Delhi High Court Upholds Rejection of Patent Application for Genetically Modified Salmonella Vaccine Due to Insufficient Disclosure, Overly Broad Claims, Non-Patentable Subject Matter, and Failure to Deposit Recombinant Organism as Required Under Indian Patent Law

1. Court’s Decision

The High Court of Delhi dismissed the appeal, affirming the decision of the Controller of Patents, who had rejected the patent application under Section 15 of the Patents Act, 1970. The court found that:

• The patent application did not provide sufficient disclosure to enable a skilled person to reproduce the invention.
• The claims were too broad and indefinite, violating Section 10(5) of the Act.
• The claims potentially covered naturally occurring biological material, making them non-patentable under Section 3(c).
• The required deposit of the genetically modified organism (GMO) was not made, further violating provisions under Section 10(4).

Since these issues rendered the patent application non-compliant with statutory requirements, the court upheld the Controller’s decision to reject the application.

2. Facts of the Case

The patent application in question was for a live vaccine based on a recombinant Salmonella microorganism. The applicant (a university-based entity) claimed that:

• The invention involved genetic modification of specific Salmonella strains through loss-of-function mutations in key genes.
• The modified Salmonella strains were designed to induce an immune response in livestock, preventing bacterial infections.
• The patent application was filed as a national-phase entry under the Patent Cooperation Treaty (PCT) and claimed priority from a US patent application.
• The Indian Patent Office issued a First Examination Report (FER), raising objections on lack of inventive step, insufficient disclosure, and non-patentability under various provisions.
• Despite amendments and written submissions, the Controller of Patents refused the application, leading to this appeal.

3. Issues Before the Court

The primary legal questions considered were:

1. Sufficiency of Disclosure – Did the patent application meet the disclosure requirements under Section 10(4) of the Patents Act, 1970?
2. Definiteness of Claims – Were the claims clear, precise, and fairly based on the description, as required under Section 10(5)?
3. Patentability under Section 3(c) – Did the claimed invention cover naturally occurring biological material, making it non-patentable?
4. Deposit Requirement – Was the applicant required to deposit the recombinant microorganism to comply with patent law?

4. Petitioner’s (Applicant’s) Arguments

The applicant, through its counsel, made the following key arguments:

• The invention was novel and involved a recombinant microorganism that does not naturally occur.
• Sufficient disclosure had been made to enable a skilled person to reproduce the invention without undue experimentation.
• The claims were not overly broad and were based on clearly defined genetic modifications.
• The requirement of depositing the recombinant organism did not arise, as the disclosure was detailed enough.
• The same patent was granted in the US, EU, and other jurisdictions, proving its patentability.

5. Respondent’s (Patent Office’s) Arguments

The Patent Office (represented by the Controller of Patents and legal counsel) defended the rejection, stating:

• The claims were too broad, covering numerous possible mutations and genetic modifications without providing clear limitations.
• The specification did not sufficiently describe insertion and substitution mutations, which were included in the claims.
• The claims potentially covered naturally occurring Salmonella variants, making them non-patentable under Section 3(c).
• Since the recombinant microorganism was not available to the public, it had to be deposited in an International Depository Authority (IDA) under the Budapest Treaty. The applicant failed to do so, violating Section 10(4)(d).

6. Analysis of the Law

A. Sufficiency of Disclosure (Section 10(4))

Section 10(4) requires that a complete specification must:

• Fully describe the invention and how it operates (10(4)(a)).
• Disclose the best method of performing the invention (10(4)(b)).
• Clearly define the scope of protection through claims (10(4)(c)).

The court found that:

• The specification only described deletion mutations but failed to provide details on insertion and substitution mutations, despite claiming them.
• This lack of detail made the disclosure insufficient, meaning a skilled person could not reproduce the invention without undue effort.

B. Definiteness of Claims (Section 10(5))

Section 10(5) mandates that claims must be:

• Clear and precise.
• Limited in scope and fairly based on the disclosure.

The court ruled that:

• The claims were too broad, covering a wide range of mutations in multiple genes.
• The lack of specific examples made it unclear what the patent actually covered.

C. Non-Patentable Subject Matter (Section 3(c))

Section 3(c) excludes naturally occurring living organisms from patentability.

• The court noted that certain genetic mutations in Salmonella occur naturally.
• Since the claims did not exclude naturally occurring mutations, the patent was rejected under Section 3(c).

D. Deposit Requirement

According to Section 10(4)(d), if a biological material cannot be fully described, it must be deposited in an International Depository Authority.

• Since the recombinant microorganism was not available to the public, the applicant should have deposited it.
• The failure to deposit the microorganism further weakened the patent application.

7. Precedent Analysis

The court cited important legal precedents:

• Novartis AG v. Union of India (2013) – The Supreme Court ruled that patent claims must not exceed the disclosure in the specification.
• AGFA NV v. Assistant Controller of Patents (2023) – The court rejected claims that were ambiguous and too broad, similar to this case.
• Patent Office Guidelines (2014) – The guidelines mandate strict requirements for biotech patents, reinforcing the deposit rule.

8. Court’s Reasoning

• The patent application lacked sufficient disclosure under Section 10(4).
• The claims were overly broad and indefinite, violating Section 10(5).
• The claims potentially covered natural biological materials, making them non-patentable under Section 3(c).
• The failure to deposit the recombinant microorganism meant that skilled professionals could not reproduce the invention.

9. Conclusion

The court dismissed the appeal and upheld the Controller’s decision to reject the patent application. The decision emphasized that biotech patents must be clear, detailed, and comply with deposit requirements.

10. Implications of the Judgment

• Stricter standards for biotech patents – Ensuring full disclosure and precise claims.
• Limits on overly broad patent claims – Preventing applicants from claiming more than they invent.
• Reinforcement of deposit requirements – Mandatory for biotech-related patents.

This judgment sets a significant precedent for patenting genetically modified organisms in India.

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