In a case brought by Actavis Group against Boehringer Ingelheim, the UK Patents Court has referred four questions to the Court of Justice of the European Union (CJEU) seeking clarification on how the Supplementary Protection Certificate (SPC) Regulation should be interpreted in relation to drug products made of a combination of active ingredients. The case concerns once more the validity of a combination SPC but there are a number of specific issues raised which have not been considered by the CJEU previously.

As it will take some time for the case to make it through the referral process, the status quo will be maintained through an interim undertaking from Actavis not to launch its product, subject to a cross-undertaking in damages from Boehringer.

Background

Boehringer’s patent EP (UK) 0 502 314 (‘the Patent’) discloses and claims a number of molecules including, a compound called telmisartan - the active pharmaceutical ingredient (API) in its hypertension drug, Micardis. Boehringer has an SPC, based on the Patent and its marketing authorisation for Micardis, which is due to expire on 10 December 2013 (‘the Telmisartan SPC’).

In 2003, Boehringer applied for a combination SPC in relation to its combination product consisting of telmisartan and hydrochlorothiazide, sold as MicardisPlus (‘the Combination SPC’). As it was necessary that the combination be clearly claimed in the Patent, the UK IPO suggested that an application to amend the Patent be made so as to insert a claim (Claim 12) to the combination of telmisartan and hydrochlorothiazide. The UK IPO stayed the application for the Combination SPC to enable the amendment process to be conducted. Subsequently, the amendment was duly granted as was the Combination SPC which is due to expire on 30 January 2017.

Actavis, wanting to launch its own combination product, applied to invalidate the Combination SPC.

The UK Judge referred a number of questions to the CJEU and it is for them to determine the answers to those questions but the Judge did express his own views on some of the issues.

The Issues

The first issue referred to the CJEU relates to the introduction of Claim 12 post grant. The question is, in essence, whether the Patent can qualify as ‘a basic patent in force’ under the Regulation when, at grant and at the time of the filing of the application for the Combination SPC, it did not explicitly identify the two active ingredients in combination. The UK Judge’s view was that such a patent can qualify as amendments to UK patents have retrospective effect.

The second issue referred to the CJEU relates to the situation where the Patent includes a claim to, in this case, telmisartan, and a further claim to a product comprising the combination of telmisartan and hydrochlorothiazide, and there is already an SPC for a product comprising telmisartan – in such circumstances, is it necessary to consider whether the combination of active ingredients is a distinct and separate invention from that of telmisartan alone? This particular issue is already before the CJEU under a separate referral (Actavis v Sanofi) where the question asked is effectively, is more than one SPC per patent permissible?

The third issue relates to the extent to which the existence of the Telmisartan SPC affects the Combination SPC – does the existence of the Telmisartan SPC preclude an SPC for the combination? If not, should the duration of the Combination SPC be assessed by reference to when the authorisation was granted for the single active ingredient product or for the combination product? The UK Judge expressed that he would be ‘surprised’ if there was any basis in the SPC Regulation for giving an otherwise valid SPC a lesser term in such circumstances.

The fourth issue concerns the UK IPO’s approach in this case and whether it was legitimate to stay the application for the Combination SPC to allow Boehringer to apply to amend the Patent. Here, the 6 month period following marketing authorisation had expired before the application for the Combination SPC recommenced. The UK Judge saw no reason for the legitimacy to be doubted yet he referred the question.

Conclusions

It will be some time before this latest referral to the CJEU is determined. The CJEU heard the references in the other SPC referrals - Actavis v Sanofi, Lilly v Human Genome Sciences and Georgetown University - in September. The Advocate General will be issuing his Opinion in the Georgetown case shortly but it is understood that there will be no Advocate General Opinion in either of the two other referrals.

In the meantime, if you find yourself in a similar position to Boehringer, serious consideration needs to be given to pending and granted cases where patent term extension is desired for a combination encompassed by the claims and supported by the specification but not specifically claimed.

For pending applications, it will be important to ensure that there are claims directed to not only the API but also any specific combinations envisaged, where possible.

There are fewer options available to proprietors of granted patents and it is difficult to see a downside other than the associated cost to simply making a post-grant amendment to specifically cover a combination and filing an application for a combination SPC since it will be some time before a decision is handed down by the CJEU. It would be prudent, where possible, to conclude the post-grant amendment procedure prior to the expiry of 6 months from the date of the relevant marketing authorisation for the combination to try to avoid any potentially adverse decision regarding the fourth issue.

http://www.aipla.org/committees/committee_pages/Biotechnology/international/Shared%20Documents/International_Buzz_201311b.pdf