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13 July 2020
On 9 July 2020, the Court of Justice of the European Union (CJEU) handed down its decision in Santen SAS v Directeur général de l’Institut national de la propriété industrielle (C-673/18), concluding that it is not possible to obtain an SPC based on a Marketing Authorisation (MA) for a new use of a previously authorised product.
This decision overturns Neurim (C-130/11), and confirms a strict interpretation of the term “product” within the SPC Regulation.
Article 3(d) of the SPC Regulation provides that an SPC cannot be granted if there has been an earlier marketing authorisation for the same “product”. A “product” is defined in Article 1(b) of the Regulation as the active ingredient or combination of active ingredients of a medicinal product.
A literal interpretation of the SPC Regulation would seem to exclude the availability of SPCs for new therapeutic applications of previously approved active ingredients. However, the interpretation of “product” has been muddled in recent years by the highly controversial decision Neurim (C-130/11). The CJEU ruled in Neurim that SPCs may also be granted for a “different application” of a previously approved drug, provided that the application is within the limits of the protection conferred by the basic patent relied on for the purposes of the later SPC application. Thus, Neurim appeared to enable SPCs for second medical uses of known active ingredients, despite the existence of an earlier marketing authorisation for the same “product”. Unsurprisingly, this ruling led to considerable uncertainty regarding the concept of “product” and “different application”, and was considered to be in conflict with previous case law and the literal wording of the SPC Regulation.
Following Neurim, the Advocate General (AG) in Abraxis (C-443/17) highlighted that Neurim was “difficult to reconcile” with pre-existing case law and advised that the decision should be overturned, or at least Neurim should be limited to scenarios where the first approval is for a veterinary product, and the subsequent approval, forming the basis of the SPC application, is for a medicinal product for human use. Thus, the AG favoured a strict interpretation of “product”.
Subsequently, two preliminary questions were referred to the CJEU in Santen, regarding the interpretation of Neurim. First, the CJEU was asked to consider whether the concept of a “different application” of an old active substance should be interpreted broadly or strictly. Second, the CJEU was asked whether, in the context of determining whether the SPC “application is within the limits of the protection conferred by the basic patent”, the scope of the basic patent should be the same as the MA relied upon.
Shortly after the preliminary reference in Santen, the CJEU had the opportunity to consider the scope and relevance of Neurim in the Abraxis case. The CJEU returned to a narrow interpretation of “product”, ruling that a new formulation of a previously authorised product may not form the basis of an SPC. However, the CJEU chose not to address the conflict of Neurim with the literal wording of the SPC Regulation, and failed to provide clarity on how “different” an application for a new therapeutic use must be.
Following the decision in Abraxis, the AG in the Santen referral criticised the CJEU’s approach, urging the CJEU to make a clear and definitive choice between either reversing Neurim and adopting a strict interpretation of “product”, or embracing Neurim wholeheartedly and adopting a broad interpretation of “product”.
The CJEU in Santen heeded the advice of the AG and chose the first option: to reverse Neurim and adopt a strict interpretation of “product”. The Court concluded:
“Article 3(d) of [the SPC Regulation] must be interpreted as meaning that a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application.”
The Court reasoned that “product” is defined in Article 1(b) independently from its use or approved therapeutic application, and therefore the fact that an active ingredient can be used for a new therapeutic indication does not make it a different “product” because of this new therapeutic use.
The Court further addressed whether an MA granted for a new therapeutic application of a known active ingredient or combination of active ingredients can be considered as the “first” MA within the meaning of Article 3(d), where this MA is the first one to fall within the scope of protection of the basic patent relied upon in the SPC application. Following the strict interpretation of “product”, the Court reasoned that Article 3(d) must be understood as relating to the first MA for any medicinal product incorporating the active ingredient (or combination of active ingredients) under consideration, regardless of the therapeutic application for which it is approved. Therefore, the scope of protection of the basic patent is irrelevant when determining the first MA within the meaning of Article 3(d), contrary to the decision in Neurim.
This ruling essentially overturns the Neurim decision and quashes the ability to obtain an SPC for a second medical use of a known and previously authorised product. It will undoubtedly be a crushing disappointment to the pharmaceutical industry.
Dr Heather West
Life Sciences & Chemistry Group
If you require further information on anything covered in this briefing, please contact Heather West; or your usual contact at the firm. This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.
© Withers & Rogers LLP July 2020