Deposit of Biological Material

1The Patent Office shall not grant patents for any biological material and method of making the same which is capable of causing serious prejudice to human, animal or plant lives or health or to the environment, including the use of those which would be contrary to public order and morality, in the light of the exceptions contained in s 3(b) of the Patents Act. The exclusion in the above section will cover terminator gene technology. (See Manual of Patent Practice and Procedure, Patent Office.) Biological materials such as organs, tissues, cells, etc and process of preparing thereof shall not be patentable under s 3(j) of the Patents Act as being a 'part' of plants and animals. However, the Patent Office may grant patents for biological material such as recombinant DNA, plasmids and processes of manufacturing provided they are produced by substantive human intervention. (Ibid.) But the Patent Office is unlikely to grant patents for gene sequences, DNA sequences which do not disclose their functions, if they lack inventive step and industrial application. (Ibid.)

2Where the invention related to a method of producing an antibiotic (porfiromycin) involving the subjection of a suitable strain of streptomyces verticillatus to aerobic fermentation, it was held that there was no obligation on the part of the patentee to supply the starting materials stated in the description. (See American Cyanamid Company (Dann's) Patent (1971) RPC 425, [1970] FSR 443 (HL).) In the case of biological material mentioned in the specification, the applicant should satisfy the requirements mentioned in cll (a) and (b) of s 10(4). If the applicant does not describe the biological material in the manner required, and if the biological material is not available to the public, then, the applicant shall deposit such material in an international depository authority under the Budapest Treaty. (Section 2(1)(aba) defines Budapest Treaty as the Budapest Treaty on the International Recognition of the Deposit of Micro-organisms done on 28 April 1977.) The applicant has to fulfil the following conditions:"

(1) The deposit of biological 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 three months from the date of filing of the application. (Patents Act 1970, s 10(4)(ii)(A); Patents Rules 2003, r 13(8).)

(2) The characteristics required to correctly identify the biological material such as name, address of the depository institution, date and number of deposit shall be included in the specification. (Ibid, s 10(4)(ii)(B).)

(3) The access to such material is available only after the date of application of patent in India or if a priority is claimed, then, after the date of the priority. (Ibid, s 10(4)(ii)(C).)

(4) The specification should disclose the source and geographical origin of the biological material. (Ibid, s 10(4)(ii)(D).)