[Ip-health] India rejects Gilead's Hepatitis C drug patent request

Priti Radhakrishnan priti at i-mak.org
Wed Jan 14 09:12:16 PST 2015

rejects Gilead's Hepatitis C drug patent request
11:45am EST

By Sumeet Chatterjee

MUMBAI, Jan 14 (Reuters) - India's patent office has rejected an
application from U.S.-based Gilead Sciences Inc for its hepatitis C drug
Sovaldi, paving the way for local drugmakers to launch cheaper generic
versions of the $1,000-a-pill medicine.

The application had been opposed by Indian generic drugmaker Natco Pharma
Ltd and New York-based Initiative for Medicines, Access & Knowledge (I-MAK)
on the grounds that the drug, chemically called sofosbuvir, is not
inventive enough compared with a previous formulation, according to patent
office order documents seen by Reuters on Wednesday.

India's patent laws allow a third party to dispute the validity of a
pending patent application.

The patent office's order said Gilead's request for Sovaldi, which is
normally given for either three or six months and costs $84,000 for a
12-week course in the United States, was rejected on the basis that "minor
changes in the molecule" did not improve efficacy of the drug.

The rejection will allow the Indian generic companies to make and sell
versions of the drug in country where a majority of people live on less
than $2 a day and health insurance is scarce.

Gilead could not immediately be reached for comment. Natco Chief Executive
Rajeev Nannapaneni was not available outside regular Indian business hours.

Foreign drugmakers in India, a global hub for making generic drugs, have
been frustrated by a series of decisions on patents and pricing, with the
government looking to improve healthcare access.

Market access and patent protection for U.S. drugs are expected to feature
when Indian Prime Minister Narendra Modi hosts President Barack Obama later
this month for India's annual Republic Day celebrations.

The patent office's order comes amid a growing clamour by healthcare
campaigners and doctors to ensure Sovaldi and other new hepatitis C pills
are affordable in developing countries.

In a bid to make Sovaldi available in 91 developing nations including in
India, Gilead licensed the drug, hailed by doctors as a breakthrough in
treating the liver-destroying disease, to seven India-based drugmakers in
April last year.

Campaigners, however, were critical of the licensing deals, saying they
would not ensure access to several middle-income countries where health
authorities would still struggle to provide treatment to patients.
(Reporting by Sumeet Chatterjee; Editing by David Holmes

*Priti Radhakrishnan*
Co-Founder and Director of Treatment Access, I-MAK
Echoing Green Fellow | Pop!Tech Fellow | Asia Society Associate Fellow

*"Where innovation meets access to affordable medicines"*

*Website: *www.i-mak.org
*Skype:* pritiwho
*Mobile:* +1 917 703 2876
*E-mail:* priti at i-mak.org

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