Court Upholds Rejection of Patent Application for Lack of Novelty and Non-Patentability
In a significant judgment, the Delhi High Court has dismissed the appeal filed by Intra-Cellular Therapies, Inc., challenging the rejection of their patent application by the Controller of Patents. The patent application, titled "ORGANIC COMPOUNDS," was rejected on the grounds of lack of novelty, inventive step, and non-patentability under the Patents Act, 1970.
The appellant sought the grant of a patent for specific deuterated heterocycle-fused gamma-carbolines used in pharmaceutical compositions for treating diseases involving serotonin and dopamine receptor pathways. However, the Controller of Patents found the claims to lack novelty, as similar compounds were disclosed in prior art documents D1 and D7. Additionally, the enhanced bioavailability claimed by the appellant was deemed insufficient to establish therapeutic efficacy, a requirement under Section 3(d) of the Patents Act.
Justice Tushar Rao Gedela, presiding over the case, examined the arguments presented by both parties. The court noted that the compounds claimed by the appellant were already disclosed in prior arts, making them non-novel. Furthermore, the appellant's claim of enhanced therapeutic efficacy due to improved bioavailability was not supported by sufficient research data, failing to meet the stringent requirements of Section 3(d).
The court emphasized that therapeutic efficacy must be proven through research data and cannot be assumed merely based on enhanced bioavailability. The judgment reiterates the Supreme Court's interpretation of Section 3(d) in the landmark Novartis AG case, where therapeutic efficacy was defined strictly as the ability to produce a desired therapeutic result.
The judgment also addressed the appellant's contention regarding the consideration of multiple selections in prior art, stating that specific disclosure under genus patents is immaterial if the product is covered by the claims of a patent.
This ruling serves as a reminder of the rigorous standards applied by Indian courts in assessing patent applications, particularly in the pharmaceutical sector. It underscores the importance of demonstrating significant therapeutic efficacy to overcome the non-patentability objections under Section 3(d).
The dismissal of the appeal is a setback for Intra-Cellular Therapies, Inc., as they sought to secure patent protection for their pharmaceutical compounds in India. The judgment reinforces the principle that patent rights are territorial and must comply with the provisions of the Indian Patents Act.
Bottom line:-
Patent Law - Novelty and Non-Patentability - A claimed invention lacks novelty if it is disclosed in prior art, even without specific disclosure under genus patents - Enhanced bioavailability alone is insufficient to establish therapeutic efficacy under Section 3(d) of the Patents Act, 1970.
Statutory provision(s):
- Patents Act, 1970 Sections 2(1)(j), 2(1)(ja), 3(d)
Intra-Cellular Therapies, Inc. v. Controller of Patents, (Delhi) : Law Finder Doc id # 2936621
