The Devil in the Label Details: A New Test for Induced Infringement

April 24, 2018 1:45pm

Emily Greb
Perkins Coie LLP (Madison, WI)

Michael P. Dougherty
Hogan Lovells (New York, NY)

Robert C. Millonig, Jr., Ph.D.
Sterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)

Joseph O’Malley
Paul Hastings LLP (New York, NY)

Wendy Petka, Ph.D., J.D.
Senior Director and Senior Patent Counsel
Theravance Biopharma US, Inc. (South San Francisco, CA)

The Federal Circuit recently issued new guidance for evaluating divided and contributory infringement of pharmaceutical method-of-use patents. In Sanofi v. Watson, the Federal Circuit held that drug product labeling “as a whole” may be used to support a claim of induced infringement, thus providing guidance for enforcing method-of-use patents, as new uses for drugs are revealed. This panel will explore this finding. Points of discussion will include:

  • Reviewing the state of the law on induced infringement and its repercussions for Hatch-Waxman
  • Understanding how extensive labeling information on a generic drug may encourage an act of inducement
    • Intent to induce vs. actual inducement
  • Looking beyond indications and usage and dosage and administration to establish inducement
  • Comprehending the importance of how the doctor’s reading of the label as a whole may lead to an act of induced infringement