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Indian Patents Act provides an applicant to deposit biological material in support of the Indian patent application. It is an exigent via which an applicant can cure what might otherwise be a conceivably fatal defect in a patent application or even for an issued patent.
A “biological deposit” can, in that case, fulfill the requirement of the best mode, sufficiently describing the invention and its operation or use and the method through which it is to be performed. Furthermore, biological material deposited and incorporated into the disclosure may be used to support a claim interpretation more broadly than that explicitly disclosed in the specification.
The grant of patent related to a biological material depends upon regulations regarding requirements for the deposition of biological material in a recognized International Depository Authority formed under Article -7 of BUDAPEST TREATY.
As per Section 10(4)(d)(ii) of the Indian Patents Act, 1970, the “biological material” “if not being described fully and is not available to the public, the said biological material is to be deposited before the IDA under the Budapest treaty before filing an application in India.” Once the deposits are made, the Authority provides an accession number, which is considered as an equivalent description of the living material. The sample of biological material or genetically modified microorganisms (GEMs) is to be submitted to Microbial Type Culture Collection & Gene Bank (MTCC), Institute of Microbial Technology, Chandigarh.
Referring to the proviso, it is compulsory to deposit the biological material if:
- such material and its use or operation and the method by which the invention is to be performed are not fully and particularly described in the specification;
- the best mode of performing such an invention is not disclosed;
- such material is not available to the public.
Stressing on the timeline — it shall be made no later than the date of filing the patent application in India and a reference thereof shall be made in the specification within the period of 3 months (as per rule 13(8) in the Indian Patent Act 1970).
What does a Deposit accomplish?
After the aforementioned mechanism, the invention is deemed to have satisfied the sufficient disclosure requirement. As part of the disclosure, the deposited material may be employed to augment or correct deficiencies in the specification of the application, specifically, as to enablement, written description, and best mode requirements.
The depository system leads to provide a mechanism to stand with the concern that fair access is given to genetic resources and benefit-sharing.
Regulation India has followed in adopting the depository system, though are not compatible with the TRIPS requirement.
[To be noted] India’s patent act and draft guidelines require the applicant to disclose the source and geographical origin of biological materials used to make an invention that is the subject of a patent application, failure to-do-so may be a basis for opposition or revocation proceedings.
TRIPS have not laid any of the aforementioned compulsion.
However, one can insight it, as TRIPS facilitates the provision for the member country to adopt a “sui-generis” system to protect the GEMs and invented biological material.
Rather, India has implemented the depository system to meet the provision of the Convention on Biological Diversity (CBD), which India has adopted in 1992. CBD aims to provide “sustainable use” of the elements of biological diversity and allowing for the “fair & equitable sharing of benefits”.
What can be deposited as a depository microorganism?
In spite of trailing with the Indian patents act and its practice, the patenting of biological material still requires to clear some aspects, such as, what is the definition for ‘biological material’. Referring to the constraint, there arise various techno-legal issues that are supposed to be addressed. Such as the expression “biological material” has not been defined in any of the Sections of the Indian patents act or rules thereunder. However, there are other ways to understand the “biological material” in light of Section 3(j) of the Indian Patents Act, 1970, providing inter-alia, patenting of microorganisms.
Conventionally, micro-organisms include bacteria, fungi, viruses, protists, and other prokaryotes. An isolated biological material in contradiction to a modified genetically biological material is still considered prima facie not to fulfill the requirement of patentability by the Indian Patent Office (IPO).
As per European Convention, the “biological material” can be construed as “any material containing genetic information and capable of reproducing itself”. However, the Indian law is yet to answer this question that is whether all biological materials which satisfy the definition stated can be considered patentable under Indian Law.
Is a Deposition Required?
The biological deposit “requirement” is a requirement per se. A deposit could be required where an invention cannot be practiced without access to an organism only obtainable from nature. Even a new formulation containing a combination of known microorganisms should also be submitted to the depository. The deposition satisfies issues of enablement and sufficiency of disclosure, dealing with section 10(4) (a) and (b).
The axiom governing biological deposits in respect of an Indian patent application provides flexibility in the preparation of the application as discussed above on the grounds of the sufficiency of disclosure, or representing best mode or method, written description, and potentially broaden the scope of claims in the event of litigation. A deposit will usually be necessary only when words fail to explain how to make and use the invention, but an applicant may reference a deposit even when not required. The public will have access to biological materials deposited in support of a patent application after the publication of the patent application.
About the Author: Ms. Priyanka Pathak, Patent Associate at Khurana & Khurana and can be reached at Priyanka@khuranaandkhurana.com
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