Hearings have begun in a Chennai court over a drug to treat rare forms of cancer in a legal case that pits Novartis AGagainst the government, with major implications for the country’s drug industry.
At the heart of the dispute, which concerns a rejected patent application by the drug giant for its Glivec (also sold as Gleevac outside India), are broad questions about what constitutes innovation, whether cheaper non-patented versions of drugs can help more patients access expensive medicines and about India’s willingness to abide by global provisions to protect intellectual property.
Complicating matters is a commerce ministry-sponsored report—the Mashelkar report—that appears to side with Novartis on the larger issue of patenting incremental innovations, but whose conclusions are being challenged because they appear to use language that mimics a position taken by a group funded by drug companies outside India.
The battle originates with Gleevac, a capsule that combats some types of leukaemia and stomach tumors. Novartis, which dubs the drug as “one of the medical breakthroughs of the 20th century”, has sought and obtained patent protection for Gleevac in 36 countries, including China.
In 2006, sales of the cancer drug exceeded $2.5 billion worldwide.
But its application for similar protection was turned down by the Indian patent office citing a 2005 domestic law that allowed product patents but narrowed what is patentable here, by excluding new combinations of existing compounds, or derivatives—slightly tweaked versions of an existing drug—unless they are significantly different from the original drug.
Novartis says that the law creates “new hurdles for pharmaceutical innovation, unjustifiably and illegally narrowing what is patentable”.
“Novartis is seeking clarity on the Indian patent law... and that the hurdles to recognizing genuine innovation in the Indian Patent Law are removed,” said Ranjit Shahani, managing director of Novartis’ India unit, in e-mailed answers to questions.
But with several Indian companies already making and selling versions of the same drug, the Indian Pharmaceutical Alliance, which represents domestic drug manufacturers, is vigorously challenging the Novartis petition.
And patient-advocacy groups across a whole slew of diseases, including HIV/AIDS, asthma, diabetes and heart ailments, have jumped on to the bandwagon, arguing that the outcome of the case will significantly impact patient access to new and often expensive treatments.
A powerful US Congressman, Representative Henry Waxman of California, has also weighed in, writing to Novartis that it should reconsider its fight because the outcome could chill the supply of affordable drugs in developing nations. Waxman chairs the powerful House Oversight and Government Reform Committee in the US Congress and has used that position to investigate how the US government approves and pays for drugs.
At a broader level, patent protection and subsequent profits generated from such patented drugs aren’t doing enough to get big drug companies to spend more on solving many diseases, says Leena Menghaney, country head of Medecins Sans Frontieres, or Doctors Without Borders, which is keeping a close eye on the Chennai case.
“Despite the incentives in the patent system, it has failed to spur research in neglected diseases,” she said. “Moreover, if Novartis were to succeed in this case, it will set a precedent for other drug makers to follow.”
Some industry observers note that many of the 9,000 pending patent applications are related to modifications of old drugs and if Novartis were to prevail, it could open the floodgates for many of these drugs to become off-limits to cheaper generics. MSF relies on cheap India-produced drugs for 80% of the medicines it uses in AIDS projects involving some 80,000 people in more than 30 countries. The Novartis case is unrelated to any AIDS drugs.
Maintains Y. K. Sapru, president, Cancer Patients Aids Association: “medicines should be available and accessible to patients at affordable prices.”
But none of this is really about patient access, argues Novartis. Because of the high costs involved in using Glivec, the Swiss company says it pretty much gives away the drug in India to some 6,700 diagnosed patients who are part of its Glivec International Patient Assistance Programme that provides the drug free of charge to some 20,000 patients in around 80 countries.
That programme is part of Novartis’ $755 million spending, in 2006 alone, on an “access-to-medicines” programme that it says reaches 33.6 million patients through public-private partnerships.
Novartis says a year’s treatment with Glivec will currently cost Rs14 lakh per patient, making it virtually unaffordable to anyone except the very rich in India. The company’s research shows that the local versions of the drug cost 8-10% of Glivec, but points out that even at Rs95,000 or so a year, that is about 4.5 times the average annual income.
Novartis also points out that the generic makers in India have not come forward with patient access programmes in any significant way.
