The Delhi High Court’s decision highlights the importance of fulfilling the detailed disclosure requirements under the Patents Act 1970, particularly in terms of the scope of the claims made in a patent application. The ruling on the patent application by the Regents of the University of California relates to a recombinant Salmonella microorganism-based live vaccine designed to prevent enteric bacterial infections
Key points from the ruling:
Insufficient Disclosure: The court emphasized that the patent application needed for a clear and comprehensive understanding of the invention. This failure resulted in non-compliance with Section 10(4) of the Patents Act, which requires a full description of the invention and the best method of performing it.
Scope of Claims: The Court found that the application broadly claimed the disruption of the gene product in any form, not just through deliberate genetic modifications. This broadness could have led to the inclusion of naturally occurring mutations, which are excluded from patentability under Section 3(c) of the Act. Therefore, the application lacked clarity and precision in defining the scope of what it intended to patent.
Failure to Enable a Skilled Person: The court noted that the patent application did not provide sufficient details for a person skilled in microbiology subject matter to carry out the invention, which is required under Section 10(4)(b) of the Patent Act. The application was seen as incomplete, leaving out important details needed for the invention’s practical implementation.
Incomplete Disclosure: Although the application included examples of deletion mutations in Salmonella, it did not sufficiently cover other forms of mutations, like insertion or substitution. This partial disclosure further contributed to the application’s failure to meet the standards of Section 10(4)(a), which mandates that the invention be fully disclosed.
Impact of the Decision: The Court’s decision focuses the necessity of precise and detailed disclosures in patent applications, particularly when the scope of the invention could potentially cover a wide variety of methods or naturally occurring phenomena. It also highlights the potential issues with vague claims that might lead to patenting something that should not be patentable, such as naturally mutated organisms.
In conclusion, the Delhi High Court upheld the controller’s decision of refusal to grant a patent, reinforcing the importance of clarity and completeness in patent applications for biotechnology-related inventions.
