EPLAW Patent Blog

BE - Lundbeck v. Ratiopharm (Teva) and Tiefenbacher (escitalopram)

H. Lundbeck A/S v. Alfred e. & CO. Tiefenbacher GmbH, Ratiopharm GmbH, Ratiopharm Belgium N.V and Teva Pharma Belgium N.V., Court of Appeal Brussels, Belgium, 14 February 2012, Case No. 2011/AR/2821, with thanks to Steven Cattoor, Hoyng Monegier, for providing the case and a head note.

As reported earlier (see here), on 3 October 2011 the Brussels Commercial Court revoked Lundbeck’s Belgian escitalopram SPC and declared its decision immediately enforceable, notwithstanding appeal.

Lundbeck appealed this first instance decision and, by way of preliminary issue, requested that the ordered immediate enforceability be declared illegal. By judgment of 14 February, the Brussels Court of Appeal upheld Lundbeck’s appeal on this point and found that a first instance decision revoking a patent or SPC cannot legally be declared provisionally enforceable. According to the Court of Appeal, such immediate enforceability is contrary to Article 51§2 of the Belgian Patent Act (BPA), which, in view of Articles 18 and 19 SPC Regulation and in absence of any specific provision relating to SPC’s, is held to be applicable to SPC’s.

Deviating from the general rule under Belgian procedural law in this respect, Article 51§2 BPA stipulates that an application before the Supreme Court against a patent revocation decision rendered by an appellate court, has a suspensive effect. Allowing the immediate enforceability of a nullity decision in first instance is irreconcilable with the necessary suspensive effect of a cassation request under Article 51§2 BPA and would render the latter devoid of any meaning. A revoked patent/SPC cannot be declared valid again. The Court added that, given the erga omnes (and ex tunc) effect of a revocation decision, the legal guarantee under the Belgian Code of Civil Procedure providing that the party enforcing a judicial ruling does so at its own risk, cannot offer sufficient protection for the patentee.

This is the first time a Belgian court has ruled on the question of the (il)legality of the provisional enforceability of a nullity decision. The merits of the case will be heard shortly.

Read the decision (in Dutch) here.

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

SE - Teva, Arrow and Ratiopharm v. Merck (Alendronat)

Teva Pharmaceuticals Industries Ltd, Teva Sweden AB, Arrow Läkemedel AB, Arrow Generics Ltd, Ratiopharm AB and ratiopharm GmbH v. Istituto Gentili SpA, MSD Overseas Manufacturing Co (Ireland) and Merck Sharp & Dome Sweden AB, Stockholm District Court, 11 June 2010, Docket Nos. T 16665-04 T 252-05, T 15175-05, T 7337-05, T 15141-05, T 30912-05 and T 13939-05 (joint cases)

In joint infringement and invalidity proceedings, the District Court of Stockholm denied Teva’s, Arrow’s and Ratiopharm’s claims that Merck’s SPC (for the pharmaceutical product Alendronat) was invalid. Consequently, Teva and Arrow were found to have infringed the same SPC. The invalidity action was first initiated by Teva already in October 2004. This judgment was also preceded by a preliminary injunction against Teva and Arrow, prohibiting them to handle generic Alendronat, granted by the Stockholm District Court in February 2006. However, the preliminary injunction was cancelled by the Svea Court of Appeal in October 2006. According to the Svea Court of Appeal, probability of patent infringement had not been shown (with respect to the validity of the basic patent (and thus also the SPC) not having been established as probable).

 

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 - Ratiopharm v. Eli Lilly / Olanzapine patent invalid

Ratiopharm GmbH, Ratiopharm Nederland B.V., Ratiopharm B.V. v. Eli Lilly and Co Ltd., District Court The Hague, The Netherlands, 24 March 2010, Case No. 2008/2126, including the English translation, with thanks to Chantal Morel & Moïra Truijens, Klos Morel Vos & Schaap

Now including the English translation and a summary/comments in English

The Dutch part of Eli Lilly's patent and SPC re olanzapine was found to be invalid since the  substance olanzapine was  already directly and unambiguously disclosed in the earlier Schauzu publication. The error in Schauzu will, according to the court in The Hague, immediately be recognized by the man skilled in the art. The way this error can be corrected can also directly be derived from Schauzu. There is no trigger for the man skilled in the art to consult an other document.

The court further states that it realizes that its decision deviates from earlier decisions in the United States, China, The Czech Republic, Slovakia, Romania, Ukraine, Russia, Germany, United Kingdom, Austria and Spain. The patent was also invalidated in Canada, but based on a different argument (not a valid selection patent).

Read the decision (in Dutch) here.
Read the decsion (in English) here.

Read a summary in English and comments (provided by András Kupecz and Peter Meyer) 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.

NL - Lundbeck v. Tiefenbacher, Centrafarm Services and Ratiopharm

H. Lundbeck a/s v. Alfred E. Tiefenbacher GmbH, Centrafarm Services B.V. and Ratiopharm GmbH, costs of procedure, Court of Appeal, The Hague, The Netherlands, 22 December 2009, Docket No. 200.039.432/01

Withdrawn application for the provisional examination of witnesses / expert opinion. Other parties object to such withdrawal if no full costs of the proceedings as based on the Enforcement Directive are paid. The Court of Appeal states that the Enforcement Directive does not distinguish between summons proceedings and application proceedings. Lundbeck's application relates to facts and grounds of a judgment by the District Court of The Hague regarding a patent (which judgment has been appealed) and is (thus) related to the enforcement of an intellectual property right. No room for the application of Article 289 Dutch Code of Civil Procedure. Lundbeck's application was declared inadmissible. Full costs are awarded (to the amount as agreed between parties).

Read the decision (in Dutch) here.