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[e-drug] Novartis and Indian Patent Act

E-DRUG: Novartis and Indian Patent Act
[The full 89-page verdict is available at  

Dear friends,

The final judgement has come from the Indian court regarding the case filed by 


Dr Gopal Dabade
57, Tejaswinagar,
Dharwad 580002,

International Herald Tribune,

Indian law on generic drugs is upheld
By Amelia Gentlemen

Monday, August 6, 2007

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.

  The 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 

  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 

  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."


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