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Bulgaria Decision Aftermath: Eu Spc Protection for 49 Combination Products at Risk


Lewes, DE -- (SBWIRE) -- 08/27/2014 -- Following on from a recent Bulgarian Supreme Court decision, up to 34 Supplementary Protection Certificates (SPCs) protecting the Efavirenz, Emtricitabine and Tenofovircombination product are potentially invalid, according to patent experts.

The Bulgarian Supreme Court’s decision, based on the preceding CJEU ‘Medeva’ case, affects SPCs for combination products where one or more of the combined active ingredients are not specified in the wording of the patent claims.For the Efavirenz, Emtricitabine and Tenofovircombination product 10 European SPCs have been rejected already and one withdrawn, leaving 34 granted and pending SPCs at risk of being invalid.

ARK Patent Intelligence data reveals that 478 European SPCs, covering 49 combination products are in danger because they, too, do not specify active ingredients in the basic patent wording.

According to expert analyst Leighton Howard (GenericsWeb CEO): “The Medeva case was clear about the need for patent claims to specify active ingredients containedin a combination product to be eligible for an SPC.The Bulgaria Tenofovirdecision shows the stark risk to combination SPCs which do not meet the criteria. Of course, this is also an important development for generics firms.”

“It is vital for innovators and generics firms to be aware of the impact of this decision, and others like it. We have been keeping a close watch on affected SPCs since the Medeva decision and this situation will move quickly,” said Howard.

“This decision presents an opportunity for generics makers to make gains in the growing antiretroviral markets and yet another risk for innovators to manage.”

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