Madras HC to rule on Novartis’ patent case

MUMBAI: When Novartis AG was accused of jeopardising patients’ access to generic medicines in India last year, the Swiss drug giant thought it would win over its critics. However, the fight between Novartis and domestic companies supported by non-governmental organisations has gathered momentum since. Members of the Government Reform Committee of the US Congress,

and of the European Parliament, are jumping in to rebuke the Swiss pharma major. The withdrawal of Dr Mashelkar panel report after it was criticised by the Left parties for alleged plagiarism came as a fresh blow to Novartis, and added to the confusion around the new Indian patent law.

A division bench of the Madras High Court on Monday heard a case that could have a profound effect on the accessibility to generic medicines in the developing world. Following the rejection of its patent application in India for anti-cancer drug Glivec, Novartis has challenged the constitutionality of Section 3(d) of the Indian patent law.

The legal provision stipulates that modifications of already-known medicines cannot be patented, unless they make the drug significantly more effective.“The TRIPS agreement sets three standard criteria for the grant of a patent.

While those standard clauses cannot be altered, the TRIPS agreement allows each country to have some exceptions, and Section 3(d) falls under this category,” said Prabuddha Ganguli, CEO, Vision-IPR, a Mumbai-based consultancy firm. This legal provisions have been designed to prevent a phenomenon commonly referred to as ‘evergreening’, whereby the patent holder patents trivial modifications of already existing drugs to extend their monopolies beyond the 20-year
period granted to the original patent.

The Glivec case has opened a debate on the value of incremental innovation — meaning new forms, derivatives and new drug delivery systems of existing molecules — and on whether they should be patented in India. Separating incremental innovation from evergreening can prove a difficult task. “Nothing is invented from scratch, innovation is always to some extent incremental,” says Joseph M Beck, partner, Kilpatrick Stockton LLP, an Atlanta-based law firm.

However, Glivec (generic name: Imatinib mesylate) is not an incremental innovation and is not either a case of evergreening. “Glivec is a new drug, which has been granted a patent in close to 40 countries,” said Ranjit Shahani, managing director, Novartis India, and president of the Organisation of Pharmaceutical Producers of India (OPPI), in a recent interview with ET.

Novartis’ patent application for Glivec was rejected by the Indian patent office on completely different grounds. “Glivec is not eligible for a patent in India because the invention of Glivec’s basic molecule is prior to 1995,” legal sources said. Novartis is seeking patent protection for a patent filed post-1995, on the chrystalline form of Imatinib mesylate, and not on the basic molecule itself.

“Therefore, even in the case Glivec is granted a patent for the chrystalline form of Imatinib mesylate, any company in India can work on Glivec’s basic molecule, and try to make a medicine out of it, as long as the chrystalline form is not copied,” pointed out Mr Ganguli. “This is not evergreening, there is no old and a new version of Glivec, but one single drug.”

The withdrawal of the Mashelkar report is of no relevance to the Glivec case. “While Novartis planned to submit the Mashelkar report in its case against the Indian patent law, this report in no way implies that the Indian patent law and more specifically Section 3 (d), is unconstitutional. It simply says that patentability should not be restricted to new molecules,” legal sources said.

“And the Indian patent law does not restrict patentability to new molecules. It allows incremental inventions to get patents, subject to improvement in efficacy.”

The outcome of Glivec’s case could yet prove critical, as it will send a strong signal to the industry. “We are keeping most of our international clients seeking patent protection for their products in India on hold, until the Glivec’s case comes out,” said Anoop Narayanan, partner, Majumdar & Co, a leading law firm in Mumbai. The Madras High Court is expected to rule on this case within the next few weeks. The next hearing is on Tuesday.