Novartis patent case in India seen as crucial for generic drugs

The Indian Supreme Court is scheduled Wednesday to take up a case that aid agencies warn could have sweeping effects on the price of medicine for the global poor.

The Swiss drug company Novartis is seeking a patent from India for a drug called Glivec, which is used to treat a rare form of leukemia and gastrointestinal tumors. The drug, known as Gleevec in the United States, has received patents in many countries and is viewed by the company as intellectual property that advances medicine and is deserving of patent protection to ensure that groundbreaking research can continue.

But those who oppose granting the patent to Novartis say that doing so could ultimately undercut the making of generic drugs that has given India a reputation as a mecca for making affordable medicine.

"The effects could be enormous," said Judit Rius, U.S. Access Campaign manager for Doctors Without Borders. "It is one of the most important cases on access to medicine right now."

Indian law allows the country to turn down patents for medicines that officials determine do not yield new benefits for patients over existing drugs. The law is meant to stop “evergreening” -- companies tweaking drugs slightly to keep them under patent longer.

The Indian law sets a higher bar than many other countries for drug patents, a frustration to pharmaceutical companies that say they need greater protection for innovation. India only started patenting medicines seven years ago when required to under a World Trade Organization agreement.

Six years ago, India turned down Novartis for a patent on Glivec, saying it was too much like older medicines on the market. Novartis argues that its form of the medicine was “a breakthrough.”

Novartis has lost earlier court challenges. Aid agencies have urged the company to drop the case, fearing that if it wins, it could open the door to rampant evergreening, paralyzing the Indian market for affordable generic drugs to treat HIV/AIDS and other maladies in the developing world.

Doctors Without Borders has called the court case an “attack on generic medicines,” Oxfam “a massive threat” to the poor and ill. Indian generics make up the bulk of medicines used to treat HIV/AIDS in developing countries, the groups said, and Glivec could set a perilous precedent.

Before granting patents, “the question has to be asked -- how much real innovation is going on?” said Tahir Amin, co-founder of the Initiative for Medicines, Access and Knowledge, which challenges drug patents it sees as questionable. “If you just improve the shelf life of a drug, that isn’t really a groundbreaking discovery. India has been trying to curb some of that behavior.”

Novartis says the case will not stop people in poorer countries from getting drugs they need. The vast majority of Indians who need Glivec get it for free through a company program, Novartis said. Generic drugs created before 2005 will still be available, it added.

“This case is not about changing the availability of existing generic medicines, but about protecting intellectual property to advance the practice of medicine and to serve patients’ unmet needs,” Ranjit Shahani of Novartis India wrote in Business Line, an Indian newspaper.

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-- Emily Alpert in Los Angeles

 
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