13 March 2015Big Pharma

CJEU clarifies rules on combination SPCs

An Advocate General in the Court of Justice of the European Union (CJEU), Niilo Jääskinen, has clarified how the regulation for supplementary protection certificates (SPCs) should be interpreted concerning medicinal products made with a combination of active ingredients.

He said patent owners cannot obtain an SPC for a combination drug if they have already been granted one just for just the product’s active ingredient and later amend the original patent to include the new substance.

The English Patents Court, a division of the English High Court, referred this case to the CJEU in November 2013. It asked the court to rule on whether an SPC covering Boehringer’s blood pressure drug MicardisPlus (telmisartan/hydrochlorothiazide) was valid.

SPCs compensate drug developers for any delay between filing for a patent and receiving marketing authorisation for the drug, by providing up to five years of additional protection.

Actavis originally brought the case to the English court, seeking to market a product using the same combination of telmisartan and hydrochlorothiazide.

Boehringer has a European patent covering blood pressure drug Micardis (telmisartan)—MicardisPlus’s predecessor—as well as an SPC for the drug, which expired in December 2013. At the time it was issued, in 1998, the patent only claimed telmisartan as the active ingredient.

However, Boehringer applied to amend the basic patent to include a new claim that covers a combination of telmisartan and hydrochlorothiazide. In 2005, it received an SPC covering the combination of active ingredients, which is due to expire in 2017.

Actavis argued at the English Patents Court that the combination SPC is invalid as, on the date of the application, the combination product was not specified in the patent’s wording.

Boehringer argued that amending patents after they have been granted is permissible, and that the basic patent retrospectively protected the combination product (MicardisPlus) after its amendment.

But the Advocate General decided on Wednesday (March 11) wrote: “Where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject matter of the invention, for which the holder of that patent has already obtained an SPC, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance, that provision precludes the holder from obtaining a second SPC for that combination.”

Jääskinen added that the second SPC should not have been granted to Boehringer for the combination therapy, “irrespective of whether a new claim to hydrochlorothiazide was added to the basic patent after it had been granted”.

Actavis did not respond to a request for comment. Boehringer could not be reached for comment.

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