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10 July 2020GenericsRory O'Neill

CJEU ‘shuts door’ on SPCs for second medical uses

The EU’s top court has ruled out extra exclusivity rewards to drug companies for products with a second medical use.

The Court of Justice of the European Union (CJEU) yesterday, July 10 issued its highly anticipated  ruling in Santen, a case dealing with supplementary protection certificates (SPCs) for products with second medical uses.

In the EU, pharmaceutical companies can apply for  SPCs, which extend the period of exclusivity they enjoy on a product.

But SPCs can only be granted under certain conditions. Under EU law, the marketing authorisation (MA) cited in an SPC application must be the “first to place the product on the market as a medicinal product”.

In its decision, the court ruled: “an MA for a therapeutic application of a product cannot be regarded as the first MA for that product as a medicinal product … where another MA was granted previously for a different therapeutic application of the same product.”

“The fact that the most recent MA is the first MA to fall within the limits of the protection of the basic patent relied on in support of the SPC application cannot call that interpretation into question,” it added.

Speaking to LSIPR, Beatriz San Martin, partner at  Arnold & Porter, said the CJEU had “shut the door” on SPCs for second medical uses.

“It’s a clear decision, and it dashes the hopes for innovators who had hoped to obtain SPCs for such products,” she said.

The decision will be welcomed by generics makers looking to manufacture cheaper versions of drugs with newly discovered medical uses.

It also provides certainty in an area of EU patent law which has been unclear since the CJEU’s 2012 decision in Neurim.

That ruling opened the door to the possible granting of SPCs for second medical uses, but left doubts over its scope, and whether it applied to new formulations and new indications of known active ingredients.

“After Neurim, there was speculation as to how broadly that decision would be applied, and whether you could get SPCs for second and further medical uses,” San Martin explained, adding: “This decision makes it clear you can not.”

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