New definitions of efficacy are helping to clarify pharmaceutical patent challenges under the notorious Section 3d of the Indian Patents Act, says Rahul Vartak.
The Indian pharmaceutical scene has been plagued by Section 3d of the Indian Patents Act for almost a decade. Section 3d has been wielded skilfully by various companies for challenging pharmaceutical patents. Various tactics have been used by innovators for overcoming the challenges posed by Section 3d, including a challenge to TRIPS compliance and constitutional validity. However, Section 3d has been able to withstand all challenges.
The significance of Section 3d
Section 3d was amended by the Patents (Amendment) Act, 2005. The intention was to prohibit so-called ‘evergreening’ by providing that only those pharmaceutical derivatives that demonstrate significantly enhanced ‘efficacy’ would be patentable. However, Section 3d has also been criticised for being overly restrictive and preventing patenting of good inventions. Section 3d has been frustrating to the extent that innovator companies had announced that they would freeze all investments in India and divert to more patent-friendly territories.
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Indian Patents Act, section 3d, pharmaceuticals, Glivec, Novartis