On July 9th 2020, in Santen, C-673/18, the Court of Justice of the European Union (CJEU) ruled that a Marketing Authorisation (MA) for a new therapeutic application of a medicine that was previously authorised for another application, can NOT be used as the basis for a supplementary protection certificate (SPC) for that medicine. This decision will disappoint many companies in the pharmaceutical industry and already, we are seeing Office Actions issued from the Intellectual Property Office of Ireland ( IPOI) in cases that had been stayed pending the Santen decision.
In Europe, SPCs are governed by the SPC EU Regulation (EC 469/2009). One of the requirements for grant of an SPC is set out in Article 3 (d) of the EU Regulation, which requires:
d) The authorisation referred to in point b) (i.e. the Marketing Authorisation covering the product) is the first authorisation to place the product on the market as a medicinal product.
For this purpose, the “Product” is interpreted as being an active agent such as a drug compound. A strict interpretation of Art 3(d) would permit an SPC to be granted only the first time a specific active ingredient was marketed, whether that was used for human medicine or in animals. This would reward the development of new active ingredients but not new uses of known active ingredients.
A relatively strict interpretation of the SPC regulation was the usual approach by the national patent offices of European Countries including the UKIPO, French patent office and German patent office until 2012 when the “Neurim” referral to the CJEU (C-130/11) changed the SPC legal landscape significantly. Thus, before the Neurim decision in 2012, the wording of Article 3(d) was interpreted as preventing any SPC for a medicinal product based on a new MA for a product previously authorised for another therapeutic use. However, in the CJEU decision in the Neurim case in 2012 (C-130/11), the CJEU, allowed an SPC based on a second medical use patent and an MA which fell within the scope of that patent, despite the existence of an earlier MA for a veterinary use of the same product.
Since the Neurim decision in 2012, there has been huge uncertainty in Europe amongst SPC practitioners over whether the decision in Neurim could be applied more widely to allow SPCs for new therapeutic uses of previously authorised products.
The Neurim decision was, of course, considered in the present case. The applicant, Santen, filed an SPC for the drug, cyclosporin, based on a second medical use patent and an MA for its use to treat keratitis. This SPC was rejected by INPI (the French patent office) on the grounds of not meeting the requirements of Article 3(d), because a prior MA had been granted for the same drug. Santen appealed the decision. The French court referred the matter to the CJEU.
Now, in the Santen decision issued on July 9th, 2020, the CJEU departed from the Neurim decision and held that the scope of the basic patent is irrelevant in determining whether the requirements of Article 3(d) are met. In fact, the Court considered that doing so would undermine the objectives of the entire SPC Regulation, and would lead to divergent decisions from national patent offices.
Thus, the CJEU decided that an MA for a new therapeutic application of a product cannot be regarded as the first MA for that product for the purposes of Article 3(d) if the product has already received an MA for a different therapeutic application.
The European court’s decision will result in an end to the possibility of obtaining SPCs at the national patent offices of European countries, for new therapeutic uses for pharmaceutical products that have already been granted a marketing authorisation. In my opinion, this is bad news for patentees who are carrying out research into new medical uses for known pharmaceutical compounds as it means that there will be no possibility of extension of patent term in Europe for such new medical uses. Many applications for SPCs had already been “Stayed” while awaiting this decision and in my view, these applications are now likely to be refused unless the particular circumstances of the subject matter of the SPC application can be differentiated from the Santen case.
Contact the author Marie Walsh or your usual HMC-IP attorney for further advice.