Just like other jurisdictions, patent applications in India are scrutinized for meeting sufficiency of disclosure requirements. General disclosure requirements apply in the same manner to all patent applications. However, for applications for inventions related to biological material and/or use thereof, special requirements are enshrined in the Patents Act, 1970. This article describes those special requirements.
India is a signatory to the Budapest Treaty. For readers who may be unaware, the Budapest Treaty 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) corresponds to these requirements, and more specifically sub sections A, B, C and D thereof.
Deposition of Biological Material
As per sub-section A, where an invention is related to biological material, and such biological material or use thereof, cannot be fully and particularly disclosed in the specification to meet the sufficiency of disclosure requirement, the applicant is required to deposit such biological material in an international depository authority prior to the date of filing the patent application in India, and to make a specific reference thereof in the specification. For domestic applicants, we recommend identifying an appropriate depository at the time of preparing the patent application and arranging to make the deposit. For foreign applicants domiciled in contracting states, we assume such deposit would have happened much prior in time. For foreign applicants not domiciled in contracting states, we advise making such deposit prior to filing the priority application or PCT application. The consequence of not depositing the microorganism before the date of filing of the application would result in the loss of priority.
Disclosure in the Patent Specification
As per sub section B, all available characteristics of the biological material, required for it to be correctly identified or indicated, including, the 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 such biological material may do so easily by contacting the concerned depository. Failure to include such details 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 (for Indian priority applications), or else this could result in loss of priority.
As per sub-section D, a sufficient disclosure should disclose in the patent specification the source and geographical origin of the biological material. Where such source and origin is known, it is advisable to include the same within the patent specification. However, this defect is curable by way of voluntary and/or involuntary amendment. Generally, we recommend amending the specification only pursuant to receipt of an objection in respect thereof in the First Examination Report.
In addition to the aforesaid, in the 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 the grant of patent.
For the purposes of compliance with the provisions under the Patents Act, it is therefore recommended to (i) assess, whether, or not the invention uses biological material, (ii) if yes, then from where, (iii) if from India, then to disclose the particulars in the specification, affirm the declaration in Form 1, and comply with requirements under the BDA (iv) if not from India, then to simply disclose the geographical source and origin to comply with the disclosure requirement. This is important, since non-disclosure, or incorrect mentioning of the source and/or geographical origin of the biological material used, can result in an insufficient disclosure and/or procedural defect and can be a reason for pre and post grant opposition and/or revocation of the patent. As such, it is important for applicants to develop a strategic approach to avoid unnecessary roadblocks. 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 concepts, it is important to consult experienced practitioners, prior to taking any unreasoned steps. Although it may be a cliché, early assessment and precaution is the name of the game.