SEXUAL HEALTH AND HUMAN RIGHTS A legal and ... - The ICHRP

India’s deadline to comply with the TRIPS Agreement came in 2005 and in amending its
Patents Act, 1970 introduced several public health safeguards. This included stricter
patentability standards, allowing oppositions both before and after the grant of a patent,
compulsory licencing, etc. In Novartis AG v. Union of India and others 707 the strict
patentability standard of the amended patent law were challenged before the Madras High
Court. The provision in question, Section 3(d) does not allow patents on new forms, new uses
or combinations of existing substances. 708 Novartis AG which was denied a patent by the
Indian patent office on a new form of a cancer medicine filed the challenge. Upholding the
provision in the Indian law, the Madras High Court held:
“We have borne in mind the object which the Amending Act wanted to achieve
namely, to prevent evergreening; to provide easy access to the citizens of this
country to life saving drugs and to discharge their Constitutional obligation of
providing good health care to its citizens.”
These provisions of India’s patent law have been used by patients groups and networks of
people living with HIV to challenge patent applications on HIV and other medicines. In
Boehringer Ingelheim v. Indian Network for People Living with HIV/AIDS (INP+) and
Positive Womens Network (PWN), the Delhi Patent Office rejected the patent application on
Nevirpaine Hemihydrate which is used in the treatment of pediatric AIDS. 709
707 Novartis AG and another v. Union of India and others, W.P. Nos 24759 and 24760 of 2006, High Court of
Madras (Date of Judgment: 6 August 2007).
708 Section 3(d), Patent Act, 1970 (India) states: The following are not inventions within the meaning of
the Act…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 or the mere discovery of any new property or new
use for a known substance or of the mere use of a known process, machine or apparatus unless such
known process results in a new product or employs at least one new reactant. Explanation.- For the
purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers,
mixtures of isomers, complexes, combinations and other derivatives of known substance shall be
considered to be the same substance, unless they differ significantly in properties with regard to efficacy.
709 In the matter of an application for patent having no. 2485/DEL1998, Delhi Patent Office, 11 June 2008
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