A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Friday 4 November 2011

Valsartan: French court upholds ex parte preliminary injunction

The SPC Blog has received further information on the French Valsartan litigation from Laëtitia Benard (Allen & Overy, Paris). This relates to the very recent decision of the Paris First Instance Court on 31 October 2011, ruling on an attempt by Sanofi to remove the preliminary injunction which had previously been granted ex parte  Laëtitia (whose firm acted for Novartis in these proceedings) takes up the story from here:
Further to a preliminary injunction rendered on an ex-parte basis against Sanofi on 27 October 2011, which ruled that Sanofi's generic medicines containing a combination of Valsartan and HCTZ infringed the SPC of Novartis for Valsartan and ordered the prohibition of the manufacturing, the importation, the offer for sale, the holding, the storing and the marketing of the infringing medicines as well as the recall of these medicines from all the distribution channels, Sanofi sought the withdrawal of this ex-parte order on the ground that the infringement was challengeable.  
Ruling on Sanofi's recourse, the President of the Paris First Instance Court rendered an inter-partes decision on 31 October 2011, confirming the ex-parte preliminary injunction previously issued as well as the measures ordered. This ruling is in accordance with the previous decisions of the Paris First Instance Court and of the Losartan decision from the Paris Court of Appeals.   
The main findings of the President of the Paris First Instance Court are as follows: 

"Article 5 of EC Regulation No. 469/2009 provides that subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations. 
Thus, since the basic patent covering the active ingredient at stake, Valsartan, protects the owner of the patent against any non-allowed manufacture or marketing of pharmaceutical products containing this active ingredient, an SPC protects its owner against any non-allowed manufacture or marketing of any further pharmaceutical products containing this active ingredient and whose marketing would have been allowed before the expiry of the certificate.
Infringement is characterised when the claims of the patent are reproduced in the litigious product. 
The protection conferred by SPC No. 97C0050 covers the active ingredient that is the subject-matter of EP No. 0 443 983, i.e. Valsartan, which has been the subject-matter of an MA for the treatment of hypertension, cardiac insufficiency and myocardial post-infarction. 
In the present case, it is not challenged that the Valsartan Hydrochlorothiazide Zentiva product is a generic product of Valsartan and that it reproduces the claims of the patent relating to the Valsartan active ingredient. It does not matter that another active ingredient is present in the pharmaceutical product, because this is a mere addition that does not change the features of the claimed active ingredient. Therefore, since the claims of the patent are reproduced, the infringement is sufficiently likely for the measures of Article L. 615-3 to be implemented.

The preliminary injunction measures as well as the measures of recall of the products already marketed must therefore be maintained
You can read the French decision here and the English translation here.
An appeal can still be lodged against this decision. 

1 comment:

Anonymous said...

Isn't this the same Article 4 issue that has been referred to the CJ by the UK courts? Did this decision come out before or after that reference? It doesn't make sense to me that courts can decide on "live" issues at the CJ, or does this court already know the answer...