[LST] Novartis loses landmark India patent case on cancer drug - The Globe and Mail

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Novartis loses landmark India patent case on cancer drug
STEPHANIE NOLEN
DELHI — THE GLOBE AND MAIL
Last updated Monday, Apr. 01 2013, 11:55 AM EDT

A pedestrian passes the logo of Swiss pharmaceutical company Novartis at the company's headquarters in Basel, Switzerland. (STEFFEN SCHMIDT/AP)

India's Supreme Court ruled against the Swiss pharmaceutical company Novartis on Monday in a landmark judgment with significant implications for India's giant generic drugs industry.
"This means millions of patients in developing countries can go to sleep tonight knowing their drugs are on the way from India," said Leena Menghaney, a lawyer with the Access to Essential Medicines Campaign of Medecins Sans Frontieres (Doctors Without Borders). Globally more than 10 million people living with HIV-AIDS rely on Indian generic medications, including many who are treated by MSF; the fate of their drugs hung in the balance in this decision, which pitted Novartis against the Government of India's patenting system.
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Novartis India Ltd. president Ranjit Shahani said the decision is a "setback for patients" because it will hinder progress in developing new treatments for illnesses that now lack them, and creates a chilly climate for multinational firms looking to invest in India because it calls into question the country's respect for intellectual property.
"Patents are the foundation of innovative drug discovery and essential to advancing medical science and treatment for patients," he said. "Patents are the lifeline for the generics industry for without patents there will be no new generics … the ecosystem for encouraging intellectual property needs to be more robust in India – it has on the contrary progressively deteriorated. All this has a huge impact for patients."
The arcane case was fought through the Indian courts for eight years, and centred on a cancer drug called Glivec (or imatinib besylate) for which Novartis sought an Indian patent. In 2006, the Indian Patent Office denied that patent, saying that it was not a new medicine but a salt formulation of a known drug. Novartis took that decision to court, and lost twice on appeal. Judges said the company had not shown the drug would have greater "efficacy" (that is, work better) than the already-patented molecule, and that's the standard Novartis had to meet under India's unusually stringent patent law.
That law has a provision that aims to safeguard public health by preventing "evergreening" – the practice through which pharmaceutical companies extend patent life by making small changes to the formulations of existing drugs. The Supreme Court on Monday agreed with all the earlier court rulings, saying Novartis had done nothing at all to show that its formulation would actually work better and thus was a new drug deserving patent protection.
The case made its way to the Supreme Court when a collective of activist lawyers took it up on behalf of a cancer patients' group. Novartis's brand-name version of the drug cost about $2,200 a month per patient, versus $170 for the generic.
But at stake here was even more than the lives of poor Indians who could not afford their leukemia treatment. The ruling affects India's entire $26-billion (U.S.) generic drug industry – which supplies almost all of the medicines used domestically, acts as "the world's pharmacy" and helped to fuel major gains in public health around the developing world over the last 15 years.
In its 112-page judgment – which delves deep into biochemistry, modern Indian history and intellectual property debates, among other topics – the court rejected Novartis's claims of innovation. Had the court allowed the patent, Ms. Menghaney said, then production of hundreds of other generic drugs could have similarly been shut down, with catastrophic consequences.
Novartis's Mr. Shahani said the decision will hinder new medical research, removing the incentive for pharmaceutical companies to spend the millions of dollars it can take to bring a new drug to market if they know their investment will not be recouped.
But Ms. Menghaney countered that the judgment makes no change to the existing patent regime – in which genuinely new innovations are patent-protected, and have been since 2005 when India's obligations to the intellectual property agreements of the World Trade Organization came into force.
Novartis has also suggested that it might opt not to release other new medications in India, if it knows they will simply be copied by generic makers. But Anand Grover, the advocate who argued the case on behalf of the cancer patient groups, called that specious – if Novartis won't sell its drugs here, then generic companies can simply apply for a compulsory licence and produce them. He also noted that the molecule in Glivec was discovered using public funds with research at the U.S. National Institutes of Health.
For decades after independence India did not patent-protect drugs, on the grounds that a country this poor needed to take broad measures to bring health care to its people. Developed countries eager to get access to the vast Indian market have pushed hard for patent reform here; but multinational firms, both pharmaceutical and others, have charged that the government and judiciary interpret the law adopted to meet WTO requirements too liberally.
Even within the coalition governing India there is a pro-business faction, which includes several powerful cabinet ministers, who make no secret of the fact they dislike the law.
"This judgment isn't important for Novartis," said Loon Gangte, who heads the Delhi Network of Positive People and who relies on Indian-made generic drugs to treat the HIV for which he has been living for 15 years. The company only had a few hundred people who could afford Glivec in India anyway, he said.
"But for us it's our lives. This judgment was about whether we live or whether we die."
Ms. Menghaney warned that while this case is a major victory that protects the ability of groups like MSF to advance public health, the battle is far from over. In two weeks' time India's government will participate in a major round of negotiations on a critically important free-trade pact with Europe.
As part of that deal, the European nations are pushing for a tightening of the patent law, including the ability for drug companies to get injunctions against generic makers to stop production while they pursue a court case – something activist groups fear mean that deep-pocketed and litigious companies could use to strangle the generic industry, which operates on much finer margins
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to be afraid and yet retain their fury."


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