The opinion of the court was delivered by: SANDRA TOWNES, District Judge
By order dated January 21, 2005, this Court referred this
matter to Magistrate Judge Viktor Pohorelsky for a Report and
Recommendation on the Plaintiffs' motions for a temporary
restraining order and a preliminary injunction.
A district court judge may designate a magistrate to hear and
determine certain motions pending before the Court and to submit
to the Court proposed findings of fact and a recommendation as to
the disposition of the motion. See 28 U.S.C. § 636(b)(1).
Within ten days of service of the recommendation, any party may
file written objections to the magistrate's report. See id.
Upon de novo review of those portions of the record to which
objections were made, the district court judge may affirm or
reject the recommendations. See id. The Court is not required
to review the factual or legal conclusions of the magistrate
judge as to those portions of the report and recommendation to
which no objections are addressed. See Thomas v. Arn,
474 U.S. 140, 150, 106 S. Ct. 466, 88 L. Ed. 2d 435 (1985).
Judge Pohorelsky has recommended that this Court deny the Plaintiffs'
motions for a temporary restraining order and preliminary injunctive relief.
Plaintiffs filed timely objection to the magistrate's report and the defendants IVAX Corporation and
IVAX Pharmaceuticals, Inc. filed a timely response in opposition
to Plaintiffs' objections.
The Court has carefully reviewed all papers in connection with:
(1) all submissions by the parties in support of and opposition
to the grant of Plaintiffs' motions; (2) the transcript of the
proceedings held before Judge Pohorelsky on January 31, 2005; and
(3) the instant objections to the Report and Recommendation and
response thereto. In addition, this Court reviewed additional
submissions by the parties on the issue of irreparable harm and
heard proof and futher argument regarding this issue on May 23, 2005.
Applying the de novo standard of review, the Court adopts and
affirms the Report and Recommendation.
"A preliminary injunction is a drastic and extraordinary remedy
that is not to be routinely granted." Intel Corp. v. ULSI Sys.
Tech. Inc., 995 F.2d 1566, 1568 (Fed. Cir. 1993). While "grant
or denial of a preliminary injunction pursuant to 35 U.S.C. § 283
is within the discretion of the district court," Novo Nordisk of
N. Am., Inc. v. Genentech, Inc., 77 F.3d 1364, 1367 (Fed. Cir.
1996), the burden is always on the movant to make a clear showing
of entitlement to such relief. Intel, 995 F.2d at 1568. To
obtain preliminary injunctive relief, the movant must show four
factors: (1) reasonable likelihood of success on the merits; (2)
irreparable harm if preliminary injunction is not granted; (3)
that the balance of hardships tips in its favor; and (4) the
impact of the injunction on the public interest. Reebok Int'l,
Ltd. v. Baker, 32 F.3d 1552, 1555 (Fed. Cir. 1994); Hybritech,
Inc. v. Abbott Labs., 849 F.2d 1446, 1451 (Fed. Cir. 1988). Upon a patentee's failure to make a clear showing of any one of
the four factors, a trial court may deny the motion. Polymer
Techs., Inc. v. Bridwell, 103 F.3d 970, 973-4 (Fed. Cir. 1996).
Likelihood of Success on the Merits
To show a reasonable likelihood of success on the merits, the
movant must show infringement and validity of the patent.
Reebok, 32 F.3d at 1555. In his Report and Recommendation,
Judge Pohorelsky concluded that the Plaintiffs failed to satisfy
their burden of proving that either of the Defendants'
non-infringing and invalidity arguments lack substantial merit.
The Plaintiffs object and argue that the recommendation as to
each issue is clearly erroneous. This Court agrees with the sound
logic employed by Judge Pohorelsky and adopts the findings made
and the analysis performed by him.
Serious issues are raised by the Defendants as to whether the
Plaintiffs' claims fail under prior art or the doctrine of double
patenting. It is premature on this incomplete record to make
findings in that regard, but since the Plaintiffs have failed to
meet their burden of establishing that these issues are lacking
in merit, a preliminary injunction should not issue.
Having failed at showing a likelihood of success on the merits,
Plaintiffs are not entitled to the presumption of irreparable
harm. Eli Lilly and Co. v. American Cyanamid Co., 82 F.3d 1568,
1578 (Fed Cir. 1996). Judge Pohorelsky determined that Plaintiffs
failed to make a showing of irreparable harm based on the
following factors: (1) "most of [the harms alleged] emanate from
an expected sharp drop in revenue," which can be compensated with
money damages, particularly when the defendant would be able to
satisfy any judgment that may be entered against it; (2) loss of
the opportunity to develop other drugs is insufficient to constitute irreparable harm; (3) Plaintiffs failed to allege loss of a
business; (4) Plaintiffs' decision to bargain away its rights to
Mutual did not weigh in favor of Plaintiffs; and (5) Plaintiffs'
failure to disclose in its January 20, 2005, SEC Form 8-K that
its viability was in danger. (Report and Recommendation at 13-16.)
In their objections to Judge Pohorelsky's Report and
Recommendation (the "Objections"), Plaintiffs ask the Court to
consider that monetary damages do not preclude a finding of
irreparable harm; that there is a short period of time remaining
on the patent; that loss of research and development constitutes
irreparable harm; and that the Court ignored a nonbinding ...