Section 3(d) is unique to India and the Patents Act, 1970 as amended in 2005, aimed to restrict patent protection for new forms of known substances unless they led to enhancement in the efficacy of the original substance. It specifically targeted so called evergreening of patents, which is understood to involve obtaining a patent for a product by making minor modifications to the original patented product. The provision aimed to limit patentability in the pharmaceutical industry to innovations that demonstrated enhanced efficacy and met the non-obviousness criteria.
The section, therefore, imposes a stricter standard for patentability on incremental innovations compared to the invention of new drug molecules. This differential treatment has raised concerns as it deviates from the non-discriminatory principle of Article 27.1 of the TRIPS Agreement, which supports granting patent rights without discrimination based on the field of technology. On the other hand, a perusal of the relevant provisions in TRIPS also indicate that the member nations have been given significant flexibilities to frame patent laws which reflect their social and economic needs. This aspect will be dealt with in another piece later.
For now, let’s see what exactly Section 3(d) of the Indian Patent Act says:
3. What are not inventions – The following are not inventions within the meaning of this Act,-
(d) the mere discovery of new form of known substances which does not result in enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substances or the mere use of a know process, machine or apparatus unless such known process, machine or apparatus 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;
The first part of Section 3(d) – which is the most contentious aspect thereof – in effect, prohibits the patentability of a “new form” of a “known substance” which does not demonstrate enhanced efficacy. Therefore, as long as it is possible to establish that what is claimed is not merely a new form of a known substance, the applicability of the proscription of this section can be challenged. However, to raise an objection under Section 3(d), is it not crucial to identify the specific “known substance”? Once so identified, the applicants may provide efficacy data related to that substance if a new form of a known substance is involved. Only new forms derived from the same known substance should ideally be subjected to the requirements of Section 3(d). This though is not religiously followed in many instances and applicants are left in lurch to establish enhanced efficacy over a “known substance”, which is essentially not known to them.
In this respect, the relevant portion from the pathbreaking order from erstwhile IPAB in Fresenius Kabi Oncology Limited v. Glaxo Group Limited & Anr., 2013 SCC OnLine IPAB 121 dealing with “known substance” is recited hereafter:
“56. It is true that it is the patentee who must prove the enhanced therapeutic efficacy of his invention. But in a revocation the applicant must plead and prove that it is hit by S.3(d) and that it has the same therapeutic efficacy as the known substance. Then the respondent will counter it either by proving that it is not a derivative of a known substance or by proving that though it is only a new form of a known substance he has shown that it has enhanced therapeutic efficacy. In the present case, there are no such pleadings. It is not enough to plead that because Ex1 and 2 are admitted prior arts, this is only a new form of those compounds. That is vague. It is only when the pleadings show how the invention is one kind of a derivative of known substance the patentee will have to explain how the grant of patent is justified because of the enhancement of therapeutic efficacy. In this case the pleadings are not adequate. We hold that the S.3(d) ground has not been proved.”
Though dealing with revocation aspect, this judgement makes it apparent that even for an applicant in a revocation petition, it is pertinent to plead and prove that the alleged invention is indeed hit by section 3(d) and that it has the same therapeutic efficacy as the known substance. Also, the pleadings ought to show how the invention in question is one kind of a derivative of known substance. Thereafter, the onus shifts on the patentee to explain how the grant of patent is justified because of the enhancement of therapeutic efficacy.
Here are a few notable cases (in a nutshell), which expressly or impliedly dealt with the epiphany of “known substance” under Indian jurisprudence.
1. Novartis AG v. Union of India & Others (2013): The Supreme Court held that for a new form of a known substance to be patentable under Section 3(d), it must demonstrate a significantly higher effect or efficacy compared to the known substance. The Court observed especially with respect to pharmaceutical entities that “Efficacy means the ability to produce a desired or intended result. Hence, the test of efficacy in the context of section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, the test of efficacy would depend upon the function, utility or the purpose of the product under consideration. Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be ‘therapeutic efficacy.’
2. F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd. (2015): The Delhi High Court observed that the identification of the specific known substance and the basis for considering the claimed compounds as new forms is crucial for a Section 3(d) objection. The court emphasized the importance of providing detailed information and evidence regarding the efficacy of the claimed compounds.
3. AstraZeneca AB v. Orchid Chemicals & Pharmaceuticals Ltd. (2015): The Delhi High Court stated that a Section 3(d) objection should be raised during the examination stage and not during post-grant opposition proceedings. It further emphasized that the Patent Office must identify the known substance and explain how the claimed compounds are new forms.
4. DS Biopharma Limited v. The Controller of Patents and Designs (2016): The Delhi High Court directed the Patent Office to identify the specific known substance and provide the basis for considering the claimed compounds as new forms when raising objections under Section 3(d). Failure to do so can lead to the rejection of the objection.
In fact, in the DS Biopharma Limited case, at Page 7 of 10, the Court referred to the observations made by Justice Prabha Sridevan in the above cited Fresenius Kabi case and considers them relevant for understanding how to raise objections under Section 3(d) regarding non-patentability or non-patent eligibility. Section 3(d) prohibits the patentability of a “new form” of a “known substance” without establishing enhanced therapeutic efficacy. To raise an objection under Section 3(d), it is essential to identify the specific “known substance.” This known substance could be a single substance, or a compound derived from a Markush formula. It is not acceptable to leave it to the applicant to deduce the known substance and subsequently provide efficacy data based on that deduction.
It goes on to say that only new forms of substances derived from the same known substance are subject to the requirements of Section 3(d). In the case at hand, the compound constituting the known substance was not identified in the hearing notice.
Therefore, when raising a Section 3(d) objection, it is crucial to identify the specific known substance and briefly mention how the claimed compounds are new forms of that substance, even if not in great detail. The presumption that applicants will figure out which known substance has been envisaged in, for instance, in an office action without specifically pointing out as such is not a premise which works (it never did) more so, given specific observations and jurisprudential mandate. The applicants for patent in pharmaceutical or life science fields have respite to the extent that they can specifically request identification of the “known substance” before responding to an objection under Section 3 (d) and if not done so, can rely on above judgements to support their stance on why Section 3 (d) objection has not been raised appropriately and should be removed.
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