Patent for HIV drug rejected, paves way for entry of generics

NEW DELHI: The Indian Patent Office has rejected the grant of a patent for dolutegravir, a crucial HIV drug marketed by Viiv Healthcare, facilitating the entry of generics and expanding access to affordable, life-saving treatment. The decision, announced after a contentious nearly decade-long battle, follows the company's patent application for the HIV treatment in 2007.

The company faced multiple pre-grant oppositions from Natco and various advocacy groups between 2013 and 2019, according to the order accessed by TOI. It led to the Patent Office rejecting the grant of a patent recently. Experts believe the ruling could serve as an example against the practice of "evergreening" patents, a practice that extends patent life through patenting of obvious forms and improvements of life-saving medicines. Over the next few years, with more players entering the market, the first-line HIV drug will likely be available at a fraction of the innovator price.

"I am of the opinion that claims are not patentable under Section 3(d) of the Act since no enhanced therapeutic efficacy has been demonstrated in the specification," the order by Deputy Controller D Usha Rao said.

Viiv Healthcare, which is majority owned by GSK and has Pfizer and Shionogi as major shareholders, is focused on HIV therapies. In April 2014, the Medicines Patent Pool and ViiV Healthcare signed licensing agreements to accelerate access to dolutegravir, for adult and paediatric care.

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