2004); For Your Ease Only, Inc. v. Natural Sci, Indus., 233 F. Supp. 2d 988, 991 (N.D. Il.
2002). Because I do not think that TAP can make a showing of reasonable probability of
success, I am not inclined to lift the stay or to allow TAP to proceed with briefing on a

preliminary injunction.?

For these reasons, Plaintiffs Motion to Proceed With Preliminary Injunction Proceedings

is DENIED.

ENTER:

Bn
ames B. Zagel a
United States Distrikt Judg

DATE: C6 Qeud 2004

3 Without a very strong showing of probability of success on the merits, it is unlikely that
a preliminary injunction, especially in this case, would be in the public interest. A preliminary
injunction would most likely prevent Defendants from bringing their 6-month formulation of
Eligard into the market, depriving patients of a cancer treatment that could be administered less
frequently than the currently available formulations. Having to sustain fewer injections is a
substantial benefit to the cancer patients who are using these drugs and one which they should
not be deprived of lightly. Thus, it is also likely that I would deny the preliminary injunction on
these grounds as well.


this suit, Defendants launched a 4-month formulation of Eligard and announced plans to launch a
6-month formulation of Eligard.

TAP, however, offers an understandable reason for its delay in filing this suit. TAP
claims that, at least initially, Defendants’ Eligard products failed to gain a significant foothold in
TAP’s market and, therefore, did not pose a significant threat to sales of its product, Lupron
Depot. Lupron Depot is currently available in 1, 3, and 4- month formulations and is the leading
product in the market. After June 2003, Eligard’s market share began to increase dramatically,
causing TAP to take notice. During the fall of 2003, TAP also learned that Defendants planned
to release a 6-month formulation of their product, which TAP believed would lead to increasing
losses of market share. It is relatively understandable that TAP did not view Defendants’ product
as a major threat to its business until Defendants started increasing their market share and started
making credible statements concerning new, improved products. Thus, I do not think TAP’s
delay in filing this suit is in any way fatal to their claim of irreparable harm.

Defendants also argue that TAP cannot make an adequate showing of a reasonable
likelihood of success. Normally, a decision upholding the validity of a patent, like the one
already handed down by the Ohio district court, would establish a reasonable probability of
success on the merits. But, here, I must also consider the PTO’s preliminary invalidation of the
‘721 patent. Since the PTO’s proceeding has only passed its first stages, I have had difficulty
determining what bearing the PTO’s preliminary invalidation of the ‘721 patent should have in
these proceedings. At the very minimum, however, the PTO’s invalidation raises a substantial
question about the patent’s validity and is, therefore, fatal to a motion for a preliminary

injunction. Nat’l Steel Car, Ltd. v. Canadian Pac. Ry., Ltd., 357 F.3d 1319, 1325 (Fed. Cir.


Minute Ofer Form (06/97)

United States District Court, Northern District of Iinois

Namestanieed seer | James B.Zagel ‘St ote er
CASE NUMBER 03 C 7822 DATE 8/26/2004
CASE TAP vs. ATRIX LABS
TITLE
[In the following box (a) indicate the party filing the motion, e.g., plaintiff, defendant, 3rd party plaintiff, and (b) state briefly the nature
MOTION: of the motion being presented.)
DOCKET ENTRY:
q) a Filed motion of [ use listing in “Motion” box above.]
(2) Oo Brief in support of motion due.
@) Qo Answer brief to motion due__. Reply to answer briefdue___.
(4) Qa Ruling/Hearingon___——ssetfor_— saat
(5) Oo Status hearing[held/continued to] [set for/re-set for] on setfor at
(6) oO Pretrial conference[{held/continued to} (set for/re-set for]on___—setfor__——sat_—
(7) o Trial[set for/re-set for]on____at
(8) oO {Bench/Jury trial] [Hearing] held/continuedto__—_at
(9) Oo This case is dismissed [with/without] prejudice and without costs[by/agreement/pursuant to}

CFRCP4(m) O Local Rule 41.1 OO FRCP41(a)(1) (1 FRCP41(a)(2).

do [Other docket entry] Motion (45-1 and 45-2) for preliminary injunction and briefing is denied.
Enter memorandum opinion and order.

a1 @ [For further detail see order attached to the original minute order.]

