The Patents Act, 1970 provides certain exemptions to the rights conferred by patents without harming the commercial interests of patentees. According to these exemptions, certain acts, even though infringing in nature, will not constitute infringement of patents when performed before the expiry of valid patent term. These exemptions however are borrowed from developed countries such as US and UK, and sometimes also referred as infringement defenses. In order to avoid any patent misuse or barrier to further scientific research, these exemptions are included as defenses against patent infringement. Article 30 of TRIPS agreements also provides its member nations to include exemptions to the exclusive rights conferred by patents, provided that such exemptions do not unreasonably conflict with normal exploitation of patents and do not unreasonably prejudice the legitimate interests of the patent owners, taking account of the legitimate interests of third parties.
A patent issued under the Patents Act, 1970 confers upon the patentee the right to prevent unauthorized third parties from making, using, offering for sale, selling or importing patented product in territorial jurisdiction of India. Any individual, who makes, uses, offers to sale, sells or imports into India a patented invention without the consent of patentee/patent owner faces liability for patent infringement. However, the rights conferred upon the patentee are subject to certain exemptions provided under the Act. There are three exemptions available under the Act, these are, (1) Government Use (also known as Crown use in UK and Australia); (2) Experimental/Research Use; and (3) Regulatory Use (also known as Safe-harbor exemption in US or Bolar-exemption in Canada).
Government Use
According to section 47 (1) and 47 (2), Government or any person/organization on the behalf of Government may import or make or use any patented product or process for the purposes merely of Government own use. In case of a patent is respect of any medicine or drug, the medicine or drug may be imported by the Government for the purpose merely of its own or for distribution in any dispensary, hospital or other medical institution maintained by or on behalf of the Government or any other dispensary, hospital or other medicinal institution which the Central Government may, having regard to the public service that such dispensary, hospital or medicinal institution renders, specify in this behalf by notification in the Official Gazette (section 47 (4)).
Experimental/Research Use
According to section 47 (3), any person can use patent product or process for the purpose of experiment or research for non-commercial activities. This provision is merely for academic purpose and further research. However, this research exemption is an affirmative defense to infringement where the alleged infringer uses patented invention for research purpose. This doctrine originated in 1813 in Whittemore v. Cutter, 29 Fed. Cas. 1120 (C.C.D. Mass. 1813) where Justice Joseph Story famously wrote that the intent of the legislature could not have been to punish someone who infringes “merely for scientific experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its describe effects.” Subsequent judicial decisions later distinguished between commercial and non-commercial research. In 2002, the Court of Appeals for the Federal Circuit considerably limited the scope of the research exemption in Madey vs. Duke University, 307 F.3d 1351, 1362 (Fed. Cir. 2002). The court limited the scope of the research exemption only for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry. However, in the absence of relevant case laws in India, the scope of experiment/research exemption is still unresolved.
To be continued ….
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