While upholding the Controller of Patents’ order rejecting Indian Patent Application titled “Organic Compounds”, the Delhi High Court has held that if claimed pharmaceutical compounds are already covered by prior art genus disclosures, they can be denied novelty even if the applicant argues that multiple selections are needed to reach them. The Court also reaffirmed that for pharmaceutical inventions, improved metabolic stability or increased bioavailability is not enough to overcome Section 3(d). The applicant must specifically show enhanced therapeutic efficacy through research data. Similar pharmacological activity and better pharmacokinetic performance do not, by themselves, satisfy the statutory standard of “efficacy” under Section 3(d) of the Patents Act.
A Single Judge Bench of Justice Tushar Rao Gedela first examined the invention and noted that the complete specification itself stated that deuterated compounds generally have biological activity similar to non-deuterated analogues, but may show improved pharmacokinetic properties and metabolic stability. The Bench also noted that the specification claimed the compounds of Formula I, II and III behaved similarly to the natural hydrogen analogues while allegedly showing unexpectedly improved metabolic stability.
On novelty, the Bench held that prior art D1 disclosed Example 1.21 in a manner that resulted in the compounds of Formula IV claimed in the subject application. It also held that prior art D7 disclosed compounds that resulted in Formula I to III claimed in claims 1-3 and 5-10. On that basis, the Bench concluded that the claimed subject matter was already disclosed in prior art and therefore was not novel under Section 2(1)(j).
The Bench rejected the appellant’s argument that multiple selections were needed from prior art to reach the claimed compounds. It held that once a compound is covered under a genus patent, lack of a separate specific disclosure is immaterial. Referring to Novartis AG vs. Union of India [(2013) 6 SCC 1], the Bench said there cannot be an artificial distinction between what is “covered” and what is “disclosed” in a patent claim, and therefore the appellant’s multiple-selection argument could not be accepted.
On Section 3(d), the Bench restated that in the pharmaceutical context, “efficacy” means therapeutic efficacy, not merely improved physicochemical or pharmacokinetic properties. It found that the known compound Q was already disclosed in D1 and D7, and the deuterated compounds claimed in the application were derivatives of that known compound. The Bench therefore tested whether the appellant had shown enhanced therapeutic efficacy over the known substance.
The Bench analysed Example 7 in the complete specification and noted that the data showed higher parent-drug exposure, reduced metabolism and improved bioavailability for the deuterated compound as compared to Formula Q. However, the Bench held that this only established pharmacokinetic improvement and not enhanced therapeutic efficacy. It stressed that increased bioavailability does not automatically amount to enhanced therapeutic efficacy unless specifically claimed and established by research data.
The Bench also independently considered the co-inventor’s affidavit, even though the appellant complained that the Controller had ignored it. The affidavit data showed reduced amide formation and lower plasma concentration of a major metabolite, and also indicated similar pharmacological activity between the claimed compound and compound Q. But the Bench held that this still did not prove that the invention treated disease better or achieved enhanced therapeutic efficacy. Therefore, even after considering the affidavit on merits, the Court found that Section 3(d) remained an independent bar. Since the Court upheld the objections on novelty under Section 2(1)(j) and non-patentability under Section 3(d), it said there was no need to examine the inventive step objection under Section 2(1)(ja).
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Briefly, an appeal was filed by Intra-Cellular Therapies, Inc. under Section 117A of the Patents Act, 1970 against the Controller of Patents’ order dated April 27, 2023 rejecting Indian Patent Application No. 201817033732 titled “Organic Compounds.” The application related to particular deuterated heterocycle-fused gamma-carbolines intended for treatment of disorders involving 5-HT2A receptor, serotonin transporter and dopamine signalling systems, including anxiety, psychosis, schizophrenia, sleep disorders and migraine. The Controller had rejected the application on the grounds of lack of novelty under Section 2(1)(j), lack of inventive step under Section 2(1)(ja), and non-patentability under Section 3(d) of the Patents Act.
The appellant argued that the invention was a species patent arising from Markush claims and that the Patent Office wrongly assessed novelty by relying on multiple prior art references instead of a single prior art document. It also argued that the novelty objection was introduced only in the second hearing notice, and that the Controller failed to properly analyse why a person skilled in the art would arrive at the claimed compounds from prior art documents D1 to D7. The appellant further contended that the Controller ignored the co-inventor’s affidavit and wrongly applied Section 3(d) without identifying the “known substance” and without comparing therapeutic efficacy.
The respondent defended the rejection by arguing that prior art D1 and D7 already disclosed the same compounds claimed in the patent application. According to the respondent, D1 disclosed Formula IV claimed in claims 4 and 5-7, while D7 disclosed Formula I-III claimed in claims 1-3 and 5-10. It also argued that claim 11, being a composition claim, would automatically fail if claims 1-10 failed. On Section 3(d), the respondent maintained that the claimed compounds were only new forms of known substances and that the applicant had not shown enhanced therapeutic efficacy.
