The following is not meant to be legal advice.
Continuing on the analysis of the July 27, 2007 ruling of the Federal Circuit in Integra LifeSciences v. Merck, the attorney studying patent cases might be interested to read that in the case, Integra argued that studies conducted by Scripps and Merck infringed Integra's patents on RGD peptides. Merck and Scripps claimed that the experiments fell under the safe harbor 35 U.S.C. § 271(e)(1), which exempts infringement uses of patented inventions that are reasonably related to obtaining information for submission to the FDA.
The court stated that whether the uses are reasonably related to the development of information for submission to the FDA is made at the time of the experiment, and does not depend on the success of the experiment or actual submission of results to the FDA. FDA exemption is not applicable to basic scientific research unrelated to development of a particular drug.
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