Applying the Supreme Court’s 2005 interpretation of the Hatch-Waxman Act (35 U.S.C. § 271(e)(1)), the U.S. Court of Appeals for the Federal Circuit held that experiments were "reasonably related" to research that, if successful, would be appropriate to include in an application to the U.S. Food and Drug Administration (FDA), fell within the statute’s infringement exemption. Integra Lifesciences I, Ltd v. Merck KGaA, Case Nos. 02-1052, -1065, (Fed. Cir., Corrected: Aug. 27, 2007) (Newman, J.; Rader, J., dissenting-in-part).
In its earlier decision, the Federal Circuit affirmed the District Court’s finding that Merck’s activities did not fall within the ambit of the § 271(e)(1) infringement exemption for activities "reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products," relying on Congress’ perceived intention to balance the interests of patent-holders and generic drug companies, as evidenced by the legislative history of the statute.
On appeal, Supreme Court found that § 271(e)(1) "exempted from infringement all uses of patented compounds ‘reasonably related’ to the process of developing information for submission" to the FDA. The Supreme Court noted that the term "reasonably related" includes uses in research that are conducted after the biological mechanism and physiological effect of a candidate drug have been recognized, such that if the research is successful it would appropriately be included in a submission to the FDA. (See IP Update, Vol. 6, No. 7)
Now on remand from the Supreme Court, the Federal Circuit recited the 16 experimental categories that were undisputedly performed by Merck and co-defendant Scripps Research Institute, along with co-defendant Dr. David Cheresh. Integra reiterated, as it had before the Supreme Court to no avail, that any work that was not included in the Investigational New Drug (IND) application, as well as more than half of the experiments performed by Merck that had nothing to do with either human safety or efficacy, were not properly within the scope of the § 271(e)(1) exemption. Integra took particular issue with the angiogenesis chick CAM assay and the tumor growth chick CAM assay, arguing that experiments with chick embryos do not necessarily or reliably predict safety or efficacy in humans. However, since the Supreme Court had interpreted the statute to encompass experiments directed towards "efficacy, mechanism of action, pharmacology, or pharmacokinetics," which Integra conceded were the types of experiments at issue, this argument was unavailing. According to the Federal Circuit, the key fact was that "all of the challenged experiments were performed after the discovery that a cyclic RGD peptide inhibited angiogenesis." According to the Court, this knowledge provided the bright line that distinguished potentially exempt "research" or "discovery" from exempt experiments directed towards "efficacy, mechanism of action, pharmacology, or pharmacokinetics."
Finally, the parties and the panel majority agreed with the Supreme Court that this case did not involve "research tools" as defined by the National Institutes of Health and thus did not provide an opportunity for the Federal Circuit to decide whether research tools fall within the scope of the § 271(e)(1) exemption.
While concurring as to two of the patents, Judge Rader’s dissent accuses the majority of interpreting the Supreme Court’s decision too broadly based on its inclusion within the exemption of the two other patents in suit, which apply only to laboratory methods "without any possibility of submission to the FDA."
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
