[Ip-health] US commerce secretary writes to India’s Anand Sharma seeking fair consideration of Gilead’s appeal for drug patent

Tahir Amin tahirmamin at gmail.com
Wed Dec 8 23:32:37 PST 2010

A powerful push for US firm’s patent

US commerce secretary writes to India’s Anand Sharma seeking fair
consideration of Gilead’s appeal for drug patent

 C.H. Unnikrishnan

 The US commerce secretary lobbying his counterpart in another country on
behalf of a company is rare, but not unknown, and in early November, just
days ahead of US President Barack Obama’s visit to India, Gary Locke did
just that, writing to India’s Anand Sharma seeking “fair consideration” of
Gilead Sciences Inc.’s patent appeal in India.
In 2009, India’s patent office rejected Gilead’s patent application for
HIV/AIDS drug Tenofovir, which is sold under the brand name Viread in some
markets, citing “lack of inventiveness”, a key criteria for patent
protection under the Indian Patent Act.
Gilead has appealed the Intellectual Property Appellate Board (IPAB), a
judicial body, and this is the appeal for which Locke sought fair
consideration from India’s commerce minister Sharma.
“Dear Minister, I look forward to meeting with you during my upcoming trip
to India with President Obama. As we advance and strengthen the US-India
bilateral commercial relationship with this visit, India should fully
consider the requisite business climate for spurring innovation, especially
with respect to intellectual property protection,” begins the letter, dated
2 November. “Therefore, I am particularly concerned that the US
biopharmaceutical firm Gilead’s HIV/AIDS drug Viread receives fair
*Mint* has reviewed a copy of the letter and Parita Shah, press secretary at
Locke’s office, confirmed that the US commerce secretary had indeed written
this letter to Sharma. A representative of pharmaceutical lobby Indian
Pharmaceutical Alliance (IPA), which represents home-grown companies (and
which, as a result, is usually opposed to the position taken by
international pharma firms operating in India), said it was highly irregular
that a foreign government was trying to influence India’s judiciary in
favour of a company.
“I doubt any other country, including the US, would entertain if the
government of India takes up such corporate issues with their judiciary
mechanism. Ideally, our government should have discarded the US plea
immediately, saying the patent tribunal here is strong enough to decide such
matters independently,” said D.G. Shah, secretary general of IPA.
To be sure, despite the preamble about a “climate for spurring innovation”
and “with respect to intellectual property protection”, Locke’s letter only
appears to be asking for a fair hearing for Gilead.
“Gilead is currently appealing its case before the IPAB. I seek your
commitment to ensure that the company’s appeal is treated in fair,
transparent and timely manner,” says the relevant portion of the letter.
A senior commerce ministry official, who spoke on condition of anonymity,
said the ministry has already forwarded the letter to the department of
industrial policy and promotion, its arm that deals with intellectual
property law implementation.
Tenofovir is a popular HIV drug in several countries. Though it enjoys
patent protection in many countries, several others, including Brazil, have
refused such protection to this drug.
Gilead’s patent application in India was for a derivative of Tenofovir.
Under the Indian Patent Act, derivatives of a previously known drug do not
qualify for patent protection, unless such medicines can claim much better
efficacy attained through new inventive steps.
India’s controller general of patents P.H. Kurian said: “Gilead’s patent
application was rejected as it doesn’t qualify for a patent under Indian
patent law.”
Interestingly, Gilead’s patent application for Viread in India had also
faced pre-grant oppositions filed by a number of activist groups, including
a foreign patient care agency, the Brazilian Interdisciplinary AIDS
Association, a Brazilian AIDS advocacy group.
Locke’s letter also notes that the Indian patent office rejected Gilead’s
application on the grounds that there wasn’t sufficient demonstration of the
creation of a new chemical entity, which was contrary to the findings of
other patent offices around the world.
Brazil rejected Gilead’s patent application for the drug in 2008 following
opposition by the non-profit Public Patent Foundation, and on the grounds
that the scientific knowledge on which the patents were based had existed
Gilead didn’t respond to an email sent on Sunday night, seeking comment.
“It’s rather unusual that the US government should step in and intervene to
further the corporate interests of one company and its patent case in India.
At worst, the letter insinuates that the Gilead case may not be decided in a
fair manner by Indian courts and tribunals. India should, therefore, respond
to it sternly, suggesting that all cases before Indian courts are treated
with fair consideration. And Gilead’s case is no different; its application
will be decided strictly in accordance with Indian law and if it is found
wanting, it will be denied a patent notwithstanding high-powered government
letters from the US subtly linking this case to trade relations between the
countries,” said Shamnad Basheer, a ministry of HRD chair in intellectual
property law at the National University of Juridical Sciences, Kolkata.
Interestingly, facing opposition to its patent application in India, Gilead
had announced in 2006 and 2007 the voluntary licensing of the drug to at
least 11 Indian drug makers, including Ranbaxy Laboratories Ltd, Aurobindo
Pharma Ltd, Hetero Drugs Ltd, Emcure Pharmaceuticals Ltd, Strides Arcolab
Ltd, and Matrix Laboratories Ltd, to manufacture a generic version of the
drug for local as well selected export markets in return for royalty
International non-profit healthcare lobby MSF’s Access Campaign India
representative Leena Menghaney said that these agreements largely “covered
countries where Gilead doesn’t have a patent and actually leave out
countries like Brazil”, where the drug could have “saved millions for the
Brazilian health ministry”.

Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)

More information about the Ip-health mailing list