India: Provisions Governing The Deposit Of Biological Material Under Indian Patents Act

Last Updated: 8 December 2016
Article by Saipriya Balasubramanian

Most Read Contributor in India, December 2018

Introduction :

Patent documents are techno-legal documents containing full scientific details of the invention and more specifically claims identifying the scope of the invention sought for protection. A patent application must disclose detailed information with regards to the invention so that a person of ordinary skill in the field related to the invention is able to perform the invention. Patent Applications relating to biological material under the (Indian) Patents Act, 1970, are subject to the provisions set out in Section 10(4) (ii) of the Patents Act, 1970, and Rule 13(8) of the Patents Rules, 2003. Further references with regard to deposit of biological material are mentioned in Form 1 (The second Schedule of The Patent Rules, 2003) and Section 6 of the National Biodiversity Act, 2002.

Public Availability of Biological Material :

For applications relating to biological material, the Act strictly requires that the description of such biological material shall be included in the complete specification including all available characteristics of the material so that the biological material is correctly and particularly identified and/or indicated in the specification.

Therefore, when a biological material is identified in a specification and such a material is not available to the public and the same cannot be fully and particularly described as required under Section 10(4)(a) and (b) of the Patents Act, such material shall be deposited with the International Depository Authority under the Budapest Treaty, on or before the date of filing as per Section 10(4)(ii) of the Act..

Budapest Treaty:

Budapest Treaty1 is an international convention governing the recognition of microbial deposits in officially approved culture collections which was signed in Budapest in the year 1973 and later on amended in 1980. Because of the difficulties and on occasion of virtual impossibility of reproducing a microorganism from description in the patent specification, it is essential to deposit a strain in a culture collection centre for testing and examination by others. It obviates the need of describing a microorganism in the patent application and further samples of strains can be obtained from the depository for further working on the patent.

As of 2016, 80 countries are party to the Budapest Treaty and there are total of 45 notified International depositories for deposition of microbial cultures. India acceded and ratified the Budapest Treaty on 17 December 2001. In India, Microbial Type Culture Collection and Gene Bank (MTCC) at the Institute of Microbial Technology (IMTECH), Chandigarh and Microbial Culture Collection (MCC), Pune India., are the two recognized international depositories of microorganisms.

Notification by IPO regarding deposit of Biological Material2:

In respect of biological material which is not available to the public, access to the material is available in the depository institution only after the date of the application of patent in India. The Controller General of Patents, Designs and Trademarks has issued a notification regarding the aforesaid, on July 2nd, 2014 which states as follows:

"According to the provisions of the Act, the deposition of such material in an International Depository Authority (IDA) under the Budapest Treaty shall not be later than the date of filing of patent application in India. However, the reference of deposition of biological material in the patent application shall be made within three months from the date of filing of such application as per Rule 13(8) of the Patents Rules, 2003.

In view of the above, it is hereby informed that applicants should ensure that the deposition of the biological material to the IDA is made prior to the date of filing of patent application in India and the reference of such deposition in the specification is made within three months from the date of filing of such application, if the same is not already made.

In case of non-compliance of the above-mentioned provisions, the concerned applications are liable to be refused under the Act."

Section 10(4)(d)(ii):

According to Section 10(4)(d)(ii), "if the applicant mentions a biological material in the specification which may not be described in such a way as to satisfy clauses (a) and (b), and if such material is not available to the public, the application shall be completed by depositing the material to an international depository authority under the Budapest Treaty and by fulfilling the following conditions, namely:-

  1. the deposit of the material shall be made not later than the date of filing the patent application in India and a reference thereof shall be made in the specification within the prescribed period;]
  2. all the available characteristics of the material required for it to be correctly identified or indicated are included in the specification including the name, address of the depository institution and the date and number of the deposit of the material at the institution;
  3. access to the material is available in the depository institution only after the date of the application of patent in India or if a priority is claimed after the date of the priority;
  4. disclose the source and geographical origin of the biological material in the specification, when used in an invention."

Relevance of Section 3(j) to create a window for patenting microorganisms:

Section 3(j) of Patent Act 1970, prescribes: 3. What are not inventions.- The following are not invention within the meaning of this Act,- (j) "Plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals are not inventions." Earlier to the 2002 amendment of the Patents Act, 1970, [with effect from 20-May-2003] the inventions on microorganisms were not patentable. TRIPS under the Article 27.3(b) stipulated that 'parties may exclude from patentability plants and animals other than microorganisms and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes' [emphasis laid]. Thus, India to be a TRIPS compliant member country had to amend the provision to allow patentability over microorganisms.

Depositable subject Matter :

Though Budapest Treaty do not define what is meant by "microorganism", the range of materials that are able to be deposited at IDAs under the Budapest Treaty includes cells such as bacteria, fungi, eukaryotic cell lines such as plant spores, genetic vectors (such as plasmids or bacteriophage vectors or viruses) containing a gene or DNA fragments; organisms used for expression of a gene (making the protein from the DNA).

When an Applicant deposits any of the aforesaid biological material with IDA, an accession number is provided to the applicant that indicates to that particular deposit. As per Rule 13(8) of the Indian Patent Rules, 2003, the Indian patent office requires the applicant to provide a reference to the deposit within three months of filing of the patent application3. Further, it is compulsory to provide all the available characteristics of the material required for it to be correctly identified. The essential data required includes the name, address of the depository institution and the date and number of the deposit of the material at the institution.

Apart from depositing the biological material, the applicant is also required to clearly mention the source of geographical origin of the biological material used in the specification. If the source of origin of biological material is from India then the applicant has to submit the permission from the National Biodiversity Authority of India before the grant of a patent over the application. While the timeline required for mentioning or providing information regarding deposit of biological material at Indian Patent Office is the same for PCT-National phase, Convention and/ first filing ordinary application, i.e., 3 months from the date of filing in India, however in case the PCT International application and/priority application does not mention the information on biological deposit the same shall be included in the complete specification in India along with a request for amending the specification to include the aforesaid as additional information.

Conclusion:

Depositing the biological samples is mandatory for enabling completion of specification, hence to complete an application, as per the Indian Patent Act. Further, a deposit could be required so that the invention can be practiced by any person by making using of the said deposit available from IDA instead of working from the scratch to obtain it from nature. The deposition satisfies issues of enablement and sufficiency of disclosure as prescribed under section 10(4) (a) and (b) in addition to representing best method of performing the invention.

Footnotes

1 http://nopr.niscair.res.in/bitstream/123456789/3613/1/JIPR%2010(1)%2044-51.pdf

2.www.ipindia.nic.in/writereaddata/Portal/News/159_1_115-public-notice-02july2014.pdf

3 http://www.ipindia.nic.in/manual-patents.htm  

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