Oppositions Filed Against Gilead Hepatitis C Patent Applications In India

Oppositions have been filed in India against two patent applications from US pharmaceutical company Gilead for important hepatitis C medicines, according to non-governmental sources. The opposition filings assert that these applications are “evergreening” patents and therefore violate Indian patent law.

The Delhi Network of Positive People (DNP+), which represents people with hepatitis C, filed the oppositions at the Indian Patent Office on 9 July, according to a release from Médecins Sans Frontières (MSF, Doctors Without Borders) Access Campaign.

“The grounds for these two patent oppositions are 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,” said the MSF release.

The opposition filings (sofosbuvir/velpatasvir, velpatasvir) came shortly after Gilead, a US pharmaceutical corporation, submitted patent applications for medications that inhibit the growth of HCV and HIV, according to the opposition filings. In the opposition filings, it states that Gilead claimed to have eliminated some liver side effects that are common after taking HCV or HIV medication.

However, the oppositions filings, under the Indian Patent Act, 1970 Section 25(1)(e), allege “that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step.” DNP+ also claims that under the Indian Patent Act Section 25(1)(f), the medications are “not an invention within the meaning of this Act, or is not patentable under this Act.”

“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,” Paul Lhungdim, Delhi Network of Positive People said in the release. “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 opposition filings are awaiting examination, according to Patent Opposition Database.

Gaensly Joseph is an intern at Intellectual Property Watch, and currently a law student at American University, Washington College of Law. Class of 2020. His core interest is in ADR with focuses in trade, transaction, and intellectual property law.