The Calcutta High Court’s decision in Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschunge vs The Controller General of Patents, Designs and Trade Marks & Anr. [IPDPTA/11/2024] reiterates that the grant of a patent is conditioned upon a complete, clear and enabling disclosure of the invention. Dismissing the appeal against refusal of patent application no. 202137013369, entitled “Method for stimulating the growth of biomass in a liquid inside a bioreactor”, the Court upheld the Controller’s finding that the specification failed to satisfy the mandatory requirements under Section 10(4)(a), (b), (c), (d), and Section 10(5)of the Patents Act, 1970, owing to insufficient disclosure, lack of clarity, and non-compliance with statutory disclosure obligations relating to biological material .

The subject application was refused under Section 15 of the Act on the grounds that the amended specification was insufficiently disclosed, lacked clarity and failed to satisfy the mandatory requirements prescribed under Section 10.

The Appellant challenged the Controller’s order asserting the following irregularities:

• Introduction of fresh objections at the hearing stage: The Controller allegedly introduced new objections under Section 10(4) at the hearing, whereas the FER had only raised a technical objection under Section 10.
• Failure to conduct a fresh examination: By raising new objections without undertaking a fresh examination, the Controller was alleged to have violated the mandatory procedure prescribed under Sections 12(2), 13(3) and 14.
• Erroneous finding on sufficiency of disclosure: The Controller incorrectly held that the claims of the subject application lacked sufficient disclosure due to the absence of working examples.
• Incorrect objection regarding biological material: The objections under Sections 10(4)(c) and 10(5), requiring disclosure of the source and geographical origin of the biological material, were stated to be inapplicable since the invention neither claimed nor created any biological material.
• Misreading of the claims: The Controller was alleged to have picked the expressions “maximum of” and “time interval” out of context to conclude that the claims were vague, broad and unclear.

The Court rejected the above contentions and held that:

• Section 10 mandates complete and enabling disclosure: A complete specification must simply and particularly describe the invention, its operation or use and the method by which it is to be verified. It should also disclose the best method of performing it and define the scope of protection through clear and succinct claims, fairly based on the description.
• The specification failed to enable a person skilled in the art to perform the invention: The claims covered a broad range of time and physical parameters but did not provide operative experimental parameters or working examples enabling the invention to be reproduced without undue experimentation. The Court remarked that the specification was based on a “trial-and-error method” and that it was a case of “shooting in the dark”.
• The specification lacked clarity and certainty: Expressions such as “time interval” used in the claims were unsupported by corresponding disclosure regarding frequency parameters. The absence of experimental data and operational instructions rendered the claims insufficient, unclear and imprecise.
• The source and geographical origin of the biological material had not been disclosed: The Court rejected the Appellant’s contention that biomass was not claimed as an invention and such disclosure was unnecessary, noting that the invention admittedly consisted of “micro-organisms, cells and/or other constituents cultivated in a bioreactor”. The Court held that the requirement under the second proviso to Section 10(4)(d) is mandatory where biological material is used in the invention. Failure to comply renders the specification deficient.
• The Controller was not required to conduct a fresh examination: Since the amendments did not add anything new or materially alter the specification, there was no requirement for a further examination under Sections 12 to 14.
• The hearing notice did not introduce new objections: The Court held that objections under Section 10 had already been raised in the FER, the hearing notice sufficiently indicated the surviving objections, and the Appellant had adequate opportunity to respond.

Finding no illegality, procedural irregularity or perversity in the Controller’s order, the Court dismissed the appeal.