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By Peter Leung
Merck Sharp & Dohme Corp. lost its U.K. patent protection extension on its Atripla HIV-treatment cocktail March 22.
The England and Wales High Court ruled that Atripla’s supplementary protection certificate (SPC), which extends the patent protection term to make up for time lost to get regulatory approval, was invalid under European Union regulation. That is because the patent claim that the certificate is based on doesn’t actually cover the Atripla combination ( Teva UK Ltd. v. Merck Sharp & Dohme Corp. , EWHC (Pat) (U.K.), 3/22/17 ).
And even if that wasn’t the case, the patent claim would still be invalid because it would have been obvious in light of the prior art, the court ruled.
Atripla generated $2.6 billion in global sales in 2016, with $520 million coming from Europe, according to Gilead.
The case highlights the challenges drug makers face in trying to extend patent protection on blockbuster drugs and their variants. These drugs are often covered by several patents, and patent holders regularly make strategic decisions to extend and maximize their protection terms.
Atripla is a combination of three viral enzyme inhibitors, efavirenz, tenofovir (TDF) and emtricitabine (FTC). MSD has the SPC covering the drug, based on claim 16 of European Patent (U.K.) No. 0 582 455. The patent expired in August 2013.
Although MSD holds the patent and SPC, Bristol-Myers Squibb Co. and Gilead Sciences Inc. have marketing authorization for the drug in the U.K. Teva U.K. Ltd., Accord Healthcare Ltd. and Generics (UK) Ltd. challenged the SPC to clear the way for a generic version.
The court sided with Teva, saying that claim 16 of the patent doesn’t cover Atripla.
Claim 16 describes a combination of efavirenz with “a nucleoside analog.” Though both TDF and FTC fit this description, the claim only calls for a combination of efavirenz with either TDF and FTC, but not both, as required for Atripla.
While other parts of the patent seem to refer to combinations involving more than one of these analogs, that doesn’t mean “a nucleoside analog” used here should be read as more than one, the court said.
The court also noted that, while there may have been other claims in the patent that may cover Atripla, MSD only relied on claim 16.
Since Section 3(a) of the EU regulation on SPCs requires that the product be protected by a patent, the SPC is invalid.
Even if claim 16 covered the combination of the three active ingredients, it would be invalid because it was obvious, the court said. At the time of the invention, skilled artisans were exploring combination therapies and already knew there were advantages to combining the drugs. Looking at publications from that time, the court concluded that skilled artisans would not consider these sorts of combinations to be inventive.
Teva said it was pleased with the ruling. Bristol-Myers Squibb declined to comment. The other parties did not respond to requests for comment.
Justice Richard Arnold wrote the decision. Barristers Charlotte May and Lindsay Lane represented the generics, along with Pinsent Masons LLP representing Teva and Accord and Taylor Wessing LLP representing Accord and Mylan. Barristers Thomas Hinchliffe, along with Hogan Lovells International LLP, represented MSD.
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