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Federal Circuit provides more detail on FDA research exemption to infringement

July 30, 2007
Post by Blog Staff

The Federal Circuit recently decided a case on remand from the Supreme Court's decision regarding the research exception to patent infringement (35 U.S.C. § 271(e)(1), "The FDA exception"). The Federal Circuit reversed the district court's finding of infringement, holding that the experiments were not infringements because they were reasonably related to research that would be appropriate to submit to the FDA if the experiments were successful. Judge Rader dissented, arguing that at least two of the patents at issue did not qualify for the exception because they were "research tools."

More detail of Integra Lifesciences I, Ltd. v. Merck KGaA after the jump.

The case involved research into a group of peptides that have the ability to block blood vessel formation, a property highly useful in the treatment of various cancers. Integra alleged infringement of five different patents, Merck claimed that the research activities were not infringing as they were in preparation for submission to the FDA. Integra argued that the exception only applied to experiments designed to test drug safety in humans, which excluded the majority of the experiments performed from the protection.

The jury found for Integra, the district court sustained the verdict, and Merck appealed. The Federal Circuit affirmed all on the basis that the research was not sufficiently connected to the clinical testing for submission to the FDA. Merck appealed to the Supreme Court, which issued an opinion focusing on the FDA exception's application to research that does not ultimately reach the FDA (failed experiments, abandoned compounds, and the like). The Supreme Court analyzed the statute and concluded 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 case was then remanded to the Federal Circuit. The present opinion came from that remand.

The Federal Circuit held that the applicability of the FDA exception depends on two factors, the allegedly infringing research must have been conducted after the particular biological process with therapeutic potential was discovered, and the research must be (in light of the recent Supreme Court decision) reasonably related to the process of developing information for submission to the FDA. The court concluded that there was no issue regarding the timing of the research. As a result, the opinion focused on the second "reasonable relationship" factor.

The core of Integra's argument was twofold. First, that the exception did not apply to compounds initially selected for research that were subsequently abandoned and secondly, that the data generated by the experiments did not meet the requirements for the exception because it was not suitable for submission to the FDA in an investigational new drug application (IND).

The Federal Circuit dismissed the first argument by stating that the Supreme Court

explained that the criterion of whether the experimental investigation of a patented compound is reasonably related to the development of information for submission to the FDA is established at the time of the experiment, and does not depend on the success of failure of the experimentation or actual submission of the experimental results.

The Federal Circuit therefore concluded that because Merck believed that the peptides under investigation were likely drug candidates at the time that the experiments began, the fact that some were failures does not make the failed experiments infringing. As stated by the court:

[S]tudies of compounds that are not ultimately proposed for clinical trials are within the FDA Exemption, when there was a reasonable basis for identifying the compounds as working through a particular biological process to produce a particular physiological effect.

Integra's second argument was that INDs are solely focused on safety issues and require the use of FDA defined "Good Laboratory Practices" (GLP). Relying on the Supreme Court opinion and the FDA requirements for INDs (21 C.F.R. § 312.23(a)(8)(i)), the court concluded that GLP practices were not required for submission to the FDA and that the IND scope was not limited to only safety data.

Finally, Integra argued that the research in question did not qualify for the FDA exception because the experiments were devoid of discovery and were merely routine. The Federal Circuit dismissed this argument stating that the FDA exception "does not depend on a distinction between 'discovery' and 'routine,' but on whether the threshold biological property and physiological effect had already been recognized as to the candidate drug.

Accordingly, the Federal Circuit overturned the District Court's decision and found that Merck's research did not infringe the patents due to the FDA exception. The majority did not reach the alternative argument that some of the patents were to "research tools," defined by the National Institutes of Health to mean:

tools that scientists use in the laboratory including cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, laboratory equipment and machines.

The parties agreed that the Supreme Court determined such an argument was outside the scope of the case.

Judge Rader dissented, and would have found infringement of two of the patents. Judge Rader contended the majority should have reached the "research tool" argument, and that two of the patents were to "research tools," which he argued should not fall under the FDA exception. As a result, because the majority did not address the issue, we are left to wait for another day to determine whether § 271(e)(1) also exempts so-called "research tools" from infringement.

In summary, this case shows a rather broad interpretation of the FDA exception, holding that as long as there is a reasonable basis to believe the compounds work through a particular process to produce a particular effect, the exception will apply, even if there are other benefits to the research.

To read the full decision in Integra Lifesciences I, Ltd. v. Merck KGaA, click here.


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