The Supreme Court of the United States (Court) in Merck KGaA v. Integra LifeSciences I, Ltd., __U.S. __ (June 13, 2005), painted a broad "safe harbor" under 35 USC § 271(e)(1) for patent infringement-free use of pharmaceutical inventions. In a 9-0 reversal of the Federal Circuit, Justice Antonin Scalia — author of Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990), the leading case on this statutory provision — eviscerated many rights of "research tool" patentees. The ruling left untouched the scope of the common law experimental use exemption from infringement that will surely now become a hot button issue for future litigation in areas outside pharmaceuticals. The Court was well-aware of the several briefs of amici supporting the "research tool" industry. While gutting the patent rights for research tool companies, the Court said that it was not dealing with the issue in this case.
On the one end of the spectrum, the Federal Circuit had held that the "safe harbor" exemption from patent infringement covered in essence only the clinical testing of a new drug, and not the upstream animal testing. By the time of the oral argument at the Court, even the respondent was conceding that the upstream bounds of the safe harbor are much further than the Federal Circuit. At the other end of the spectrum, the United States as amicus curiae in its brief on behalf of the U.S. Food and Drug Administration (FDA) had taken the view that screening to identify the ultimate drug target is exempt from infringement even where "'hundreds or even thousands [of compounds] must be tested.' As long as a scientist is working on developing a particular drug… the number of compounds screened has nothing to do with whether the screening was reasonably related to the development and submission of information to FDA. Instead, it reflects the luck (or intuition) of the scientist, or the difficulty of the task." (Government brief, citations omitted).
The Court clearly came down on the side of the government. It first determined that there are upstream limits that remain: "Basic scientific research on a particular compound, performed without the intent to develop a particular drug or a reasonable belief that the compound will cause the sort of physiological effect the researcher intends to induce, is surely not ‘reasonably related to the development and submission of information' to the FDA." Immediately thereafter, however, the Court concludes that "[i]t does not follow from this, however, that § 271(e)(1)'s exemption from infringement categorically excludes either (1) experimentation on drugs that are not ultimately the subject of an FDA submission or (2) use of patented compounds in experiments that are not ultimately submitted to the FDA. Under certain conditions, we think the exemption is sufficiently broad to protect the use of patented compounds in both situations."
The Court emasculated much of the patent rights of the pharmaceutical "research tool" industry: "There is simply no room in the statute for excluding certain information from the exemption on the basis of the phase of research in which it is developed or the particular submission in which it could be included."
In sweeping statements, the Court eviscerated the upstream boundaries of the safe harbor to essentially permit screening or testing of compounds where there was a pharmaceutical motivation.
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