The Hindu Business Line : Novartis loses plea; HC upholds Patents Act provision

The Madras High Court on Monday rejected the contention of multi-national pharma major Novartis that the amended law on products eligible for patent is beyond the legislative powers of Parliament.

A Division Bench, comprising Mr Justice R. Balasubramanian and Ms Prabha Sridevan, while dismissing writ petitions filed by Novartis also declined to rule that the specific clause was not in compliance with various articles of agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) signed by member-nations, including India, under the WTO.

It said that the Court had no jurisdiction to do so. These agreements were discussed, analysed and entered into, at the highest level of the nations participating in such meeting. Therefore, the Bench said, the agreements were binding on them.

Settlement mechanism

When such nations decided that they shall have a common settlement mechanism, “we see no compelling reason at all as to why we must disregard it”. The Switzerland-based Novartis had filed an application to patent a chemical substance (imatinib mesylate in beta crystalline form) sold under the brand name Gleevec/Glivec.

But the Assistant Controller of Patents & Designs, Chennai, rejected it after pre-grant objection from other companies and on the basis of the amended Section 3(d) of the Patents Act.

The amended law denied patent protection to the discovery of a new member of a family of a previously known chemical substances, if that new chemical entity did not enhance the therapeutic efficacy of the substance already available in the market. Novartis’ Glivec, the patent office ruled, failed this test.

Novartis’ contention

Assailing the rejection order, Novartis said that the amended section was unconstitutional as it was against the agreement on TRIPS.

The Union Government, the company alleged, had not carried out its obligations arising out of TRIPS. The amended section was also vague and arbitrary, and violative of Article 14 of the Constitution, the company contended. In deciding whether there was enhancement of the known efficacy of that substance, uncontrolled discretion was given to the Patent Controller, the company claimed.

The Bench said in clear terms that the amended section had in-built protection enabling each of the patent applicant to establish before the Patent Controller that his discovery had resulted in the enhancement of the efficacy of the substance already known or that the derivatives were significantly different in property.