The following is not meant to be legal advice.
On July 27, 2007, the Federal Circuit in Integra LifeSciences v. Merck ruled on the Supreme Court's interpretation of the patent infringement exemption set forth in 35 U.S.C. § 271(e)(1). The Federal Circuit found that all of the uses at issue qualified under the safe harbor provision of 35 U.S.C. § 271(e)(1) because they were reasonably related to research. If the research was successful, they would be appropriate to include in a submission to the FDA, though not all of the experiments resulted in information submitted to the FDA.
As to background, Integra LifeSciences owns patents related to amino acids arginine (R), glycine (G) and aspartic acid (D), known as RGD peptide sequence. Scripps Research Institute saw RGD peptides as inhibiting angiogenesis, a factor in diseases such as solid tumor cancers and rheumatoid arthritis. Scripps executed a collaborative agreement with Merck to develop a drug and evaluate several RGD peptides towards obtaining permission to conduct clinical trials through an Investigational New Drug (IND) application to the FDA.
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