Patentability of Micro-organisms

1Section 3(j) of the Patents Act allows for patents for micro-organisms. It is worded in the form of an exception to an exception. The permissibility of patenting micro-organisms was considered in Dimminaco AG v Controller of Patents and Designs, a case which involved an invention relating to a process for preparation of infectious Bursitis vaccine for protecting poultry. See Dimminaco v Controller of Patents and Designs (2002). The Assistant Controller of Patents and Designs rejected the application on the ground that it did not constitute an invention under s 2(1)(j) of the Patents Act, holding that the process of preparing the vaccine which contains a living virus cannot be considered as ‘manufacture’ under the old definition of invention. The Assistant Controller further held that the vaccine with living organisms cannot be considered a substance. An inanimate object can be described as a thing or item but not as a living one. Micro-organisms cannot be considered an inanimate substance as it cannot be converted physically or chemically to any other product. On an appeal preferred under s 116 of the Patents Act to the Calcutta High Court, the court took into account the practice of the Patent Office in granting patents for end-products containing living virus and quashed the order of the Controller and directed the reconsideration of the patent application.

2The above case was decided under the provisions of the Patents Act before the Patents (Amendment) Act 2002 came into force. The said Amendment introduces s 3(j) which allows patents for micro-organisms. The decision in Dimminaco considers the practice of the Patent Office in granting patents for end-products containing living virus and arrives at its conclusion to allow patents for living virus on the basis of such practice. (Dimminaco AG v Controller of Patents and Designs (2002) IPLR 255, pp 264-70.) In Dimminaco v Controller of Patents and Designs (2002) the Calcutta High Court held that “It is also admitted that there is no statutory bar to accept a manner of manufacture as patentable even if the end-product contains a living organism.” (p 268) Of the Patent Office’s stand that lyophilizing kills the living cells, it held that “by lyophilizing nothing is killed and destroyed” and that “In fact, freeze drying does not kill the mirco-organizm activity.” (p 270)

3The controversial question pertains to how micro-organisms are to be defined. By a broader definition, it will include any microscopic organism. A narrower definition of the word would limit the definition to only unicellular organisms. The narrow definition of micro-organism confines the application of the definition to organisms such as viruses, algae, bacteria, fungi and protozoa. It would exclude cell lines, genes and gene sequences.

4The language of art 27.3(b) of the TRIPS Agreement adopts the wordings of the equivalent provision in the EPC. But it does not follow that the practice in EPO should be followed. EPO adopts a broader definition for micro-organisms to include cells and cell parts." (See G01/98 Novartis/Transgenic plant [2000] EPOR 303, p 320 (Enlarged Bd App); T356/ 93 Plant Genetic Systems/Glutamine synthetase inhibitors [1995] OJ EPO 545, [1995] EPOR 357, pp 377-78 (Technical Bd App).) Since the TRIPS Agreement approves patents for micro-organism, member countries of the WTO have shown a tendency to expand the scope of the micro-organism and microbiological process to include genetic material and plants and animals. (See Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries, OUP, 2001, pp 133-34.) But the TRIPS Agreement does not define the term ‘micro-organisms’, leaving the member countries the necessary flexibility to decide the kinds of micro-organisms that will be entitled to protection. The Patent Office is unlikely to grant protection for micro-organisms which are living entities of natural origin. (See Manual of Patent Practice and Procedure, Patent Office.)