Novartis Persists In Challenge To Indian Patent Law; India Rejects More AIDS Drugs Patents

Undeterred by two previous decisions by Indian authorities holding that under Indian Patent Law, its leukaemia drug – Glivec is not patentable, Novartis now wants to take the fight to the Indian Supreme Court. Meanwhile, also this week, Indian authorities were said to reject applications for patents on two HIV/AIDS drugs, opening the way for cheaper generic versions to be developed and marketed.

In the Glivec (or Gleevec) case, the Swiss drug company filed a special petition, available here, seeking leave to appeal to the Supreme Court. The petition was to be heard on 31 August, but according to news and blog sources in India, the matter was adjourned until later after the presiding judge recused himself.

In its case, Novartis is mainly seeking to challenge the validity and interpretation of a provision under Indian patent law which disqualifies from patentability “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance,” according to the petition.

This is a provision that various advocacy groups, such as Médecins Sans Frontières and the Swiss-based Berne Declaration, claim has been effective in preventing the evergreening of patents on pharmaceutical drugs.

The Berne Declaration said it “strongly condemns” Novartis’ appeal as demonstrating that the company is “relentlessly” trying to challenge the Indian law, in particular its section 3(d), which Berne called “a crucial safeguard against the multiplication of patents around the same substance.”

“A Glivec monopoly situation would deprive thousands of blood cancer patients from access to a vital drug, in India and beyond,” Berne said in a release.

But Novartis argues in its petition that the provision was misinterpreted and is not applicable to their drug owing to the enhancements made from the original substance.

On 26 June, the Indian Intellectual Property Appellate Body (IPAB) while upholding the denial by the Chennai Patent Office decided that Novartis was not entitled to a patent on Glivec, which is a beta crystalline form of imatinib mesylate, as the claimed product did not meet the requirement of increased therapeutic efficacy, according to sources. This was despite the fact that IPAB found Glivec to meet the requirements for novelty and inventive step, they said.

The latest move by Novartis runs against international pressure to drop the suit (IPW, Developing Country Policy, 15 February 2007).

The petition was remitted to India’s Chief Justice for reassignment, sources said, which may sit within a week, according to Indian blog SpicyIP, and will determine whether Novartis will have their appeal heard by the Indian Supreme Court and set new the direction for this decade-long battle.

AIDS Drugs Patents Rejected

Separately, this week MSF announced that India’s patent office rejected patents on new AIDS drugs tenofovir and darunavir, which the nonprofit group said are expensive but needed for AIDS patients failing on their existing treatments. Brand-name producer Gilead also previously failed to win a patent for tenofovir in Brazil, according to MSF (IPW, Public Health, 4 July 2008).

Intellectual Property Watch has not yet confirmed the rejection of the patents with official sources. MSF credited Indian Law Section 3(d) with preventing the evergreening of drug patents and opening the way for generics competitors to enter the market. India is the leading producer of generics in the world.