Actavis v Sanofi, High Court
To the frustration of the parties and judge alike, the High Court has decided to refer particular questions on the interpretation of Article 3(a),(c) and (d) of the Supplementary Protection Certificate (“SPC”) Regulation to the European Court of Justice (“ECJ”) in a case between Sanofi and Actavis, a generics company. An SPC is granted in the pharma sector as an extension to patent rights to recognise the fact that a large time can elapse before patents are used because the innovations need to go through extensive time-consuming clinical trials. The SPC Regulation regulates the way that occurs.
Actavis wished to develop a generic version of Sanofi’s drug, CoAprovel; this was a combination of an antihypertensive drug called irbesartan and a diuretic hydrochlorothiazide (the “Combined Drug”). Sanofi’s patent covering irbesartan had expired in March 2011 and Sanofi successfully applied for and was granted an SPC in respect of the Combined Drug (the “Combined SPC”) until October 2013.
Actavis argued that under Article 3(a) of the Regulation, Sanofi was prevented from using the Combined SPC as the basic patent under which it had been granted only applied to irbesartan and therefore that the Combination Drug was not protected by the patent. In addition, it was argued that the Combined SPC should be revoked on the grounds set out in Article 3(c) and (d), which stated that not more than one SPC and one marketing authorisation could be granted with regards to the same active component for which the original patent had been granted – in this case, irbesartan.
Sanofi argued that the Combined SPC was valid because the original patent had referred to the Combined Drug separately under claim 20 of the patent and independently of irbesartan. The Combination Drug was, therefore, covered by protection of the patent. In addition, Sanofi counter-argued that as the two drugs were independent of one another under the protection of the patent, an SPC and marketing authorisation could be granted in respect of each.
The High Court decided that the outcome in this case was entirely dependent on the interpretation of Article 3(a), (c) and (d) in relation to the substance of the original patent. On consideration of the key case law in this area, namely the cases of Medeva BV v Comptroller-General of Patents, C-322/10 and Georgetown University and others v Comptroller-General of Patents C-422/10, it considered that discrepancies on interpretation remained, including between the national law courts of different EU nations. As such, the High Court said that the ECJ should be called upon to clarify the meaning of Articles 3(a), (c) and (d) for the benefit of not just the parties involved but of legal cohesion across the EU, in order for an appropriate ruling to be made.
Laura Mole, a solicitor in the Pharmaceutical and Life Sciences team at Matthew Arnold & Baldwin LLP, comments, “This referral to the ECJ highlights once again the difficult role national Judges have been given when being asked to interpret widely drafted EU legislation on specific issues, which, by their very nature, will almost always apply to patent challenge cases involving SPCs. With the effects of the patent cliff and struggling innovation making the use of SPCs of critical importance, this ruling will be fundamental to key players in the industry.”