Under pressure from its Left allies and the National Democratic Alliance, the government today announced several changes in the Patents (Amendments) Bill aimed at reducing chances of possible misuse in the new product patent regime.
In order to curb "evergreening" of patents by global pharmaceutical companies, the government has now said "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", will not be sufficient ground for granting of a patent.
Defining "pharmaceutical substances" as any new entity involving one or more inventive steps, the government has decided to include "salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of known substances" which will be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.
"A patent should be granted only when there is a quantum improvement over existing treatment," Sanjiv Kaul, a management adviser with ChrysCapital, said, adding, "The government has covered the grey areas in the Bill."
The government has decided to restrict the scope of patentability by modifying the definition of "inventive step", which will now mean a feature of an invention that involves technical advancement.
The Bill has also defined "new invention" as any invention or technology that has not been anticipated by publication or used in the country or elsewhere in the world before the date of filing of the patent application.
It has also decided to exclude embedded software from the ambit of the product patent regime.
It also proposes to provide a maximum of six months from the date of publication for filing pre-grant opposition as against the three months provided earlier.
With regard to strengthening of pre-grant opposition, the government noted that the Act provided only for pre-grant opposition and that too with open-ended timeliness.
There was no provision for post-grant opposition, nor for appeal within the patent office set-up. The Ordinance introduced post-grant opposition in addition to pre-grant opposition. It also defined timelines for each of these.
Further, it provided for appeal to the Intellectual Property Appellate Board in addition to the normal judicial recourse available.
The government expanded the condition of obtaining licence for export of patented pharmaceutical to less developed countries by adding "provided compulsory licence has been granted by such country or such country has by notification or otherwise allowed importation of the patented pharmaceutical products from India" in section 92 (a).
The 'reasonable period' in relation to compulsory licensing in section 84 (6) (iv) has also been defined as less than six months. In an application for compulsory licence, the Controller of Patents is required to consider "whether the applicant has made efforts to obtain a licence from the patentee on reasonable terms and conditions and such efforts have not been successful within a reasonable period as the Controller may deem fit."
Section 90 (1) (vii) and (viii) has been redrafted in the Ordinance in order to clarify that even when compulsory licence is granted for pre-dominant purpose of supply in Indian market, the licensee may export the patented product.
Similar facility of export is also permitted when licence is granted to remedy a practice determined after judicial or administrative process to be anti-competitive.
In order to allay the fear that opposition proceedings were being 'diluted', the proposed new chapter concerning opposition, namely, "Representation and Opposition Proceedings" would now revert to earlier heading, namely, "Opposition to Grant of Patent".
