NEW DELHI: The Indian Patent Workplace has rejected the grant of a patent for dolutegravir, an important HIV drug marketed by Viiv Healthcare, facilitating the entry of generics and increasing entry to inexpensive, life-saving therapy. The choice, introduced after a contentious practically decade-long battle, follows the corporate’s patent utility for the HIV therapy in 2007.
The corporate confronted a number of pre-grant oppositions from Natco and varied advocacy teams between 2013 and 2019, in keeping with the order accessed by TOI. It led to the Patent Workplace rejecting the grant of a patent not too long ago. Consultants imagine the ruling might serve for instance in opposition to the follow of “evergreening” patents, a follow that extends patent life via patenting of apparent kinds and enhancements of life-saving medicines. Over the following few years, with extra gamers getting into the market, the first-line HIV drug will seemingly be obtainable at a fraction of the innovator worth.
“I’m of the opinion that claims will not be patentable underneath Part 3(d) of the Act since no enhanced therapeutic efficacy has been demonstrated within the specification,” the order by Deputy Controller D Usha Rao mentioned.
Viiv Healthcare, which is majority owned by GSK and has Pfizer and Shionogi as main shareholders, is targeted on HIV therapies. In April 2014, the Medicines Patent Pool and ViiV Healthcare signed licensing agreements to speed up entry to dolutegravir, for grownup and paediatric care.
