In Monsanto Technology LLC Vs the Union of India and others (June 2023), the petitioner [Monsanto] filed a writ petition in the High Court of Madras seeking to challenge and quash an order issued by the Assistant Controller of Patents [Respondent] rejecting their patent application and requesting a re-hearing of the matter. The petitioner had applied for a patent related to a transgenic event involving the insertion of specific DNA molecules into a corn plant as well as the method relating thereto. After submitting their application, they received a First Examination Report (FER) from the Controller of Patents, which contained several observations and objections.
The petitioner responded to the FER by submitting amended claims and subsequently attended a hearing. However, the Assistant Controller of Patents issued an order upholding the objections raised in the FER without providing sufficient reasoning for their decision. The petitioner’s counsel argued that certain objections raised in the order were not mentioned in the FER or the hearing notice, which deprived the petitioner of the opportunity to address them properly. Additionally, the impugned order referred to a specific paragraph in the specification [paragraph 53] that was not referenced in the FER or the hearing notice, thereby breaching the principles of natural justice.
The court examined the FER and noted that it contained numerous objections or observations, including one relating to claim 1. The petitioner’s counsel pointed out that claim 1 had been substantially modified in the amended claims, rendering the observation irrelevant. The court found that the Assistant Controller had referred to this observation in the impugned order without providing any basis for concluding that the amendment was insufficient to overcome the objection.
Furthermore, the court observed that the hearing notice issued by the Controller of Patents had narrowed down the scope of the hearing to specific issues, but it failed to mention other relevant sections of the Patents Act. The impugned order, on the other hand, referred to those sections without proper notice to the petitioner. These factors constituted a breach of natural justice. In the words of Justice Ramamoorthy:
“Apart from the reference to the alleged non-conformity with Section 10(4)(ii)(D), the hearing notice does not draw reference to the other clauses of Section 10(4). By contrast, the impugned order draws reference to Section 10(4)(a), (b) and (c) of the Patents Act. As a consequence of the failure of the Controller of Patents to set out the scope of inquiry in the hearing notice, the petitioner was denied the opportunity of meeting the objections at the hearing. As correctly contended by learned counsel for the petitioner, the impugned order draws reference to paragraph 53 of the specification and records a finding, on such basis, that the subject matter of the claims is the discovery of naturally existing DNA molecules which were isolated. The said paragraph 53 of the specification is not referred to either in the FER or in the hearing notice.”
Just to clarify, Section 10(4)(ii)(D) of The Patents Act, 1970 mandates disclosure of the source and geographical origin of the biological material in the specification, when used in an invention. A declaration must be submitted, stating that the invention uses biological material from India and permission from the National Biodiversity Authority (NBA) will be obtained. Failure to obtain NBA permission can result in objections during examination. However, if the biological resource is not from India, NBA approval is not needed. The patent application should clearly state the non-Indian origin of the material and its source country and geographical origin.
Based on the above considerations, the Madras High Court allowed the writ petition and quashed the impugned order. The matter was remanded to the Assistant Controller of Patents for re-consideration. The Assistant Controller was instructed to issue a fresh hearing notice to the petitioner, including all the objections to be addressed at the hearing. After providing the petitioner with a reasonable opportunity to respond, the Assistant Controller could proceed to pass a reasoned order within a maximum of six months. No costs were awarded in this case.
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