The Doctrine of Equivalents in Pharmaceutical Actions

The Doctrine of Equivalents was outlined by the Supreme Court - a patentee's rights are not limited to the literal wording of claims, but extend to equivalents that a competitor might use to capture the invention's essence.  In this conversation, the presenters will review the two tests for the doctrine of equivalents ("DOE"), application of the DOE in pharmaceutical actions generally, as well as defenses and limitations to the DOE.  They will also discuss practice pointers to avoid limiting or negating a patentee's ability to rely on the DOE.

Learning Objectives: 

1. Explain the origins and purpose of the Doctrine of Equivalents (DOE) as established by the U.S. Supreme Court and its role in defining the scope of patent protection beyond literal claim language

2. Differentiate between the two primary tests for determining equivalence-the function-way-result test and the insubstantial differences test-and understand when each applies

3. Analyze the application of the DOE in pharmaceutical patent litigation, including how courts assess equivalence in the context of chemical and biological inventions

4. Identify key defenses and limitations to the DOE, such as prosecution history estoppel and the dedication-to-the-public doctrine

5. Apply practical strategies to preserve or challenge reliance on the DOE, including drafting, prosecution, and litigation techniques that can expand or limit the scope of patent protection