NPPA pulls Gilead on price exemption plea for its Hepatitis B drug

New Delhi: The apex drug price regulator, National Pharmaceuticals Pricing Authority (NPPA) has recently sought clarifications from the US-drugmaker Gilead Sciences for its application seeking exemption from price control for its chronic Hepatitis B drug Tenofovir Alafenamide tablets, under the brand name Vemlidy. The Authority has pulled the drugmaker after it observed that the company has used 3 different entities and has also given voluntary license to many companies for manufacturing/marketing the products in India.

This came during the recently held meeting under the DPCO, 2013, under the Chairmanship of Shubhra Singh, Chairman, NPPA. 

The Authority deliberated upon the matter in detail and noted that the issue for exemption under para 32(i) of DPCO, 2013 is multilayered and Gilead had used three separate entities, one for seeking patent, another for approval of the drug and a third for price exemption.

Elaborating upon the issue, NPPA observed that the application for exemption was filed by Gilead Sciences Inc, which is a US-based company. The patent was granted to Gilead Sciences Inc, a US company for "Methoxy Phosphonate Nucleotide Prodrug" by the Office of the Controller General of Patents, Designs & Trademarks, Deptt of Industrial Policy and Promotion, Ministry of Commerce and Industry, Government of India; and the drug controller granted permission to import finished formulation of Tenofovir Alafenamide 25 mg tablet to Gilead Sciences India, an Indian company and the new drug is to be manufactured by Gilead Sciences Ltd, Ireland. 

Accordingly, NPPA has sought information from the company about the relationship among the three entities namely, Gilead Sciences, Inc (the Patent holder), Gilead Sciences India Pvt. Ltd (to whom the import licence for the new drug has been granted) and Gilead Sciences Ltd, Ireland (manufacturer). 

"After receipt of details of relationship status from the company, the further necessary examination would be undertaken regarding eligibility for exemption under para 32(i) of DPCO 2013," NPPA said.

It further directed to seek clarification from Department of Pharmaceuticals(DoP) as to whether the foreign company, the applicant, the Patent holder and the manufacturer can be treated as the same entity for the purpose of granting exemption under para 32(i) of DPCO 2013.

It was also observed that the Patent No. 241597 dated 14.07.2010 has been granted for a term of 20 years from 20th July 2001. However, Gilead is seeking exemption from price control under DPCO 2013 for 5 years from the date of commencement of its commercial marketing by the company which would be a case of evergreening of Patent. The clarification sought from the Department of Pharmaceuticals in the matter is awaited. 

NPPA further noted that Gilead's plea is for exemption from price fixation of Tenofovir Alafenamide tablet under para 32(i) of DPCO, 2013 whereas the patent has been granted for "Methoxy Phosphonate Nucleotide Prodrug". A clarification sought from the Office of the Controller General of Patents, Designs & Trademarks (CGP), Deptt of Industrial Policy and Promotion, Ministry of Commerce and Industry, Government of India is still awaited. Accordingly, the Authority directed the representative from the Office of the CGP to expedite the same. 

The price regulator also observed that the company has given voluntary license to many companies for manufacturing/ marketing the products "Tenofovir Alafenamide 25 mg tablet" in India. Accordingly, it directed to obtain the details of the companies and the terms and conditions at which the voluntary licenses were given by Gilead Sciences Inc for manufacturing/ marketing the products "Tenofovir Alafenamide 25 mg tablet" in India. The Authority further directed to confirm that the exemption, if granted, would not be applicable to the manufacturing/ marketing companies to whom voluntary licenses have been given by Gilead Sciences Inc for manufacturing/ marketing the products "Tenofovir Alafenamide 25 mg tablet" in India. 

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