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.
Brian Druker, one of the scientists who developed imatinib.
Mint, 15 August 2007
These words of Brian Druker, the man behind the development of imatinib mesylate (sold by Novartis as Glivec), convey the real battle behind what has been dubbed around the world as the Novartis case.
It is little known that the fight for affordable generic versions of imatinib mesylate predates the 2005 amendments to the Indian Patents Act, 1970. Before 2005, Novartis was already claiming exclusive marketing rights on imatinib mesylate, a crucial medicine used in the treatment of chronic myeloid leukemia. The Cancer Patients Aid Association (CPAA), which was relying on affordable generic versions of the drug made by Indian companies (at Rs.8,000 to Rs.10,000 per patient per month), challenged this move as Novartis’ price (Rs.1.2 lakh per patient per month) was clearly unaffordable.
In 2005, CPAA’s concerns echoed through the Indian Parliament as it pondered upon the grave consequences of complying with the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and changing the Indian law granting patents on medicines, something India had not done since 1970. The Parliament was also acutely aware of the millions of people living with HIV across the world who relied on Indian generic medicines that resulted in the reduction of the price of first line HIV medicines from $10,439 per person per year to less than $100 per person per year. It finalized a crucial provision to act as a public health safeguard against the unabated patenting of known medicines by drug makers in the West.
Section 3(d) was thus born—a provision that prohibits patents on new forms of known medicines unless they result in significantly enhanced efficacy over the known medicine. This provision emerged from growing evidence from the West that multinational companies were succeeding in obtaining patents on minor modifications to known medicines, thus extending their monopoly over those medicines.
A new molecule would receive a 20-year patent, followed thereafter by a new patent for a salt form of that medicine followed by a yet another patent on another version of that same drug. Most people assume that there is one patent for one medicine. The European Commission Competition Authority found 1,300 patents and patent applications on one medicine alone!
This is known as evergreening.
Section 3(d) became the basis for the rejection of Novartis patent application for the beta crystalline version of imatinib mesylate at the patent office and at the Intellectual Property Appellate Board. Imatinib, it must be noted, was discovered before 1995, the date when India had to start recognizing medicines eligible for patenting.
Novartis tried at first to have Section 3(d) stricken from the law books, challenging its constitutional validity before the Madras high court. The court found instead that the provision arose from the government’s constitutional obligation under Article 21 to protect the right to life and health of all Indians. Novartis then moved the Supreme Court, continuing its attempts to dislodge the provision by asking for a weaker interpretation. Novartis also argued that the efficacy standard under section 3(d) should be interpreted to include physico-chemical properties of the new form of the old medicine.
In this case, it argued that the polymorph of imatinib mesylate that it was trying to patent led to better flow properties, better thermodynamic stability and lower hygroscopicity and that this should be considered an improvement in efficacy. It should be noted that these properties of polymorphs are well-known and, as CPAA argued before the Supreme Court, could not be considered patentable under the Indian law.
Novartis also argued that the Indian patent law’s compulsory licensing provisions were sufficient to deal with any concerns that may arise over the pricing of the patented medicine. This is ironic, since Novartis India’s vice-chairman, Ranjit Shahani, has been the most vocal opponent of the Indian patent office’s issuance of a compulsory licence on another cancer medicine.
The Supreme Court has rejected Novartis’s contentions, holding that in the case of medicines, efficacy means “therapeutic efficacy”, that this standard must be interpreted “strictly and narrowly” and that physico-chemical properties, while they may be beneficial to some patients, do not meet this standard. It also laid out a strict standard of proof for patent applicants, requiring that they prove any claimed increase in therapeutic efficacy based on research data and that “bald assertions” would not suffice to meet the requirements of the law.
The CPAA has stood strong and fast in challenging Novartis’ attempts to dislodge section 3(d). Seven years of protracted litigation in the face of an opponent with unlimited financial resources is no easy task. Ultimately, CPAA as well as all health and public interest groups that have campaigned against the Novartis case have been vindicated.
Novartis’s assertions that the ruling will affect investment or future innovations have been belied time and again, including at the World Health Organization, which has found that intellectual property does not result in the kind of innovation in medicines required by us as a developing country. Novartis’ threat that it would not introduce new medicines in India after the verdict further adds strength to the assertion of health groups that India must jealously guard its generic manufacturing capacity in the face of such threats from multinationals if they do not have their way.
The lives of many cannot be held ransom to the profits of a few. Section 3(d) strikes the right balance between innovation and access. Section 3(d) leaves “the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds,” the Supreme Court said.
India’s patent law is now among the strictest in the world. The Supreme Court decision should encourage other developing countries to follow suit as the Philippines, Argentina and Zanzibar have already done. If these fundamental changes to the runaway patent system of the West can be effected, we may truly have an intellectual property system that works for everyone and not just for the firms.
The right to life and health is sacrosanct. Every Indian should be proud of the Supreme Court’s clear and unflinching judgement recognizing the intent of the Indian Parliament in this regard. This decision benefits not just millions in India, but across the developing world. It is a proud day for all of us.
Anand Grover is senior advocate and director, Lawyers Collective—who represented the Cancer Patients Aid Association at the Supreme Court.