India's NPPA sees Gilead's pricing application as ever-greening

7 February 2020

The Indian National Pharmaceutical Pricing Authority (NPPA) has sought clarification on US biotech Gilead Sciences' (Nasdaq: GILD) drug pricing plea for its Vemlidy (tenofovir alafenamide tablet to treat chronic hepatitis B. The apex regulator has observed in a detailed document that the submission by Gilead would amount to ever-greening.

The Office of the Controller General of Patents, Department of Industrial Policy and Promotion, Ministry of Commerce and Industry, Government of India had granted a patent to Gilead’s 'Methoxy Phosphonate Nucleotide Prodrug' (patent number 241597) on July 14, 2010.

The Authority observed that the Patent was granted for 20 years, but the company was seeking exemption from price control for five years from the date of commencement of its commercial marketing, which would tantamount to "a case of evergreening of patent."

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