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Ferring B. v. V. Apotex, Inc.

United States District Court, D. Nevada

April 7, 2014

FERRING B. V. Plaintiff,
v.
APOTEX, INC. et al., Defendants.

ORDER

ROBERT C. JONES, District Judge.

The Court recently held a bench trial on four cases (the "Consolidated Cases") arising out of several defendants' manufacture and prospective sale of (and applications to the Food and Drug Administration ("FDA") to manufacture and sell) generic versions of tranexamic acid tablets, a drug patented by the plaintiff. The present case is related to the Consolidated Cases but was not filed until October 25, 2013 and was not tried together with them. Pending before the Court is Plaintiff's Motion for Temporary Restraining Order and Order to Show Cause ("TRO") (ECF No. 31). For the reasons given herein, the Court grants the motion in part. For the reasons given herein, the Court denies a TRO but will order Plaintiffs to show cause why a preliminary injunction should not issue.

I. FACTS AND PROCEDURAL HISTORY

These five related cases arise out of the alleged infringement of Plaintiff Ferring B.V.'s ("Ferring") tranexamic acid-related patents: (1) U.S. Patent No. 7, 947, 739 for tranexamic acid tablets sold under the trademark Lysteda® (the "739 Patent"), ( see Compl. ¶¶ 13-17, July 7, 2011, ECF No. 1 in Case No. 3:11-cv-481; Compl. ¶¶ 9-13, July 8, 2011, ECF No. 1 in Case No. 3:11-cv-485); (2) U.S. Patent No. 8, 022, 106 for tranexamic acid formulations and methods of treating menorrhagia therewith (the "106 Patent"), ( see Compl. ¶¶ 13-17, Nov. 25, 2011, ECF No. 1 in Case No. 3:11-cv-00853; Compl. ¶¶ 9-13, Nov. 25, 2011, ECF No. 1 in Case No. 3:11cv-00854); and (3) U.S. Patent No. 8, 487, 005 for tranexamic acid formulations and methods of treating menorrhagia therewith (the "'005 Patent"), ( see Compl. ¶¶ 9-13, Oct. 25, 2013, ECF No. 1). In the 481 and 485 Cases, respectively, Ferring sued several Watson Labs entities (collectively, "Watson Defendants") and several Apotex entities (collectively, "Apotex Defendants") in this Court for infringing the 739 Patent. In the 853 and 854 Cases, respectively, Ferring sued several Watson Defendants and several Apotex Defendants in this Court for infringing the 106 Patent. In the present case, Ferring has sued Apotex Defendants for infringing the 005 Patent.

The Court has consolidated the cases, except the present case, with the 481 Case as the lead case. In the Consolidated Cases, the Court ruled on several pre-trial motions, held a Markman hearing, issued a claim construction order, held a bench trial, and gave its findings of fact and conclusions of law from the bench, requesting counsel to draft a written order. The parties have since filed several motions disputing the language of the proposed order, and the Court has held a hearing to clarify its instructions.

II. LEGAL STANDARDS

Under Fed.R.Civ.P. 65(b), a plaintiff must make a showing that immediate and irreparable injury, loss, or damage will result to plaintiff without a temporary restraining order. Temporary restraining orders are governed by the same standard applicable to preliminary injunctions. See Cal. Indep. Sys. Operator Corp. v. Reliant Energy Servs., Inc., 181 F.Supp.2d 1111, 1126 (E.D. Cal. 2001) ("The standard for issuing a preliminary injunction is the same as the standard for issuing a temporary restraining order."). The standard for obtaining ex parte relief under Rule 65 is very stringent. Reno Air Racing Ass'n v. McCord, 452 F.3d 1126, 1130 (9th Cir. 2006). The temporary restraining order "should be restricted to serving [its] underlying purpose of preserving the status quo and preventing irreparable harm just so long as is necessary to hold a hearing, and no longer." Granny Goose Foods, Inc. v. Bhd. of Teamsters & Auto Truck Drivers Local No. 70, 415 U.S. 423, 439 (1974).

