Exploring the Research Exemption: Balancing Patent Rights and Scientific Advancement

The research exemption, commonly known as the safe harbour exemption, provides an exception to the rights granted by patents. This exemption holds particular relevance in the field of drugs and pharmaceuticals, where the question arises whether conducting research activities related to a patented drug or medicine would infringe on patent rights.

In the United States, Section 271(e)(1) of USC 35 states that such research activities do not amount to infringement. In the case of Merck v. Integra (2005), the Supreme Court declined to dispute the conclusion of the Court of Appeals that the exemption does not universally encompass all experimental activities that may, however indirectly, lead to the FDA approval process.

In the same case, the Supreme Court interpreted the scope of the Hatch-Waxman exemption and determined that the statute exempts from infringement all uses of compounds reasonably related to the submission of information to the government for the regulation of drug manufacture, use, or distribution.

A similar question arose in the case of Roche Products, Inc. v. Bolar Pharmaceutical Co. (1984), where the Court of Appeals for the Federal Circuit rejected Bolar’s contention that the experimental exemption did not apply. The court found that Bolar intended to sell generic medicines after Roche’s patent expired, indicating a commercial objective behind their research. Consequently, the court held that Bolar’s research activity violated Roche’s patent rights.

Furthermore, the court rejected Bolar’s argument that public policy favouring the availability of generic drugs immediately after patent expiration justified the experimental use of the patented chemical. The court opined that decisions regarding such policy matters should be made by Congress, not the courts.

In response to this ruling, Congress passed a law permitting the use of patented products in experiments for the purpose of obtaining FDA approval (Section 271(e)(1)). Since then, the research exemption under patent law has been known as the Bolar provision or Roche-Bolar provision. In Europe, the research exemption is permitted under EC Directives 2001/82/EC and 2001/83/EC.

In common law, the research exemption was established by Justice Joseph Story in Whittemore v. Cutter, where it was held that the legislature could not have intended to punish someone for infringing merely for scientific experiments or for assessing the effectiveness of a machine. However, the scope of the research exemption was later limited by the Court of Appeals in Madey v. Duke University.

Finally, Article 30 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) allows members to provide limited exceptions to the exclusive rights conferred by a patent. These exceptions should not unreasonably conflict with the normal exploitation of the patent or unreasonably prejudice the legitimate interests of the patent owner, while considering the legitimate interests of third parties.