Many inventions, particularly those that relate to biological material include such material which is not available to the public. The Indian Patents Act has strict rules relating to the inclusion of description of such biological material. Section 10 prescribes that such material shall be fully and particularly described  in the specification and if there is a process using such biological material, the operation or use of the biological material and the method by which that process is performed needs to be also so provided in the specification.

Further, in respect of methods and processes the Act also requires that the applicant provides the best method of performing the process known to the applicant. In respect of biological material, therefore, the Act strictly requires that the description of such biological material should be included in the specification including all available characteristics of the material so that the biological material is correctly identified or indicated. In respect of biological material which is not available to the public, the Controller General has issued a notification 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.”

Therefore in respect of patent applications which include biological material, it is important to ensure that information should be provided in the specification itself at the time of filing or within three months from the date of filing. National Phase PCT Applications entering into India generally do not have this information and therefore applicants are well advised to include this information if not originally provided in the PCT application within three months of the filing of the application in India.  This information can be included along with a request for amending the specification to include this additional matter.

Link:   http://www.ipindia.nic.in/iponew/publicNotice_02July2014.pdf