EPLAW Patent Blog

FR - Novartis v. Sanofi / Valsartan (ex parte)

Novartis AG and Novartis Pharma v. Sanofi-Aventis France, Sanofi-Aventis Winthrop Industries and Zentiva K.S., the President of the Court of First Instance (ex parte preliminary injunction), Paris, France, 27 October 2011, Case No. 11/15302, with thanks to Pauline Debre, Bird & Bird, for providing a summary and comments in English

On 27 October 2011, the President of the Court of First Instance in Paris ordered ex parte preliminary injunctions against Sanofi-Aventis France, Sanofi-Aventis Winthrop Industries and Zentiva K.S. (hereinafter "Sanofi"), prohibiting the Valsartan generic Zentiva from being sold on the French market.

This ruling is important in two respects:

1. It is one of the first decisions in which an ex-parte preliminary injunction has been ordered in a patent case in France; and

2. It seems to conflict with a recent decision of the Court of Appeal in Paris on the extent of protection given by supplementary protection certificates.

Read the entire summary below the break:

 

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

NL - Ratiopharm v. Sanofi-Aventis / Clopidogrel

Ratiopharm GmbH, Ratiopharm Nederland B.V. v. Sanofi-Aventis, District Court The Hague, The Netherlands, 28 April 2010, Case No. 342791 / HA ZA 09-2375

The District Court of The Hague invalidated Sanofi-Aventis’ patent in invalidity proceedings inititated against Sanofi-Aventis by Ratiopharm. The patent related – in short – to a pharmaceutical composition comprising a combination of active substances, i.e. aspirin and clopidogrel. The combination allegedly would have a syngergetic activity in preventing or treating  thrombosis, e.g. as a result of bloodplatelet aggregation due to the placement of metal endovascular prostheses in arteries.

The Court held that the patent was invalid due to lack of inventive step. According to the Court, it was known on the priority date that the combination of aspirin and ticlopidine had a synergetic effect in preventing bloodplatelet aggregation. On the priority date, clopidogrel – of which it was known that it was similar to ticlopidine in both structure and method of operation – had moreover already been described as having significant advantages over ticlopidine. The Court held that combining aspirin and clopidogrel was therefore obvious for the skilled man on the priority date. Sanofi-Aventis’ statements to the contrary were rejected by the Court.

Read the judgment (in Dutch) here.

NL - Aventis v Apothecon and Ratiopharm / fexofenadine: selection for group of patients

Aventis Inc v. Apothecon B.V., Ratiopharm B.V. and Ratiopharm Nederland B.V., Appeal, Court of Appeal The Hague, The Netherlands, 16 March 2010, Case No. 105.007.817/01, with thanks to Mark van Gardingen and Peter Burgers, Brinkhof

Aventis asked for a preliminary injunction based on alleged infringement by the generic companies Apothecon and Ratiopharm -by marketing fexofenadine products as anti-histaminics- of its European patent for the 'Use of terfenadine derivates as antihistaminics in a hepatically impaired patient'.

Like the judge in first instance preliminary injunction proceedings, the Court of Appeal holds that Aventis is not entitled to a preliminary injunction because there is a serious chance of nullification of the patent in a case on the merits. The Court of Appeal finds the patent is not new (the anti-histaminic effect of fexofenadine was already known, and the group of patients to which the claims are directed does not qualify as a valid selection), and that the patent lacks inventive step.

Read the decision (in Dutch) here.