For the Americans (and some Europeans) it’s “that pesky section”. And the US government is throwing its weight behind an industry campaign to discredit this section if not get it removed from India’s Patent Act. Yes, of course, it is Section 3(d) that is under attack from big pharma which has lost no opportunity in pointing out that this law will stifle the growth of India’s own drug companies and also choke off foreign investment in the sector. In recent weeks, this campaign has picked up in tempo both here and abroad.
Section 3 (d) is a singular provision aimed at preventing the evergreening of patents by drug inventors. What it does is to make it pretty much impossible for foreign drug giants to extend the life of patents by patenting new forms of known substances which do not enhance the efficacy of a medication. This is done in many ingenious ways and the framers of the amendment to the Patent Act were careful to plug all loopholes by declaring that “salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”.
That’s how Novartis was refused a patent for its Gleevec anti-cancer drug in the most high-profile case to test the new product patent regime introduced by India on January 1, 2005. The subsequent constitutional challenge against Section 3(d) that was mounted by Novartis came to naught in 2007 when the Madras High Court upheld India’s right to have this section which is widely viewed as a critical public health safeguard. But another case challenging the rejection of a patent for Gleevec (generic name: imatinib mesylate) is heading for a denouement in the Supreme Court where the Swiss multinational has sought to define the way Section 3(d) is interpreted. The case in the apex court was filed in August this year after the Intellectual Property Appellate Board (IPAB) rejected its appeal for the patent on Gleevec on the grounds that it did not satisfy Section 3(d).
In a special leave petition (SLP) Novartis has raised 16 questions of law on Section 3(d), beginning with the issue of whether IPAB was right in applying Section 3(d) to reject its appeal on Gleevec. The main import of the multinational’s legal challenge relates to the interpretation of ‘efficacy’ since there are no guidelines as to what constitutes enhanced efficacy. This is a case which, needless to say, is being watched with extreme interest by the global pharma industry.
However, it’s what is happening outside the court that is turning out to be more rivetting. Just before the IPAB decision in July, the US India Business Council (USIBC) released a report whose title was a dead giveaway of its intentions. The Value of Incremental Pharmaceutical Innovation: Benefits for Indian Patients and Indian Business, as it is titled, was prepared by a legal consulting firm to make the case for reforming the Patents Act to allow Indian industry to benefit from incremental innovation by claiming that the majority of Indian companies (76.4 per cent) had introduced incremental innovations. It also claims that incremental innovations were the primary reason for the success and growth of the industry. The report has seen many launches in different forums, the most recent being in Geneva at a roundtable organised by the Coalition for Innovation Employment and Development, which ostensibly is seeking to ensure that the voice of the patient is not lost in the row over intellectual property rights (IPR).
The report was being presented by a USIBC group which goes by the name of Coalition for Healthy India (CHI). At the Geneva meet, the CHI’s Greg Kalbaugh was quoted as saying: “Incremental pharmaceutical innovation has very real benefits for patients around the globe. It leads to the development of life-saving drugs as well as drugs that markedly improve quality of life. These are important innovations.” But India’s Section 3(d) “actively discourages just that sort of life-saving innovation.”
It is difficult to understand how CHI speaks for patients. This USIBC group’s primary objective, according to its own website, is to “continue to promote advancement, quality control and IP Protection in this essential industry, and will remain vigilant against any back-sliding by India towards compulsory licensing” although it does claim to include NGOs, patient advocacy organisations and health professionals.
Not far behind in the campaign for a more liberal patent regime in India is the US embassy which, with the support of drug major Pfizer, has been holding a series of workshops for media and NGOs across the country to extol the virtues of incremental innovation, data exclusivity and patent linkages to drug regulation, all which India has set its face against.