Seven years of uncertainty and litigation have come to an end with the Supreme Court dismissing Swiss drug-major Novartis’ plea to get patent protection for its blood cancer drug Glivec.
The drug, a beta crystalline form of imatinib mesylate, fails to meet the requirement of being a “new invention”, the 112-page judgment said, dismissing the appeal filed by Novartis AG.
The landmark judgment allows drug companies to continue making similar and less expensive versions of Glivec, used to treat chronic myeloid leukaemia, and opens the marketplace for newer players.
Getting some relief from this move are cancer patients, who will now be able to access the medicine at lower prices.
After Novartis’ patent application was rejected by the Indian Patent Office in January 2006, Glivec has been through a complex process of litigation, including a challenge to the validity of Section 3(d) of the Indian Patents Act 2005, in the Madras High Court.
Known medicine
The two-member Bench of the Supreme Court ruled that Glivec failed to meet the standard of efficacy under Section 3(d), which does not recognise incremental innovations of a known medicine and requires a patented drug to show enhanced therapeutic efficiency.
“When all the pharmacological properties of the beta crystalline form of imatinib mesylate are equally possessed by imatinib in free base form or its salt, where is the question of the subject product having any enhanced efficacy over the known substance of which it is a new form?” the judgment observed.
Benchmark case
The ruling is a watershed as it defines the yardstick against which medicines will be measured before patents are granted.
The case is also the first drug-patent related case after India amended its Patents Act in 2005 to honour product patents. Patents allow an innovator 20 years of manufacturing and marketing exclusivity.
The concern when it comes to medicines, though, is that such a monopoly could price the drug beyond the reach of patients. The Glivec judgment comes on the heels of other judgments in the country that ruled in favour of public health.
This included the granting of the country’s first compulsory licence to Natco, allowing it to make its version of Bayer’s advanced kidney cancer drug, on the payment of a seven per cent royalty. The Novartis petition was dismissed on the grounds that imatinib mesylate was a known substance, had no novel or inventive characteristic and did not show greater efficacy to merit a patent, said Anand Grover of Lawyers Collective who represented the Cancer Patients Aid Association (CPAA), one of the respondents in the case. Local drug-maker Natco and Cipla were the other respondents in the case.
Disappointed
“Clearly disappointed”, is how Ranjit Shahani, Novartis India-head, reacted to the judgment, at an impromptu media interaction. Glivec is an innovative drug and changed the way research was done for cancer, he added.
Novartis will continue with its patient access programme for Glivec, under which the medicine is given free of cost to patients who cannot afford the drug, he said.
The company would continue to launch new products in India, but “cautiously”, he added. However, it will not invest in research, he said.
CPAA’s Y.K. Sapru said that the ruling goes beyond Glivec and will be quoted every time there is a dispute about evergreening (a process where an existing drug is given minor tweaks).