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16 Stan. Tech. L. Rev. 1 (2012-2013)

handle is hein.journals/stantlr16 and id is 1 raw text is: STANFORD TECHNOLOGY LA W REVIEW VOLUME 16, NUMBER 1 FALL 2012 WHY THE SCOPE OF THE PATENT TEST CANNOT SOLVE THE DRUG PATENT SETTLEMENT PROBLEM Michael A. Carrier* CITE AS: 16 STAN. TECH. L. REv. 1 (2012) http://stir.stanford.edu/pdf/scopeofthepatent.pdf IN T R O D U C T IO N ........................................................................................................... 1 I. H ISTORY OF THE SCOPE TEST ........................................................................... 2 A . Cardizem O utside the Scope ................................................................... 2 B. Valley Drug A Calibrated Test .............................................................. 2 C. Taxmoxifen A Shrinking Test ................................................................. 3 D . Cipro The N oose Tightens ..................................................................... 3 E. Androgel The Ambiguity Disappears ..................................................... 4 F. K-Dur A Turn Toward Scrutiny ............................................................ 4 II. CRITIQUES OF THE SCOPE TEST ....................................................................... 5 A . Transform ed Scope ................................................................................... 5 B . A ssumption of Validity ............................................................................... 6 C. Inapplicability to Infringement ................................................................. 7 C O N C L U S IO N .............................................................................................................. 8 INTRODUCTION One of the most difficult legal issues today involves settlements by which brand-name drug companies pay generic firms to delay entering the market. Such conduct requires courts to consider not only patent and antitrust law, but also the Hatch-Waxman Act, the complex regime governing behavior in the pharmaceutical industry. Courts have analyzed these agreements by relying on a test that asks if the settlement falls within the scope of the patent. They have found, in nearly all * Professor of Law, Rutgers University School of Law-Camden.