The Draft Manual of the Patent Office and SpicyIP’s recommendations on Section 3(d)

As many of you must already know the Patent Office has been having stakeholders meetings in various cities in regards the Draft Manual released by the Patent Office some months ago. It needs no repeating that the Draft Manual does not have the force of law and is merely indicative of the practices of the Patent Office. The Delhi and Bombay meetings have already been concluded. The patent office discussed the participation in a press release which can be accessed here. For those of you who may have missed out on attending those meetings, fear not, there are three more rounds left: on the 21^st of August in Kolkotta, on the 28^th of August in Chennai and a special session on the 27^th of August in Bangalore for the sole purpose of discussing software patents.

In this post SpicyIP would like to make a couple of observations in regards the Patent Office’s comments on Section 3(d) in the Draft Manual. However before going any further we would like to announce, with some amount of joy, that the article on Section 3(d) that Shamnad and me have been working on for the last year or so has finally been published in Script-Ed – A Journal of Law, Technology & Society which is associated with AHRC SCRIPT (the AHRC Centre for Research in Intellectual Property and Technology Law, based in the School of Law, University of Edinburgh. For those of you who want to view our article titled The “Efficacy” of Indian Patent Law: Ironing out the Creases in Section 3(d), you can download a copy from the website of Script-Ed, over here, for free.

The nature of our recommendations on Section 3(d) is two fold: The first pertains to legislative amendments to Section 3(d) while the second pertains to certain clarifications regarding the Patent Office’s approach as evidenced by their decisions and the Draft Manual.

In regards the legislative amendment Shamnad, in an attempt to lend some amount of clarity to the ambiguities of Section 3(d), went through the pains of re-drafting a new Section 3(d) without disturbing the pith and substance of the existing provision. I reproduce a draft of the proposed amendment below:

3. What are not inventions: The following are not inventions within the meaning of this Act….

d) a new form of a known substance, unless it differs significantly in properties with regard to efficacy, when compared with the known 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 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 structurally similar forms of a known substance shall be deemed to constitute “new forms of a known substance.”

For the purposes of this clause, a “known substance,” against which the efficacy of a “new form” ought to be compared, shall be taken to be a substance which is not “new,” in that it does not satisfy the “novelty” criterion for patentability.

For the purposes of establishing that a “new form” differs significantly in properties with regard to efficacy, an applicant must provide data comparing the efficacy of the new form with that of a “known” substance. Such data need not prove this “difference” in property as a matter of statistical certainty, nor does the applicant have to provide actual evidence of trials in humans. Instead, the applicant has to demonstrate a reasonable correlation between the efficacy claimed and the data provided in support of this. Such reasonable evidence of the correlation can be established by relying on, inter alia, statistically relevant data documenting the activity of the new form and/or known substance, documentary evidence (e.g. articles in scientific journals), data generated using in vitro assays, or from testing in an animal model, other preclinical test data or any combination thereof.

For the purposes of this clause, a determination as to whether a difference in property with regard to “efficacy” is “significant,” shall be assessed with reference to the views of a person skilled in the relevant art.”

The highlighted portion of the above amended section however would be relevant to the Patent Office practices in understanding Section 3(d) even as it stands right now.

The first recommendation is in regards how the patent office understands ‘known substances’ against which the improvement in efficacy of the derivative is measured. As of now the practice of the Patent Office as per para 4.5.3 of its manual is as follows “The examiner makes comparison with regard to properties or enhancement of efficacy between the known substance and the new form of known substance. In case the new form is further converted into another new form, the comparison is made between the already existing form and another new form but not between the base compound and another new form.” This clarification seems to have been inserted in a clear bid to pre-judge the Novartis case where the applicant had claimed that the known substance, against which the comparison for efficacy was to be made, would have to be the base compound and not Imatinib Mesylate. This when it was not yet decided as to whether Imatinib Mesylate was merely obvious or whether it was anticipated by a previous patent. Such a blanket observation by the Manual is erroneous since there maybe situations where an intermediate form (i.e. between the new form and the base compound) although obvious may not be novel and is therefore not ‘known’. It is unlikely that Section 3(d) was drafted with the intention of defining known substances as all obvious substances but rather it is likely that it was drafted with the intention of equating known substances with those substances which are deemed novel. Hence there is a need to clarify that ‘known’ would have the same meaning as ‘novel’.

The second recommendation is in regards the standard of proof required to establish the increase in efficacy. In the Novartis case the Patent Office had rejected the results from the animal trials (basically tests on 6 rats) produced by Novartis to establish an increase in efficacy. Although the Patent Office rejected this standard they never mentioned their own standard. However the fact that it rejected the animal trials seemed to suggest that the Patent Office was of the opinion that human trials would be required to satisfy the efficacy requirement. However such clinical trials are extremely expensive and it is unlikely that any patentee would proceed to human trials without first receiving patent protection. In this regard the proposal is for the patent office to deem sufficient any data which establishes a reasonable co-relation to the claim of increased efficacy. The standard therefore should be one of reasonable co-relation and not absolute empirical accuracy. Therefore data from animal testing and in vitro assays must be accepted as sufficient evidence.

For previous posts on the Novartis patent litigation please click here.