Section 3(d) of the Indian Patent Act was first introduced in the year 2005, which states that:
“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 of 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”.
For example: salts, esters, ethers, polymorphs, metabolites, pure form, particular 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.
US raised Opposition to Section 3(d) of the Indian Patent Act-
Section 3(d) of the Indian Patent Act 1970 (amended in 2005) does not allow patent to be granted to inventions involving new forms of a known substance unless it differs significantly in properties with regards to therapeutic efficacy. Thus, the Indian Patent Act does not allow ever-greening of patents. This is a cause of concern to the US pharma companies.
Thus on 30th April, 2014, USA brought out a special 301 report, which includes some flagged issues. These issues were:
- Issues of inter-alia, concerns over the provision of section 3(d) of the Indian Patent Act which relates to non-patentability of inventions involving chemical forms that do not show increased efficacy;
- Issues of Compulsory License by the Controller General of Patent, Designs and Trademarks under section 84 of the Patent Act; and
- Inclusion of a statement relating to Compulsory License for green technologies in India’s National Manufacturing Policy and challenges relating to enforcement of IP Rights.
- In April, 2007, the Central Government issued a notification under Section 117G of the Act whereby all appeals from the order of Controller, pending before the High Court, were transferred to the IPAB set up in Madras. Therefore, the Madras High Court transferred the appeal from the Controller’s order rejecting patent to the IPAB. However, the Madrs High Court, reserved the right to pronounce its judgment on the issue of the Constitutional validity of Section 3(d) of the Act.
- On 6th August, 2007, Madras High Court held that Section 3(d) does not violate Article 14 (right to equality) of the Constitution of India. This order was not appealed further by Novartis.
- On 26th June, 2009, IPAB reversed the decision of the Assistant Controller on the issues of anticipation and obviousness. However, the IPAB held that the subject matter of the patent application was barred from patentability under Section 3(d) of the Act and therefore rejected the patent. However, it allowed the process patent for the Product.
- On 11th August, 2009, Novartis filed a special leave petition (SPL) under Article 136 of the Indian Constitution in the Indian Supreme Court, against the order of the IPAB.