Alkermes Pharma Ireland Limited (successor to Elan Pharma International Limited) v. Etypharm, Tribunal de Grande Instance, Paris, France, 21 December 2012, Case No.10/05718, With thanks to Marina Cousté, Reed Smith LLP, for sending in the judgment and a summary and translation in English
The Tribunal de grande instance de Paris rendered a very interesting decision on December 21, 2012, admitting the validity of a disclaimer restoring the novelty of the claim 9 of the European Patent n° 0 644 755 owned by Alkermes. This patent, entitled "Nanoparticles of surface-modified nonsteroidal anti-inflammatory agents", concerns pharmaceutical compositions containing
nanoparticles of surface-modified crystalline nonsteroidal anti-inflammatory agents (NSAID) exercising a reduced gastric irritation following oral administration and/or having a faster action.
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 raised inter alia the invalidity of claim 9 of the opposed patent both for lack of novelty as inventive step, in view of the prior art constituted by application U.S. 07 647 105 and by European Patent n° 0 499 299. Prior art opposed by Ethypharm constituted by application US 105 was rejected on the ground that none of its claims deals with the onset of action or irritability and as a
consequence was a speculative mention, “a mere possibility that is not justified by any example, test or result” Regarding the prior art constituted by EP 299, the judge noted that it was published 2 months after the priority date of patent owned by Alkermes and so could not be enforceable under inventive activity but remained possibly enforceable under novelty according to article 54 of EPC. Alkermes argued here that introduced at the end of claim 9 of the challenged patent, the disclaimer is used as authorized by article 123 EPC, i.e. in order to restore novelty in relation to prior art resulting from a document filed at an earlier date but that has not been published.