited, Court of Appeal, Paris, France, 3 November 2015, No. 184/2015, with thanks to Raphaëlle Dequiré-Portier, GIDE LOYRETTE NOUEL, for sending in the case, together with a head note and translation in English
In this decision, the Court of Appeal has reversed the First Instance decision of 21 December 2012 and held that Claim 9 was invalid as it was a treatment method.
Claim 9 is written as follows: “9. Use of particles consisting essentially of a drug substance with an adsorbed surface modifier on the surface, in an amount sufficient to maintain an average particle size less than 400 nm or a pharmaceutical composition of the latter for the preparation of a drug in order to accelerate the onset of action after administration to a mammal, provided that the drug substance is not naproxen or indomethacin.”
Ethypharm had raised several grounds for invalidity, including that claim 9 of patent EP 0 644 755, as amended by the "disclaimer" of 18 August 1995, is a "Swiss type" claim, circumventing the prohibition against patenting a treatment method, excluding naproxen or indomethacin, already taught in patent EP 0 499 299 but that it did not refer to a specific substance or composition but to all existing active substances, without stating their therapeutic use, because it covers use of the nanoparticles of any drug substance to treat any illness, any patient, irrespective of how it is administered and its dosage. As such, it was not patentable as it was a treatment method.
The Court held that claim 9 of patent EP 0 644 755 relates to any drug substance (excluding only naproxen or indomethacin already taught by the state of the art) with the sole aim of hastening the onset of its action after administration to a mammal. The Court specified that the claimed hastened onset of drug action is only one mode of drug action, albeit not defined, and could not be deemed a therapeutic use of this drug.
Accordingly, claim 9 was revoked pursuant to Article 53 (c) and Article 138 (1) of the Munich Convention and Article L. 614-12 of the French Intellectual Property Code.
The Court also specified that any infringement claims by Alkermes were therefore dismissed, and ordered Alkermes to pay 150,000 euros in legal fees.