Gilead Sciences' Indian patent request for hepatitis C drug sofosbuvir faces opposition

Gilead Sciences' application to patent its hepatitis C drug sofosbuvir in India is facing opposition from the Initiative for Medicines, Access & Knowledge (I-MAK) on the grounds that the compound lacks innovation, according to the advocacy group's director Tahir Amin. He stated that "India's patent law does not give monopolies for old science or for compounds that are already in the public domain. We believe this patent on sofosbuvir does not deserve to be granted in India and have the legal grounds to prove it."

I-MAK said it filed a "pre-grant" application at India's Patent Office to block Gilead's patent submission for sofosbuvir there. The legal action, which could stall the granting of patents for the medicine in India for several years, could allow local drugmakers to market generic versions of the product domestically and export it to other developing countries without strong patent protection laws.

Médecins Sans Frontières (MSF) also announced that it supports I-MAK's patent opposition. "Gilead is expected to charge around $80 000 for one treatment course of sofosbuvir in the US. Even if [it] is offered at a fraction of this price in developing countries, this drug will be priced out for most people," MSF said. The group indicated that the patent opposition "was filed to ensure that affordable generic versions of sofosbuvir can be produced to help those infected with chronic hepatitis C in developing countries."

Gilead has previously sought to develop an access programme for patients in low-income countries by licensing its HIV drugs to generic manufacturers while controlling for quality. The company noted on its website that "as Gilead [hepatitis C] medicines advance through the R&D pipeline, we will evaluate opportunities to incorporate them into our access programmes."

Sofosbuvir garnered recent positive reviews from advisory panels in the US and in Europe, where Gilead proposes to market the drug under the brand name Sovaldi. The company anticipates a decision regarding the marketing of sofosbuvir in the US early next month.

For related analysis, see ViewPoints: Regulatory momentum builds for Gilead Sciences' sofosbuvir – now branded as Sovaldi and Physician Views Poll Results – Convenient dosing and stronger than expected launch in 2014 to drive Gilead Sciences' dominance of hepatitis C market?

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