Infringement of SPCs by combination products

Philippe de Jong from Altius in Brussels has directed us to a couple of articles written for the EPLAW patent blog (http://www.eplawpatentblog.com/) relating to SPCs and combination products.

The articles are entitled:

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

SPCs and combination products - Validity Issues, by András Kupecz (Simmons & Simmons)

Philippe also provides three recent decisions concerning losartan and SPCs, two of which are Belgian decisions (and for which he has provided English translations), and the third from the French courts. We'll put them onto the SPC resources page too.

English summaries of the 3 decisions are as follows:

Brussels court of appeal, 23 February 2010, Du Pont et al. / Mylan, losartan SPC, decision in summary proceedings (appeal) (English translation here)

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.


Pres. Brussels commercial court, 12 February 2010, Du Pont et al. / Mylan, losartan SPC, decision in summary proceedings (first instance) (English translation here)

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.


Pres. Paris district court, 12 February 2010, Du Pont et al. / Mylan, losartan SPC, decision in summary proceedings (first instance)

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.