A powerful push for US firm’s patent

A powerful push for US firm’s patent

Mumbai: 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 consideration."

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 earlier.

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 payments.

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".