Patent

NY Times on the Novartis Patent Case


The NY Times weighs in on the Novartis patent case that has been simmering before our Supremes for a while now.

The article reflects a nuanced take on the issue by Vikas Bajaj and Andrew Pollack, who made the effort of understanding highly complex patent concepts and interviewing a diverse range of stakeholders before crafting their story. The matter is posted for hearing at the end of this month, but my guess is that it will be adjourned again.

Pregnant with technical nuances and surrounded by controversy, it will take a very determined judiciary to sink their teeth into the matter and issue a verdict without fear or favour.

For those interested, I’ve excerpted parts of the NY Times piece below:

“The case, involving the drug Gleevec, is before the Indian Supreme Court, which is preparing to hear final arguments this month. It represents a high-stakes showdown between defenders of intellectual property rights, who say the generic knockoffs stifle innovation by drug makers, and Indian drug companies and international aid groups, who warn that a ruling in favor of Novartis could dry up the global supply of inexpensive medicines to treat AIDS, cancer and other diseases.

The case has attracted international attention. AIDS activists and others protested recently outside Novartis’s annual shareholders meeting in Basel, Switzerland, and also at Novartis offices in New York, Washington and Cambridge, Mass., demanding that the company drop the case.

“There will be nothing left to defend if we lose,” said Leena Menghaney, a manager based in New Delhi for Doctors Without Borders, which advocates for generic drugs. “People are definitely on edge about this case.”

“The implications of the case go to all medicines,” said Brook K. Baker, a professor of law at Northeastern University in Boston and a policy analyst for the Health Global Access Project, which works to improve access to H.I.V. drugs. “The question is, Do you get one patent monopoly for the basic ingredient or do you keep tweaking it to get more patents?”

Tahir Amin, a director of the Initiative for Medicines, Access and Knowledge, a group based in New York that works on patent cases to foster access to drugs, said many drugs for AIDS and other diseases have been denied patents in India because of the clause and manufacturers might benefit from a victory for Novartis.

Gilead Sciences, for instance, is appealing India’s rejection of a patent application for its drug Viread, or tenofovir disoproxil fumarate, which is used to treat H.I.V. infection. And Roche is fighting several court cases to uphold its patent on the anticancer drug Tarceva, or erlotinib, that Indian drug makers argue does not meet the effectiveness standard. Courts have allowed generic versions of that drug to be sold in India while the case is being litigated.

India’s patent law does not define “efficacy” or say how it should be measured. Novartis is arguing that the term should encompass modifications that might make a drug safer or easier to use, not just more effective in treating a disease. It says more than 40 other countries have granted a patent on Gleevec.

Paul Herrling, chairman of the Novartis Institute for Tropical Diseases in Singapore, said this was not a case of evergreening because the initial compound was never marketed or intended for market…..

Dr. Herrling said Novartis was not dropping the case because, “We wanted to have clarity about what kind of innovation is and is not patentable in India.”

Shamnad Basheer, a law professor who has filed a friend of the court brief suggesting ways the effectiveness standard could be clarified, said both sides of the case have valid points….”

Shamnad Basheer

Shamnad Basheer

Prof. (Dr.) Shamnad Basheer founded SpicyIP in 2005. He's also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof. Amartya Sen. Professional History: After graduating from the NLS, Bangalore Prof. Basheer joined Anand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Later, he was the Honorary Research Chair of IP Law at Nirma University and also a visiting professor of law at the National Law School (NLS), Bangalore. Prof. Basheer has published widely and his articles have won awards, including those instituted by ATRIP, the Stanford Technology Law Review and CREATe. He was consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also served on several government committees.

2 comments.

  1. Avatarrajeev

    Dr Basheer,
    You have rightly pointed out that decision of Novartis case is being eagerly awaited. This is expected to clearly define efficacy and possibly draw a discernable line between what is patentable and what may not be. Incremental inovcation being patenetable or not wil be clear. But I am concerned with the timing and interest of this article in NY times. Is it pure reporting or an indirect way of putting pressure on govt/judicairy citing the envisaged fallout of negative verdict to Novartis and trade relations between India & U.S. As a freind of court you may be in a better position to appreciate this and perhaps build your arguments recgnising this.
    Your intituion suggests that the verdict may be postponed. This is ominious. Hope that ssome positive comes out of this long standing dispute. I convey my best wishes for all your efforts in the coming case.
    R.K.Jain
    Patent Agent

    Reply

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