[Ip-health] Hindu Business Line: Gilead, local generic players in talks to bring hepatitis C drug into India

Baker, Brook b.baker at neu.edu
Tue Feb 4 07:07:58 PST 2014

If the intended territorial scope of licenses is only 60 countries, it
will be far less than what Gilead first offered through it voluntary
licenses for ARVs and much more limited than the licensed territory
negotiated with the Medicines Patent Pool.  Moreover, if the territories
are limited to sub-Saharan Africa, India, and low-income countries, it
will miss key countries with with very high HEP C burdens, e.g., Egypt.

In addition, there is a certain cynicism in Gilead seeking voluntary
licenses with a select number of preferred supplier in India, especially
since the underlying patent is facing a fierce opposition by I-MAK.  In
its initial ARV voluntary licenses, Gilead tried to restrict licensee
challenges to its IP - a clause that was per se anti-competitive under
several the law of multiple nations.  Although it seems doubtful that
Gilead would try to impose such a clause again, it is possible that it's
preferential voluntary licenses will undermine generic oppositions.
However, even if the opposition in India is successful, it will not
directly address sofosbuvir's patent status in other countries.

In addition, the initial price of $2000, though welcome compared to
extortionate pricing in the U.S., is still far too high.  Reports on
projected costs of production indicate that a much lower selling price is
possible and it will only be robust generic competition that produces such
a result.  Accordingly, Gilead should issue licenses to all qualified
generic producers who can manufacturer bioequalivalent sofosbuvir to
global Good Manufacturing Practices standards.

Gilead should also describe its efforts to help ensure registration of
generic equivalents, preferably by first registering the product itself
and then allowing reference/reliance on such registration by its generic

Professor Brook K. Baker
Northeastern U. School of Law
Affiliate, Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
Senior Policy Analyst Health GAP (Global Access Project)
Alternate NGOs Board Member UNITAID
(w) 617-373-3217
(cell) 617-259-0760
(fax) 617-373-5056
skype: brook_baker
b.baker at neu.edu

On 2/4/14 4:16 AM, "Shailly Gupta" <shailly.gupta at geneva.msf.org> wrote:

>Gilead contemplating of pegging the Sofosbuvir price at 2000$ in India.
>Also it seems like that they plan to sign VLs with more than one generic
>company here and the drug would be made available to 60 countries. See
>the news report below.
>Gilead, local generic players in talks to bring hepatitis C drug into
>Price to be pegged lower than the current standard of care, estimated at
>$2,500 for six months
>California-based drug-maker Gilead Sciences Inc is in discussions with a
>handful of local pharmaceutical companies to bring its much anticipated
>oral Hepatitis C drug Sovaldi (sofosbuvir) into India.
>“We are going to give licence to Indian companies, so there will be
>Indian production of our hepatitis C product. We are in discussions right
>now. We hope to announce those in the next couple of months,” Gregg H
>Alton, Gilead’s Executive Vice- President, Corporate and Medical Affairs,
>told Business Line.
>Gilead’s move comes at a time when the patent on sofosbuvir is being
>contested at the Kolkata patent office. The opposition was filed late
>last year by US-based legal group I-MAK (Initiative for Medicines, Access
>& Knowledge).
>On how the drug would be priced, Alton said the imported and locally-made
>versions would be pegged lower than the current standard of care with
>existing generic products, estimated at $2,500 (around ₹1.5 lakh) for six
>Gilead proposes to peg its imported branded product at about $2,000, he
>indicated, adding discussions were under way with patient-groups before
>the price is finalised. “We’ll be substantially less than that (current
>standards of care), and we’ll be more effective, less toxic and easier to
>use and without side-effects… We leave it up to the Indian companies to
>bring the price down – should they choose to do that,” he added.
>You need three or more companies to compete against each other to truly
>get the cost down, and “so, we’ll be working probably with three-to-five
>different companies”, he said. In the US, Gilead’s drug is priced at
>$84,000 for 12 weeks.
>Gilead’s soon-to-be sealed deal will include royalty payments and cover
>about 60 low and middle-income countries, he said, adding details were
>discussed during their latest visit to India.
>Without getting into details on the patent case, Alton said: “We will
>defend the patents, but at the same time, we are going to be pushing very
>hard to enable generic production in India with multiple companies.”
>By traditional timelines, it would take at least two years before the
>product is available in India, said Alton.
>Clinical trials to test the drug on the local population have been
>approved and efforts are on to fast-track this process, he added.
>About 15 sites have been identified to run Phase III trials on the drug,
>involving about 120 people.
>Touted to be among “the biggest breakthroughs in medicine in the last 10
>years”, Alton said the drug was launched in the US last December, and
>Gilead and its partners were working to bring it to India soon.
>Shailly Gupta
>Advocacy and Communication Officer
>MSF Access Campaign
>K-30 First Floor, Jangpura Extension
>New Delhi –  14
>Ph: +91-11-41823783/84
>M: +91-9899976108
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