[Ip-health] Fwd: PRESS RELEASE: Community groups take on Gilead’s monopoly of life-saving medicines

rameshwari rao rameshwarirao at gmail.com
Fri Jan 30 21:14:57 PST 2015

Community groups take on Gilead’s monopoly of life-saving medicines

*Fourth pre-grant opposition to Sofosbuvir filed in the Delhi Patent Office*

*30 January 2015, Delhi: *Stepping up efforts to ensure the access to
affordable and effective treatment for people living with Hepatitis C (HCV)
in India and the rest of the world, another pre-grant opposition to
Gilead’s patent application on *Sofosbuvir* in India has been filed. The
opposition was filed at the Delhi Patent Office by Sankalp Rehabilitation
Trust, represented by Lawyers Collective.

On 13 January 2015, the Delhi Patent Office rejected Gilead’s patent
application on the ground that it did not meet the requirements of Section
3 (d) of the Indian patent law. On challenge before the Delhi High Court,
however, it seems likely that the matter will be remanded to the Patent
Controller to be heard along with the pending oppositions. This is the
fourth pre-grant opposition to be filed against Sofosbuvir’s base patent
application. Oppositions filed by I-Mak together with the Delhi Network of
Positive People (DNP+), NATCO Pharma Ltd and BDR Pharmaceuticals
International Limited are also pending disposal.

“We have studied the patent application closely and are convinced that it
has no merit” said Anand Grover, Director, Lawyers Collective. “It fails to
satisfy any grounds required to meet the threshold of what is patentable
under India’s patent law. Not only is it not new or inventive, it also does
not comply with the requirements of Section 3 (d)” he added.

Globally, there are around 180 million people living with HCV, 12 million
of whom live in India alone. A large number of these people will require
treatment to prevent liver-related illness which, if left untreated, can be
fatal. Sofosbuvir, a once-a-day oral pill, is poised to revolutionize
treatment for people living with HCV with cure rates of upto 95% as
compared to 65-70% with weekly-injections of Pegylated Interferon, the
standard current treatment. Gilead has priced the drug at $84,000 per
treatment course in the US. Gilead made $ 5.7 million on the sales of
Sofosbuvir in the first half of 2014 alone.

Without waiting for a patent on Sofosbuvir in India, Gilead went ahead and
signed voluntary licenses on Sofosbuvir and its combinations with several
Indian generic companies back in September 2014.  The licenses are
restrictive not only in the scope of their geographical coverage but also
in terms of Gilead’s control over the ability of the licenses to buy and
sell the active pharmaceutical ingredient, a crucial raw material used in
the preparation of medicines. Under the licenses, generic versions of
Sofosbuvir could cost anywhere between $300 to $900 per treatment.

“We know that even $300 is too expensive for the average person in India,
let alone the poor. Open, unrestricted competition by Indian generic
companies was responsible for drastic price reductions in ARV prices which
allowed scaling-up of treatment to millions. If people living with HCV
across the world have any hope to access affordable treatment it is vital
that Gilead not be allowed to manipulate competition to further their
profit motives. Treatment should be available for all.” said Eldred Tellis,
Director, Sankalp Rehabilitation Trust. “It is unfortunate that generic
companies in India, who once played David to MNC’s Goliath have now chosen
to go down this road. As civil society, we will continue to use pro-public
health provisions to further access to medicines” added Mr. Grover.

Earlier this month Gilead was granted marketing approval for Sofosbuvir in
India in a record time of 4 months and 10 days. “While we welcome the
government’s swift regulatory approval to bring this much needed medicine
to India, this alone will not help wide access to life-saving medicines.
Our focus is now on fighting against any patent protection to Gilead” added
Mr. Tellis.

 *Contact: Anand Grover **+919899439593* <%2B919899439593>* and **Eldred
Tellis **+9820194363* <%2B66866000738>


Legal Officer,
*Lawyer's Collective*
63/2, 1st Floor, Masjid Road,
Bhogal-Jangpura,New Delhi – 110014

*Contact No**. : *+91 9873960781

*"If the doors of perception were cleansed, everything would appear to man
as it is, Infinite". -William Blake.  *

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