[Ip-health] Gilead Solvaldi Case Reveals Patent-Health Fissures In India

Shailly Gupta shailly.gupta at geneva.msf.org
Wed Mar 9 02:27:56 PST 2016

Gilead Solvaldi Case Reveals Patent-Health Fissures In India
09/03/2016 BY PATRALEKHA CHATTERJEE <http://www.ip-watch.org/author/patralekha-chatterjee/> FOR INTELLECTUAL PROPERTY WATCH 


NEW DELHI — Are patient groups, health activists and manufacturers of low-cost generic drugs always on the same page? Do India’s generic companies think alike? The short answer: not necessarily, though their interests have overlapped on many occasions. 

Both questions are once again being debated in India in the wake of the patent opposition hearings in case involving sofosbuvir (brand name Sovaldi).

Last month, the Indian Patent Office in Delhi heard arguments by several parties on why US pharmaceutical Gilead Sciences’ patent application for the hepatitis C drug Sovaldi should be rejected. Sovaldi costs $1,000 per pill <http://www.wsj.com/articles/gileads-1-000-hep-c-pill-is-hard-for-states-to-swallow-1428525426> in the United States.

Indian generic versions of the drug are available at a retail price of around $300 for 28 tablets in 400 mg dosage form because of a series of licensing deals that Gilead has entered into with Indian generic companies.

The matter, however, is far from being settled.

The patent challenge hearings (which were not open to the public) have now concluded. However, all parties can still file a note supplementing their arguments till 10 March.

After that, the Patent Office will take a call on whether to grant or reject Gilead’s patent application. If the patent is granted, those opposing it will have to file a writ in the High Court. If the patent is rejected, the applicant (Gilead) can go to the Intellectual Property Appellate Board in Chennai, southern India.

“It is difficult to say when the decision will come, but given the sensitivity around the case, we could expect a decision between 3-6 months at the earliest,” said Tahir Amin of US-based legal group Initiative for Medicines, Access & Knowledge (I-MAK), which has challenged the validity of Gilead’s patent for Sovaldi, along with several other organisations.

The pre-grant opposition hearings (which allow interested parties to oppose a patent application before the patent office, decides on whether or not to grant the drug a patent) raised several important questions about implications for India’s generic drug makers and millions of people waiting for affordable access to the hepatitis C drug.

The hearings in the Patent Office in Delhi relate to a “patent opposition” filed by lawyers from I-MAK together with the Delhi Network of Positive People (DNP+) back in November 2013. I-MAK and DNP+ had argued that the science behind the drug does not meet India’s patent standards.

Today, others who are also challenging Gilead’s patent claim for its hepatitis C drug include non-government organisation Sankalp Rehabilitation Trust, represented by the Lawyers Collective and Indian generic companies Optimus Pharma Ltd and BDR Pharmaceuticals Ltd.

International medical humanitarian organisation Médecins Sans Frontières/Doctors Without Borders, which is heavily dependent on generic medicines for its medical activities around the world, supports the patent challenge.

India’s Deputy Controller General of Patents had rejected Gilead’s patent claim earlier <http://www.ip-watch.org/2015/01/14/key-hepatitis-c-patent-rejected-in-india-for-lack-of-novelty-inventive-step/>, leading Gilead to subsequently approach the Delhi High Court which set aside <http://www.thehindubusinessline.com/companies/more-patentopposition-on-gileads-hepatitis-c-drug-sofosbuvir/article6847904.ece> the Patent Office’s order.

Now, the matter is being reviewed once again at the Patent Office.

However, a parallel narrative has emerged, giving a twist to the tale. Even as the legal battles were going on, Gilead entered into licensing deals with 11 Indian generic drug makers including some of the big names – Hetero Labs Ltd, Cipla and Aurobindo Pharma Ltd – to make and sell generic sofosbuvir in 101 developing countries.

The licensing deals allow the development of combination medicines with other companies, but they do not cover many middle-income countries with very high burdens of hepatitis C.

Health activists say this means that around 50 million people in such countries, accounting for more than 40 percent of the global hepatitis C burden, don’t have affordable access to this vital drug.

Egypt, China and Ukraine have rejected patents for Gilead’s hepatitis C drug and further patent oppositions have been filed in Argentina, Brazil, Russia, Thailand and the European Union.

