Healthy Skepticism Library item: 11169

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Publication type: news

Gentleman A.
Indian law on generic drugs is upheld
International Herald Tribune 2007 Aug 6
http://www.iht.com/articles/2007/08/06/business/drug.php?page=1

Notes:

The full 89-page verdict is available at
http://www.lawyerscollective.org/%5Eamtc/current_issues/Judgement.pdf

Full text:

NEW DELHI: Indian pharmaceutical companies can continue making low-cost generic drugs, ensuring their flow to patients in the developing world, after a seminal challenge to patent laws in India was rejected Monday.

Aid organizations declared the ruling a victory for the “rights of patients over patents,” but the Swiss drug company Novartis, which filed the case, warned that the judgment would “discourage investments in innovation” and would undermine efforts by drug companies to improve their products.

Despite disagreeing, Novartis said that it was unlikely to appeal.

The test case mounted by Novartis last year asked the High Court in Madras to clarify a significant element of India’s 2005 patent legislation, arguing that it breached the Indian Constitution. At issue was the question of granting patents for incremental developments.

The full text of the judgment was not immediately released, but Reuters reported that the judge said the court had no jurisdiction over whether Indian patent laws complied with the World Trade Organization guidelines on intellectual property law.

Today in Business
Spotlight: Heinz Schimmelbusch’s comebackCentral banks act again to combat subprime crisisA glorious 25th anniversary for the DowThe details of the case are complex, extending far into the precise analysis of chemical formulations of popular drugs while simultaneously making a constitutional challenge, but the issues at the heart of the case are simple.

Both the international pharmaceutical industry and global relief organizations have been scrutinizing the progress of this long-running case in the southern city of Madras, aware that the judgment would have profound implications for their work.

“This is a huge relief for millions of patients and doctors in developing countries who depend on affordable medicines from India,” said a statement from Tido von Schön-Angerer, director of the Médecins Sans Frontières, or Doctors Without Borders, campaign for access to essential medicines.

Novartis said in a statement that the case would “have long-term negative consequences for research and development into better medicines” that could benefit people in India and beyond.

“It is clear there are inadequacies in Indian patent law that will have negative consequences for patients and public health in India,” Paul Herrling, head of research at Novartis, said. “Medical progress occurs through incremental innovation. If Indian patent law does not recognize these important advances, patients will be denied new and better medicines.”

The Novartis test case sought to determine whether an Indian court had been right to deny a patent on a freshly modified form of its leukemia drug Glivec. The application was rejected last year on the grounds that the new drug was insufficiently different.

Indian patent legislation does not allow “evergreening,” the practice of issuing patents for already known drugs that have undergone modification.

Novartis argued that the section of the legislation saying that patents must not be granted to products that are “incremental innovations” contravened the World Trade Organization’s agreement on trade-related aspects of intellectual property rights.

If the Madras court had ruled the other way, the decision could have set an important precedent that might have allowed other international companies to receive patents on newly modified versions of already known medicines, thereby extending the time frame of their exclusive right to produce the drug.

Such drugs account for the vast majority of about 9,000 patent applications waiting for approval in India, according to Médecins Sans Frontières, which warned that such a ruling would have resulted in a “shutdown of the pharmacy for the developing world.”

Indian companies provide 84 percent of the drugs to fight AIDS that Médecins Sans Frontières supplies to patients worldwide. They also provide more than 25 percent of other essential drugs used by the organization.

Indian companies would have been prevented from making generic versions of Glivec, which they sell both domestically and internationally for around a tenth of the $2,600 charged by Novartis for a monthlong treatment.

This could have left large numbers of patients without access to the cancer therapy.

Officials from Novartis said that they were awaiting the release of the full text of the judgment “to better understand the court’s decision.”

Ranjit Shahani, a vice chairman of Novartis in India, said in a statement: “We disagree with this ruling, however we likely will not appeal to the Supreme Court.”

A spokeswoman for the company said Novartis believed it had “advanced the debate” with this court case, and now wanted to combine forces with other interested parties to continue its campaign.

Novartis is awaiting a ruling in a separate case before the intellectual property appellate board in Delhi, appealing against the earlier decision not to grant a patent for the modified form of its drug Glivec.

The position of the Indian government became clear in April when the health minister, Anbumani Ramadoss, said that the government was “very concerned” that the challenge by Novartis would restrict the Indian ability to produce low-cost AIDS drugs.

Y.K. Sapru, the head of the Cancer Patients Aid Association, a support group in Mumbai, welcomed the decision.

“This is a very major victory domestically and internationally,” Sapru said. “India has a $5 billion pharma industry and 65 percent of those drugs are sold to the developing world and poorer people in the developed world. All that would have been suspended if the judgment had gone the other way and there would have been a dearth of affordable drugs.

“That calamity has been prevented.”