The Court of Appeals in the past set forth two separate sets of criteria for determining whether to grant preliminary injunctive relief:

Under the traditional test, a plaintiff must show: (1) a strong likelihood of success on the merits, (2) the possibility of irreparable injury to plaintiff if preliminary relief is not granted, (3) a balance of hardships favoring the plaintiff, and (4) advancement of the public interest (in certain cases). The alternative test requires that a plaintiff demonstrate either a combination of probable success on the merits and the possibility of irreparable injury or that serious questions are raised and the balance of hardships tips sharply in his favor.

Taylor v. Westly, 488 F.3d 1197, 1200 (9th Cir. 2007). "These two formulations represent two points on a sliding scale in which the required degree of irreparable harm increases as the probability of success decreases." Id.

The Supreme Court recently reiterated, however, that a plaintiff seeking an injunction must demonstrate that irreparable harm is "likely, " not just possible. Winter v. NRDC, 555 U.S. 7, 19-23 (2008) (rejecting the Ninth Circuit's alternative "sliding scale" test). The Court of Appeals has recognized that the "possibility" test was "definitively refuted" in Winter, and that "[t]he proper legal standard for preliminary injunctive relief requires a party to demonstrate that he is likely to succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in his favor, and that an injunction is in the public interest.'" Stormans, Inc. v. Selecky, 586 F.3d 1109, 1127 (9th Cir. 2009) (quoting Winter, 129 S.Ct. at 374) (reversing a district court's use of the Court of Appeals' pre- Winter, "slidingscale" standard and remanding for application of the proper standard).

A Court of Appeals ruling relying largely on the dissenting opinion in Winter parsed the language of Winter and subsequent Court of Appeals rulings and determined that the sliding scale test remained viable when there was a lesser showing of likelihood of success on the merits amounting to "serious questions, " but not when there is a lesser showing of likelihood of irreparable harm. See Alliance for the Wild Rockies v. Cottrell, 632 F.3d 1127, 1134 (9th Cir. 2011). This case presents some difficulty in light of Winter and prior Court of Appeals cases. To the extent Cottrell 's interpretation of Winter is inconsistent with Selecky, Selecky controls. See Miller v. Gammie, 335 F.3d 889, 899 (9th Cir. 2003) (en banc) (holding that, in the absence of an intervening Supreme Court decision, only the en banc court may overrule a decision by a three-judge panel). In any case, the Supreme Court stated in Winter that "[a] plaintiff seeking a preliminary injunction must establish that he is likely to succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in his favor, and that an injunction is in the public interest." Winter, 555 U.S. at 20 (citing Munaf v. Geren, 128 S.Ct. 2207, 2218-19 (2008); Amoco Prod. Co. v. Gambell, 480 U.S. 531, 542 (1987); Weinberger v. Romero-Barcelo, 456 U.S. 305, 311-12 (1982)) (emphases added). The test is presented as a four-part conjunctive test, not as a four-factor balancing test, and the word "likely" modifies the success-on-the-merits prong in exactly the same way it separately modifies the irreparable-harm prong. In rejecting the sliding-scale test, the Winter Court emphasized the fact that the word "likely" modifies the irreparable-injury prong, see id. at 22, and the word modifies the success-on-the-merits prong the same way, see id. at 20. In dissent, Justice Ginsburg opined that she did not believe the Court was abandoning the rule that it was permissible to "award[ preliminary injunctive] relief based on a lower likelihood of harm when the likelihood of success is very high." Id. at 51 (Ginsburg, J., dissenting). But Justice Ginsburg, like the majority, did not address whether she believed relief could be granted when the chance of success was less than likely. A "lower likelihood" is still some likelihood. We are left with the language of the test, which requires the chance of success on the merits to be at least "likely."

In summary, to satisfy Winter, a movant must show that he is "likely" to succeed on the merits. According to a layman's dictionary, "likely" means "having a high probability of occurring or being true." Merriam-Webster Dictionary, http://www.merriam-webster.com/ dictionary/likely. Black's defines the "likelihood-of-success-on-the-merits test" more leniently as "[t]he rule that a litigant who seeks [preliminary relief] must show a reasonable probability of success...." Black's Law Dictionary 1012 (9th ed. 2009). The Court must reconcile the cases by interpreting the Cottrell "serious questions" requirement to be in harmony with the Winter / Selecky "likelihood" standard, not as being in competition with it. "Serious questions going to the merits" must therefore mean that there is at ...


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