[Ip-health] Newsreport from India - Gilead's local alliances on Hepatitis C drug Sovaldi set for a rough ride

Jamie Love james.love at keionline.org
Mon Sep 15 04:52:20 PDT 2014


Mohga, there are notes on the various compulsory licenses on HCV diagnostic
patents, held by Chiron (now owned by Novartis) here:
http://www.keionline.org/hcvtimeline

I have been told by one HCV drug developer that the Chiron/Novartis patents
delayed work on the new HCV drugs for several years, and also that the ACLU
case on gene patents was helpful in clearing out some of the
Chiron/Novartis patent claims.

Jamie

On Mon, Sep 15, 2014 at 7:48 AM, Mohga Kamal-Yanni <mkamalyanni at oxfam.org.uk
> wrote:

> Hi Jamie
>
> Do you have more in for on : "I note that the patents
> on HCV diagnosis technologies have in the past been subject to compulsory
> licensing cases, in high income countries such as the US, the UK, Germany,
> Italy and Australia, going back several years."
>
>
> Best wishes
> ___________________________________
> Mohga (Dictating to the computer so please forgive silly mistakes)
> Dr. Mohga M Kamal-Yanni
> Senior health & HIV policy advisor, Oxfam GB
> John Smith Drive, Oxford, OX4 2JY, UK
> UK Mobile   + 44 (0)777 62 55 884
> Follow me @MohgaKamalYanni
>
>
>
> From:        Jamie Love <james.love at keionline.org>
> To:        leena menghaney <leenamenghaney at gmail.com>
> Cc:        Ip-health <ip-health at lists.keionline.org>, Thiru
> Balasubramaniam <suryavamsha75 at gmail.com>
> Date:        15/09/2014 12:21
> Subject:        Re: [Ip-health] Newsreport from India - Gilead's local
> alliances on Hepatitis C drug Sovaldi set for a rough ride
> Sent by:        "Ip-health" <ip-health-bounces at lists.keionline.org>
> ------------------------------
>
>
>
> We are waiting to see the text of the licenses that are issued, but our
> expectation is that Gilead licenses to generic manufacturers will
> accelerate access to inexpensive HCV treatments for a significant number of
> persons living with HCV in developing countries, and enhance the bargaining
> power of of countries not included in the licenses who can obtain drugs
> from the manufacturers under a compulsory license.   We expect the licenses
> will have features we like, and features we don't like.  The fact that
> Gilead is acting to license its patents should also be contrasted to
> actions by BMS, Merck, Abbott, J&J, Novartis, Roche and other companies
> that been aggressive in litigation over HCV patents, and which may have
> patents that are important, and present barriers to
> effective diagnostics and treatment.   As an aside, I note that the patents
> on HCV diagnosis technologies have in the past been subject to compulsory
> licensing cases, in high income countries such as the US, the UK, Germany,
> Italy and Australia, going back several years.
>
> Jamie
>
> On Mon, Sep 15, 2014 at 5:00 AM, leena menghaney <leenamenghaney at gmail.com
> >
> wrote:
>
> > *Gilead's local alliances on Hepatitis C drug Sovaldi set for a rough
> ride*
> >
> > P.T. JYOTHI DATTA, The Hindu BusinessLine
> >
> >
> >
> > *MUMBAI, SEPT 15:  *
> >
> > California-based Gilead is set to stir the pot as it forges India-based
> > alliances on its Hepatitis C drug sofosbuvir.
> >
> > Multi-company agreements on the drug are expected to be announced later
> > today.
> >
> > Never before has a Hepatitis C drug attracted so much global attention.
> > High-pitched debates on breakthrough drugs that are beyond the reach of
> > patients because of their exorbitant prices - is a space that has in the
> > past been occupied by cancer and HIV/AIDs drugs.
> >
> > So why is Gilead's sofosbuvir, marketed under the brandname Sovaldi,
> > creating such a stir?
> >
> > Sofosbuvir is the first of several oral hepatitis C drugs and it came
> into
> > Gilead's fold after it decided to buy Pharmasset for over $11 billion in
> > late 2011. And it is known to be more effective, less toxic and easier to
> > use.
> >
> > The drug is pegged at $84,000 in the US for 12 weeks, though newer
> versions
> > threaten to go higher in price.
> >
> > In February, Gregg H Alton, Gilead's Executive Vice-President, Corporate
> > and Medical Affairs had told Business Line, they were in talks with a
> > clutch of Indian companies to bring in sofosbuvir at about $2,000 for 24
> > weeks.
> >
> > Gilead has in the past tied up with Mylan, Strides, Emcure and Ranbaxy
> for
> > other drugs in India.
> >
> > But this "alliance route" is unlikely to be smooth for Gilead's
