Amgen Inc. et al v. Sandoz Inc. et al

Filing 106

*** FILED IN ERROR. PLEASE SEE DOCKET # 107 . *** (cl, COURT STAFF) (Filed on 9/8/2017) Modified on 9/8/2017 (cl, COURT STAFF).

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UNITED STATES DISTRICT COURT

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NORTHERN DISTRICT OF CALIFORNIA

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AMGEN INC., et al.,

Case No. 16-cv-02581-RS

Plaintiffs,
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United States District Court
Northern District of California

v.

ORDER DENYING MOTION TO
SEPARATE EQUITABLE RELIEF

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SANDOZ INC., et al.,
Defendants.

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I. INTRODUCTION

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Defendants Sandoz Inc., Sandoz International GmbH, Sandoz GmbH, and Lek

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Pharmaceuticals d.d. (collectively, “Sandoz”) move to separate Plaintiff Amgen’s claims for

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injunctive relief until after the merits of Amgen’s patent infringement suit have been resolved by

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jury trial. Pursuant to Civil Local Rule 7-1(b), the motion is suitable for disposition without oral

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argument and the hearing set for September 14, 2017 is vacated. Because Sandoz has not met its

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burden of proving that bifurcation is warranted, its motion is denied.

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II. BACKGROUND
The patent disputes at issue between Amgen and Sandoz began in 2014. They involve two

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different products and two different cases brought under the Biologics Price Competition and

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Innovation Act (“BPCIA”). The first case involves Sandoz’s efforts to make and market a

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biosimilar version of Amgen’s pharmaceutical product filgrastim. This second case involves

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similar efforts related to an Amgen pharmaceutical called pegfilgrastim. While Sandoz’s

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biosimilar filgrastim product has been approved by the FDA, its pegfilgrastim biosimilar will not

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be approved until 2019 at the earliest. Both cases are on the same discovery and trial schedules.

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Fact discovery closed on June 23, 2017. Expert discovery closes on October 6, 2017. Trial is set

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for March 26, 2018.

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The 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

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related to FDA approval, marketing, and sales. Sandoz refused to produce documents or a witness

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on such topics. The parties subsequently submitted letter briefs outlining their positions and, on

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July 17, 2017, the magistrate judge overseeing discovery ruled that Sandoz was required to

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produce the material. The magistrate judge noted that the requested information regarding

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Sandoz’s pegfilgrastim biosimilar was relevant to Amgen’s claims for injunctive relief and those

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claims were set to be tried before a jury in March 2018. Unless and until Sandoz obtained a ruling

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limiting the issues being heard at trial, Amgen was entitled to the discovery requested. In response

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to this ruling, Sandoz filed the instant motion to separate Amgen’s claims for equitable relief.

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III. LEGAL STANDARD
Federal Rule of Civil Procedure 42(b) permits district courts to order a separate trial “of

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one or more separate issues, claims, crossclaims, counterclaims, or third-party claims” for

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purposes of “convenience, to avoid prejudice, or to expedite and economize.” Fed. R. Civ. P.

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42(b). Generally, a district court “has broad discretion to bifurcate a trial to permit deferral of

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costly and possibly unnecessary proceedings[.]” Jinro Am. Inc. v. Secure Invs., Inc., 266 F.3d 993,

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998 (9th Cir. 2001). Courts consider several factors in determining whether bifurcation is

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appropriate including separability of the issues, simplification of discovery, conservation of

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resources, and prejudice to the parties. See Hirst v. Gertzen, 676 F.2d 1252, 1261 (9th Cir. 1982);

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Arnold v. United Artists Theatre Circuit, Inc., 158 F.R.D. 439, 459 (N.D. Cal. 1994). The party

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requesting bifurcation bears the burden of proving it is warranted in a particular case. Spectra-

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Physics Lasers, Inc. v. Uniphase Corp., 144 F.R.D. 99, 102 (N.D. Cal. 1992).

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ORDER DENYING MOTION TO SEPARATE EQUITABLE RELIEF
CASE NO. 16-cv-02581-RS

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IV. DISCUSSION

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Sandoz apparently believes that “bifurcation” is too dramatic a word to describe its request

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and thus has styled its motion as seeking to “separate equitable relief.” Nonetheless, bifurcation is

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in fact what Sandoz seeks.

