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INDIAN BIOTECH


Under the Indian Patents Act, once the subject matter has been scrutinised for novelty and innovativeness, a second level of


scrutiny is


undertaken by the Indian Patent Office under Section 3. Some of the important provisions of Section 3 that have an impact on the grant of patents to biotechnology inventions include:


• Section 3(c) prohibits the grant of a patent to a mere discovery of any living thing or non- living substance occurring in nature. Terefore, from the biotech perspective, in order for Section 3(c) not to be invoked, the applicant needs to establish that the subject matter is an invention and that human intervention was involved. Tis would particularly apply in cases where the subject matter relates to ‘isolation’ of biological materials.


• The second provision is Section 3(d) of the act. According to this provision, the following are not inventions and hence are not patentable:


. mere discovery of a new form of a known substance that does not result in the enhancement of the known efficacy of that substance


. mere discovery of any new property of a known substance


. mere discovery of new use for a known substance . mere use of a known process unless it results in a new product or employs at least one new reactant . mere use of a known machine or apparatus.


Te interpretation of this provision of law has been dealt with by the Intellectual Property Appellate Board in the Novartis case, in which it held that for a new form of a known substance to be patentable under Section 3(d), the applicant has to establish that the new form results in enhanced efficacy. Te definition of ‘efficacy’ adopted by the IPAB, particularly in the field of pharmacology, was limited to ‘therapeutic efficacy’. At the outset, this provision clearly makes a distinction between an invention and discovery. Secondly, the interpretation of the expressions ‘known substance with a known efficacy’ and whether efficacy is understood to mean ‘therapeutic efficacy’ will be decided by the Supreme Court in the Novartis case.


• Section 3(h) excludes ‘a method of agriculture or horticulture’ from patentability. Inventions that


fall in this category will particularly


include inventions in the agri-biotech industry, such as methods for producing mushrooms or cultivating algae.


• Section 3(i) excludes inventions directed to methods of treatment of human beings or animals, and encompasses surgical, diagnostic, therapeutic or curative treatment. Te 2002 Amendment modified this provision so as to permit grants of patent to inventions that relate to the treatment of plants so as to render them free of diseases or to increase their economic value. What this could mean is


that inventions such as gene therapy


or in-vitro methods of diagnosis are not considered as inventions within the meaning of the act.


• Section 3(j) excludes the following subject matter:


. plants in whole or in part . animals in whole or in part . seeds . varieties and species of plants and animals . essentially biological process(es) for production or propagation of plants and animals.


Micro-organisms, other than the ones discovered from nature, are considered as being patentable. One of the reasons for excluding plants from protection under the Indian Patents Act is on account of the sui generis legislation provided for


70 Life Sciences Intellectual Property Review 2011


www.worldipreview.com


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