11 J. Tech. L. & Pol'y 1 (2006)
Pharmaceutical Patent Settlements: Fault Lines at the Intersection of Intellectual Property and Antitrust Law Require a Return to the Rule of Reason

handle is hein.journals/jtlp11 and id is 11 raw text is: Journal of Technology Law & Policy

Volume 11                 June 2006                 Number 1
ARTICLES
PHARMACEUTICAL PATENT SETTLEMENTS: FAULT LINES AT
THE INTERSECTION OF INTELLECTUAL PROPERTY AND
ANTITRUST LAW REQUIRE A RETURN TO THE
RULE OF REASON
John Fazzio*
1.   INTRODUCTION ....................................... 3
H.   PATENT SETTLEMENTS: PURPOSE, POLICY,
ENFORCEMENT, AND MODIFICATION ..................... 6
A. Hatch- Waxman Agreements .......................... 6
B. The Statutory Framework  ........................... 9
1. The Hatch-Waxman Amendments .................. 9
2. Forms of Settlement Agreements .................. 13
a.  Supply Agreements  .......................... 13
b.  License Agreements  ......................... 13
c. Agreements with Brand Payments .............. 14
C. Congressional Response: The Medicare Act ............ 14
1. Only One 30-Month Stay Allowed ................. 15
2. The 180-Day Exclusivity Period May be Shared ...... 17
3. ANDA Applicants Can File for
Declaratory Judgment ........................... 17
4. ANDA Applicants May File a
Counterclaim  to De-List ......................... 18
5. The 180-Day Exclusivity Period May be Forfeited .... 19
* J.D., Brooklyn Law School, 2005; B.A., The College ofN.J., 2002. The author would like
to thank his parents, John and Susan, and his brothers, Justin and Jason, for their unconditional love
and support, Dr. Bernard Bearer for sparking a love of writing, and Professor Murumba for his
guidance and knowledge in the field of intellectual property.

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