Section 3(d) of the Patents Act, 1970 underwent an amendment in the year 2005, the amendment laid down the condition of "enhancement of the known efficacy".

The inference is that not all advantageous or beneficial properties are relevant but only such properties that directly relate to efficacy (which is therapeutic efficacy in case of medicine). This article covers the same provision as discussed in the latest judgement of Ovid Therapeutics v. Assistant Controller of Patents and Anr. 2024.

About The Case
This case is an appeal under section 117A of the Patents Act, 1970 challenging the order dated 31st August 2021 issued by the ld. Assistant Controller of Patents and Designs (hereinafter 'Controller').

Facts Of The Case
By the impugned order, the Appellant's patent application bearing number 201717000025 titled 'Methods of Increasing Tonic Inhibition and Treating Secondary Insomnia' (hereinafter 'subject patent') was refused under Section 15 of the Act.

The ld. Controller after considering the submissions of the Appellant, refused the subject patent application under Section 15 of the Act on the following grounds: (i) non-patentability under Section 3(d), Section 3(e); (ii) lack of inventive step over the cited prior art documents as required under Section 2(1)(ja); (iii) insufficiency of disclosure, in violation of the requirements in Section 10(4), Section 10(5) and; (iv) broadening the scope of the Claims in violation of Section 59 of the Patent Act, 1970.

Aggrieved with the said decision of the ld. Controller, the Appellant filed an Appeal under Section 117A of the Act.

Law Point

• Section 3(d) - Not an invention within the meaning of this act:
• 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 for 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.
   
• 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 substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

Issues:

• Whether the amended claims are within the scope of the original claims?
• Whether the composition is liable to be granted patent protection under the Patents Act?

Arguments Of Appellant

1. That the pharmaceutical composition as claimed was also contained in the main Claim of the originally filed Claim.
2. The prior art document D1 disclosed that high doses of Gaboxadol may cause adverse effects, so explicitly it proposes that low doses of Gaboxadol potentially may be an effective treatment for Cerebellar Ataxia in Angelman syndrome. Therefore, administration of about 10 mg to about 50 mg of Gaboxadol for the treatment of Angelman Syndrome would not have been considered obvious to one skilled in the art based on the disclosure in D1.
3. A single daily dose would not be expected to provide long-term improvements and thus the present invention involved an inventive step.
4. The STARS Phase 2 clinical trial topline data confirmed the effect of once-daily administration.
5. Further, with respect to the objection raised under Section 59 of the Act, it was argued that the Claims were clear and succinct based on the subject matter disclosed in the specification and pharmaceutical composition.

Arguments Of The Controller

1. The amended claims were not supported by the description as the initial Claims were method Claims but the final Claims are composition Claims. The amended Claims 1-8 do not fall within the scope of the originally filed Claims. The composition Claims do not find any support in the complete specification.
2. The amended Claims were not inventive as prior art documents D-1 to D-5 related to the various Gaboxadol compositions which were already known.
3. The Claims were affected by both Section 3(d) and Section 3(e) of the Act since the composition had not been disclosed and merely a reference to the compound already documented in prior arts had been made.

Judgement
The Court observed that there were three differences between the originally filed Claim 1 and the amended Claim 1: (i) that the amended Claim omitted the limitation and also reference to the specific disease for which the composition was intended; (ii) that the amended Claim pertained to a composition Claim, while the initially filed Claim related to a method as also a composition Claim; (iii) that the amended Claim specified the range of Gaboxadol that was to be used.

It was observed by the court that Section 59(1) of the Act shows that the amended Claim has to be within the amended scope of unamended Claims and within the complete specification. In this instance, the omission of the name of the disease in the amended claim expanded the scope within which the composition could be applied and therefore, the amended claim expanded the scope of the subject of the patent.

In the present case the field of description clearly described that the method and composition was to be used for the purpose of treating secondary insomnia and the fact that the medical condition was not written in the amended claims showed that the same had gone beyond the specification as also the description of the invention.

In the case of Novartis AG v. Union of India, (2013) 6 SCC 1 it was observed 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. Hence, the mere change of form with properties inherent to that form would not qualify as "enhancement of efficacy" of a known substance.

Though a press release of phase 2 trial data had been produced on record, phase 3 data which was available with the Appellant and was also publicly available, has not been produced. Under these circumstances, the appeal was bereft of merit and the patent was not liable to be granted, both due to expansion of the scope of the Claims and there being not enough data to demonstrate significant enhancement of therapeutic efficacy.

Effect
The court reaffirmed that "it is not in doubt that the composition is at best a derivative and would be the same substance as the 'known substance', therefore, unless and until significant enhancement of therapeutic efficacy is shown, such a composition would not be liable to be granted patent protection." and laid a clear standard for the application of Section 3(d) in granting of patent.

Analysis
This case underscores the stringent application of Section 3(d) of the Patents Act, 1970 requiring pharmaceutical inventions to show significant enhancement of therapeutic efficacy for patent eligibility. The court upheld the rejection of the patent application, citing broadened claims beyond the original scope and insufficient evidence of enhancement of efficacy. This decision reaffirms the need for clear and substantial proof of therapeutic benefit in patent applications for pharmaceutical compositions, aligning with previous legal precedents on patentability criteria.