[Ip-health] AP: Novartis Fights Patent Rejection In Indian Court

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Tue Sep 6 04:50:23 PDT 2011

Novartis Fights Patent Rejection In Indian Court

by The Associated Press

NEW DELHI* September 6, 2011, 06:42 am ET*

In a case that could affect India's role as drug provider to the developing
world, the Supreme Court began hearing arguments Tuesday over whether the
government had the right to deny a patent to Swiss drugmaker Novartis AG for
its lifesaving cancer treatment Gleevec.

A victory for the company, aid groups warned, could open the door to
patenting dozens of other generic medicines made by India's $20 billion drug
industry and sold to needy nations at far lower costs than those charged by
Western drug manufacturers.

"There will be nothing left to defend if we lose," said Leena Menghaney of
Medicins Sans Frontieres, or MSF. "The generic industry is just going to
pack up and leave."

The case, launched soon after India passed its Patent Act in 2005, revolves
around a legal provision aimed at preventing companies from seeking patents
or extensions based on minor changes to existing treatments — a practice
known as "evergreening" that is common in Europe and the United States.

The provision has allowed India to reject patents for a range of older drugs
for cancer, AIDS, tuberculosis, malaria and other illnesses that are made by
India's generics industry.

It also led to the rejection of Novartis' application for Gleevec, in which
it argued a newer, more easily absorbed version qualified for a patent
because it was demonstrably more effective. The blockbuster drug keeps
chronic myeloid leukemia and some other cancers in remission. Its earlier
version was ineligible for an Indian patent because the country gives no
protection to drugs invented before 1995.

Novartis insisted the revamped Gleevec, marketed outside the United States
as Glivec, represents a unique breakthrough rather than just a tweak to the
old formula, and that the Indian law "intended as a hurdle for
'evergreening' is not applicable at all," the company said in a statement.

But Indian patent officers and an appellate court said the change only
amounted to an obvious development on an existing treatment. It's not known
when the Supreme Court might rule.

Novartis now is arguing for a wider understanding of the provision requiring
innovation toward improved drug efficacy, hoping to set a legal precedent it
says is key to preserving financial incentives for companies to develop new

"We believe there are important issues to be addressed that are essential to
the future of intellectual property law in India and the viability of the
innovative pharmaceutical business in this country," the company statement

Lawyer Anand Grover for the Cancer Patients Aid Association, which has
joined the government to defend the patent rejection, said Novartis' stance
represents "a very dangerous argument" to India's effort to prevent patent

The case is just one of many challenges to India's generics industry, which
has frustrated multinational pharmaceuticals since 1972 when India decided
not to recognize patents on drug products and began churning out low-cost
copies of branded medicines.

Current trade talks with the European Union have snagged on the issue of
intellectual property, with EU officials wanting stricter provisions that
activists say would also kill the generics industry.

India now makes one-fifth of the world's generics, sending about half

Given India's own enduring poverty — with more than 800 million people
living on less than $2 a day — many argue the limits still make sense
domestically, particularly as Indian patients bear at least 80 percent of
their own medical costs.

Branded and patented drugs are often 10-40 times pricier than generics, said
Dr. Amit Sengupta of the People's Health Movement. In the case of Gleevec's
generic equivalent, a monthly treatment in India costs about 8,000 rupees,
or $175 — one-fifteenth the $2,600 price charged by Novartis in the country.

"That is really the margin between life and death," Sengupta said,
particularly if the verdict leads to more drug patents on older products
relied on globally. In treating HIV, for example, the medical charity MSF
says it buys 80 percent of its medicines from India.

The pharmaceuticals "don't even care if people live or die so long as they
make their money," said AIDS activist Loon Gangte of the Delhi Network of
Positive People. "We can't let them win."


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