Lapas attēli
PDF
ePub
[blocks in formation]

pateat.

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.

After District

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

transferred venue

to the

Eastero District of New York for a

[blocks in formation]

Plaintiff Roche Products, Inc. (Roche) holds patent number

3,299,053 for flura ze pam hydrochloride (flura ze pam hcl).

That

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

[blocks in formation]

manufacture or

sell flur azepam hcl before the patent expires, por

is it contended that Roche has authorized Bolar to make, use

[ocr errors]

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

COwrence

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
any patented invention, within the voited States
during the term of the pateat therefor, infringes
the patent.

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

constitutes a

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

U.S.c. 5271(a)?

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.

Bolar asserts

that

it will take two years

to

a mass required data

and obtain approval, in effect delaying entry into the market and

exending the patent de facto for the

same period.

Roche claims

that

ic is entitled to that delay in competition, but

can point

tono legal support.

It

can only be observed that patent

protection is contained in a single, general body of law meant

[blocks in formation]

delaying regulations of the FDA could hardly be considered a

part

of the monopoly benefits Congress sought to bestow.

See 35

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

recent

case of Pfizer, Inc.

International

Rectifier Corp., 217 U.S.P.Q. 157 (C.D. Calif. 1987). There the

[blocks in formation]

The defendant in Pfizer was clearly doing more, for a longer

period of time than Bolar intends to do here.

[merged small][merged small][merged small][merged small][merged small][merged small][ocr errors][merged small][merged small][ocr errors][merged small][merged small][merged small][merged small][merged small]

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.

Sea

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

amusement

At

the

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

[blocks in formation]

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

« iepriekšējāTurpināt »