[Ip-health] Civil society groups strike again: BMS’ patent bid for Hep C treatment Daclatasvir challenged

rameshwari rao rameshwarirao at gmail.com
Fri May 1 22:25:51 PDT 2015


*2 May 2015*: Stepping up efforts to counter patents on life-saving
medicines, three civil society groups working to increase access to
affordable, life-saving Hepatitis C (HCV) medicines, have challenged
Bristol-Myers Squibb (BMS’) pending patent application on Daclatasvir
before the Delhi Patent Office. The pre-grant opposition has been filed by
Hepatitis Coalition, Nagaland (HepCon), Sankalp Rehabilitation Trust
(Sankalp Trust), Mumbai and Asia Pacific Network of Positive People (APN+),
all of whom are represented by the Lawyers Collective.

“BMS’ patent application has no merit” said Anand Grover, Director, Lawyers
Collective. “We have made out a clear case that the application lacks
inventive step and does not fulfill the requirements of section 3(d), being
similar to existing technology which is excluded from patentability under
the law.  The application ought to be rejected.”

Daclatasvir, a direct acting antiviral (DAA) is a part of the class of new
oral treatments to treat chronic HCV. It works to block the NS5A protein in
the HCV without which the virus cannot replicate. In combination with other
oral DAAs like Sofosbuvir, it has shown very promising treatment outcomes
moving towards an all-oral, simplified and well-tolerated regimen from the
current treatment regimen of painful and side-effect laden pegylated
interferon injections.

Despite these treatment benefits that could treat and potentially cure
treat millions of people living with chronic HCV, the high price of the
medicine means that it might not be available for those who need it. “We
know that Daclatasviris selling at US $15,000per bottle in the EU. By no
measure is this price affordable to the common man in India, particularly
marginalized groups like People Who Inject Drugs (PWIDs) who have a high
burden of HCV and also HIV co-infection” said Ketholelie Angami, of HepCon.
“Along with affordability, availability of better drugs is of utmost
importance” he added. Infact, a study by Andrew Hill and other researchers
at the Liverpool University shows that a 12-week combination therapy with
Sofosbuvir could cost as little as $100 - $250 a person to produce.

BMS has not been forthcoming about their pricing or access strategy on
Daclatasvir for high burden countries like India. “We know from sources
that BMS is attempting to negotiate voluntary licenses despite there being
no patent on Daclatasvir in India, similar to what Gilead did for
Sofosbuvir. There is no transparency about the details of these
negotiations and we’re very concerned about the replication by BMS of
restrictive and unethical terms of Gilead type licenses.” said Eldred
Tellis of Sankalp Trust.

Shiba Phurailatpam, Regional Coordinator, APN+, pointed out that “There is
ample evidence from ARV drugs that open generic competition results in the
most dramatic fall in prices. If we are to even consider scaling-up
treatment with the newer DAAs there needs be several more players in the
market producing drugs like Daclatasvir. We hope this patent opposition
will help achieve just that”.

Contact: *Anand Grover +91 9899439593,  Eldred Tellis +91 9820194363*

-- 
 -RAMESHWARI.

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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