> sofosbuvir,
> > as it is greeted in India by at least a handful of oppositions filed at
> the
> > Indian Patent Office. These pre-grant oppositions are against granting
> > patent protection to sofosbuvir.
> >
> > A pre-grant opposition is a feature in the amended Patents Act that
> allows
> > interested parties to oppose a patent application before a decision is
> > taken by the Patent Office to grant or deny a patent.
> >
> > A patent gives an inventor 20 years of exclusivity to market a product.
> And
> > public health advocacy groups fear that such exclusivity could lead to
> > monopolies in terms of pricing, making it unaffordable for a patient.
> >
> > *Opposed*
> >
> > In November last year, legal group I-MAK (Initiative for Medicines,
> Access
> > & Knowledge) had filed a pre-grant opposition at the Kolkata patent
> office.
> >
> > Gilead's patent application had been opposed on the grounds that it was
> an
> > "old science, known compound," Tahir Amin, lawyer and director of
> US-based
> > I-MAK.org, had then said.
> >
> > "India's patent law doesn't give monopolies for old science or for
> > compounds that are already in the public domain. We believe this patent
> on
> > sofosbuvir does not deserve to be granted in India and have the legal
> > grounds to prove it," he had added.
> >
> > A slew of oppositions followed against sofosbuvir, from the Delhi Network
> > of Positive People, the Indian Pharmaceutical Alliance (a forum of large
> > Indian drug companies) and Hyderabad-based drugmaker Natco.
> >
> > The Gilead representative, had in his earlier interaction with the
> > correspondent said, that they would defend their patents, even as they
> push
> > for local production of the product to help bring down prices.
> >
> > But, the pitch gets further queered, if the Indian Patent Office rules
> > against giving Gilead a patent on this drug. This would allow more Indian
> > drug companies to make the drug, even without a tie-up with Gilead. What
> > happens to Gilead's local alliances on this drug, in such a situation, is
> > something that will then play out in full public display.
> >
> > *Strangle exports?*
> >
> > While such a day is in the realm of speculation, public health advocates
> > fear that voluntary agreements between innovators and generic drugmakers
> > could "strangle" exports from Indian companies - as the terms of such
> > agreements are seen to be restrictive.
> >
> > Based on the terms of the licence, it is clear Gilead is ensuring that
> its
> > main competitors from India are tied up and cannot supply middle-income
> > countries excluded from the licence, which is where there is significant
> > demand/ economies of scale for the generics and where access is hardest
> for
> > low-income patients, explains Amin.
> >
> > Such voluntary licensing deals are "a slow strangulation" of generic
> > medicine supplies from India, where patents are involved. As generic
> > companies get locked into such deals, public health groups will have to
> > find alternative generics suppliers who are willing to supply to excluded
> > countries where there are no patents/ patents pending and or willing to
> > challenge patents, which will be difficult.
> >
> > Gilead had in the past said its agreement would cover 60 low- and
> > middle-income countries, and would include royalty payments.
> >
> > With 180 million people living with Hepatitis C today, and 350,000 dying
> > annually of it -- price negotiations on this drug will be closely watched
> > by
> > both advocacy and patient groups.
> >
> > jyothi.datta at thehindu.co.in
> >
> > (This article was published on September 15, 2014)
> >
> >
> >
> http://www.thehindubusinessline.com/companies/gileads-local-alliances-on-hepatitis-c-drug-sovaldi-set-for-a-rough-ride/article6412522.ece
> >
> >
> > --
> > Leena Menghaney
> >
> > Mobile: 9811365412
> > _______________________________________________
> > Ip-health mailing list
> > Ip-health at lists.keionline.org
> >
> http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
> >
>
>
>
> --
> James Love.  Knowledge Ecology International
> http://www.keionline.org/donate.html
> KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
> +41.76.413.6584, twitter.com/jamie_love
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>
>
>
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-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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