March 26 2012
The Paris Court of Appeal recently rejected a request for a preliminary injunction brought by Novartis, the owner of a supplementary protection certificate (SPC) for a medicinal product, against Actavis, which used the product in combination with another active ingredient.
Swiss company Novartis AG is the owner of Patent EP 0443983 for a group of anti-hypertensive compounds, including valsartan. Novartis extended the protection until November 13 2011 by obtaining an SPC (97 C 0050) and a paediatric extension. In France, Novartis Pharma is the exclusive licensee of the French designation of the patent and the SPC.
On November 30 2009 Icelandic company Actavis Group PTC EHF obtained marketing authorisations for its pharmaceutical products valsartan hydrochlorothiazide Actavis 80 milligrams (mg)/12.5mg and valsartan hydrochlorothiazide Actavis 160mg/25mg in France. The products are a combination of valsartan with another active ingredient (ie, hydrochlorothiazide (HCTZ)). Actavis France is designated as the exploiting company of these marketing authorisations.
After informing Actavis of the existence of its rights, Novartis filed for a preliminary injunction, claiming that the French designation of its patent and SPC covering valsartan could be asserted against any product containing valsartan - including a product containing valsartan and another product such as HCTZ. It requested that the presiding judge enjoin Actavis from infringing its patent and SPC.
In its order of January 28 2011 the presiding judge of the Paris First Instance Court granted the preliminary injunction, based on Articles 4 and 5 of EU Regulation 469/2009. The judge held that "the protection conferred by a SPC shall extend only to the active ingredient [ie, valsartan] covered by the marketing authorisations and for any use of the product as a medicinal product that has been authorised before the expiry of the SPC". The SPC conferred on its subject matter "the same rights as conferred by the basic patent". Consequently, Novartis "could oppose any use of this active ingredient for treating high blood pressure, alone or in combination with another active ingredient".
Actavis appealed to the Paris Court of Appeal, which overruled the order and rejected the preliminary injunction.
The court found that according to the definition set out in Article 1 of EU Regulation 469/2009, the subject matter of the protection conferred by the certificate was the product and not the active ingredient as the first level judge had mistakenly ruled.
The court then pointed out that EU Regulation 469/2009 states that the product may be a combination of active ingredients. As in this case the subject matter of the protection conferred by the SPC was the valsartan product only, its combination with another active ingredient (eg, HCTZ), was another product and as such was not covered by the SPC.
The Paris Court of Appeal concluded that Novartis could therefore assert the rights on its SPC only against third parties manufacturing or selling valsartan alone. Products which did not contain valsartan alone did not infringe the SPC.
This issue has been vigorously debated both in France(1) and abroad. On August 26 2011 the UK High Court of Justice referred questions to the Court of Justice of the European Union for a preliminary ruling on the interpretation of Articles 4 and 5 of EU Regulation 469/2009 (C-442/11, Novartis AG v Actavis UK Ltd).(2)
For further information on this topic please contact Stanislas Roux-Vaillard at Hogan Lovells International LLP by telephone (+33 1 53 67 47 47), fax (+33 1 53 67 47 48) or email (firstname.lastname@example.org).
(2) See the subsequent ECJ decisions in Medeva and Georgetown.
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