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INTELLECTUAL PROPERTY ASPECTS OF PHARMACEUTICAL AND BIOTECH
BUSINESSES (INDL8310)
Prerequisite: Intellectual Property.
2 credits. Lecture.
This course focuses on the recent case law, relevant
legislation, and underlying policies, related to intellectual
property protection in the pharmaceutical and biotech industry.
We will concentrate on key patent cases from the Court of Appeals
for the Federal Circuit and U.S. Supreme Court, and aspects of the
FDA law that form the basis for IP protection in these industries.
Recent patent cases, including those on enablement, written
description, inherent anticipation, infringement under the
doctrine of equivalents, inequitable conduct, and research tools,
will be reviewed. We will also analyze the Hatch-Waxman Act
and competition law that impact both the innovative and generic
drug industries, and proposed legislation that is currently being
considered by Congress that could dramatically affect these
industries. |
