© The Author (2006). Published by Oxford University Press. All rights reserved
Expansion of the US ‘safe harbour’ provisions—an American perspective
*Registered Patent Attorney; Associate, McCarter & English LLP Newark, US
Legal context. Since the mid-1980s, US patent law has exempted certain research activities in the pharmaceutical field from liability for patent infringement. Recently, the US Supreme Court expanded this exemption (‘safe harbour’) by holding that any type of research activity, regardless of its timing or phase, may be exempt from liability for patent infringement where it can be shown that the such activity is reasonably related to the development and submission of drug approval information under a federal law.
Key points. The timing or phase of research activities is immaterial to determining whether the safe harbour provisions apply. The critical inquiry in determining the applicability of the safe harbour provisions is whether the activity in question is reasonably related to the submission of drug approval information to the US Food and Drug Administration (FDA).
A research activity is ‘reasonably related’ to the submission of drug approval information where it can be shown that (i) a drug-maker has a reasonable basis for believing that a patented compound may work to produce a particular physiological effect and (ii) the drug-maker uses that compound in research which, if successful, would be appropriate for submission to the FDA. The ultimate absence of experimental data from an FDA submission may not adversely impact the potential applicability of the safe harbour provisions. Mere intent to submit information to the FDA is insufficient; rather, intent must be coupled with actual research activities.
Practical significance. The safe harbour provisions of the US patent law are not confined to specific types of research, nor are they bounded by temporal limitations. Rather, any research activity, regardless of its timing or phase, may qualify for protection. Importantly, industry researchers must take care to document actual research activities and be prepared to demonstrate that such activities are reasonably related to the submission of information to the FDA.