1 May 2013Jurisdiction reportsUnnati Agrawal and Abhishek Malhotra

Key cases: developments in India

Novartis AG v Union of India, Supreme Court of India

A two-judge bench of the Supreme Court has confirmed the finding of the Intellectual Property Appellate Board (IPAB) and the Indian Patent office and rejected the patent application filed by Novartis for Glivec in 1998.

The main ground for appeal was under Section 3(d) of the Patents Act. Section 3(d) seeks to prevent ‘evergreening’ by refusing to grant patent for new forms of known substances. The only exception to the general rule is if the new form results in a demonstrable increased efficacy. For the application of the exception, defining the scope of “efficacy” and “known substance” is imperative.

The Madras High Court, in an earlier connected proceedings, which concerned the constitutional challenge to Section 3(d) of the Patents Act, 1970, had interpreted “efficacy” to mean “therapeutic efficacy”.

The Supreme Court clarified that the definition of “efficacy” would depend upon the product in question. The court observed that:

“Efficacy means the ability to produce a desired or intended result. Hence, the test of efficacy in the context of section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, the test of efficacy would depend upon the function, utility or the purpose of the product under consideration. Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be ‘therapeutic efficacy’.”

“A DIVISION BENCH OF THE DELHI HIGH COURT CHASTISED THE GOVERNMENT ON ITS FAILURE TO SET UP AN APPELLATE TRIBUNAL UNDER THE ACT, AS IT REQUIRES.”

The Supreme Court did, however, observe that “increased bioavailability alone may not necessarily lead to an enhancement of therapeutic efficacy. Whether or not an increase in bioavailability leads to an enhancement of therapeutic efficacy in any given case must be specifically claimed and established by research data”.

For determining the “known substance”, the Supreme Court followed the series of innovations leading to the claimed invention and held that imatinib mesylate was the “known form” for the purposes of Section 3(d). It observed that “the issue of enhanced efficacy of the subject product in light of the finding … that imatinib mesylate (non-crystalline) is a known substance from the Zimmermann patent and is also the substance immediately preceding the patent product, that is, imatinib mesylate in beta crystalline form”.

The Supreme Court also clarified that Section 3(d) does not bar patent protection for all incremental inventions of chemical and pharmaceutical substances. “It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Patent Act. That is not said in this judgment”.

Maharashtra Hybrid Seeds v UOI, High Court of Delhi

In probably a first judgment by a High Court under the Protection of Plant Varieties and Farmers’ Rights Act, 2001, a division bench of the Delhi High Court chastised the government on its failure to set up an Appellate Tribunal under the act, as it requires.

The main issue for determination before the court was whether the registrar had the power to condone a delay in the filing of an opposition.

The court analysed Rules 32 and 33 of the Protection of Plant Varieties and Farmers Rights Rules, 2003 and Section 21(2) of the act to answer the question.

The court observed that Rule 32 seeks strict compliance with time schedules provided for in the act with respect to advertisements, oppositions, etc, and cannot be extended. Under Rule 33(6), the registrar has the power to condone a delay with respect to submission of evidence, but that power cannot be extended to Rule 32.

The court further observed that Section 21(2) provides a three-month period from the date of advertisement for filing of opposition. However, the act does not have any provision for sanctioning cases of non-compliance with the time period. Therefore the registrar can extend the time.

The court reasoned that since the act is a beneficial piece of legislation which provides for protection and recognition of the rights of farmers, it should be interpreted liberally, and procedural matters should not deter recognition of rights conferred under the act.

The court observed that provisions in other IP statutes such as the Trade Marks Act, 1999, expressly prohibit filing of oppositions after the prescribed time period. However this negative connotation is missing from the present act and therefore this furthers the legislative intent of condoning a delay.

The court therefore laid down that Rule 32 is directive and not mandatory.

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