Intellectual Property Primer

a lex-warrier initiative

Patents and research exemption

Research exemption which is popularly known as safe harbor exemption is a rule of exemption to the rights conferred by patents. Such an exemption is very relevant in case of drugs and pharmaceuticals. Whether carrying out research activity in connection with a patented drug or medicine will infringe the patent rights?

Re, to Section 271(e)(1) USC 35, any such research activity does not amounts to infringement in the United States of America. In Merck v. Integra, the apex court refused to “quibble” with the Court of Appeals over its conclusion that the exemption “does not globally embrace all experimental activity that at some point, however attenuated, may lead to an FDA approval process.

In Merck v. Integra, Supreme Court of United States of America while considering the scope of Hatch-Waxman exemption, it was held that, the statute 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.

Similar question was raised in Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984). However, the Court of Appeals for the Federal Circuit rejected the contentions of Bolar that, an experimental exemption does not apply in the given case. Because, Bolar is anticipated to sell generic medicines after the expiry of Roche’s patent life. Hence, court was of the opinion that, a commercial objective is hidden behind Bolar’s research. Thus, the research activity carried out by Bolar is in violation of Roche’s patent rights.

Court even rejected the contention of Bolar that, the public policy in favor of availability of generic drugs immediately following patent expiration justified the experimental use of the patented chemical because denying such use would extend Roche’s monopoly beyond the life of a patent. However, court opined that, decisions in connection with such policy matters shall be taken by the Congress and not the Courts.

Soon after this judgment, the Congress passed a law permitting use of patented products in experiments for the purpose of obtaining Food and Drug Administration (FDA) approval [Section 271(e)(1)]. Thereafter, the research exemption under patent law is also known as Bolar provision or Roche-Bolar provision. In Europe the research exemption is permitted under the EC Directives 2001/82/EC and 2001/83/EC.

In common law, the research exemption is propounded by Justice Joseph Story in Whittemore v. Cutter, 29 Fed. Cas. 1120 (C.C.D. Mass. 1813), where it was held 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 described effects. However, the Court of appeal limited the scope of the research exemption in Madey v. Duke University, 307 F.3d 1351, 1362 (Fed. Cir. 2002).

Last, but not the least, by virtue of Article 30 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.