Source: The Asian Age
14 September 2012
“Most Indians depend heavily on local, low-cost generic drugs. But Big Pharma argues that current flexibilities or safeguards offered by India’s IPR deter innovation.”
Most readers of this newspaper would not know what is “beta crystalline form of imatinib mesylate”. Many may take it as one of those jaw-cracking long names that only chemistry majors spell effortlessly and which leave the rest of us reeling.
This active ingredient of a cancer drug, sold under the brand name Glivec, however, has morphed into a major newsmaker. This week, Glivec grabbed headlines as the final hearing of a long-running legal dispute over the medicine kicked off at the Supreme Court.
The tussle, which has been going on for several years, pits Novartis, the Basel-headquartered Swiss pharmaceutical giant, against four Indian drug companies and the Cancer Patients Aid Association. Novartis is seeking a patent on Glivec, its blockbuster drug, used in the treatment of chronic myeloid leukaemia (CML). Currently, the medicine is being manufactured in its generic form by Natco, Cipla, Ranbaxy and Hetero as well as by Novartis under the brand name Glivec. Treatment with Glivec, the Novartis’ brand, costs about `1.2 lakh per month. The monthly tab for the Indian generic versions is below `10,000.
Why so much fuss about a court hearing about a cancer drug? The answer: because the issues at stake go beyond one drug or one disease. Most Indians have no choice but to pay for their treatment in case of illnesses, be it minor or major. They depend heavily on local, low-cost generic drugs. But Big Pharma argues that current flexibilities or safeguards offered by India’s intellectual property rights (IPR) deter innovation.
The Glivec case has touched a raw nerve in the country because it is being made out to be a test case by public health activists as well as those working in the area of IPR. The final outcome could change the rules of the game, both in healthcare sector and patents in India and other countries in the developing world.
The case has already gone through the various rungs of India’s legal system, including the Intellectual Property Appellate Board (IPAB), which is responsible for hearing appeals on patent applications. At the heart of the dispute is a provision of India’s patent law, called Section 3(d) which states that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”
The dispute raises a fundamental question: what is an “invention”? Or more precisely, how much innovation is required to obtain a patent in India?
This week’s case in India’s highest court is the final act in a legal joust that has been going on since 2006 when Novartis pitched for a patent for Glivec but failed. Currently it is challenging the interpretation and application of Section 3(d) by Indian courts and patent offices on the Glivec case. The packed room on Tuesday, when the final hearing started in India’s top court, speaks of the intense interest in the case.
India embarked on a new patent regime in 2005, which allowed product patents. However, unlike many other countries in the developing world, India’s patent law has safeguards, such as Section 3(d), which seek to prevent patenting on incremental innovations of known compounds unless they provide enhanced therapeutic efficacy and to ensure that essential life-saving drugs continue to be available to consumers at affordable prices. This clause has strong defendants and detractors alike.
Novartis says it is fighting the case not for money but to vindicate its “honour”. It stresses that Glivec is a medical breakthrough, which warrants its patent protection and points out that it has been granted a patent in nearly 40 countries. On the question of the high price of its blockbuster drug in a country where most people are not covered by health insurance, it flags its patient assistance programme. More than 95 per cent of all Glivec patients in India — around 15,000 — reportedly receive their medicine free of charge through the Glivec International Patient Assistance Programme (GIPAP), sponsored by Novartis since 2002. Public health activists, who have been campaigning against Novartis, however, point to the voluntary, discretionary nature of such programmes.
In the coming days, we will hear the other side, represented by the Government of India, the country’s generic drugs manufacturers and the Cancer Patients Aid Association which are challenging Novartis’ claims.
Interestingly, the flexibilities which act as public interest safeguards in India’s intellectual property regime and which are heavily criticised by Big Pharma, are catalysing popular movements for patent reforms in many parts of the world. Argentina is a case in point, says Leena Menghaney, Campaign Co-ordinator (India) for Medecins Sans Frontieres (MSF) or Doctors Without Borders which runs a Campaign for Access to Essential Medicines to push for access to, and the development of life-saving and life prolonging medicines, diagnostic tests and vaccines for patients in MSF programmes and beyond.
In May 2012, Argentina announced new guidelines for patents, which among others, listed strict conditions similar to the ones provided in Section 3(d) of Indian IP laws. The Philippines also has a similar safeguard; China has also amended its IP laws, making it somewhat easier for local firms to produce low-cost versions of patented drugs under certain conditions. “Fix the Patent Laws”, a campaign of the Treatment Action Campaign (TAC), a South Africa-based non-profit organisation, runs a blog to highlight how amending South Africa’s Patents Act 57 of 1978 will reduce the cost of medicines, improving the health and saving the lives of millions. Botswana has adopted pre-grant opposition of patents, taking a leaf out of the Indian model.
Can the needs of patients, patents and profits be ever reconciled? How does one retain public interest safeguards, yet not stifle innovation? While we wait for the answers, India, the “pharmacy of the developing world”, has a great opportunity to leverage its experiences to lead the IPR discourse along with other countries facing similar challenges.