A Chinese twist in the tale involving Hepatitis C drug Sofosbuvir

Jyothi Datta PT | Updated on August 17, 2018

istock/Niyazz   -  Niyazz

Hepatitis C drug Sofosbuvir has weathered many a storm and in different countries. But a recent development in China involving the drug’s patent has caught the attention of health advocacy representatives fighting for greater access to medicines.

Sofosbuvir from US drugmaker Gilead is an oral, anti-viral that’s less toxic and more effective than older Hepatitis C treatments.

Earlier this week, the Initiative for Medicines, Access & Knowledge (I-MAK ) said that a patent challenge by it before China’s State Intellectual Property Office resulted in Gilead “withdrawing its key patent claims on the base compound for sofosbuvir, the core component of its hepatitis C drugs Sovaldi, Harvoni, and Epclusa”.

“The removal of key claims from Gilead’s main patent for sofosbuvir — which until now blocked production of affordable generic versions in China — has far-reaching implications,” I-MAK said. China has about 10 million living with chronic Hepatitis C, among the largest in the world and almost none of them receive treatment, it added.

The latest development is expected to open the door for affordable generic treatments as early as 2019.

This news is creating ripples across geographies engaged in Sofosbuvir discussions, including in India, which is no stranger to the drug. In India, Gilead addressed Sofosbuvir price concerns by forging alliances with a clutch of domestic drugmakers to make the medicine at a reduced price for the local market and certain export markets. But on the patent front, the issue is in the Delhi High Court after the Indian Patent office first rejected and later granted patent protection on the base compound.

Calling for a reassessment of Sofosbuvir’s patent in India, Leena Menghaney with humanitarian organisation Medicins Sans Frontieres (MSF’s) Access Campaign says the China development proves the merit in challenging patents.

Tahir Amin, I-MAK Co-Executive Director, adds, “India needs to still examine patents in the spirit of the law irrespective of any licences Gilead offers. There needs to be a significant policy shift in this regard.”

Plight of Chinese patients

The Chinese twist in the Sofosbuvir tale comes even as Chinese film Dying to Survive spotlighted the plight of Chinese patients needing expensive cancer drugs. The protagonist imports (illegally) less-expensive versions of Novartis’ blood cancer drug Glivec from India, in a sense benefiting from a decision taken by the Indian patent system.

In contrast, the Sofosbuvir case has the Chinese patent system showing the way by keeping the door open for local companies to make the drug for its citizens, and export, says Menghaney. Currently, access is not an issue in India because of the local alliances, but in the long term, these alliance companies will not be able to export to other countries needing the drug. And here Egyptian and Chinese companies will step up, she explains. In response, a Gilead spokesperson said it had “not withdrawn” claims to the Sofosbuvir (SOF) compound patent application in China. “This patent application is currently being reviewed by the Patent Review Board (PRB). Last week China’s PRB confirmed the validity of claims covering the SOF metabolites. This decision has no impact on our SOF compound patent application,” Gilead said, adding that it was confident about the intellectual property covering the sofosbuvir compound and all its hepatitis C medicines.

Amin counters, “There is a separate prodrug patent that we challenged at the pre-grant stage and successfully got refused. Gilead is currently appealing that.” Alleging that confusion was being created by mixing up the two cases, Amin says, “They are separate patents and both now are no longer a barrier.”

Either way, the next move on Sofosbuvir will be of interest, as India engages with China to expand pharmaceutical ties.

Published on August 17, 2018

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