Expansion of the US 'safe harbour' provisions--an American perspective

Legal context. Since the mid-1980s, US patent law has exemptedcertain research activities in the pharmaceutical field fromliability for patent infringement. Recently, the US SupremeCourt expanded this exemption (‘safe harbour’) byholding that any type of research activity, regardless of itstiming or phase, may be exempt from liability for patent infringementwhere it can be shown that the such activity is reasonably relatedto the development and submission of drug approval informationunder a federal law. Key points. The timing or phase of research activities is immaterialto determining whether the safe harbour provisions apply. Thecritical inquiry in determining the applicability of the safeharbour provisions is whether the activity in question is reasonablyrelated to the submission of drug approval information to theUS Food and Drug Administration (FDA). A research activity is ‘reasonably related’ to thesubmission of drug approval information where it can be shownthat (i) a drug-maker has a reasonable basis for believing thata patented compound may work to produce a particular physiologicaleffect and (ii) the drug-maker uses that compound in researchwhich, if successful, would be appropriate for submission tothe FDA. The ultimate absence of experimental data from an FDAsubmission may not adversely impact the potential applicabilityof the safe harbour provisions. Mere intent to submit informationto the FDA is insufficient; rather, intent must be coupled withactual research activities. Practical significance. The safe harbour provisions of the USpatent law are not confined to specific types of research, norare they bounded by temporal limitations. Rather, any researchactivity, regardless of its timing or phase, may qualify forprotection. Importantly, industry researchers must take careto document actual research activities and be prepared to demonstratethat such activities are reasonably related to the submissionof information to the FDA.