Summary: The Delhi High Court clarifies that patent applicants must strictly comply with disclosure requirements in drafting complete specifications, and interprets the scope of Sections 3(c), 10(4) and 10(5) of the Patents Act in a recent decision.
Complying with disclosure requirements in drafting complete specifications is not negotiable – this is the message that the Delhi High Court has sent out with its recent decision in The Regents of the University of California v. The Controller of Patents (C.A.(COMM.IPD-PAT) 481/2022). The Court in this case reviewed the rejection of a patent application under Section 3(c) of the Patents Act, 1970 (the “Act”) in conjunction with Sections 10(4) and 10(5), which this note discusses in detail.
Legal context
Section 3(c) excludes from patentability “the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substances occurring in nature”.
Section 10(4) requires the complete specification to:
- fully and particularly describe the invention and its operation or use and the method by which it is to be performed;
- disclose the best method of performing the invention, which is known to the applicant and for which he is entitled to claim protection;
Further, if the specification mentions a biological material, which may not be described as mentioned above, and if such material is not available to the public, the Applicant must also deposit the material to an international depository authority under the Budapest Treaty as per the conditions mentioned under 10(4)(d)(ii).
Section 10(5) requires that claims be clear, succinct and fairly based on the matter disclosed in the specification.
Case history
The Regents of the University of California (“Appellant”) had filed an appeal under Section 117A of the Act against the Assistant Controller of Patents’ Order refusing their Indian Patent Application No. 201717005699 titled ‘Vaccine for Livestock Production Systems’. The application related to a recombinant Salmonella microorganism-based live vaccine for preventing enteric bacterial infection. The rejection was on the grounds that the claims in the patent application did not fulfil requirements under Sections 10(4) and 10(5), and that the subject matter claimed was not patentable under Section 3(c).
On Section 3(c), the Order stated that the claims under consideration were very broad and wide and covered any Salmonella microorganism with a loss of function mutation in the dam gene, and at least one further loss of function mutation in a gene selected from the group consisting of: sifA, spvB and mgtC. The Controller held that the claim was more of a concept claim covering the genus Salmonella with mutations in dam gene + one or more of (sifA, spvB and mgtC).
On Section 10(4) and 10(5), the Order stated that the claims lacked support, clarity, and definitiveness. The claims covered a wide range of microorganisms, which were unique in themselves due to the attributed genetic modification. The claimed microorganisms were not adequately disclosed nor were they available to the public. The specification lacked adequate disclosure to identify what was covered by the claims or what exactly was claimed. The claims did not recite any specific microorganism, gene sequences or their mutations, and only recited permutation combinations. A statement that the microorganism had been modified to have specific activity/ immune response in a host without disclosing the microorganism or mutants and how it could be worked out to achieve desired results puts the burden of undue experimentation on the skilled person. The claim directed to a vaccine was also refused on similar grounds.
Analysis and Decision
On Section 3(c)
In its Appeal before the Delhi High Court, the Appellant argued that claim 1 of the subject patent application specifically covered a novel recombinant Salmonella microorganism from serovars under the sub-species of Salmonella referred to in claim 1. The mutation exemplified in the subject patent application did not arise naturally, as recombinant microorganisms were artificially produced. It also resulted in complete loss of function mutations that would not occur naturally.
However, the Court noted that a combined reading of the claims under consideration and the relevant text of the complete specification indicated that the patent application covered and encompassed various types of loss of function mutations in selected genes of Salmonella microorganisms. The detailed description further specified the relevance of these genetic mutations. The detailed description clarified that the target genes did not necessarily need to be deliberately mutated as long as the expression of the native gene product was functionally disrupted in some way. The Court held that this broadened the scope of the patent application to include any method of gene disruption, not limited to deliberate genetic modifications. Hence, it was crucial to have sufficient disclosure to define the scope of subject patent application and to make sure that the subject patent application did not cover naturally mutated Salmonella microorganism, which was excluded under Section 3(c) of the Act.
On Sections 10(4) and 10(5)
In its appeal, the Appellant said that, a reading of claim 1 showed that the combinations of the loss of function mutations would be 7 for each organism. Thus, for six organisms, as claimed in claim 1, the total combinations would be 42, thus clearly define the scope of protection sought in the subject patent application. Therefore, the refusal under Section 10(4) was erroneous.
Regarding the Appellant’s submission that claim covered 42 combinations, which clearly define the scope, the Court noted that claim covered three mutations i.e., insertion, substitution and/ or deletion. The three mutations, if performed on one or more nucleotides in the said genes of serovar selected from the six Salmonella microorganisms referred to in claim 1 for obtaining loss of function mutation, would cover a large number of mutant Salmonella organisms, which has not been clearly defined in the amended claims of the patent application. The Court said that the lack of specific disclosures for insertion and substitution mutations resulted in insufficiency of disclosure and therefore, non-compliance with Section 10(4)(a).
The Court also held that such partial disclosure would not be sufficient to enable a person skilled in the field of microbiology to perform the invention, as mandated under Section 10(4)(b), without additional guidance. Given that the disclosure itself was incomplete, it was not compliant with the requirement to disclose the best method for performing the invention in terms of Section 10(4)(b).
The Court also referred to the Supreme Court’s decision in Novartis AG v. Union of India and Ors. (2013 (6) SCC 1), where it said that the scope of the claims must be commensurate with the actual disclosure in the complete specification and, under no circumstances, could it exceed the extent of that disclosure. The Delhi High Court noted that these observations were particularly relevant here, where the claims as drafted appeared to extend beyond the actual disclosure by covering insertion and substitution mutation, which were not defined in the complete specification, while also encompassing naturally occurring mutations, and thereby creating ambiguity regarding the true inventive contribution. The Court held that the claims failed to provide a clear and precise definition of the full scope of claimed recombinant Salmonella microorganisms, even after a conjoint reading of the claims and the complete specification. Moreover, the claiming of insertion and substitution mutation would not be regarded as fairly based on the disclosed subject matter, in the absence of detailed support or working embodiments demonstrating these mutations. Therefore, the claims failed to fulfil the requirements under Sections 10(4)(c) and 10(5).
With regard to the deposition of recombinant microorganisms, the Appellant submitted that this requirement only arises when the description in the specification did not satisfy clauses (a) and (b) of Section 10(4), and if such material is not available to the public. Based on the disclosure made in the complete specification of the subject patent application, any skilled person could reproduce the invention without needing to access a deposit. Moreover, the Salmonella microorganism used in the subject patent application is available to the public. However, the Court disagreed and held that the claimed recombinant Salmonella microorganism was a modified bacteria, which was not accessible to the public, and therefore had to be deposited in accordance with the Budapest Treaty.
Thus, the Court upheld the Assistant Controller’s Order refusing the patent application.
Conclusion
This case highlights the disclosure requirements for a patent specification especially in biotechnology domain. As highlighted by Court, Section 10 uses the word ‘shall’, which makes it clear that every requirement under Sections 10(4) and 10(5) is mandatory for the complete specification to be valid in India. In other words,
- the disclosure must be enabling, i.e., the invention must be described in a manner that is sufficient for a person skilled in the art to work the invention without any undue experimentation;
- the disclosure must include the best mode for working the invention that was known to the application at the date of filing the application; and
- the disclosure must support the complete breadth of claims by way of some examples or experimental data.
The Applicant may also consider submitting additional experimental data during the prosecution to strengthen their arguments on patentability and technical contributions.
It is also important to ensure that the claims as drafted do not cover any subject matter specifically excluded under the Act, for example, a claim directed to a microorganism should not be so broad as to cover a naturally occurring microorganism as well.
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