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| It has contended before the Madras High Court that it neither violated the Trade-Related Aspects of Intellectual Property Rights agreement nor provided "unguided power" to patent controllers to reject applications for patents on the ground that they are not inventions. |
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| Section 3(d) of the IPA disallows patenting of minor improvements in known molecules, or derivative of a known substance, unless they differ significantly in properties with regard to efficacy. |
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| The Mashelkar Committee had recommended to the government that improvements and derivatives be granted patent cover. Mashelkar subsequently withdrew his report on grounds of plagiarism. |
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| Arguing before a division bench, additional solicitor general V T Gopalan said the provision, whose constitutional validity has been challenged by Novartis, was valid, and could hardly be termed arbitrary. |
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| He said the section, taken along with the explanation given in the Act, fully complied with the agreement on TRIPS, as the trade agreement itself gave freedom to member countries to determine the appropriate method of implementing the provisions of the agreement within their own legal systems. |
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| Gopalan was replying to submissions made by Novartis senior counsels Soli Sorabjee and Shanthi Bhushan last week. The company had contended that the impugned provision provided arbitrary powers to the patent controllers to reject patent applications even if they were new or innovative. |
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| He said the objective of the provision was to prohibit "camouflage inventions" or frivolous variations of known substances masquerading as inventions for the purpose of continuing in the patent regime. |
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| There was nothing vague about the provision, which made it clear that "an invention with a mere change of form, without any enhanced efficacy cannot be granted a patent". "In fact, if granted, such a move would be arbitrary," he added. |
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| Gopalan referred to Articles 7 and 8 of the TRIPS agreement to point out that the accord itself permitted member countries, while formulating or amending their laws and regulations, to adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance. |
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| He discounted the theory advanced by Novartis counsel that the legislation was targeted at the company in particular, or the company's name. |
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The possibility of 'evergreening' (the practice of getting new patents on old substances by presenting minor variations or improvements as something new) had figured in parliamentary debates before Section 3(d) was introduced through an amendment.
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