United States District Court, N.D. California
ORDER DENYING MOTION TO SEPARATE EQUITABLE
RICHARD SEEBORG United States District Judge
Sandoz Inc., Sandoz International GmbH, Sandoz GmbH, and Lek
Pharmaceuticals d.d. (collectively, “Sandoz”)
move to separate Plaintiff Amgen's claims for injunctive
relief until after the merits of Amgen's patent
infringement suit have been resolved by jury trial. Pursuant
to Civil Local Rule 7-1 (b), the motion is suitable for
disposition without oral argument and the hearing set for
September 14, 2017 is vacated. Because Sandoz has not met its
burden of proving that bifurcation is warranted, its motion
patent disputes at issue between Amgen and Sandoz began in
2014. They involve two different products and two different
cases brought under the Biologics Price Competition and
Innovation Act (“BPCIA”). The first case involves
Sandoz's efforts to make and market a biosimilar version
of Amgen's pharmaceutical product filgrastim. This second
case involves similar efforts related to an Amgen
pharmaceutical called pegfilgrastim. While Sandoz's
biosimilar filgrastim product has been approved by the FDA,
its pegfilgrastim biosimilar will not be approved until 2019
at the earliest. Both cases are on the same discovery and
trial schedules. Fact discovery closed on June 23, 2017.
Expert discovery closes on October 6, 2017. Trial is set for
March 26, 2018.
motion at issue stems from a discovery dispute. In April of
2017, Amgen sought discovery of Sandoz's financial
projections for its pegfilgrastim biosimilar including
information related to FDA approval, marketing, and sales.
Sandoz refused to produce documents or a witness on such
topics. The parties subsequently submitted letter briefs
outlining their positions and, on July 17, 2017, the
magistrate judge overseeing discovery ruled that Sandoz was
required to produce the material. The magistrate judge noted
that the requested information regarding Sandoz's
pegfilgrastim biosimilar was relevant to Amgen's claims
for injunctive relief and those claims were set to be tried
before a jury in March 2018. Unless and until Sandoz obtained
a ruling limiting the issues being heard at trial, Amgen was
entitled to the discovery requested. In response to this
ruling, Sandoz filed the instant motion to separate
Amgen's claims for equitable relief.
Rule of Civil Procedure 42(b) permits district courts to
order a separate trial “of one or more separate issues,
claims, crossclaims, counterclaims, or third-party
claims” for purposes of “convenience, to avoid
prejudice, or to expedite and economize.” Fed.R.Civ.P.
42(b). Generally, a district court “has broad
discretion to bifurcate a trial to permit deferral of costly
and possibly unnecessary proceedings[.]” Jinro Am.
Inc. v. Secure Invs., Inc., 266 F.3d 993, 998 (9th Cir.
2001). Courts consider several factors in determining whether
bifurcation is appropriate including separability of the
issues, simplification of discovery, conservation of
resources, and prejudice to the parties. See Hirst v.
Gertzen, 676 F.2d 1252, 1261 (9th Cir. 1982); Arnold
v. United Artists Theatre Circuit, Inc., 158 F.R.D. 439,
459 (N.D. Cal. 1994). The party requesting bifurcation bears
the burden of proving it is warranted in a particular case.
Spectra-Physics Lasers, Inc. v. Uniphase Corp., 144
F.R.D. 99, 102 (N.D. Cal. 1992).
apparently believes that “bifurcation” is too
dramatic a word to describe its request and thus has styled
its motion as seeking to “separate equitable
relief.” Nonetheless, bifurcation is in fact what
support of its motion, Sandoz first argues that bifurcation
would promote efficiency and judicial economy because issues
regarding the validity of Amgen's patent and Sandoz's
alleged infringement must be decided before Amgen can seek
injunctive relief anyway. If Sandoz prevails on these earlier
issues, bifurcation would prevent the unnecessary waste of
time or resources involved in addressing injunctive relief.
Second, Sandoz argues that Amgen would not suffer prejudice
as a result of bifurcation because: a) Amgen has no right to
a jury trial for the issue of injunctive relief; b) there is
minimal overlap between the issues of injunctive relief and
the other issues to be tried; and c) if the jury finds that
Sandoz has infringed on Amgen's patent, Sandoz would then
provide immediate discovery of its pegfilgrastim biosimilar
financials as needed to litigate the issue of injunctive
relief. Lastly, Sandoz argues it would suffer prejudice if
the proceedings were not bifurcated because: a) revealing the
information sought by Amgen would put it at a competitive
disadvantage; and b) providing the information would require
depositions and written discovery that would burden the
parties as they prepare for trial.
in response, argues that bifurcation would not promote
judicial economy and would in fact cause Amgen to suffer
prejudice. With regard to economy, Amgen asserts that: a)
Sandoz's motion comes too late (after the close of fact
discovery) to conserve resources through a stay on discovery;
b) it would be more efficient for the parties to complete
discovery now in accordance with their stipulated case
schedule than to wait until after trial to conduct further
discovery of information Sandoz currently possesses; and c)
the documentary and witness evidence presented at trial will
overlap with evidence relating to Amgen's claim for
equitable relief and would be more efficiently addressed all
at once. With regard to prejudice, Amgen argues: a) it should
not be denied access to information that may be relevant to
the resolution of issues raised at the jury trial; b) Amgen
has already produced analogous financial information to that
which Sandoz now seeks to withhold; and c) Amgen has until
now prepared for trial and conducted discovery based on an
understanding that equitable issues would not be bifurcated.
Finally, Amgen asserts that the prejudice Sandoz alleges it
will suffer is contingent on Amgen improperly using the
information it receives from Sandoz and thus violating the
Protective Order already in effect in this case.
has not met its burden of proving that bifurcation is
warranted. First, it is not clear that bifurcation would
conserve judicial resources. While Sandoz is correct that the
issue of injunctive relief will be decided by the Court not
by the jury, it is far from clear that evidence related to
injunctive relief (including the material Amgen seeks to
discover) will prove irrelevant to other issues in the case.
It seems quite possible that Sandoz's proposed bifurcated
approach would end up requiring a post-trial hearing to
resolve the issue of injunctive relief that involves live
witnesses who will have already testified at trial.
the prejudice that Sandoz claims it will suffer is
overstated. The burden on Sandoz of providing Amgen with its
pegfilgrastim biosimilar financials via deposition and
documentary discovery, as ordered by the magistrate judge in
July, seems less significant than the burden that might be
imposed on the Court and on both parties should supplemental
discovery be required after trial. Furthermore, Sandoz's
claim that the financial information it produces to Amgen
might put it at a competitive disadvantage is predicated on