MUMBAI: 2 hepatitis drugs of Gilead Sciences have drawn the attention of patient group over its patent. A patient advocacy and support group called Delhi Network of Positive People (DNP+) has challenged the additional patent claims by Gilead Sciences for its 2 hepatitis C drugs before the Mumbai Patent Office.
TOI reports that DNP+ wants to prevent the firm from obtaining patent rights on sofosbuvir and velpatasvir, in order to stop the firm to continue charging exorbitant prices from countries across the world.
According to the statement of medical humanitarian organisation, Médecins Sans Frontières (MSF), the patent applications of the fixed-dose combination of sofosbuvir/velpatasvir and the polymorph form of velpatasvir has been challended by Delhi Network of Positive People (DNP+).
It has been reported that the challenge is based on provisions in the Indian Patents Act that prevent patent ‘evergreening’ — which restricts the patentability of a host of secondary patents, i.e., new forms of known substances, new property or new use of known substances, use of known processes without showing any enhanced therapeutic efficacy, and admixtures without synergistic effect.
In 2016, Gilead Sciences launched sofosbuvir/velpatasvir in the US at over $74,000 for a 12-week regimen.
Paul Lhungdim of DNP+ told TOI, “Just like Gilead attempted to patent different forms and combinations of the key HIV drug tenofovir many years back, the corporation is again using evergreening tactics to block affordable options of hep C drugs that other countries can import in the future. With these patent challenges, we hope to prevent Gilead from obtaining unmerited patent rights on sofosbuvir and velpatasvir, which would allow them to continue charging exorbitant prices from governments in many middle- and high-income countries.”
The daily reports that Initiative for Medicines, Access & Knowledge (I-MAK), along with the DNP+, had challenged the basic patent claims on sofosbuvir in 2013 through pre-grant oppositions which is remains under dispute before the Delhi high court and Intellectual Property Appellate Board.
The basic patent claim on velpatasvir, asserting that the drug is an obvious structural change to an earlier hepatitis C drug ledipasvir, and thus, cannot be patented had been also challenged by I-MAK and DNP+ in February 2017 for which the decision is awaited.
Indian patent law allows third parties, including civil society organizations to file ‘pre-grant’ oppositions to challenge patent applications until the patent is rejected or granted by the Indian Patent Office.
Quoting a note, TOI reports that such ‘evergreening’ tactics allow the company to extend their control over the market, in turn delaying the introduction of affordable generic drugs and patient access to treatment in a number of countries.