EPLAW Patent Blog

FR - Alkermes Pharma Ireland v. Etypharm

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.

IT - Giellepi Chemicals S.R.L. v. Meda Pharma GmbH & Co. KG

Milan court 23 September 2010 - 17 December 2010, Giellepi Chemicals  S.R.L.  vs. Meda Pharma GmbH & Co. KG
 
This judgment is apparently the first one which discusses the admissibility of a disclaimer in a patent claim in Italy. Such admissibility has been confirmed substantially to the same extent accepted by the European patent office (pages 20 to 22). The court dismissed the challenging party's argument that on one hand the Italian law does not provide for such disclaimers, on the other hand that a disclaimer introduces some new matter (albeit in negative terms) which was not disclosed in the original application.