[Ip-health] Fresh opposition on Gilead’s Hepatitis C drug

K.M. Gopakumar kumargopakm at gmail.com
Mon Sep 22 06:45:03 PDT 2014


Fresh opposition on Gilead’s Hepatitis C drug PT Jyothi Datta
  Flüge buchen - Fluege.de
<http://www.googleadservices.com/pagead/aclk?sa=L&ai=CDU9cFTocVLyiK4OO7gb184GQCbOTpJAD08Xkrn3LvfT9CBABIL2DvxNQ682ksfz_____AWD1jbuBmASgAbP30usDyAEBqQJzAQiQw5a1PqgDAaoE2AFP0AQ9jZwiaF_RJ4SJPyh8c8xiOiI_jihg6d8xIc46zHXJi399ODzOveuNa7z6zxV9nE_hs0URrU7szh6Ix9TqvT6M7gOryI6gXETOHAAOtvJCldBop-Rl4BFcSLwFA-pNXYXH2v-M7AyySAMsb-n6dsVvKMs2VFVdddngEQF0abgIXoWG7NfNWvDEvxOD70vjwBkSaY2p9CblqKx8xM3pRPnCBWdz5uVL0Jv7IGjL1CXeRC7p_OcZhQrTa0k33IfTv3tjtiC_TIW4TKzLjFvb1PzfDnhO--6IBgGAB7WIrRQ&num=1&cid=5GgvHsYKfln9f3CCZx2FYGXi&sig=AOD64_33XK9oQ5r9CfyyPmfBS5Nkx-GJWA&client=ca-hindu_site_html&adurl=http://www.fluege.de>
- Flüge so günstig wie nie buchen Jetzt Bestpreise 2014 sichern!
www.fluege.de
<http://www.googleadservices.com/pagead/aclk?sa=L&ai=CDU9cFTocVLyiK4OO7gb184GQCbOTpJAD08Xkrn3LvfT9CBABIL2DvxNQ682ksfz_____AWD1jbuBmASgAbP30usDyAEBqQJzAQiQw5a1PqgDAaoE2AFP0AQ9jZwiaF_RJ4SJPyh8c8xiOiI_jihg6d8xIc46zHXJi399ODzOveuNa7z6zxV9nE_hs0URrU7szh6Ix9TqvT6M7gOryI6gXETOHAAOtvJCldBop-Rl4BFcSLwFA-pNXYXH2v-M7AyySAMsb-n6dsVvKMs2VFVdddngEQF0abgIXoWG7NfNWvDEvxOD70vjwBkSaY2p9CblqKx8xM3pRPnCBWdz5uVL0Jv7IGjL1CXeRC7p_OcZhQrTa0k33IfTv3tjtiC_TIW4TKzLjFvb1PzfDnhO--6IBgGAB7WIrRQ&num=1&cid=5GgvHsYKfln9f3CCZx2FYGXi&sig=AOD64_33XK9oQ5r9CfyyPmfBS5Nkx-GJWA&client=ca-hindu_site_html&adurl=http://www.fluege.de>
   Mumbai, September 18:

The last word is far from heard on drugmaker Gilead’s Hepatitis C drug
sofosbuvir in India.

Asian and Indian groups have come together to file a fresh bout of
opposition at the Kolkata patent office against sofosbuvir’s patent
application.

The pre-grant opposition has been filed by Bangkok-based Asia-Pacific
Network of People living with HIV/AIDS (APN+), the Sankalp Rehabilitation
Trust and the Hepatitis Coalition of Nagaland. And the groups are being
represented by the Lawyers Collective.

The move seeks to keep the breakthrough oral Hepatitis C drug affordable,
by ensuring that generic drug companies are allowed to make the drug, and
at low prices.

"We believe this patent application should be rejected," Anand Grover,
Director, Lawyers Collective and senior counsel at the Supreme Court, said
in a statement. "The patent application fails not only Section 3(d) of
India's patent law that prohibits evergreening but it is neither new nor
inventive."

A pre-grant opposition under the amended Patents Act allows interested
parties to oppose a patent application on a product before the Patent
Office decides on whether to grant or deny a patent. Patents grant an
inventor 20 years market exclusivity, and public healthworkers fear that
such monopolies could price medicines beyond the reach of patients.

In fact, Section 3 (d) has been a powerful touchstone provided in the
amended Act to assess the inventiveness of a product. It disallows
companies from seeking fresh patents on incremental changes made on
existing compounds - a process called evergreening, unless they establish
reasonable efficacy.

*Deals and oppositions*

The latest pre-grant opposition comes even as Gilead entered into an
agreement with seven India-based companies, earlier this week. Companies
including Cipla, Ranbaxy and Mylan will now be able to make sofosbuvir at
reduced prices in certain markets.

But even this much anticipated deal came against the backdrop of a slew of
existing pre-grant oppositions against sofosbuvir’s patent application.

First of the block in November last year was the opposition filed by legal
group I-MAK, (Initiative for Medicines, Access & Knowledge). Also opposing
sofosbuvir were the Indian Pharmaceutical Alliance (a platform of large
Indian drug companies), Hyderabad-based drugmaker Natco and the Delhi
Network of Positive People.

Sofosbuvir sold by California-based Gilead as Sovaldi is priced at $ 84,000
for 12 weeks in the US. And the company expects to bring its product into
India at less than $ 1000 for 12 weeks.

The drug’s pricing has received much flak in India and overseas. According
to Sankalp Rehabilitation Trust’s Eldred Tellis, Gilead's pricing on the
drug has no relation to the reality of patients in need of the treatment
whether they are in the United States or in the poorest countries in the
world.

"The price at $900 per treatment course may sound good compared to the
$84000 US price. That's until one remembers that one-third of Indians live
on less than half a dollar a day." he said, in the statement.

Referring to the role of Indian generic drugmakers, Shiba Phurailaptam,
Regional Co-ordinator of APN+ says: “Indian companies like Cipla were once
trailblazers in providing generic access when MNCs turned their backs on
us. We ask them not to become party to strategies of MNCs that put profits
before lives."

Gilead representatives in the past have told Business Line that they will
defend their patents in India, even as they enter into deals to stir local
generic production of the drug to bring down prices.

Meanwhile, they have also met Commerce Minister Nirmala Sitharaman this
week to apprise her of the agreement Gilead has on the hepatitis drug with
local alliance partners. The deal covers 91 developing countries.

jyothi.datta at gmail.com

 (This article was published on September 18, 2014)



More information about the Ip-health mailing list