SPC referral to CJEU: Actavis v Boehringer

The CJEU has handed down its judgment in the Actavis v Boehringer referral. This judgment deals with questions referred by the High Court of England and Wales that relate specifically to SPCs for combinations of active ingredients.

In this case an SPC was granted in respect of the active ingredient, telmisartan, and, based on the same basic patent, the patentee subsequently sought an SPC for a later authorised product comprising a combination of telmisartan and a second active ingredient, hydrochlorothiazide. As Boehringer’s basic patent contained only claims which related to one of the product’s active ingredients, namely the telmisartan component, the UK IPO suggested that Boehringer should apply to amend that basic patent to insert a claim to the combination of telmisartan and hydrochlorothiazide. Boehringer then applied to the UK IPO to amend its basic patent, as granted, by inserting a new claim, namely claim 12, relating, inter alia, to a pharmaceutical combination of telmisartan and hydrochlorothiazide.

Actavis brought proceedings claiming that the combination SPC is invalid, on the ground that, at the date on which the application was originally made for that certificate the product in question was not specified in the wording of the claims of Boehringer’s basic patent.

The High Court referred four questions to the CJEU but the referral dealt with two general issues.

Firstly whether, where a basic patent includes a claim to a product comprising an active ingredient 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, Article 3(a) and (c) precludes the holder from obtaining a second SPC for that combination. This issue had previously been dealt with by the CJEU. In Actavis v Sanofi (C 443/12), the CJEU had held that Article 3(c) precluded the grant of a combo-SPC, where the “core inventive advance” of the patent, ie the active ingredient, had already been the subject of an SPC, particularly when the SPC relating to the combination product had a later expiry date.

The second issue is whether it is allowable to amend the basic patent after grant to satisfy Article 3(a). Post-grant patent amendment, for example to add a claim which explicitly identifies all active ingredients present in an authorised combination product, is a common way to address earlier CJEU decisions requiring the basic patent to “specify” the active ingredients. Unfortunately, this second issue regarding post-grant amendment was not answered by the CJEU in light of its answer to the first issue.

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