Losartan and HCTZ: now it's the turn of the French Cour d'appel

The Cour d'appel de Paris

The SPC Blog is grateful to Laëtitia Bénard (Partner, Allen & Overy LLP, Paris) for sending The SPC Blog some information concerning recent litigation before the Cour d'appel de Paris on 15 March 2011 in which that court ruled on Mylan's appeal against the order of the Tribunal de Grande Instance de Paris of 12 February 2010.  That earlier order had previously prohibited Mylan from launching a generic product containing Losartan and HCTZ on the basis of EI Du Pont de Nemours' SPC for Losartan (the first instance decision has previously been noted on The SPC Blog). For full disclosure, Laëtitia reminds readers that her firm acted as counsel to E.I. Du Pont de Nemours and Merck in this case.

The case, in short, is summarised as follows:

Du Pont - Merck v Mylan: the Paris Court of Appeals confirms that combination products infringe mono-SPCs and sets a precedent on the requirements for obtaining a paediatric extension 

Mylan and Qualimed had lodged an appeal against the preliminary injunction rendered on 12 February 2010, enjoining them, on the basis of Du Pont's SPC granted for Losartan as extended by a paediatric extension, from marketing a generic drug comprising Losartan and HCTZ. The appeal essentially rested on two grounds: 

(i) the appellants alleged that the owner of an SPC must file, along with his initial application for a paediatric extension, all "paediatric" (varied) marketing authorisations for each of the 27 Member States of the European Union, without a possibility to supplement the file at a later stage and
(ii) the appellants argued that a combination product does not infringe the SPC granted for one of the active ingredients of the combination. 

The Court of Appeals dismissed both arguments, and confirmed the first instance injunction. 

1. As far as the validity of the SPC is concerned, the Court first noted (in line with an earlier decision of the Dutch Patent Office of 2 June 2009) that it would place an undue burden on owners of SPCs to require them to provide all 27 "paediatric" marketing authorisations along with the application for paediatric extension: 

"This provision [Article 36 of the SPC Regulation], which only mentions the fact that the product must be authorised, does not specify that, at the date of the filing of the application, all the paediatric MAs must have been granted. Indeed, requiring the filing of the 27 paediatric MAs on the day of the filing of the application is in practice not possible in the absence of a centralised registration procedure and due to the variable speediness of the different agencies in charge of granting these authorisations." 

The Court went on to decide, in conformity with the practice of the French patent office, that the applicant for a paediatric extension must only prove that the product has been authorised in all 27 Member States, i.e. provide the initial ("non-paediatric") marketing authorisations: 

"The provision can only refer to the requirement to provide the initial MAs, while the paediatric MAs can be provided during the course of the granting procedure of the extension. It should be mentioned in this respect that this position has eventually been adopted by the INPI, as confirmed by the circular letter of the pharmaceutical industry trade union dated 7 January 2011. 

Du Pont filed its application for an extension on 27 February 2009 and the copies of the MAs for all other Member States were enclosed. Consequently, the procedure is lawful and the extension granted further to this application is not to be nullified."

2. The Court further confirmed, as also recently ruled by the President of the Paris First Instance Court in Novartis v Actavis (Valsartan), that an SPC covering a compound (Losartan in the present case) obviously prohibits the marketing of pharmaceutical products containing Losartan alone or in combination with another active ingredient. 

In this respect, the Court first referred to the basic principles of patent law: 

"It should be remembered that, under French law, infringement is assessed according to resemblances and not differences only, such that the inclusion of additional features to those claimed in a patent does not put an end to the infringement." 

It also analysed the purpose of SPCs: 

"An SPC, which aims at supporting innovation in the field of health, grants a protection to a product as a medicament under all the forms that fall within the protection of the basic patent." 

The Court concluded from this that: 

"Consequently, in the case at hand, the certificate which has been extended grants the same rights as those of the basic patent covering losartan, and the protection granted by this certificate concerns the product covered by the MA for any use of this product as a medicament that has been authorised prior to the expiry of the certificate. Consequently, the protection encompasses any use of losartan as a medicament." 

The Court also specifically addressed the appellants' argument based on the fact that the claimants had also been the owners of a (then-expired) SPC specifically covering the combination product (Losartan and HCTZ°). In this regard, the Court followed a classical intellectual property reasoning, and held that

"The existence of another SPC whose protection is expired is irrelevant in the case at hand." 

A further appeal to the Supreme Court is still possible".

The authentic French version of the decision can be read here.  The English translation can be read here.