A recent decision from the UK High Court has shed further light on the granting of multiple SPCs to protect single ingredient products and related combination products. In this case the claimants, Teva, Accord and Mylan, challenged the validity of Merck Sharpe & Dohme’s SPC, which was directed to a combination product for the treatment of HIV. The claimants contended that the SPC did not comply with either Article 3(a) or Article 3(c) of the SPC Regulation (469/2009/EC). In finding MSD’s SPC invalid, the judge reviewed recent case law from the CJEU concerning Article 3 and confirmed that, at least in the UK, a combination product including an active ingredient for which an SPC has already been granted must represent a distinct invention in order for a combination SPC to be granted.
Facts of the case
MSD’s combination product, marketed under the name Atripla, consists of three active ingredients: efavirenz; tenofovir; and emtricitabine. The combination product is provided in the form of a single tablet for administration once daily to HIV-1-infected patients, to simplify treatment regimens. Atripla was granted marketing authorisation on 13 December 2007. MSD relied upon this first marketing authorisation and upon European patent EP(UK)0582455 as basis for the combination SPC.
MSD had previously been granted an SPC for the single active ingredient, efavirenz, based on the same European patent, and a separate marketing authorisation for efavirenz granted on 20 November 1998.
Taking this into account, the claimants argued two-fold:
- The SPC does not comply with Article 3(a) because the combination product is not protected by the European patent relied upon; and
- The SPC does not comply with Article 3(c) because MSD had previously obtained an SPC for the single active ingredient, efavirenz, based on the same patent.
The issue surrounding Article 3(a) was relatively straightforward in this case. MSD relied upon claim 16 of the patent to assert that the combination product was protected by a basic patent in force. Claim 16 recites:
“A combination of the compound of claim 12 [efavirenz] or a pharmaceutically acceptable salt thereof with a nucleoside analog having biological activity against HIV reverse transcriptase.”
It was held that while both tenofovir and emtricitabine are nucleoside analogs, the claim only permits for “a” singular additional active ingredient, and not two additional substances. Therefore, the triple combination product was found not to be protected by the patent, such that the SPC did not comply with Article 3(a).
Despite the finding in relation to Article 3(a), the judge continued to address the issue surrounding Article 3(c) and in doing so, reviewed several of the CJEU decisions relating to interpretation of this provision (see here for our previous reports). In particular, it was noted that in both the Actavis v Sanofi (C-443/12) and the Georgetown University (C-484/12) decisions, it was established that it is possible in principle to obtain more than one SPC per patent provided that each of the products is protected ‘as such’ by that basic patent. The judge also referred to the CJEU decision in Actavis v Boerhinger (C-577-13), in which it was stated that Article 3(a) and (c) must be interpreted as meaning that, where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, and a claim to that active ingredient and another substance, the patentee cannot obtain a second SPC for the combination.
In the present case, the judge went a step further, stating that to obtain a second SPC for a combination of active ingredients, it is necessary to determine whether the combination represents a “distinct invention” (as compared to the single ingredient product) such that it could in principle form the subject-matter of a separate patent. In other words, it is necessary to demonstrate that the combination product itself satisfies the criterion of possessing an inventive step. This reasoning is in line with the main objective of the SPC Regulation, namely to compensate patentees for the delay to the marketing of a product constituting the ‘core inventive advance’ of a patent.
In this case, the SPC for Atripla was not held to satisfy the requirements of Art 3(c) because there was no evidence in the patent to suggest that the combination was a separate invention over the single product, efavirenz. Based on the common general knowledge at the priority date, the judge considered that it would have been obvious to try combining efavirenz with a nucleoside analog, such as tenofovir and/or emtricitabine, and that this combination was likely to be synergistic or additive, i.e. the combination product was obvious.
This decision provides a useful framework for assessing when a second SPC directed to a combination product may be permitted when an SPC has already been granted in respect of one of the active ingredients. In particular, it has been made clear that the combination must represent a distinct invention irrespective of whether it is protected by the same patent as the single product or by a different patent.