The Supreme Court’s rejection of Swiss pharma major Novartis AG’s case seeking patent protection for Glivec today signified three major gains.
First, the judgment makes it possible for patients to legitimately use cheaper generic versions of the drug to treat chronic myeloid leukemia and some other cancers.
Given the large price gap between Glivec and generic drugs – broadly Rs 1.2 lakh for a month’s supply of Glivec to about Rs 9000 for generics – the SC judgment is a victory for the drug users and public health professionals.
Second, the judgment meant a green signal for Indian pharmaceutical companies, in this case primarily Ranbaxy and Cipla, to manufacture cheaper generic versions of a drug as long as it does not carry a patent.
Novartis AG consistently argued, from Indian Patents Office in Chennai, Madras high court to the apex court, that the drug had received patents in 40 countries and that it had undertaken a successful patient-support programme to supply Glivec at a reduced price or no charge.
However, as YK Sapru of the Mumbai-based Cancer Patients Aid Association, a litigant in this case, remarked: “The generic version makes it affordable to so many more poor people, not just in India, but across the world”.
Third, the SC judgment settles the controversy around the Section 3 (d) of the IPA. In its legal battles, Novartis AG had claimed that the Section be declared “unconstitutional” and in violation of India’s obligation under international intellectual property rights regime.
The Madras HC affirmed that the Section was not unconstitutional; today’s SC judgment has re-affirmed it.
Section 3 (d), largely, states that “if a new form of a known substance is capable of showing increased efficacy” then the new variant can be patented.
Novartis AG claimed that Glivec had a new form of a known substance -- beta crystal form of imatinib mesylate used in the drug – was new. The SC rejected this backdoor attempt at patenting.
It means pharmaceutical companies cannot indulge in “ever-greening”, a widely prevailing practice to keep highly profitable drugs under patent regimes by making minor or cosmetic changes to them to get new/renewed patents.
The SC judgment forces pharmaceutical companies to focus on innovation and hardcore research instead of incremental improvement to claim patents.
Today’s judgment, therefore, goes beyond Glivec; it offers a window of opportunity to have cheaper generic drugs in the fight against AIDS, cancer, malaria, tuberculosis and declines to treat chemical tinkering as innovation.