[Ip-health] FT: Novartis loses Indian patent cas

Thirukumaran Balasubramaniam thiru at keionline.org
Tue Apr 2 06:22:14 PDT 2013


http://www.ft.com/intl/cms/s/0/7e7dbd46-9a95-11e2-b982-00144feabdc0.html

<SNIP>

Novartis this week threatened to stop supplying India with new medicines if the patent was not approved.

India’s generics industry, currently valued at $26bn, is the primary supplier of low-cost drugs to many developing countries, especially in Africa. The sector is also seen as essential for keeping medicines affordable in India, where 70 per cent of health costs are borne by individuals.


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Last updated: April 1, 2013 6:55 pm
Novartis loses Indian patent case
By Amy Kazmin in New Delhi

Healthcare activists say the landmark court ruling means poor patients worldwide will continue to have access to affordable medicines

India’s Supreme Court has rejected a plea from Novartis, the Swiss pharmaceuticals group, to patent its cancer drug Glivec, in a landmark ruling health activists say will allow India’s generics industry to keep making cheaper versions of newer medicines.

The judgment is likely to infuriate multinational pharmaceuticals companies already frustrated at the way Indian patent officials and courts have repeatedly interpreted New Delhi’s 2005 patent law to permit Indian generics companies to override their patents.

The seven-year battle over Glivec has been closely watched by both the global pharmaceuticals industry and campaigners for access to affordable drugs, who say its precedent would affect the ability of other multinationals to obtain patents for newer versions of existing drugs.

Novartis this week threatened to stop supplying India with new medicines if the patent was not approved.

India’s generics industry, currently valued at $26bn, is the primary supplier of low-cost drugs to many developing countries, especially in Africa. The sector is also seen as essential for keeping medicines affordable in India, where 70 per cent of health costs are borne by individuals.

“It is a huge victory for human rights,” said YK Sapru, an activist from the Cancer Patients Aid Association. “The court has recognised the right of patients to access affordable medicines over profits for big pharmaceutical companies.”

Novartis called the decision “a setback for patients that will hinder medical progress for diseases without effective treatment options”.

India’s 2005 patent law – adopted as part of the process of joining the World Trade Organisation – provides patent protection for innovative drugs, but sets a high threshold for patenting new versions of existing drugs, saying the modified compound must show improved efficacy.

Glivec has been patented in 40 countries, but its application for similar protection in India was rejected in 2006, as the patent office ruled that the active ingredient, imatinib myselate, was a known compound before Glivec’s development – and was therefore ineligible.

However, Novartis, argued that the original compound was too unstable for human use, and thus should be granted a patent for the newer crystal form of the drug, which made it a viable cancer treatment.

Anand Sharma, India’s commerce minister, called the verdict a “historic judgment which reaffirms the position of Indian law . . . which mandates the need for a substantive innovation while deciding on a case for grant of a fresh patent”.

Novartis sells Glivec for about Rs120,000 ($2,200) per patient per month, but says that only 165 of the estimated 16,000 patients using the drug in India were paying full price for it, while the rest obtained it free through a donation programme.

Indian companies sell generic versions of the cancer drug at Rs8,000 per patient per month. India has around 41,000 leukaemia patients.

Richard Bergstrom, head of Efpia, the European innovative pharmaceutical industry trade body, said the ruling was “very disappointing”.

“It is a pity that India does not focus on such a constructive approach to make tiered pricing work. Attacking patents only supports the Indian copycat industry – and pleases western NGOs that think removing patents will give everyone access to the medicines they need.”



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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)

thiru at keionline.org



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