Exemptions available under the Patents Act, 1970 - Part II

Regulatory Use According to section 107A (1), any act of making, constructing, using, selling or importing a patented invention solely for used reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India that regulates the manufacturing, construction, use, sale or import of any product will not be considered as infringement of patents. According to this exemption, despite the patent in alive, performing research and tests for preparing regulatory approval, for instance by the Food and Drug Administration, does not constitute infringement. This exemption is particularly relevant to drugs manufacturing, allowing generic manufactures to prepare generic versions in advance of the patent expiration. However, this exemption originated from infamous case Roche Products v. Bolar Pharmaceutical and famously known as Bolar-provision. In US, this exemption is known as Safe-harbor exemption or technically called as § 271(e)(1) exemption or Hatch-Waxman exemption. The US Supreme Court recently revisited Merck v. Integra to determine the scope of Hatch-Waxman exemption. The Supreme Court held that the statue exempts from infringement all uses of compounds that are reasonably related to submission of information to the government under any law regulating the manufacture, use or distribution of drugs. However, issue of stockpiling is still not been dealt my Indian Patent Law.