Santen case: SPC law on second medical use products faces CJEU update

In a non-binding opinion issued on Thursday morning, Giovanni Pitruzzella proposed that the Court of Justice of the EU (CJEU) should overrule its previous ruling on the issue – the 2012 Neurim judgement – and instead favour a literal interpretation of the SPC Regulation that would preclude new applications of previously authorised products from being eligible for SPCs.

A formal judgment of the CJEU is anticipated in the coming months.

"This case goes to the heart of the controversial and much debated question of what incentives should be made available to pharmaceutical companies involved in medical research to encourage their investment in innovative new treatments," said patent law expert Jules Fabre of Pinsent Masons, the law firm behind Out-Law.

"The central question the CJEU will have to answer is whether pharmaceutical innovation that is to be rewarded by means of an SPC should only concern the discovery and development of entirely new active substances, or whether it should also concern research on other new treatments, including new applications of old ingredients," he said.

Specifically, the case relates to the interpretation of Article 3(d) of the SPC Regulation which states that the marketing authorisation serving as a basis for the SPC application must be "the first authorisation to place the product on the market as a medicinal product".

In the 2012 Neurim case, the CJEU determined that Article 3(d) does not preclude pharmaceutical companies from obtaining an SPC for a 'different application' of the same product for which a marketing authorisation had already been granted "provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate".

The CJEU, however, did not provide guidance as to what should be considered a 'different application' and Fabre has previously explained how the Neurim judgment has been interpreted differently be patent offices and courts across EU member states, resulting in a fragmentation of rights for pharmaceutical companies within the trading bloc.

According to Pitruzzella, the interpretation in the Neurim judgment is not consistent with the objectives of the SPC Regulation, which were to provide a uniform, simple, transparent and balanced system within the internal market of the EU.

He also said that this was not consistent with the CJEU's strict interpretation of the concept of 'product', which is defined in Article 1(d) of the SPC Regulation as excluding any new medical uses of an active ingredient.

Pitruzzella also looked into the issue of which types of research the SPC Regulation intended to encourage. While he acknowledged that the wording of the SPC Regulation is "anything but clear" in this respect, he considered that the intention of the legislator was nevertheless to limit the scope of protection offered by SPCs to new active ingredients only.

"Pitruzzella said that it may well be the case that the rationale for the SPC Regulation is decades old now and that today significant investment is ploughed into research for second medical uses. His view, though, was that whether such research should be incentivised is an issue for EU law makers to address, not the courts," Fabre said.

While Pitruzzella believes the CJEU should rule that second medical use products are not eligible for SPCs, he did outline an alternative conclusion the CJEU could draw should it decide against overruling the Neurim judgment and to instead clarify its scope.

If the CJEU favours that alternative outcome, Pitruzzella said it should rule to limit the scope for SPCs to be granted for second use medical products. The limitation should extend only to cases where the new use of an active ingredient is for treating a new disease – or new therapeutic indication – or where an old active ingredient exerts a new pharmacological, immunological or metabolic action of its own.

Fabre said there is recent precedent to show that the CJEU may yet decide to favour Pitruzzella's alternative views, or indeed reach an entirely different view in its formal judgment altogether.

"In the Abraxis case that the CJEU ruled on last year, the court elected not to follow the opinion of the advocate general who had reached a similar view to Pitruzzella – that the Neurim test should be abandoned and that second medical use products are not eligible for SPCs in any circumstance," Fabre said. "Probably due to the narrow scope of the question posed to it in the Abraxis case, the CJEU formulated a narrow answer, ruling that new formulations of an old active ingredient are not eligible for SPC protection. It neglected to go further and explain whether the 'different application' test set in the Neurim case should still stand and, if so, what the term means in practice. This is not the case here as the Paris Court of Appeal has specifically asked the CJEU to clarify its Neurim judgment and thus there is a chance that the CJEU may use that opportunity to finally take a general position on the issue."

The underlying dispute before the Paris court involves pharmaceutical laboratory Santen. Santen is seeking to overturn a previous decision by France's National Institute for Industrial Property (INPI) to reject its application for an SPC for ciclosporin for use in treating keratitis - an inflammation of the eye's cornea. Ciclosporin was the active ingredient in another eye treatment for which marketing authorisation was granted in 1983.