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

[James Love]

---------- Forwarded message ----------
Date: Fri, 20 Oct 2000 17:30:03 -0400
From: Thiru Balasubramaniam <thiru@cptech.org>
Subject: Follow up of SmithKline/Polacrilex Gum dispute over
    copyright in labeling info

T.H. sent the the following note on the SmithKline Beecham Consumer
Healthcare v. Watson Pharmaceuticals Inc. dispute over copyright
infringement.  He attached the nine page court decision in pdf format.  
I will only provide excerpts from the decision.

Thiru


"Here is the appeals court's ruling that the Supreme Court denied
SmithKline the chance to appeal (you just forwarded an article related
to the case).  During the recent House debate on the drug import
provision included in the ag approps bill, Rep. Emerson argued that the
courts' ruling in this case
ensured future importers of prescription drugs would be able to relabel
them with FDA-approved labeling even if such labeling is copyrighted."

----------Excerpts from the decision follow---------------------


United States Court of Appeals

For the Second Circuit

August Term 1999

(Argued: January 13, 2000 Decided: April 04, 2000)

Docket No. 999501

SmithKline Beecham Consumer Healthcare, L.P.,

PlaintiffApellant,

-v.-

Watson Pharmaceuticals, Inc., Watson Laboratories, Inc. and Circa
Pharmaceuticals, Inc.,

DefendantsAppellees.


Before: WINTER, Chief Judge, JACOBS, and KATZMANN, Circuit Judges.


Appeal from an order of the United States District Court for the
Southern District of New York (Denny Chin, Judge) dissolving a
preliminary injunction that prevented Watson Pharmaceuticals from
infringing upon SmithKline's copyrighted label used on its Nicorette gum
in Watson's marketing of a competitive nicotine gum.  Because the FDA
required Watson to use the infringing label in selling its drug, the
injunction effectively prevented Watson from making sales.  We hold that
the HatchWaxman Amendments to the Federal Food, Drug, and Cosmetic Act
require generic drug sellers to use labeling that may infringe a
copyright in the label of the pioneer drug.  We further hold that, as a
result, copyright liability cannot attach to Watson's use of
SmithKline's label.  We therefore affirm.

<SNIP>

Appellees cannot be liable for copyright infringement because the
HatchWaxman 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.  We therefore affirm.