The seven-year legal battle waged by Novartis for patent protection for its leukemia-fighting drug, Gleevec, came to an end last month as the Supreme Court of India ruled against the pharmaceutical giant. The 112-page ruling touched on the many facets of the case, reconciling India’s self-interests with the necessity for allowing innovation.
The case highlighted the difficulties many multinational pharmaceutical companies face when trying to protect their products in India. India’s patent system has been slow to adopt many of the features present in many other countries, and it was only in 2005 when India began issuing patents for drug molecules and not just their manufacturing process. As a result of their relatively lax intellectual property processes, a large generic drug market was able to flourish in India. This, in turn, created a host of problems for companies like Novartis but allowed many patients and doctors in impoverished nations to get the generic drugs they needed to fight diseases like HIV/AIDS. It wasn’t until international pressure forced India to change its patent system to comply with the World Trade Organization’s agreement on Trade-Related Aspects of Intellectual Property Rights. (TRIPS)
The crux of the case lay on the if the Gleevec’s active ingredient, imatinib mesylate, a derivative of imatinib, which showed “enhanced therapeutic efficacy” when compared to the parent chemical. Imatinib was invented before India recognized patents on pharmaceuticals so it cannot be patented. As Novartis could not demonstrate that Gleevec “enhanced therapeutic efficacy” when compared to other imatinib-based drugs, the court upheld the rejection that the India Patent Office had issued on the patent application for the drug.
The qualifications for granting patents in India are stiffer than in the United States. The Patent and Trademark Office often approves drugs that are only minor modifications of existing drugs in a process known as “evergreening.” The rationale behind the policy is that it frees companies able to fund the R&D necessary to produce new drugs from the nagging business threat of generic manufactures. This, ideally, allows for more investment in R&D and therefore more innovation.
As a side effect, “evergreening” allows brand name manufactures to retain patentability on popular drugs and drive up the prices for consumers. The Indian court system has been sympathetic to the plight of it citizens and has taken active steps to protect. The ruling referrers to observation of the Madras High Court that its purpose has been to “[…] prevent evergreening; to provide easy access to the citizens of the country to life saving drugs and to discharge their constitutional obligation of providing good health care to its citizens.” Many of India’s citizens cannot afford to pay the same prices for goods as American consumers and the legal system has molded itself to address that disparity.
Feeling taken advantage of by the Indian legal system, drug companies have now tried to get the United States to pressure India to change how it handles intellectual property issues. In March, the Chief Intellectual Property Counsel of Pfizer testified before the House Ways and Means Subcommittee on Trade in a hearing on U.S.- India Trade Relations. In brief, he argued that India went beyond the requirements of TRIPS and thus stifled innovation and weakened “the competitiveness of the U.S. innovative pharmaceutical sector in India.” Only time will tell if this run-and-tell-dad approach will bring about meaningful change.
In the world of high-stakes patent litigation, the Novartis case further entrenches two competing interests: large multinational pharmaceutical companies fearful of losing profits and the India’s court system protecting its citizens. The broader contention between a company and the wellbeing of a people will not be resolved with a single case but will take the combined wisdom of many.
Wakanene Kamau is a first year, majoring in Biological Chemistry and Geophysical Sciences