Academic journal article The Journal of High Technology Law

Merck KGaA V. Integra: More Answers Than Questions?

Academic journal article The Journal of High Technology Law

Merck KGaA V. Integra: More Answers Than Questions?

Article excerpt

In Merck KGaA v. Integra Lifesciences, (1) the Supreme Court clarified the uncertain scope of the safe harbor under [sections]271(e)(1), following the Federal Circuit's vacillating pronouncements which suggested that the statutory exemption is limited to generic drug applications and to data from human clinical trials. (2) The Supreme Court rejected the Federal Circuit's narrow interpretation, holding that the exemption includes information reasonably related to the development of information submitted for approval of a new drug, as well as a generic equivalent. (3) The statutory immunity from infringement extends to preclinical studies that are reasonably related to approval of an original Investigational New Drug application (IND), including in vitro and animal studies demonstrating the safety or efficacy of a new drug candidate compound, which are required by the FDA prior to human trials. (4)

The Court clearly rejected the view that the exemption is restricted to specific phases of research or information developed for particular FDA submissions, and did not attempt to draw a bright line boundary at which experimentation involving a patented compound becomes exempt. Although the decision broadly states that the safe harbor exemption from infringement "extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA," (5) its holding is considerably narrower. The Court repeatedly emphasized that the limited question which it considered and resolved was the scope of immunity for the use of a patented compound which is a new drug candidate, and held that the exemption extends only to uses of the compound "in research that, if successful, would be appropriate to include in a submission to the FDA." (6)

I. The Statutory Safe Harbor Exemption

The safe harbor immunity from infringement is defined by 35 U.S.C. [sections]271(e)(1), which provides in pertinent part as follows (emphases added):

   It shall not be an act of infringement to make, use, offer to sell,
   or sell within the United States or import into the United States a
   patented invention ... solely for uses 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.

II. Divergent Interpretations of the Statutory Exemption

The opinions of the Federal Circuit and the Supreme Court reveal widely divergent concepts of the nature and scope of the statutory exemption, which may be generally characterized as a "temporal" limitation, a "use" limitation, and a "subject matter" limitation.

A. Temporal Limitation: the "Chain of Experimentation"

The Federal Circuit majority clearly considered that the "reasonably related" requirement imposes a definite, temporal limitation on the scope of exempt research and development, and characterized the issue as determining the last protected link in a "chain of experimentation:"

   The Scripps-Merck experiments did not supply information for
   submission to the United States Food and Drug Administration (FDA),
   but instead identified the best drug candidate to subject to future
   clinical testing under the FDA processes. Thus, this court must
   determine whether the [sections]271(e)(1) safe harbor reaches back
   down the chain of experimentation to embrace development and
   identification of new drugs that will, in turn, be subject to FDA
   approval. (7)

Under Judge Rader's interpretation, all uses of patented inventions, including biotechnology "research tools," evidently would be exempt from infringement after a threshold event in the chain occurs, such as the submission of a New Drug Application. (8) Prior to the threshold event, no use of a patented invention, including a drug candidate compound, would qualify for the exemption. …

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