What happens in India would be crucial. The patent challenge hearings have brought to the fore the differences among India’s generic drug makers and reignited the debate surrounding compulsory licensing and voluntary licensing.

“We support provision for CL [compulsory licence] to pre-empt abuse of monopoly. However, the CL route is full of thorns and uncertainties,” the Indian Pharmaceutical Alliance’s (IPA) D G Shah told Intellectual Property Watch this week. “VL [voluntary licensing] offered the same outcome without pain. We see in it a better solution than confrontation with Big Pharma.”

“We want the VL route to be adopted by more and more companies to provide access and create competition,” Shah said. “It is the most effective way of reducing medicines prices. Hence, when the objective of access and affordability were addressed by VL, we had no reason to oppose. We have left it to the Patent Office to take a call.”

In 2015, IPA, which collectively accounts for almost 85 percent of the private sector investment in domestic pharmaceutical research and development, withdrew its opposition to the patent application for Gilead’s Sovaldi after the US pharma company entered into a voluntary licensing agreement with several Indian companies to sell the generic version at a lower price.

Hyderabad-based Natco Pharma, which had also filed a pre-grant opposition against Gilead’s patent application with the Indian Patent Office, has also pulled out from the litigation after entering into a licensing agreement with the US pharma giant.

Gilead, meanwhile, told Intellectual Property Watch that it stands by its innovation and protection of its intellectual property.

“We believe that innovation should be recognized and we strongly defend our intellectual property. As this patent application remains pending before the Indian Patent Office, the company will be making no further comment at this time. These proceedings do not impact agreements with our licensed Indian manufacturing partners to enable access to low cost, high quality hepatitis C medicines in developing countries throughout the world,” Nick Francis, a spokesperson for Gilead, said in an emailed response to queries.

Not everyone agrees. Critics, including those who are opposing Gilead’s patent application, point out that though patients in India are paying less for the hep C drug than those in the US and many other countries, there are serious public policy issues at stake which can ultimately work to the detriment of India’s generic industry and access to affordable life-saving medicines.

“I speak on behalf of I-MAK and Delhi Network of Positive People (DNP+),” said Tahir Amin of I-MAK, which has taken on Gilead in India and elsewhere. “Our rationale for the pre-grant opposition is simple – Gilead’s patent does not meet India’s (and even other countries’) legal standards for granting a patent. Therefore, the law should be applied correctly as it was intended, to ensure non-merited patents are not granted and cause harm to public health and legitimate open competition/research.”

Gilead’s critics argue that a patent to Gilead would prevent legitimate competition by generic producers (those that are not licensed) who are currently able to make the active ingredient and/or end product.

Amin argues that “the VL [voluntary licensing] strategy as developed by Gilead (first used in 2006 for the drug VI read) and now followed by others and the Medicines Patent Pool is designed to control the Indian competition whilst undermining India’s progressive patent laws.”

How is India’s Generic Drug Industry Reacting? 

Most companies are reluctant to speak about the case but the split within the ranks is being perceived with concern.

“Generic drug manufacturers in India are passing through a very difficult phase. The most unfortunate part is that the industry is vertically divided with many voices speaking in different directions. This is due to absence of a strong representation, reflecting the whole industry or lack of unanimity among the stake holders. Many generic drug makers are really tired and scared of long legal battle, especially since it is a long drawn-out exercise. It is also very expensive,”” Dharma Shah of BDR Pharmaceuticals, an Indian generic drug company which has challenged Gilead’s patent application, told Intellectual Property Watch. Shah was unwilling to comment on the specifics of the case to which he is a party but made observations about the big picture.

“In their submissions to United States Trade Representative [USTR] for the 2016 Special 301 Review, at least four industry bodies, the US Chamber of Commerce, Pharmaceutical Research and Manufacturers of America (PhRMA), USIBC (The US-India Business Council) and Alliance for Fair Trade with India (AFTI) — have said that the Indian government has developed a “positive” approach over the compulsory licensing issue. At least two submissions say that the Controller General of Patents, Designs and Trademarks has rejected at least two applications for CLs applied last year,” the Indian Express newspaper reported <http://indianexpress.com/article/business/business-others/compulsory-licensing-india-gave-private-reassurance-says-us-business-council/> this week.

Shailly Gupta
MSF Access Campaign
New Delhi

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