India's top court to deliver Novartis judgment

March 31, 2013 by Nirmala George
In this Jan. 29, 2007 file photo, Indian police officers block demonstrators protesting against Swiss drugmaker Novartis AG's case against the Indian government on drug patents in New Delhi, India. India's Supreme Court is to rule Monday, April 1, 2013, whether to deny a patent to Novartis AG for its cancer treatment in a landmark case that would allow Indian companies to continue producing cheaper versions of many lifesaving medicines. (AP Photo/Saurabh Das, File)

India's Supreme Court is to rule Monday on a landmark patent case involving Swiss drugmaker Novartis AG that focuses on demands by major companies that their investments be protected, against Indian companies that say they should be allowed to continue producing cheaper generic versions of many lifesaving medicines.

A decision in the seven-year legal battle is keenly awaited by the two most interested parties— big pharma companies and groups—with both sides saying the outcome will set a precedent with far-reaching consequences for the future availability of the drugs.

"Across the world, people rely on India for supplies of affordable versions of expensive patented medicines," said Leena Menghaney of Doctors Without Borders. "This case will have fundamental consequences."

The case goes back to 2006 when Novartis' application for a fresh in India for its cancer imatinib mesylate was rejected by the Indian .

The patent authority cited a legal provision in India's 2005 patent law aimed at preventing companies from getting fresh patents for making only minor changes to existing medicines—a practice known as "evergreening."

The drugmaker has argued that its Gleevec, known in Europe and India as , was a newer, more easily absorbed version that qualified for a fresh patent.

The company filed an appeal, but India's patent appeals office turned it down in 2009 on the grounds the company was unable to show significant increase in efficacy of the drug.

Novartis then approached the Supreme Court in August 2009, which heard arguments seeking to challenge the interpretation and application of India's in the case.

, used in treating and some other cancers, costs a patient about $2,600 a month. Its generic version was available in India for around $175 per month.

"The difference in price was huge. The generic version makes it affordable to so many more poor people, not just in India, but across the world," said Y.K. Sapru, of the Mumbai-based Cancer Patients Aid Association.

The case once again pits big pharmaceutical companies against health activists and aid groups with both sections arguing that the judgment would be an important milestone for the future of the pharmaceutical industry worldwide.

"The Novartis verdict is important because it will determine whether India gets to limit patents to genuine new drugs, or whether drug companies get to "evergreen" their patents until eternity, simply by re-patenting a slightly modified version of a known substance," said Ellen 't Hoen, a pharmaceutical law and policy consultant.

Western pharmaceutical companies have warned that a rejection of Novartis' application would discourage investment in research and innovation, and would hobble drugmakers' efforts to refine and improve their products.

The international drug majors have been pushing for stronger patent protection in India to regulate the country's $26 billion generic drug industry, which they say often flouts intellectual property rights.

In a statement sent to The Associated Press late last year, Novartis said patent protection was important to ensure effective protection for innovation.

"Knowing we can rely on patents in India benefits government, industry and patients because research-based organizations will know if investing in the development of better medicines for India is a viable long-term option," the company said.

Groups such as Doctors Without Borders say cheaply made Indian generics are a lifesaver for millions of patients in poor countries who cannot afford to pay Western prices to treat diseases such as cancer, malaria and HIV.

India, which has emerged as the world's pharmacy for the poor, has come under intense scrutiny from pharmaceutical giants who say India's 2005 Patent Act fails to guarantee the rights of investors who finance drug research and development.

The country's recent decision to allow a local manufacturer to produce a of Bayer's patented cancer drug Nexavar, to make the drug available to the public at a reasonably affordable price, has also not gone down well with Western pharmaceutical companies.

Health and aid groups were clearly nervous before the top court rules on the Novartis case.

"Generic companies depend on the freedom to operate. If there are too many intellectual property-related challenges, then the companies very quickly withdraw from making that drug," said Menghaney.

The groups fear that a ruling in favor of would lead to a proliferation of patents—some based on a minor tweaking of formulation and dosages —on dozens of other generic medicines that Indian companies have been producing and supplying to needy nations at far lower costs than those charged by Western drug manufacturers.

And the fallout of the judgment will be felt across the world, says Menghaney. "It's not just about India."

"If generic competition on many crucial medicines ends, then prices for these medicines will increase, both in India and across the developing world. This would be devastating for millions who rely on India for affordable medicines."

Explore further: Indian court to rule on generic drug industry


Related Stories

Indian court to rule on generic drug industry

January 4, 2013
(AP)—From Africa's crowded AIDS clinics to the malarial jungles of Southeast Asia, the lives of millions of ill people in the developing world are hanging in the balance ahead of a legal ruling that will determine whether ...

India rejects Bayer plea against cheap cancer drug (Update)

March 5, 2013
India's patent appeals office has rejected Bayer AG's plea to stop the production of a cheaper generic version of a patented cancer drug in a ruling that health groups say is an important precedent for getting inexpensive ...

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.

Novartis fights patent rejection in Indian court

September 6, 2011
(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 ...

India licenses generic copy of patented Bayer drug

March 12, 2012
(AP) -- India effectively ended Bayer's monopoly on a patented cancer drug Monday, licensing a much cheaper generic under a unique law aimed at keeping costs affordable.

NGOs protest Novartis' Glivec patent quest in India

February 23, 2012
Several NGOs protested Thursday at the annual meeting of Novartis against the attempt by the Swiss pharmaceutical group's India company to obtain a patent for its anti-cancer drug Glivec.

Recommended for you

Mind-body therapies immediately reduce unmanageable pain in hospital patients

July 25, 2017
Mindfulness training and hypnotic suggestion significantly reduced acute pain experienced by hospital patients, according to a new study published in the Journal of General Internal Medicine.

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 ...


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.