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Disclosure, Deposit and Declaratory requirements in India for inventions based on Biological material

Like other jurisdictions, patent applications in India are scrutinized for sufficiency of disclosure. General disclosure requirements apply in the same manner to all patent applications. However, for inventions related to biological material and/or use thereof, special requirements are enshrined in the Patents Act, 1970.

India is a signatory to the Budapest Treaty, which requires contracting states to recognize deposition of biological material at international depositories for local disclosure requirements, where it is not possible to disclose in writing, the biological material or use thereof in the patent specification. In India, Section 10(4)(d)(ii) sub-sections A, B, C and D corresponds to these requirements.

Deposition

As per sub-section A, where an invention relates to biological material, and such material or use thereof, cannot be fully and particularly disclosed in the specification to satisfy disclosure requirements, the applicant is required to deposit such biological material in an international depository authority prior to filing the patent application in India, and to make a specific reference thereof in the specification. Such a reference to the deposit shall be made in the specification within three months from the date of filing. The consequence of not depositing the microorganism before the date of filing of the application and/or not making the reference to the same in the specification, would result in the loss of priority.

Disclosure

As per sub section B, all available characteristics of the biological material, required for it to be correctly identified or indicated, including, name and address of the depository, date and accession number of the deposit, are to be included in the specification, so that any person wishing to receive access to the biological material may, by contacting the concerned depository. Failure to do so may result in an insufficient disclosure.

As per sub-section C, access to the deposited material should be made available only after the date of priority and/or the date of filing the patent in India.

As per sub-section D, for sufficiency, the source and geographical origin of the biological material should be disclosed in the patent specification. However, this defect is curable by an amendment, to mute an objection in respect thereof raised in the First Examination Report.

Declarations

Additionally, in Form 1 (patent application form), an applicant is required to declare, whether, or not, the invention uses biological material from India, and if yes, that the necessary permission from the National Biodiversity Authority or NBA (the competent authority under the Biological Diversity Act, 2002 or BDA) will be submitted to the patent office before grant of patent.

Our View

For satisfying the requirements under the Patents Act, it is advisable to assess, whether, or not, the invention uses biological material, at the time of drafting the patent specification, (i) make the deposit in compliance with the Budapest Treaty and make a reference of such a deposit in the specification (ii) identify where the biological material is from, (iii) disclose the geographical source and origin to satisfy the disclosure requirement (iv) if the biological material is from India, then affirm the declaration in Form 1, and comply with requirements under the BDA. This is important, since, erroneous or non-disclosure of the source and/or geographical origin of the biological material can result in an insufficient disclosure and a justified reason for refusing the grant of a patent application or a revocation thereof. Therefore, it is important for applicants to develop a strategic approach. Moreover, since certain issues, such as what constitutes biological material, the linkage of the Patents Act to the BDA and the provisions of the BDA, are still evolving, early assessment and precaution is the name of the game.

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