As the Novartis Glivec patent case in India reaches the final phase of a long-running legal battle, there’s one point on which both the Swiss pharmaceutical company and its critics agree: the significance of this case goes far beyond the protection of a single medication.

For access to medicine campaigners, Novartis’s legal action could threaten the availability of affordable medicines for the world’s poorest patients. For the pharmaceutical company, the protection of massive R&D investment and innovation is on the line.

Following the denial of a patent in India for Glivec (Gleevec in the US), a medication indicated for the treatment of two rare cancers, Novartis has challenged the decision all the way up to country’s highest court. Recently postponed due to court delays, India’s Supreme Court has re-scheduled to hear Novartis’s appeal on 28 March.

In the run-up to the hearing, several non-governmental organisations (NGOs) protested the case outside of the Novartis Annual General Assembly (AGM) on 23 February in Basel, Switzerland. On behalf of a coalition of these groups, including Act Up, Oxfam, and Health Gap, the Berne Declaration made a statement during the meeting, calling on the company to drop the case.

“What is at stake goes far beyond the only granting of a patent for this anticancer drug. This legal challenge aims in fact at weakening a legitimate and invaluable public health clause of the Indian law, Section 3(d), which intends to limit the multiplication of patents on trivial changes to existing medicines, a common practice by multinational pharmaceutical companies known as ‘evergreening,’” said Patrick Durisch, the health programme coordinator of the Berne Declaration.

Challenging Section 3(d)

In 2005, India amended its patent law to comply with the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), allowing patents on medicines. But, Indian patent law requires that applicants prove that their medical product demonstrates a certain level of innovation.

Unique to Indian patent law, Section 3(d) outlines inventions that are not patentable. The section reads: “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”

Under Section 3(d), an Indian Patent Office (IPO) rejected Novartis’s Glivec patent application, arguing that it was only a new form of a known substance. Novartis has contested the decision ever since it was made in 2006 (IPW, Public Health, 9 February 2009).

In a Novartis briefing document, the company states, “We developed the mesylate salt of imatinib and then the beta crystal form of imatinib mesylate [Glivec] to make it suitable for patients to take in a pill form that would deliver consistent, safe and effective levels of medicine. This process, which took years, was more than just an incremental improvement – it was a breakthrough – and certainly cannot be interpreted as “evergreening.”

This is one of Novartis’s core arguments and what has become one of the fundamental questions of the case: the definition of what constitutes enhancement of efficacy. So far, Indian courts require applicants to show that their medication demonstrates an increase in therapeutic efficacy. In other words, reductions in side effects or improved bioavailability aren’t enough to earn a patent.

Generics at Risk?

NGOs and HIV/AIDS activists are concerned that a ruling in favor of Novartis would trim obligations under Section 3(d) and reduce India’s capacity to produce the generic medications that they rely on. According to a 2010 study, ( more than 80 per cent of the generic ARVs purchased with donor funds for developing countries come from India.

“If Novartis succeeds in weakening the interpretation of Section 3(d) for the purpose of obtaining a patent on a specific salt of the anti-cancer drug imatinib, it would force India to grant far more patents than it currently does or is required to under international trade rules,” Dr Amit Sengupta of the People’s Health Movement told Intellectual Property Watch previously (IPW, Public Health, 9 June 2011).

Leading up to the Novartis AGM, demonstrations were held in several US cities, including Boston, New York, and Washington, and in India as part of a global day of action aimed at drawing attention to the case. Additionally, over 40,000 online protestors have signed a petition, organized by the global web movement Avaaz, urging Novartis to halt their legal action in India.

Médecins Sans Frontières (Doctors Without Borders, or MSF) participated in the Basel protest. An MSF access policy advisor told Intellectual Property Watch, “The case that Novartis is pursuing in India is really aimed at closing down any space left for generic companies to operate. And to really push TRIPS-plus and IP-plus measures on India in a way that will really constrain not only the medicine in question but on any future medicines.”

It’s an argument that Novartis continues to refute. During its AGM, Chairman of the Board of Directors Daniel Vasella responded to criticism about the case. He said, “That the decision by the Supreme Court would lead to India no longer being able to produce generics for the poor in the world is simply not true. According to the WHO, 95 percent of essential medicines are free from patents and if there was a change, this would only apply to new drugs introduced. But new drugs can only be developed thanks to patent protection. So this is a deep-rooted dilemma behind this cause, which I understand very well,” he said.

Glivec has been granted patents in 40 countries. Novartis argues that India is denying the company the intellectual property protection it counts on to fuel future R&D research. Chairman of the Board of the Novartis Institute for Tropical Diseases, Prof. Paul Herrling, told Intellectual Property Watch, “The entire world accepted Glivec as a breakthrough in medicine. Indian law seems not to. This sends a message that maybe other breakthroughs won’t be protected in India, which would be a detriment to patients. There would be no incentive to develop medicines there.”

Prof. Herrling agrees that the significance of the case goes beyond Glivec. “This case is about a larger question: which innovations can be protected in India? This case represents a major debate between generic companies and companies that are interested in developing science based innovative medicines and wanting that research to be rewarded.”

On 27 February, Glivec received clearance in the EU for longer use in certain post-operative stomach cancer patients. The drug can now be used for up to 36 months of treatment instead of only 12. The drug also received extended-use clearance in the US in January. Glivec earned Novartis $4.66 billion in 2011 and is the company’s second biggest drug following Diovan, a hypertension medication that is coming off patent in the US in 2012.

An Ongoing Legal Battle

Following the rejection of their Glivec patent application in India in 2006, Novartis filed two legal challenges in the Madras High Court. One to appeal the rejection of the patent and the other challenging Section 3(d), arguing that it is not conform to the TRIPS Agreement or to the Indian Constitution.

The High Court’s decisions came in 2007. Regarding TRIPS compatibility, the High Court said that it did not have jurisdiction over such matters and that the proper authority would be the WTO dispute settlement panel. The High Court also confirmed Section 3(d)’s constitutional validity.

In 2009, the Intellectual Property Appellate Board (IPAB), the Indian authority responsible for hearing appeals on patent applications, rejected Novartis’s appeal. While the IPAB recognised that Glivec was both novel and inventive, it said that the medication failed to demonstrate the enhancement of efficacy required under Section 3(d).

Now, Novartis is challenging the interpretation and application of Section 3(d) in the Supreme Court. India’s highest court could provide authoritative interpretation of this section to further guide IPOs and Indian courts going forward. The tone and direction that the Supreme Court takes in its analysis could have significant bearing on both the future of pharmaceutical patents in India as well as the scope of the country’s generic manufacturing capacity.

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