India revokes cancer drug patent in fresh industry blow

August 2, 2013 by Penelope Macrae

India has revoked a local patent granted to Britain's GlaxoSmithKline for a breast cancer drug in the latest blow to global companies seeking a bigger presence in the country's $13 billion medicine market.

Tykerb, one of the most widely prescribed treatments in India used to treat advanced forms of the disease, is a newer version of GlaxoSmithKline's (GSK) original anti- .

The Indian patent board revoked the patent for Tykerb, calling it an incremental improvement of the original compound and not sufficiently innovative to warrant a patent.

The ruling underscores Indian authorities' tough stance against what is called "evergreening" or minor changes to a drug to extend its patent shelf life, said lawyer Dominic Alvares, part of the team which challenged GSK's Tykerb patent.

"India has some of the toughest patent laws—and they are based on public interest," Alvares, of S. Majumdar and Co, told AFP.

Once drugs go off patent, they can be sold more cheaply. India is known as the "pharmacy to the world" for its huge generics industry that turns out cheaper copycat versions of life-saving branded drugs for poor patients in developing nations.

The Tykerb ruling comes after the Supreme Court in April struck down a patent for an updated version of Swiss giant Novartis's blockbuster drug Glivec used to treat a deadly form of leukaemia.

Novartis had argued the compound was a significant improvement because it was more easily absorbed by the body but the court said it did not pass the test of innovation.

Experts then said the Novartis court ruling could pave the way for a rush of similar Indian decisions.

The latest ruling only affects GSK's newer patent, not the original patent for the main active ingredient in the drug, lapatinib, which expires in 2019.

For the first time, the patent board acted on a complaint filed by another international rather a local Indian company.

The challenge to GSK's patent was launched by an Indian subsidiary of German health group Fresenius. It had disputed the patents both for the original molecule and Tykerb.

"We are pleased that the Intellectual Property Appellate Board in India has upheld our basic patent for the lapatinib compound, the active ingredient in Tykerb," said a GSK official who did not wish to be named.

"We are, however, disappointed that the board has revoked our later expiring (in 2021) for the lapatinib ditosylate salt," the official said, adding GSK was considering an appeal.

Western drug-makers are seeking to win a larger part of India's rapidly expanding drugs market, valued at around $13 billion, to compensate for slowing sales in advanced markets.

But they say that India fails to respect intellectual property rights.

"Intellectual property protection is an important aspect in ensuring innovation is encouraged and appropriately rewarded," the GSK official said.

India earlier did not grant drug patents but resumed awarding them in 2005 as part of a World Trade Organization agreement.

Explore further: Bayer vows to fight for patent on anti-cancer drug in India

Related Stories

Bayer vows to fight for patent on anti-cancer drug in India

March 4, 2013
German pharmaceuticals giant Bayer, maker of Aspirin, vowed Monday to fight a ruling by the patent authorities in India allowing a local company to produce and sell a generic copy of its anti-cancer drug Nexavar.

Drug maker Novartis loses India patent battle (Update)

April 1, 2013
India's Supreme Court on Monday rejected drug maker Novartis AG's attempt to patent an updated version of a cancer drug in a landmark decision that health activists say ensures poor patients around the world will get continued ...

India generics giant wins cancer drug patent case

September 8, 2012
Indian generics giant Cipla says it has scored a "landmark" court win in a patent challenge launched by Switzerland's Roche Holding over the Mumbai firm's version of a lung-cancer drug.

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 ...

Bayer challenges India cancer drug ruling

May 6, 2012
German pharmaceutical giant Bayer AG has challenged a ground-breaking Indian ruling that allowed a local firm to produce a vastly cheaper copy of its patented drug for kidney and liver cancer.

India's top court to deliver Novartis judgment

March 31, 2013
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 ...

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 ...

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.