It is unclear how many patients in India need Glivec or its local versions. Novartis says globally there are only about one lakh Glivec patients. The Cancer Patients Aids Association estimates some 20,000 Indians are diagnosed with chronic myeloid laeukaemia, which Glivec targets. Both numbers make it a relatively small target group for drug companies in general.
While big companies battle it out in Chennai, patients, such as Asian Games medallist Nitin Mongia, who is participating in the Glivec programme for the past 18 months, swear by the drug.
The 34-year-old sailor from Mumbai, part of the national sailing team, says availability of the drug has made a big difference to his life and credits Glivec for putting him on track to try and qualify in June for the 2008 Beijing Olympics.
While the battle over Glivec isn’t about HIV/AIDS per se, activists in India involved in other healthcare issues say any decision in this case will spillover into their turf.
“We have filed 13 oppositions to patent applications on anti-AIDS drugs and we will lose ground” if Novartis wins and sets a precedent, says Loon Gangte, a 40-year-old patient who also heads the Delhi wing of the Indian Network of HIV+ People. Meanwhile, patients simply can’t depend on the largesse of Novartis as “these doles are not dependable,” he adds.
Novartis also notes that under Indian law, which protects products on the market prior to 1995, even if it wins the case, generic versions of Glivec will remain in the market.
The company points out that copies of Glivec are ending up in many countries outside India, and especially in countries where the income levels—and thus an ability to afford the drug—are higher than India’s per-capita gross domestic product. It says such copies aren’t really going into some 49 poorer markets where Glivec is available, suggesting the makers of copies aren’t focused as much on access as they are on profits.
Novartis research points out that drug copies originating from India—and all available as branded drugs—are being sold for 50-70% of the price of its patented drug, thus potentially hurting its revenues outside India. The company says products from several Indian companies, including Natco Pharmaceuticals(Veenat), Cipla(Imatib) and Sun Pharmaceuticals(Imalek) have surfaced in some of these markets, including China.
“So what’s wrong with Indian companies making profits by supplying affordable drugs across the world?” asks D.G. Shah, secretary-general of the Indian Pharmaceutical Alliance. “It is on account of these Indian players that drug prices have crashed all over.”
There is also a major trade backdrop to the whole saga. India signed up in 1994 to the Agreement on Trade Related Aspects of Intellectual Property Rights (Trips), a pact that required all WTO member-countries to grant patents on technological products, including pharmaceuticals, by 2005. It is a subsequent change in Indian patent laws that Novartis says puts the country in non-compliance with international trade law.
Adding significant drama to the saga has been the Mashelkar report that was commisioned by the commerce ministry. A panel headed by R.A. Mashelkar, former head of the Council of Scientific and Industrial Research, was asked to decide whether Indian patent law was being Trips-compliant by placing limits on what is eligible for a patent. In December, the Committee came out with its 56-page report (available at http://www.dipp.nic.in/) saying the restriction wasn’t in national interest, thus opening the door for Novartis to assert its patent claims.
“It would not be Trips-compliant to limit granting of patents for pharmaceutical substances to new chemical entities only,” the report concluded. “However, every effort must be made to provide drugs at affordable prices to the people of India. Further, every effort should be made to prevent the grant of frivolous patents and ‘ever-greening’,” a practice in the drug industry of making trivial modifications on drugs to try and extend their patent lives.
But many groups that are opposing Novartis, including the Alliance, have been quick to call the report a sell-out, pointing out that the Mashelkar report’s key language mimics a 2006 report by Shamnad Basheer, a University of Oxford doctoral candidate, that was commissioned by the Intellectual Property Institute, a United Kingdom-based think-tank and financially supported by Interpat, a Swiss association of major European, Japanese and US research-based pharmaceutical companies committed to the improvement of intellectual property laws around the world.
Mashelkar was said to be travelling in the US and couldn’t immediately be reached for comment.
Novartis’ Shahani says the company has not funded the report. “What matters in this case are the conclusions reached by the authors of the Mashelkar report after getting inputs from “different stakeholders” and referring to “relevant literature,” Shahani said. “We believe the report supports our view that India’s denial of a patent for Glivec was not in line with international agreements.”
It is unclear when the court will rule. Hearings are scheduled for the next several days.