[Pharm-policy] SmithKline/Polacrilex Gum dispute over copyright in labeling info

[James Love]

This is an interesting case.  The US Supreme Court has let stand a
ruling that SmithKline Beecham cannot prevent a generic competitor from
using the same labeling information on its products, and that this is
not a copyright infringement.  Jamie

------- Forwarded message ----------
Date: Tue, 17 Oct 2000 12:37:35 -0400
From: James Love <love@cptech.org>
To: "Love, James" <love@cptech.org>
Subject: gum

October 3, 2000

Supreme Court Rejects ....

By ROBERT S. GREENBERGER 
Staff Reporter of THE WALL STREET JOURNAL

  [snip]

The court also refused to review SmithKline Beecham PLC's claim that a
users' guide offered by a rival, involving a product similar to
SmithKline's Nicorette gum, infringed on its patent. And the justices
turned away an appeal by France's Pernod Ricard SA of the dismissal of a
trademark-infringement lawsuit against rum maker Bacardi Ltd.

In the patent-infringement case, the justices rejected an appeal by
SmithKline's consumer health-care unit, which said an audiotape and
other materials used by Watson Pharmaceuticals Inc. to promote its
Nicotine Polacrilex Gum, meant to help smokers quit the habit, infringed
on its copyrights. Watson said its presentation of the material followed
directives from the Food and Drug Administration. (SmithKline Beecham
vs. Watson Pharmaceuticals)

  [snip]


CONTACTS:
Watson Pharmaceuticals, Inc.
Sara Swee
Director, Corporate Communications
(909) 270-1400

Morgen-Walke Associates, Inc.
Jim Byers, Carolyn Bass (Investors)
Sheryl Seapy (Media)
(415) 296-7383

FOR IMMEDIATE RELEASE

     APPEALS COURT RULES FOR WATSON ON NICOTINE GUM
          Appeals Court Affirms District Court?s Decision and
      Orders District Court to Dismiss SmithKline?s Case Against Watson

CORONA, CA - April 4, 2000 - Watson Pharmaceuticals, Inc. (NYSE: WPI)
announced today that the U.S. Court of Appeals for the Second Circuit
has ruled in Watson?s favor, affirming the District Court's previous
decision to allow Watson to ship and sell its Nicotine Polacrilex Gum.
The Appeals Court also directed the District Court to dismiss the
underlying infringement action brought by SmithKline Beecham Consumer
Healthcare LP against Watson. In its decision, the Appeals Court found
that Watson "cannot be liable for copyright infringement because the
Hatch-Waxman Amendments require generic drug producers to use the same
labeling as was approved by the FDA for, and is used by, the producer of
the pioneer drug."

  [snip]

-- 
James Love  mailto:love@cptech.org http://www.cptech.org
Consumer Project on Technology, P.O. Box 19367, Washington, DC 20036
voice 1.202.387.8030  fax  1.202.234.5176