On 20 October 2009, the Lyon Court of Appeal upheld a decision of the President of the First Instance Court, and became the first jurisdiction in France to elaborate an exhaustive reasoning with regards to one of the new provisions of Law n°2007-1544 of 29 October 2007 on the “Fight against Infringement”.
This provision (new article L.615-3 of the French Intellectual Property Code) gives the patentee the possibility of requesting that the judge in charge of summary proceedings order preliminary measures to prevent an imminent infringement if it is likely that the patentee’s rights are about to be infringed. Previously the Court could only forbid the continuation of the infringing acts.
In this case, the pharmaceutical company Grünenthal, the exclusive licensee of a patent covering a controlled release formulation of Tramadol (an analgesic) owned by Mundipharma, asked the judge of the summary proceedings to order preliminary measures against Mylan. Mylan had obtained a marketing authorisation for an “essentially similar” generic drug Tramadol Merck which was about to be launched on the French market and which fell within the scope of protection of Grünenthal’s patent.
The marketing authorisation mentioned the manufacturers of the generic drug: Medochemie (a Cypriot company ) and FAL (a Dutch company).
The difficulty for Grünenthal was to demonstrate the “imminent infringement” in the absence of any infringing product actually on the French market. Another difficulty lay in convincing the judge not to act as if ruling on the merits as regards the validity of the patent. This was strongly disputed by Mylan.
The Court provided a solution which is to a great extent favourable to the patentee: it firstly refused to make an “in depth and critical analysis of the validity” of the patent at stake, which is the role of the judge ruling on the merits.
The judge merely verified that the invoked rights indeed existed, presuming that the patent granted by the EPO was valid and considered that the arguments raised by Mylan with regard to the alleged invalidity of the patent could not lead to the refusal of the request for a preliminary injunction.
Rather, the judge focused on gathering evidence to demonstrate the imminence of infringement. Demonstration of the imminence of the infringement was done in two stages:
- To evidence the infringement itself, Mundipharma and Grünenthal seized other generic products, manufactured by Medochemie and FAL, and sold by other generic companies in three other European countries (Sweden, Czech Republic, Austria). Mundipharma and Grünenthal had conducted technical reports on these generic products which demonstrated that they did fall within the patent.
Grünenthal argued that there was no reason to believe that Medochemie and FAL would manufacture a different product for the French market and that it was likely that the product launched in France would be identical and therefore infringing.
The defendants only argued on the insufficiency of evidence of the infringement, stating that the analysis which had been made regarding the other generic products had not been a process in which both parties were heard. Yet Mylan did not really contest the fact that the generic product about to be launched in France would be identical to these products, nor that the generic products already sold in the other European countries fell within the scope of the patent. For these reasons, the judge ruled that it was likely that the launching of the product on the French market would infringe the patent.
- Next, the difficulty was to demonstrate the “imminence” of the infringement.
Having noted that the mere fact of obtaining a market authorisation is not sufficient to constitute a willingness to immediately place the drug for sale on the market (and therefore before expiry of the patent), the judge identified positive acts carried out by Mylan from which it was possible to deduce the imminent launch of the product:
- the fact that Tramadol Merck was manufactured by Medochemie and FAL who were already the manufacturers of the other generics being sold in different European countries and falling within the patent;
- the advertisement placed in trade publications by Mylan in January 2008, announcing the availability of the drug from February 2008; and
- a letter sent by Mylan to the French Economic Committee of Health Products in charge of setting the price of drugs, in which Mylan confirmed its intention to launch the product “as soon as the price is fixed”.
From all these observations, the judge concluded that infringement was imminent and added that the launch of this generic drug would cause serious harm to Mundipharma and Grünenthal and that the preliminary injunction appeared to be an appropriate and proportionate measure.
This decision is very important since it was the first time that a French judge has ordered a preliminary measure in a case of imminent infringement. It is also remarkable considering that it remains very difficult to obtain preliminary injunctions in patent cases in France (either on imminent or actual infringements). In particular, the Paris Court continues to make an in-depth analysis of both the validity of the patent and the infringement, which often leads to the refusal of the preliminary injunction in patent cases.
This decision was probably one of the last decisions of the Lyon Court in patent cases as the Paris Court now has exclusive jurisdiction over patent litigation (Decree of 9 October 2009). It is hoped that the Paris Court will strike a balance between the two interpretations and be more favourable to the patentee by refusing to act as a judge ruling solely on the merits.