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The past two weeks have been marked by significant decisions on lawsuits that have put India's patent regulations to test. The case in the headlines has been one related to Natco's compulsory licence for the manufacture of German drug giant Bayer's cancer treatment drug Nexavar. The Patent Office's appellate tribunal upheld the decision to allow the Hyderabad-based company to produce a cheaper generic copy of Bayer's patented drug, overriding its patent for a variety of reasons. Much has been written about Justice Prabha Sridevan's well-considered decision which set a record of its own. She dictated her decision for close to seven hours, laying out clearly why the Intellectual Property Appellate Board (IPAB) thought the compulsory licence was in order.
Bayer, of course, is unhappy that its appeal was rejected by IPAB. It says the decision "weakens the international patent system and endangers pharmaceutical research". Its argument is: "The limited period of marketing exclusivity made possible by patents ensures that the costs associated with the research and development of innovative medicines can be recovered." This is the familiar, contentious debate in which innovator companies seek to protect their intellectual property rights against the health lobby's demand for reducing the prices so that more people can access these drugs. It is in this context that the views of some scientists on the long-running Novartis case against India's patent laws become important.
These are scientists who need to be heard widely because one of them happens to be the oncologist Brian Druker, professor of medicine at the Oregon Health and Science University Cancer Institute. Druker was the key researcher behind the discovery of the original molecule imatinib that is at the heart of the Novartis patent dispute in India.
But first, some background on the case. In 2006, the Indian Patent Office rejected the Swiss multinational's patent application for cancer drug imatinib mesylate, marketed as Glivec in India, on the ground that it was a new form of an old medicine imatinib. Section 3 d of the Patent Amendment Act of 2005 bars patents for incremental improvements on existing drugs unless these offer "increased therapeutic efficacy".
The case is in the Supreme Court where arguments have been concluded and a verdict is expected in coming days. Does imatinib mesylate represent a significant scientific advance over the original therapeutic imatinib? Or, is the addition of a salt group to improve solubility of a compound a common practice with pharmaceutical companies to improve existing drugs? Novartis maintains that its fight is more than Glivec, and that it is essentially about the patent law in India, to get clarity on what kind of innovations can be protected and what cannot be. It also says it challenged the rejection of the patent "because we strongly believe safeguarding incentives for innovation through the granting of patents leads to better medicines".
While agreeing with this, Erin May, executive board member of the Harvard GSAS Science Policy Group, says: "However, for intellectual property rights to continue to stimulate medical breakthroughs, they must be reserved for true innovation." May, who works on early-stage drug development research at Harvard, wrote in the Toronto Star last week that she has seen first-hand how partnerships between drug companies and academia stimulate intellectual discovery and result in breakthrough therapies with the potential to save lives. "Imatinib shows how such collaborations can succeed.
Nevertheless, there are fair patents that reflect those investments, and there are desperate attempts to extend patent life beyond what is reasonable to encourage investment," says May in direct criticism of the Swiss drug major. "It is alarming that Novartis is attempting to abuse the patent system to extend its monopoly, and in doing so, could limit the availability of life-saving medicines in developing nations."
The sharper criticism comes from Druker who made this point a few years ago: "Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments. But this does not mean the abuse of these exclusive rights by excessive prices and seeking patents over minor changes to extend monopoly prices. This goes against the spirit of the patent system and is not justified given the vital investments made by the public sector over decades that make the discovery of these medicines possible."
In his hard-hitting 2007 essay, Druker wrote: "Without access medical research becomes a luxury good. Most of my colleagues would be very uncomfortable if we felt that this would be the result of our decades of effort." Druker's words bear repetition as the country waits for one of the most critical decisions on patenting of medicines.
Reprinted with permission from Down to Earth magazine
