District Court Extends Safe Harbor Provision to Cover "Research Tools" Under 271(e)(1)

In a case before the District Court of Maryland, Northern Division, Classen Immunotherapies asserted two of its patents against Elan, alleging that Elan's study regarding the effect of food on the bioavailability of Skelaxin, and the subsequent use and commercialization of the study data to identify a new use of the drug, was infringement.

One of Classen's patents dealt with computer systems and proprietary databases for gathering, storing, processing and distributing adverse events data associated with medical and non-medical products. Another dealt with computer systems and databases for managing product data.

Elan moved for summary judgment, arguing that even if its conduct fell within the scope of the patents, it is immune from patent infringement under the "safe harbor" provision of 35 U.S.C. 271(e)(1), because the results of the research were submitted to the FDA under a Citizen Petition and labeling supplement pursuant to a New Drug Application.

Under 271(e)(1), no infringement can be found when the sole uses of the invention are reasonably related to the development and submission of information under a federal law which regulates the manufacture, use or sale of drugs.

In Merck v. Integra Life Sciences, the Supreme Court interpreted this statute broadly, holding that the provision "extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA." However, the Court declined to rule on whether the use of "research tools" was protected.

While the district court found that Classen's patented process could be considered a "research tool," the court found extension of the safe harbor to cover the use of these tools under the language of Merck and a plain reading of the statute. Accordingly, summary judgment was awarded in favor of the defendant Elan.

This appears to be the first district court decision that addresses whether research tool patents are covered by the safe harbor provision. The case is Classen Immunotherapies v. King Pharmaceuticals (Westlaw cite is 2006 WL 3716920), and the case number is WDQ-04-3521


A special thanks goes out to Sanjay Murthy for pointing out this case.