7 November 2013Europe

SPC questions referred to CJEU in Actavis v Boehringer

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 questions, put by Justice Colin Birss, concern whether German pharmaceutical company Boehringer Ingelheim should be allowed to keep its SPC on MicardisPlus, a hypertension drug made of a combination of active ingredients telmisartan and hydrochlorothiazide, which is due to expire on January 30, 2017.

An SPC is intended to compensate the inventor for any delay between filing the patent and receiving marketing authorisation by providing additional protection.

Boehringer has a European patent on MicardisPlus’ predecessor Micardis, which has the active ingredient telmisartan. It also received an SPC on Micardis that expires on December 10, 2013.

At the time the patent was filed, there was no claim specifically directed to the combination of active ingredients. Boehringer later applied to amend the patent to include an additional claim that covers the combination.

US generic maker Actavis wanted to sell a product made of the same combination of telmisartan and hydrochlorothiazide.

On September 12, 2013, the CJEU heard three similar referrals about how to interpret the SPC Regulation in relation to the Actavis v Sanofi, Eli Lilly v Human Genome Sciences and Georgetown cases. The CJEU has not yet made a decision in this regard.

Camilla Balleny, a partner at Pinsent Masons LLP, said that it is “incredibly difficult” to tell what approach the CJEU will take in relation to this later pending case, though said it is clear the court is trying to “do battle” with the SPC Regulation to find resolution on at least some of the points in relation to it.

“My strong sense is that the CJEU is trying to give answers that don’t provoke further questions,” she said.

She added that some of the questions asked at the hearing demonstrated the CJEU’s level of frustration at the volume of references it receives from the patent courts.

“[The case] will be further underlining to [the CJEU] what these issues are and that they do need to be resolved one way or the other,” she said.

Edward Oates, a partner at Carpmaels & Ransford LLP in London, said that a decision in the Actavis v Sanofi case could have a big effect on the Actavis v Boehringer case, particularly if the CJEU takes an extreme pro-innovator or pro-generic stance.

“It might even do away with the need to answer the Boehringer questions, although that is perhaps wishful thinking” he said.

He said that if the court takes an extreme pro-innovator position, granting Sanofi an SPC and expounding a very broad “protection” test, there will be no need to “debate the minutiae of the Boehringer case.”

On the other hand, if the court sides with Actavis, taking the view that only one SPC per patent is permissible, the Boehringer referral will almost become irrelevant as Boehringer already has an SPC on the basic patent, he said.

However, he added, these are not the most likely outcomes: “It’s more likely that the CJEU will find some middle ground.

“Then it will become a question of to what extent the CJEU wants to dispose of the Boehringer judgment when answering the Sanofi questions.”

He said that in some cases in the past, the CJEU has had “one eye on a case that’s coming down the track,” which may influence its decision on the case in hand, but that it doesn't always do this: “One of the problems that we’re seeing with the CJEU is that it has been quite tunnel-visioned in answering the questions that have been put before it insofar as they relate to the specific facts in question, without thinking about the consequences for the wider industry when different facts are in dispute.”

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