[Ip-health] Sofosbuvir (Sovaldi(R))

Jamie Love james.love at keionline.org
Tue Aug 12 05:00:18 PDT 2014

George,  Christiane, others. As Ruth and others have mentioned, governments
and/or judges can always break patent monopolies, if they want. The legal
instruments are somewhat different in every country, but a common feature
is that it is, in a legal and procedural sense, easier for the State to
authorize non-voluntary use of patented inventions than for private parties
acting on their own initiative (Thailand, Brasil, Indonesia, USA for CIPRO
or influenza manufacturing patents, UK for Crown us of HCV diagnostic
patents, etc).  However, politically, sometimes it seems easier for private
parties to be the lead actors (TAC in RSA, Natco in India, USA for
compulsory licenses on eight or more medical devices, Australia for HCV
diagnostic patents, Italy for several drugs, Germany for HIV and HCV
diagnostics and for Fabry patents, and Canada recently for psoriasis).

We have prepared a guide for Non-Voluntary use of HCV patents in the United
States (http://www.keionline.org/node/2058), and are working on one for the
European context.   Recently KEI Europe has requested licenses from BMS and
Gilead for HCV related patents, for the country of Romania, and from Roche
for patents on the expensive breast cancer drug T-DM1, for Europe,
including for the UK, Spain and other countries.  See:
http://keieurope.org/actions.html.  If these negotiations do not produce
licenses, in theory, one option would be to ask governments or courts in
various countries to grant compulsory license, Crown use, or other public
use mechanisms.

We are aware of one New York based non-profit entity that is exploring the
options for private parties set out in the KEI memo for the US.

For any individual country, there would normally be an effort to obtain a
voluntary license (not necessarily required for some legal mechanisms), and
then a review of the specific statutory procedures for various
non-voluntary options, including such approaches as general compulsory
licenses for requests by private parties, limitations on remedies for
infringement (currently the preferred US and Canadian option for compulsory
licensing), or some type of Crown, ex officio or government use
non-voluntary authorizations.

All of these efforts are complicated by the challenges of finding
suppliers, importing products from other countries, and registering
products. In Europe, the United States and in several other countries,
Gilead has several years of exclusive rights in the test data they used to
register the products.  In India, Gilead has not registered sofosobuvir,
and after they do, for I believe four years, domestic firms are faced with
obligations to conduct trials on patients in India, for sales for patients
in India, a requirement the government could waive, if it wanted. We have
approached firms in India and Canada about manufacturing HCV drugs
currently sold by BMS and Gilead.  There are promising leads, but it may
take a while for some suppliers, and in North America, Europe and in
several other countries, you have to deal with the test data barriers. If
Canada is to be a supplier under their Doha Paragraph 6 option, they have
to list HCV as a qualifying disease.  It might also be good to confirm the
possibility of WHO pre-qualification of HCV drugs, for countries where this
is helpful.


On Tue, Aug 12, 2014 at 6:53 AM, George Carter <fiar at verizon.net> wrote:

> Can a state demand a compulsory license? While we focus on low- and
> middle-income countries and rightly so, there's also a "low-income" section
> of the US population, prisoners and MANY others, including those with
> private insurance, being told by Gilead's Death Panels of Ransom Demands NO.
> Also interested in thoughts around eminent domain as well as importation
> of daclatasvir. Is there any generic form (aside from in China where there
> is plenty of sof and dac as generic but I am still learning about the
> quality/reliability of the companies).
> We have to have some serious leverage against Gilead's juggernaut of
> greed, suffering and death.
> George M. Carter
> On Aug 11, 2014, at 9:56 AM, Ruth Lopert wrote:
> > CL is always an option.
> >
> >
> > On Mon, Aug 11, 2014 at 11:24 PM, <cf at bukopharma.de> wrote:
> >
> >> Dear all,
> >>
> >> does anybody see an option to denie a patent on Sofosbuvir (Sovaldi®) or
> >> to get an compulsory licence?
> >>
> >> Christiane
> >>
> >>
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James Love.  Knowledge Ecology International
http://www.keionline.org, 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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