[Ip-health] China rejects Gilead hepatitis C drug patent -advocacy group

Tahir Amin tahir at i-mak.org
Thu Jun 18 21:27:18 PDT 2015

 Dear All,

An important decision that will hopefully embolden other countries where
challenges have been filed, but also patent offices currently examining the
same application.


June 19 | By Brendan Pierson

China has rejected Gilead Sciences Inc's application for a new patent
related to its costly hepatitis C drug Sovaldi, removing a potential
barrier to generic versions of the drug there, a U.S. legal group announced
on Friday.

The New York-based group, Initiative for Medicines, Access & Knowledge, or
I-MAK, challenged Gilead's patent application this year as part of its
campaign to make generic Sovaldi available in several countries. The group
said on Friday it had received notice of the patent application rejection
from officials in the China State Intellectual Property Office.

I-MAK said it challenged the Gilead patent applications in China and other
countries so hepatitis C patients could get cheaper generic versions of the
drug. Tahir Amin, I-MAK's director of intellectual property, said the
latest decision makes it more likely that advocates may challenge another
Gilead drug patent in China that currently prevents the introduction of
generic treatments for hepatitis C.

The application China has rejected was on a so-called prodrug, a chemical
used to activate Sovaldi's active chemical once it is in the body,
according to I-MAK.

Gilead still has a patent in China on sofosbuvir, the main ingredient of
Sovaldi, a highly effective treatment for hepatitis C which costs $1,000
per pill in the United States. That adds up to $84,000 for a typical
12-week course.

California-based Gilead agreed last year to make the drug available for
lower prices in 91 developing countries, although I-MAK has said that more
than 59 million low-income hepatitis C patients worldwide are still without
access to the drug.

In May I-MAK said it had brought legal challenges against Gilead's patents
or patent applications in five countries not covered by the agreement:
China, Argentina, Brazil, Russia and Ukraine.

Amin said he believed the decision by China's patent office to reject the
prodrug patent application would encourage challenges to the sofosbuvir
patent as well.

If that patent were invalidated, he said, it would open the door for
Chinese companies to sell generic Sovaldi, as well as to supply raw
materials for the drug to manufacturers in other countries.

In January, India's patent office refused to grant Gilead a patent on
Sovaldi, finding it was not inventive enough. Gilead is appealing the

Last month, the United Nations' World Health Organization added Sovaldi to
its essential medicines list and urged lower prices, especially in middle
income countries. (Editing by Ted Botha and David Gregorio

Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)
*Website:* www.i-mak.org
*Email:* tahir at i-mak.org
*Skype: *tahirmamin
*Tel:* +1 917 455 6601/+44 771 853 9472

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