The Delhi High Court has overturned a Patent Office decision that rejected Japanese firm Taiho Pharmaceutical's application for an anticancer compound, ordering the matter be reconsidered with proper procedural fairness. Justice Amit Bansal ruled that the Patent Office failed to provide the company adequate opportunity to demonstrate the enhanced therapeutic efficacy of their novel compound.
In his judgment, Justice Bansal stated: "By not identifying any particular 'known substance' in the hearing notice, the appellant was not afforded a fair opportunity to respond to the same, by demonstrating, through comparative research data, that the claimed compound possesses enhanced therapeutic efficacy over the particular 'known substance'."
Patent Application History
Taiho Pharmaceutical, part of the Otsuka Group, filed a national-phase patent application in August 2014 for a 'Novel Piperidine Compound or Salt thereof,' claiming priority from a Japanese Patent Application dated August 27, 2012. The application was published by the Indian Patent Office in April 2015.
The Patent Office issued a First Examination Report (FER) in March 2018, raising objections regarding lack of inventive step under Section 2(1)(ja) of the Patent Act and non-patentability under Section 3(d). After a hearing in November 2019, the Assistant Controller of Patents and Designs rejected the application on June 18, 2021.
The Controller's order stated that the compound constituted a new form of known substances already disclosed in prior art and failed to demonstrate enhanced therapeutic efficacy as required under Section 3(d). Additionally, the order claimed the compound was obvious to a person skilled in the art, failing to meet the inventive step requirement under Section 2(1)(ja).
Court's Analysis
The High Court's examination revealed a critical procedural flaw in the Patent Office's approach. The court found that the rejection under Section 3(d) was unsustainable because the Patent Office never specifically identified which 'known substance' from prior art was being used as the comparison point.
Justice Bansal noted that the reasoning under Section 2(1)(ja) regarding lack of inventive step was closely intertwined with the assessment under Section 3(d). Therefore, both objections warrant reconsideration upon proper identification of the 'known substance' from the closest prior art and comparison with enhanced efficacy data that Taiho might submit.
Legal Context
Section 3(d) of the Patents Act, 1970 specifies that "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" is not considered an invention. This provision, unique to Indian patent law, was designed to prevent "evergreening" of pharmaceutical patents.
Section 2(1)(ja) defines an 'inventive step' as a feature that involves technical advancement compared to existing knowledge, has economic significance, or both, making the invention non-obvious to a person skilled in the art.
Path Forward
The court has directed the Patent Office to afford Taiho Pharmaceutical a fresh opportunity for a hearing before deciding on the patent application. The Controller must issue a proper hearing notice and consider all valid submissions made by the company.
During reconsideration, any research data demonstrating enhanced therapeutic efficacy submitted by Taiho will need to be duly considered while examining both the Section 3(d) objection and the inventive step under Section 2(1)(ja).
This ruling highlights the importance of procedural fairness in patent examinations, particularly for pharmaceutical innovations where the demonstration of enhanced efficacy can be critical to patent approval in India. The decision could have significant implications for how the Indian Patent Office handles similar applications in the future, especially those involving incremental pharmaceutical innovations.
