A joint press release between I-MAK, DNP+ and MSF Access Campaign on challenges to patents (patent oppositions) was filed in India on key hep C drugs sofosbuvir, daclatasvir and velpatasvir.
New Delhi/New York, 14 February 2017–Five new challenges against patents on crucial new medicines to treat hepatitis C filed in India and Argentina are the latest in a global push to ensure access to affordable treatment. The patent challenges could remove barriers to production and distribution of affordable generic versions of direct-acting antiviral (DAA) medicines, including sofosbuvir, daclatasvir and velpatasvir.
Gilead has licenced sofosbuvir and velpatasvir to 11 generic manufacturers in India, but the number of countries able to access these generic versions represents only half the global burden of disease. A detailed analysis of the licensing agreement is available here: https://msfaccess.org/content/msf-analysis-gilead-hepatitis-c-license-march-2015
Egyptian companies were not included in any licensing deals and have freedom to operate and supply low cost generic DAAs where there are no granted patents. Once patents are granted in a country, they have a chilling effect on the introduction of more affordable DAAs that are essential to create universal access to the cure for hepatitis C.
In India, two cases challenge the crystalline forms of sofosbuvir and daclatasvir and should be rejected for not being in compliance with Indian law. India’s law recognizes that crystalline forms of known medicines are not inventions and should not be awarded patents. This approach was confirmed by the Indian Supreme Court on 1 April 2013, which refused a patent by holding that a crystalline form of a known pharmaceutically active compound cannot be regarded as involving an inventive step.
A critical third opposition shows that the patent on velpatasvir is an obvious structural change to an earlier hepatitis C drug, ledipasvir. This is a classic example of Gilead gaming the patent system in order to strengthen its control on the hepatitis C market. The fourth opposition also seeks to open up the supply of raw materials from India by challenging the patent on the intermediate form of daclatasvir.
In Argentina, people living with HIV have challenged the patent on sofosbuvir in light of evidence that discloses substantially similar antiviral compounds for treating hepatitis C. Civil society has a strong case as Gilead has also failed to fully disclose/describe the invention claimed in a sufficient manner, a requirement of patent law that is often ignored by pharmaceutical corporations.
Copy of these patent oppositions filed in India are available on Patent Oppositions Database (an online platform that provides support, information and collaborative tools for groups and individuals wanting to challenge patents on medicines) and can be accessed using the following links: