In Integra LifeSciences I Ltd. v. Merck KGaA (Fed. Cir. June 6, 2003), a majority of a panel of the Federal Circuit ruled the 35 U.S.C. § 271(e)(1) safe harbor does not reach back down the chain of experimentation to embrace the development and identification of new drugs to be subsequently presented to the United States Food and Drug Administration (“FDA”) for approval.

Integra owns patents related to a short tri-peptide segment of fibronectin having the sequence Arg-Gly-Asp (“RGD peptide,” in single-letter notation).  The RGD peptide sequence promotes cell adhesion to substrates in culture and in vivo by interacting with avß3 receptors on cell surface proteins called integrins.  A scientist at Scripps discovered that blocking avß3 receptors inhibits angiogenesis, the process for generating new blood vessels.  Merck hired the scientist and Scripps to identify potential drug candidates that might inhibit angiogenesis.  Believing the angiogenesis research was a commercial project that infringed its RGD-related patents, Integra offered licenses to Merck.  After lengthy negotiations, Merck declined.  Integra then sued Merck, Scripps, and the scientist.  A significant issue on appeal was whether Merck’s work with Scripps fell under the safe harbor afforded by § 271(e)(1):

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.

This provision creates a safe harbor, during the lifetime of a pioneer drug patent, that permits a competitor to engage in activities “reasonably related” to acquiring FDA approval for a generic version of the drug.  A dispute arose whether the Scripps-Merck experiments were “solely for uses reasonably related to the development and submission of information” to the FDA.

• To qualify at all for the exemption, an otherwise infringing activity must reasonably relate to the development and submission of information for the FDA’s safety and effectiveness approval processes.

The Scripps-Merck experiments constituted general biomedical research to identify new pharmaceutical compounds and the best drug candidate to be subjected to future clinical testing under the FDA processes.  Because the activity did not contribute relatively directly to information the FDA considers in approving a drug, the Scripps-Merck experiments were not “solely for uses reasonably related” to clinical testing for the FDA.

• Thus, § 271(e)(1) simply does not globally embrace all experimental activity that at some point, however attenuated, may lead to an FDA approval process.
• The safe harbor does not reach any exploratory research that may rationally form a predicate for future FDA clinical tests.

Merck, Scripps, and the scientist therefore did not qualify for the safe harbor afforded by § 271(e)(1) and were exposed to liability for patent infringement.

Recommendations:

With respect to inventions and experimental activities in the biomedical arts:

• Reduce your exposure to liability for patent infringement by ensuring your experimental activities with respect to your competitors’ patents have the proper relationship to a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.
• Confine your competitors’ experimental activities with respect to your patents to only activities that have the proper relationship to a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

June 11, 2003

Text Copyright © 2003 Bob Brill et al.

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