No notices required, advised in open court.

No notices required,

Notices mailed by judge’s staff.
Notified counsel by telephone,
a | Docketing to mail notices.

Mail AO 450 form. wena sary
Copy to judge/magistrate judge. N
courtroom 42:8 WY - das h002
Dw deputy’s _ mene
initials soa
central Clerk's Office



UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION

TAP PHARMACEUTICAL PRODUCTS,
INC., TAKEDA CHEMICAL
INDUSTRIES, LTD., and WACO PURE
CHEMICAL INDUSTRIES, LTD.
Plaintiffs,
v.

ATRIX LABORATORIES, INC., and
SANOFI SYNTHELABO, INC.

Defendants.

E [DUM O.

No. 03 C 7822
Judge James B. Zagel

IN AND ORDE

DOCKETED

SEP 03 2004

On November 3, 2003, Plaintiffs Tap Pharmaceutical Products Inc. (“TPP”), Takeda

Chemical Industries, Ltd. (“Takeda”), and Wako Pure Chemical Industries, Ltd. (“Wako”)

(collectively “TAP”) filed suit against Defendants Atrix Laboratories, Inc. (“Atrix”) and Sanofi-

Synthelabo, Inc. (“Sanofi”) alleging infringement of United States Patent No. 4,728,721 (“721

patent”). Prior to filing this suit, TAP successfully pursued a similar claim against Oakwood

Laboratories, L.L.C. (“Oakwood”) in an Ohio district court. After the court upheld the patent as

valid, Oakwood requested and was granted a reexamination of the ‘721 patent by the Patent and

Trademark Office (“PTO”). Because of this pending reexamination, I stayed the proceedings

before me. I did, however, invite TAP to pursue a motion for a preliminary injunction, which it

did. During preliminary briefing of this issue, the PTO formally rejected the claims of the ‘721

patent as invalid. TAP has appealed this decision with the PTO.

With this motion, TAP asks that I lift the stay and allow them to proceed with a hearing

on a preliminary injunction. To obtain a preliminary injunction, a party must show (1) a


reasonable likelihood of success on the merits, (2) irreparable harm, (3) that the balance of
hardships tips in favor of the injunction, and (4) the injunction is in the public interest. Jack
Guttman, Inc. v. Kopykake Enters., 302 F.3d 1352, 1356 (Fed. Cir. 2002) (citations omitted).
Since the majority of the briefing submitted dealt with the first two factors,' that is where I will
focus my attention.

Defendants argue that because of TAP’s significant delay in filing this suit, TAP cannot
now show that they will be irreparably harmed by Defendants’ continued market presence. In
some cases, an unexcused delay in filing suit can be fatal to claims of irreparable harm. See High
Tech Med. Instrumentation v. New Image Indus., 49 F.3d 1551, 1557 (Fed. Cir. 1995) (“Absent a
good explanation...17 months is a substantial period of delay that militates against the issuance of
a preliminary injunction by demonstrating that there is no apparent urgency to the request for
injunctive relief.”); Am. Permahedge v. Barcana, Inc., 857 F. Supp. 308, 325 (S.D.N.Y. 1994)
(plaintiff's fifteen month delay in filing patent suit “is fatal to plaintiff's claim of irreparable
injury”); Rexnord, Inc. v. Laitram Corp., 628 F. Supp. 467, 474 (E.D. Wis. 1986) (the “court
believes that such failure to promptly commence a suit [until six months after discovery of the
alleged infringement] is fatal to defendants’ contention of irreparable harm.”). The Defendants
launched their first allegedly infringing product, the 3-month formulation’ of Eligard, nearly 18

months before TAP filed this suit in November 2003. In between the introduction of Eligard and

' Trreparable harm and reasonable likelihood of success are generally thought to be the
most important factors in determining whether a preliminary injunction should issue. Polymer
Techs. v. Bridwell, 103 F.3d 970, 973 (Fed. Cir. 1996); Jack Guttman, 302 F.3d at 1356.

2 The formulation refers to the number of months the patient may go between treatments.

2