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No protection for new formulation of old active ingredient

Posted on 25 March 2019

No protection for new formulation of old active ingredient

The CJEU has adopted a narrow interpretation of Article 3(d) of the SPC Regulation, finding that a supplementary protection certificate cannot be granted where a product protected by a marketing authorisation is a new formulation of an active ingredient which is protected by an earlier marketing authorisation.  In particular, the CJEU noted that the intention behind the SPC Regulation was not to protect all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but "to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product". An alternative finding would frustrate that objective, and would lead to legal uncertainty and inconsistencies.

The decision in Abraxis Bioscience v Comptroller General of Patents was in response to questions referred by Arnold J in the Patents Court, following a refusal by the UKIPO of an SPC for a product described as "paclitaxel formulated as albumin bound nanoparticles" (called nab-paclitaxel by Abraxis, and marketed under the trade mark Abraxane), because it did not comply with Article 3(d). Abraxane is indicated for the treatment of certain cancers, used alone or together with other anti-cancer treatments. Before the marketing authorisation for Abraxane had been obtained, paclitaxel had been marketed by other parties under earlier MAs.  Whilst SPC protection was refused in the UK (and Sweden), certificates were granted to Abraxis in nine Member States.

Arnold J decided to refer questions to the CJEU (as discussed in our April 2017 edition), but his preliminary view was that SPCs should not be available for new formulations of old active ingredients (as opposed to new applications i.e., new therapeutic uses). Whilst he recognised the SPC Regulation's primary purpose was to reward innovative research and compensate patentees for delays in obtaining marketing authorisations, he stressed that it was also intended to provide a simple and predictable system that could be operated by national patent offices in a uniform manner, and which balanced the interests of patentees with other stakeholders. As such, it was necessary to have 'bright-line rules', even if they might sometimes deprive meritorious inventions of extended protection.

The CJEU's decision could have been an opportunity to revisit its controversial Neurim decision but it did not do so, merely finding that Neurim did not call into question the interpretation it had reached.  In Neurim, the CJEU had endorsed SPC protection for new therapeutic applications for existing 'old' active ingredients. Applying a teleological approach to the Regulation and focusing on its objectives, the CJEU decided that the existence of an earlier MA for a medicinal product would not preclude the grant of an SPC for a different application of the same product. As we discussed in January 2019, Advocate General Saugmandsgaard ØE proposed a move away from the teleological interpretation of Article 3(d) back to a literal interpretation in all situations or, as an alternative, limiting its application to the factual constraints of Neurim, namely a product previously authorised for a therapeutic indication in veterinary medicine which is subsequently granted a marketing authorisation for a new therapeutic indication in human medicine.

The opportunity to revisit Neurim may, however, come in a forthcoming reference from the French courts, Santen.

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