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

NO - Novartis v. Actavis / Valsartan

Novartis v. Actavis, Valsartan, District Court Oslo, Norway, 10 February 2011, Case No. 10-062600TVI-OTIR/04

On 10th of February 2011 the Oslo District Court rendered its decision in a case between Novartis AG/Novartis Norge AS (hereafter Novartis) and Actavis Group PTC hf/Actavis Norway AS (hereafter Actavis) regarding Novartis’ patent NO 304023. Novartis had initiated the proceedings, requiring preliminary measures to stop Actavis’ infringement of patent NO 304 023 by producing and selling products containing the pharmaceutical ingredient valsartan.

The patent in question is a process patent and the question before the court was whether the process used by Actavis to fabricate valsartan – QSSA Route C – constituted an infringement of patent NO 304 023.The District Court assessed the question using the doctrine of equivalence.

 

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.

FR - Du Pont v. Mylan, Losartan SPC (first instance)

Du Pont et al. / Mylan, Losartan SPC, decision in summary proceedings (first instance), Pres. Paris District Court, France, Docket No. 10/51453, 12 February 2010

*Now including the English translation*

According to the President of the Paris District Court, the basic patent for Losartan covers any product comprising Losartan, including a product comprising Losartan and another product such as a diuretic, like HCTZ.

Since pursuant to Article 5 of the SPC-Regulation, an SPC confers the same rights as the basic patent and since pursuant to the Article 4 of the SPC-Regulation the SPC protects any subsequently authorised use of the product as a medicinal product, the combination product Losartan+HCTZ falls under the scope of protection for the losartan-SPC. The fact that the paediatric extension was only granted for the Losartan SPC and not for SPC for the combination product, was not held to be relevant.  According to the court, the extended protection of the basic patent and the subsequent SPC, could only lead to the conclusion that any medicament containing Losartan as an active ingredient amounted to an infringement.

As to the prima facie validity of the SPC-extension, the court held, inter alia, that the relevant provisions of the SPC-Regulation and Regulation 1901/2006 do not specify that the MAs need to have been obtained at the time of the filing of the application. The paediatric MAs must have been applied for on the day of the filing of the application, but can be communicated whilst the application is under examination.

Read the decision (in French) here.

Read the decision (in English) here. Translation provided by Pierre Véron, Véron & Associés

SPCs and Combination Products

There have been quite a number of recent developments in European SPC cases relating to combination products. Courts seem to have difficulties in dealing with this issue and various tests regarding validity and infringement have been developed by different national courts.

In today's SPC and Combination Products special, editors Philippe de Jong (Altius) and András Kupecz (Simmons & Simmons) focus on these validity issues and infringement issues. The contributions can both be read jointly and separately.

SPCs and combination products - Infringement Issues, by Philippe de Jong


SPCs and combination products - Validity Issues, by András Kupecz

BE – Du Pont et al. v. Mylan / Losartan SPC (Appeal)

Du Pont et al. / Mylan, Losartan SPC, decision in summary proceedings (appeal), Brussels Court of Appeal, 23 February 2010, Case No. A.R. nr. 2010/KR/53

According to the Brussels Court of Appeal, the scope of protection of the SPC for the active ingredient Losartan does not, at first sight (“prima facie”), extend to a generic version of the medicinal product Cozaar Plus® (containing the active ingredients Losartan and HCTZ) under Article 4 of the SPC-Regulation.  The main reason raised by the court is that, since the combination of Losartan and HCTZ was itself protected by an SPC, a medicinal product containing that combination could not infringe the SPC for Losartan alone.  According to the court, this would appear to run counter with Articles 3(c) and (d) of the SPC-Regulation.

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

BE - Du Pont et al v. Mylan / Losartan SPC (first instance)

Du Pont et al. / Mylan, Losartan SPC, decision in summary proceedings (first instance), Pres. Brussels Commercial Court, 12 February 2010, Case No. R.K. 00014/2010

According to the President of the Brussels Commercial Court, the scope of protection of the SPC for the active ingredient Losartan, whose duration had been extended pursuant to Article 36 of the Paediatric Regulation 1901/2006, does not at first sight (“prima facie”) extend to a generic version of the medicinal product Cozaar Plus® (containing the active ingredients losartan and HCTZ). 

The main reason raised by the court is that, since the paediatric extension was applied for and granted only for the Losartan-SPC and not for the separately obtained “Losartan + HCTZ”-SPC, the combination product Cozaar Plus®” could not benefit from the paediatric extension of the Losartan-SPC.  Consequently, generic versions of Cozaar Plus® could not fall under the scope of protection of the Losartan-SPC either.

Read the decision (in Dutch) here.

Read the decision (in English) here.