JURISDICTION REPORT: INDIA
Disclosure requirement for biological material in Indian Patents Act
By Manisha Singh and Vijaya Choudhary of LexOrbis
Patent is a right granted to a patentee for a limited period in lieu of disclosing the invention to the public so that it may be utilised for further development of technology. To ensure compliance to said perquisite, the Indian Patents Act, 1970 (hereafter the Patents Act), has provisioned for the requirement of sufficiency of disclosure in Section 10 read with Rule 13 of the Indian Patents Rules, 2003.
Section 10 (4) of the Patents Act states that every complete specification shall (a) fully and particularly describe the invention and its operation or use and the method by which it is to be performed; (b) disclose the best method of performing the invention which is known to the applicant and for which they are entitled to claim protection; (c) end with a claim or claims defining the scope of the invention for which protection is claimed; and (d) be accompanied by an abstract to provide technical information on the invention.
Further, the specification may be supplemented with one or more examples depending on the scope of claims, to satisfy the enablement requirement of the patent specification. As the patent specification ends with claim(s) defining the matter for which protection is sought, to satisfy the written description requirement, the claims shall be fully supported by the description. There must be a basis in the description for the subject matter of every claim and the scope of claims must not be broader than what is justified by the description and drawings appended thereto.
Defining biological materials
Sufficiency of disclosure requirement is universal to all fields of inventions however, for inventions related to biological material or using biological materials, there are certain additional requirements that need to be complied with. The Indian Patents Act does not provide a definition of ‘biological material’; the definition provided in the Indian Biological Diversity Act, 2002 (hereafter the BD Act), which also provides statutory provisions for obtaining intellectual property rights on inventions based on any research or information on a biological resource, is considered as a reference.
Section 2 (c) of the BD Act defines ‘biological resources’ as plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value-added products) with actual or potential use or value but does not include human genetic material. Thus, the term ‘biological material’ or ‘biological resource’ is a wide term and encompasses all the plants, animals and micro-organisms of the ecosystem.
Deposits
As per Section 10 (4) (ii) of the Patents Act, where an invention is related to a biological material and such biological material or use thereof cannot be fully and particularly described in the specification to meet the sufficiency of disclosure requirement and if such material is not available to the public, the applicant is required to deposit the biological material in an International Depository Authority (IDA), in compliance with the Budapest Treaty, and a reference thereof is to be made in the patent specification.
The deposit of the material shall be made not later than the date of filing the patent application and a reference thereof shall be made in the specification within three months from the date of filing the application. In case a request for publication under rule 24A of the Indian Patents Rules 2003 is made, such reference shall be made on or before the date of filing such a request. Further, the applicant is required to provide all the available characteristics of the biological material to enable it to be correctly identified in the patent specification.
“India has taken a lead in introducing a substantive legislation for conservation of biological diversity that is in consonance with granting patents on inventions based on biological resources.”
Manisha Singh
Vijaya Choudhary
Source and geographical origin
In cases where well known biological materials are used in inventions, the disclosure of source and geographical origin to confirm the public availability of the biological material for carrying out further research or experimentation should satisfy the requirement of sufficiency of disclosure of the Patents Act.
Access to biological resources and its public availability is subject to various national and international regulatory and legal compliances. As per Section 10 (4)(ii) (C) of the Act, access to the biological material is available in the depository institution only after the date of the patent application in India or if the priority is claimed after the date of priority.
Where the applicant uses biological resources sourced from India, they are also required to seek approval from the National Biological Diversity Authority (NBA) as per Section 6 of the BD Act, 2002, before the patent is granted. Once the NBA approval is granted, the applicant would inform the Indian Patent Office about the same. Accordingly, India has taken a lead in introducing a substantive legislation for conservation of biological diversity that is in consonance with granting patents on inventions based on biological resources.
In view of above, for inventions that use well known biological material, only the source and geographical origin of the biological material are required to be described in the patent specification, to comply with the sufficiency of disclosure requirement under Section 10 of the Act. If the invention is directed to the development of a modified biological resource, for example a mutant strain, the applicant is required to provide a brief disclosure of all the available characteristics of the mutant strain along with its IDA deposition details, to comply with sufficiency of disclosure requirement of the Act. Otherwise, the applicant must provide an elaborate disclosure of the method of preparing the modified strain so that a skilled person would carry out the invention without undue experimentation.
Further, for inventions based on biological material procured from India, the necessary permission from the competent authority is required before the grant of patent. Keeping in view the above statutory requirements, the applicant should carefully draft the patent specification as non-disclosure, or wrongful mention of the source or geographical origin of the biological material may not only be problematic in prosecution but may also be a ground for pre and post grant opposition and revocation of patent.
Manisha Singh is partner at LexOrbis. She can be contacted at (+91) 9811161518
Vijaya Choudhary is managing associate at LexOrbis. She can be contacted at (+91) 9717321371
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