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In support of its motion, Sandoz first argues that bifurcation would promote efficiency and

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judicial economy because issues regarding the validity of Amgen’s patent and Sandoz’s alleged

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infringement must be decided before Amgen can seek injunctive relief anyway. If Sandoz prevails

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on these earlier issues, bifurcation would prevent the unnecessary waste of time or resources

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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

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United States District Court
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injunctive relief; b) there is minimal overlap between the issues of injunctive relief and the other

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issues to be tried; and c) if the jury finds that Sandoz has infringed on Amgen’s patent, Sandoz

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would then provide immediate discovery of its pegfilgrastim biosimilar financials as needed to

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litigate the issue of injunctive relief. Lastly, Sandoz argues it would suffer prejudice if the

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proceedings were not bifurcated because: a) revealing the information sought by Amgen would

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put it at a competitive disadvantage; and b) providing the information would require depositions

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and written discovery that would burden the parties as they prepare for trial.

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Amgen, in response, argues that bifurcation would not promote judicial economy and

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would in fact cause Amgen to suffer prejudice. With regard to economy, Amgen asserts that: a)

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Sandoz’s motion comes too late (after the close of fact discovery) to conserve resources through a

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stay on discovery; b) it would be more efficient for the parties to complete discovery now in

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accordance with their stipulated case schedule than to wait until after trial to conduct further

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discovery of information Sandoz currently possesses; and c) the documentary and witness

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evidence presented at trial will overlap with evidence relating to Amgen’s claim for equitable

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relief and would be more efficiently addressed all at once. With regard to prejudice, Amgen

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argues: a) it should not be denied access to information that may be relevant to the resolution of

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issues raised at the jury trial; b) Amgen has already produced analogous financial information to

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ORDER DENYING MOTION TO SEPARATE EQUITABLE RELIEF
CASE NO. 16-cv-02581-RS

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that which Sandoz now seeks to withhold; and c) Amgen has until now prepared for trial and

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conducted discovery based on an understanding that equitable issues would not be bifurcated.

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Finally, Amgen asserts that the prejudice Sandoz alleges it will suffer is contingent on Amgen

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improperly using the information it receives from Sandoz and thus violating the Protective Order

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already in effect in this case.

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Sandoz has not met its burden of proving that bifurcation is warranted. First, it is not clear

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that bifurcation would conserve judicial resources. While Sandoz is correct that the issue of

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injunctive relief will be decided by the Court not by the jury, it is far from clear that evidence

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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

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would end up requiring a post-trial hearing to resolve the issue of injunctive relief that involves

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live witnesses who will have already testified at trial.

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Second, the prejudice that Sandoz claims it will suffer is overstated. The burden on Sandoz

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of providing Amgen with its pegfilgrastim biosimilar financials via deposition and documentary

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discovery, as ordered by the magistrate judge in July, seems less significant than the burden that

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might be imposed on the Court and on both parties should supplemental discovery be required

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after trial. Furthermore, Sandoz’s claim that the financial information it produces to Amgen might

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put it at a competitive disadvantage is predicated on the belief that Amgen might improperly use

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that information in violation of the Protective Order, a premise which Sandoz offers no basis to

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presume.

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These cases started years ago and fact discovery has already closed. The bifurcated

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approach that Sandoz proposes risks further prolonging the dispute between the parties well

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beyond the March trial for which both have been preparing for some time. Taking such a course

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might delay resolution of the dispute and could end up imposing greater burdens on the Court and

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the parties over the long term. The better and more efficient approach is to deal with any

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depositions and discovery that might be relevant now so that the trial in March can conclusively

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address all aspects of the dispute.

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ORDER DENYING MOTION TO SEPARATE EQUITABLE RELIEF
CASE NO. 16-cv-02581-RS

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V. CONCLUSION

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Sandoz’s motion to separate equitable relief is denied.

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IT IS SO ORDERED.

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Dated:
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RICHARD SEEBORG
United States District Judge

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United States District Court
Northern District of California

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ORDER DENYING MOTION TO SEPARATE EQUITABLE RELIEF
CASE NO. 16-cv-02581-RS

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