Atripla (owned by pharmaceutical companies Merck, BMS and Gilead) is a single-tablet containing a combination of three drugs: Sustiva (efavirenz), Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine) for use by people living with HIV. Atripla was approved by the US Food and Drug Administration in July 2006 and generated $2.6 billion from global sales in 2016.
The UK patent protection extension was lost on the Atripla HIV-treatment following an England and Wales High Court ruling. The ruling stated 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 on two counts under European Union regulation. Firstly is the patent claim that the SPC certificate was based did not cover the Atripla combination and secondly it would have been obvious in light of the prior art. At the time Atripla was invented others were exploring combination therapies and knew there were advantages to combining the drugs.
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