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Triple combination SPC held invalid
12 June 2017 by Dr Ryan Mitchell

In March 2017, the UK High court held that Merck Sharp & Dohme Corporation's (MSD) SPC for an anti-HIV triple combination product was invalid.

The SPC

MSD's SPC was granted based on claim 16 of EP (UK ) 0582455 and their European marketing authorisation covering the triple combination product (marketed as "Atripla"), which combines efavirenz, emtricitabine and tenofovir into a single fixed-dose tablet.

The patent

Claim 16 of EP (UK ) 0582455 reads:

"A combination of the compound of claim 12 or a pharmaceutically acceptable salt thereof with a nucleoside analog having biological activity against HIV reverse transcriptase."

The compound of claim 12 is efavirenz. The issue became whether the term "a nucleoside analog" meant a single nucleoside analog or at least one nucleoside analog.

Mr Justice Arnold held that claim 16 covered a combination of efavirenz and emtricitabine OR efavirenz and tenofovir, but not a combination of the three.

Therefore, the court found the SPC invalid because the product was not protected by the basic patent, which is one of the requirements of the SPC Regulation (Article 3(a)).

Pre-existing SPC

MSD already possessed an SPC for efavirenz based on the same patent.

The court also deemed that unless claim 16 represented a product that was distinct invention from the claims that protected efavirenz, then the product would already be the subject of the pre-existing SPC.  This principle adopted by the court follows from CJEU decisions in Actavis v Sanofi (C-443/12) and Georgetown (C-422/10).

The court found that claim 16 did not represent a distinct invention because, at the priority date of the patent, it would have been obvious to the skilled person to combine efavirenz with a nucleoside analog with a reasonable expectation of the combination having biological activity against HIV reverse transcriptase (i.e. the product of claim 16 lacked inventive step over the claims protecting efavirenz).

As the combination product of claim 16 was not a distinct invention from the single product (efavirenz), which was the subject matter of a pre-existing SPC, the court found that the SPC did not meet the requirements of the SPC regulation (Article 3(c)) for the further reason that the product of this later SPC had already been the subject of an SPC.

Summary

The SPC was found invalid for not protecting the product and for the product having already been the subject of an earlier SPC granted to MSD.

The case law in the area of combination products is complex.  Our Forresters attorneys are on hand to navigate you through the complexities to provide a strategy for your portofolio.