EPLAW Patent Blog

NL - Sanofi Aventis v. Ratiopharm / Clopidogrel and aspirin

Sanofi Aventis v. Ratiopharm GmbH and Ratiopharm Nederland B.V., Court of Appeal The Hague, the Netherlands, 1 November 2011, Case No. 200.068.342/01
 
In its judgment of 1 November 2011, the Court of Appeal of The Hague has confirmed the District Court’s decision that Sanofi-Aventis’ patent EP 0 881 901 relating to a pharmaceutical composition comprising a combination of the active substances clopidogrel and aspirin was invalid for lack of inventive step.  Clopidogrel and aspirin have a synergistic effect on the inhibition of blood platelet aggregation, which means the combination product is useful for the treatment of thrombosis.

The Court dismissed Ratiopharm’s argument on claim construction. According to the Court, the term “composition containing ” (both clopidogrel and aspirin) did not necessarily mean that both active substances had to be included in one dosage form. However, the Court did agree with Ratiopharm that the patent was obvious, in light of the prior art publications that indicated to the skilled person that a combination of ticlopidine, an active substance with properties similar to clopidogrel, and aspirin had a synergistic effect on blood platelet aggregation. The skilled person would have had an incentive to replace ticlopidine with clopidogrel, in light of other prior art documents indicating that clopidogrel had shown better results and less side-effects than ticlodipine.

Sanofi-Aventis’ argument that the skilled person would not consider combining the two active substances, in light of the known risk of extended bleeding time, was dismissed. The Court held that the skilled person would not be deterred by the data relating to extended bleeding time from using the combination product, but would weigh the severity of the condition to be treated and the known potential benefits of the combination product against the known risks.

Read the decision (in Dutch) here.  

Head note: Jaap Bremer

UK - Yeda v. The Comptroller General of Patents

Yeda Research and Development Company Ltd v. The Comptroller General of Patents, Patents Court, Chancery Division, High Court of Justice, London, UK, 12 July 2010, EWHC 1733 (Pat)

The Patents Court has dismissed Yeda’s appeal of the decision of the UK Intellectual Property Office (UKIPO) to refuse two applications for SPCs relating to a combination treatment for cancer.

Yeda’s patent EP (UK) 667 165 B1 was filed in 1989 and claimed a therapeutic composition comprising a monoclonal antibody and an anti-neoplastic agent. A Marketing Authorization was granted by the European Commission on 26 June 2004 for the monoclonal antibody cetuximab and mention was made in passing to its use in combination with the anti-neoplastic agent, irinotecan.

Yeda subsequently file two SPC applications. The first specified the product to be protected as “cetuximab in combination with irinotecan” and the second specified the product as “cetuximab”. UKIPO rejected the first application as the Marketing Authorization relied on was for cetuximab alone and rejected the second application because cetuximab (as opposed to the combination of cetuximab and irinotecan) was not protected by the patent.

HU - Preliminary Injunction refused concerning a Combination Patent

Metropolitan Appeal Court, Budapest, Hungary, preliminary injunction/combination patent, 2 April 2010, with thanks to József Tálas, Sár and Partners Attorneys-at-Law and Imre Molnár, Danubia Patent and Law Office

The Metropolitan Appeal Court, acting as court of second instance has refused to grant preliminary injunction based on a patent covering the combination of two known pharmaceutical active ingredients for the treatment of cancer. The product of the defendant that comprised only one of the active ingredients of the patented combinations was found to fall out of the scope of the patent.