Section 3(d) and the Bar on Evergreening

1The history of patent law is replete with exceptions to patentability. The exceptions to certain product patents were made usually on grounds of public policy. The exceptions to certain processes were made either because they were deemed not to be inventions or even if inventions, were deemed to be non-patentable as they did not otherwise satisfy the criteria of patentability. (See Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries, OUP, 2001, p 96.) Though every country has made exceptions to patentability, the following instances will show that the exceptions to patentability need not be exhaustive or confined to the ones mentioned in the TRIPS Agreement.

2The TRIPS Agreement, being a minimum-standard setting agreement, provides for the following exceptions to patentability in cll (2) and (3) of art 27:

Article 27. Patentable Subject Matter.— … (2) Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law. (3) Members may also exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals; (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

3On the face of it, s 3(d) will be read as an exception to patentability which should be applied before the three tests of patentability in s 2(1)(j) are satisfied. Section 3(d), though worded in the form of an exception to patentability, does provide for conditions in which such exceptions may become patentable. In effect, s 3(d) may be applied at two stages, ie, before and after determining the three prerequisites of patentability. As s 3(d) figures in ch II of the Patents Act containing the general exceptions of what are not inventions, by reason of the argument that the exceptions have to be applied first, s 3(d) may be applied before determining the three prerequisites of patentability, ie, novelty, inventive step and industrial application.

4A patent may be granted for a pharmaceutical process or a product which is new, involves an inventive step and is capable of industrial application. Section 3(d) may also become applicable, depending upon the particular circumstances, after the individual ingredients of patentability, ie, novelty, inventive step, and industrial application are determined. This is so because s 3(d) encompasses elements of novelty (’new’ form, ’new’ property, ’new’ use, ’new’ product and ’new’ reactant) inventive step or obviousness (‘known’ substance, ‘known’ efficacy and ‘known’ process) and industrial application (’efficacy’, ‘use’ of known substance or process).

5The exceptions to patentability in s 3 can be broadly classified as absolute exceptions and conditional exceptions. Section 3(d) consists of three individual parts, as detailed below. The first and the third parts contain a conditional exception to patentability, ie, the exception can be overcome when certain conditions mentioned in the parts are present. The second part, however, encompasses an absolute exception to patentability.

6Section 3(d) comprises three parts and one explanation. For the sake of clarity, the parts of s 3(d) are detailed separately. The section states that the following are not inventions within the meaning of the Patents Act:

(1) 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
(2) the mere discovery (i) of any new property or new use for a known substance; or (ii) 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.

8The three parts are dealt with below separately and referred to individually as the first part, second part and third part of s 3(d). The common element in all the three parts, ‘mere discovery’ is discussed below followed by the three situations contained in the three parts.

9In F Hoffmann-La Roche v Cipla (2009) the Division Bench held that “Section 3 (d) read with its Explanation is, in the context of pharmaceutical products, an anti-evergreening provision” (para 33). It held that “It is not possible to accept the contention of the Plaintiffs that the Section 3(d) does not bring any significant change to the Patents Act. Not only has the substantive portion of Section 3(d) indicated a change in 2005 but the Explanation which has been added appears to particularly target pharmaceutical products. It discourages evergreening and prevents such derivative or other forms of the already patented product being granted patent unless the derivatives or other forms ‘differ significantly in properties in regard to efficacy.’” (para 60)