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Orange Book Listings For Unapproved Uses May Be OK, Appeals Court Says

Executive Summary

Congress should revisit Waxman/Hatch to clarify whether the statute is intended to restrict the scope of patent protection to only approved uses of a drug, U.S. Federal Circuit Judge Richard Linn said

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Supreme Court lets Waxman/Hatch ruling stand

Supreme Court declines to hear dispute over whether Waxman/Hatch allows a patent holder to sue an ANDA filer for infringement of a patent covering an unapproved use. Allergan appealed from a Federal Circuit ruling that patents covering the unapproved use of Alphagan for the treatment of ocular injuries are not infringed by Alcon and Bausch & Lomb ANDAs for the approved use of brimonidine in lowering intraocular pressure. High court refuses to hear case despite Federal Circuit panel's statements that it disagreed with the controlling case law under which it found noninfringement (1"The Pink Sheet" April 7, 2003, p. 25)...

Supreme Court lets Waxman/Hatch ruling stand

Supreme Court declines to hear dispute over whether Waxman/Hatch allows a patent holder to sue an ANDA filer for infringement of a patent covering an unapproved use. Allergan appealed from a Federal Circuit ruling that patents covering the unapproved use of Alphagan for the treatment of ocular injuries are not infringed by Alcon and Bausch & Lomb ANDAs for the approved use of brimonidine in lowering intraocular pressure. High court refuses to hear case despite Federal Circuit panel's statements that it disagreed with the controlling case law under which it found noninfringement (1"The Pink Sheet" April 7, 2003, p. 25)...

Generic Firms Warned Of First-To-File Risk: Willful Infringement Cases Rising

The pressure on generic companies to be first-to-file in patent challenges will lead to a "boom" in willful infringement cases against generics makers, an industry attorney maintains

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