Novartis fights patent rejection in Indian court

September 6, 2011 By KATY DAIGLE , Associated Press

(AP) -- 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 made by India's $20 billion drug industry and sold to needy nations at far lower costs than those charged by Western .

"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 keeps 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.

insisted the revamped , marketed outside the United States as , 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 drugs.

"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 said.

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 abuse.

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 abroad.

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."

Explore further: India patent case threatens cheap drug supply: MSF

shares

Related Stories

India patent case threatens cheap drug supply: MSF

September 5, 2011
Supply of cheap, copycat drugs for the developing world could be badly threatened if Swiss firm Novartis wins a challenge to India's patent law, medical charity MSF said on Monday.

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.