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Suit was originally filed in 0.s. District Court in New
Jersey pursuant to 35 U.S.C. $$271 and 283, and under the grant
of jurisdiction provided in 28 0.s. c. $1338.
Judge 1. Lee Sarokin issued a temporary restraining order on
September 2, 1983, defendant was granted a change of venue pursuant to 28 U.S.c. $1406(a). District Judge Debevoise
Eastero District of New York for a
Plaintiff Roche Products, Inc. (Roche) holds patent number
3,299,053 for flura ze pam hydrochloride (flura ze pam hcl).
compound is the active ingredient in a prescription sleeping pill
manufactured by plaintiff under the brand name DAL MANE.
Plaintiff's seventeen year patent expires on January 17, 1984. Bolar Pharmaceutical company (Bolar) is a generic drug company that duplicates drugs no longer under patent and sells the
compounds to wholesale distributors.
Bolar is in possession of
five kilograms of florazepam bel, which it imported from a foreigo manufacturer not subject to United States patent law.
Plainti£f-seeks to permanently enjoio defendant from performing required FDA experiments with the drug during the term of the
sell flur azepam hcl before the patent expires, por
is it contended that Roche has authorized Bolar to make, use
sell the drug. Defendant acknowledges that it is in possession of five kilograms of imported flurazepam hel and freely admits
that it intends to form the compound into capsules and
che teseing and experiments aecessary for a New Drug Application
to the food and Drug Administration (FDA) before the January 17,
1984 expiration date of the pateat.
Title 35 U.S.c. 5271(a) provides in pertinent part:
[Wlhoever without authority makes, uses or sells
Plaintiff argues that putting the drug through the FDA required testing and experimentation before the pateat expires constitutes infringement under section 271(), even if there is ao intent to make, sell or otberwise realize a monetary gain
until after January 17, 1984.
Roche asserts that such action
use prohibited by the lav.
Bolar coacedes that its
tests do aot fall under the infringement excepcion known as
experimentation for philosophical, amusement, or curiosity
purposes. It maintains that its testing' does not constitute infringement use because ië is de nisinis, it does not by its dature infringe and no commercial value or profit will be realized before the patent on the drug expires. The defendant characertizes its activity is limited pre-expiration preparation for post-expiration entry into the market.
The questioa before the court is a very narrow one: does
the limited use of i patented drug for experiments strictly
related to FDA drug approval requirements during the last six
DOBths of the term of the patent constitute use prohibited by 35
The court holds that it does not.
da underlying issue in this case is the procedure for
getting FDA approval, without which a drug cannot be marketed.
it will take two years
a mass required data
and obtain approval, in effect delaying entry into the market and
exending the patent de facto for the
ic is entitled to that delay in competition, but
tono legal support.
can only be observed that patent
protection is contained in a single, general body of law meant
delaying regulations of the FDA could hardly be considered a
of the monopoly benefits Congress sought to bestow.
U.S.C. $154. Viewed from this vantage, what is at stake is a post-expiration competitive benefit fox. Bolar at Roche's expease.
The plaintiff urges the adoption of the reasoning and
holding of the
case of Pfizer, Inc.
Rectifier Corp., 217 U.S.P.Q. 157 (C.D. Calif. 1987). There the
The defendant in Pfizer was clearly doing more, for a longer
period of time than Bolar intends to do here.
declines to make a wholesale adoption of the California court's
reasoning and holding.
The Pfizer court, although it draws on the analysis and
reasoning of cases from all the circuits, is bound by the Ninth
Circuit Court of Appeals' reading of the law, which strictly
limits the experimental use exception to purposes of amusement
and philosophical gratification.
Spray Refrigeration Co. v.
Spray Fishing, Inc., 322 F.2d 34 (9th Cir. 1963).
This court, of
course, is not bound by the Ninth circuit, and although plaintiff
advocates their analysis, the
court instead turas
to the line of
reasoning followed by the Court of Appeals for the second
Circuit. Bolar's experimentation cannot be classified as merely for or philosophical gratification.
same time, it
cannot be connected with any act of competition or profit during
the term of the patent in either domestic or foreign-marketse. Its experimentation is connerical preparation of a nonproduction
Marble Co., 18 F. Supp. 305 (N.D.W.Va. 1937), the experimentation with a marble manufacturing device covered by plaintiff's patent
prior to going into production was held not an infringing use. The use of the apparatus was clearly a commercial test, yet in
the absence of any profit from the activity, the court found no
infringement. Similarly, in Dugan v. Lear Avia, Inc., 55 F. supp. 223 (S.D.N.Y. 1944), aff'd 156 F.2d 29 (2d Cir. 1946),
building and commerciai testing of a device without commercial