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Isis Pharmaceuticals, Inc. v. Santaris Pharma A/S Corp.

United States District Court, S.D. California

May 28, 2014

ISIS PHARMACEUTICALS, INC., a Delaware Corporation, Plaintiff,
SANTARIS PHARMA A/S CORP., a Delaware Corporation, and SANTARIS PHARMA A/S, a Danish Corporation, Defendants. AND RELATED COUNTERCLAIMS.


GONZALO P. CURIEL, District Judge.

Prior to this patent infringement case's transfer to the undersigned, the Honorable Barry Ted Moskowitz, Chief Judge, denied Defendants' first motion for summary judgment as to whether Defendants' allegedly infringing conduct fell within the "safe harbor" provided by 35 U.S.C. § 271(e)(1). (ECF No. 53.) On February 27, 2014, after a lengthy period of limited discovery, this Court denied Defendants' second motion for summary judgment on the safe harbor issue. (ECF No. 250.)

Presently before the Court is Defendants' motion for reconsideration of this Court's February 27, 2014 order, (ECF No. 258), which has been fully briefed, (ECF Nos. 266, 268), and which the Court finds suitable for disposition without oral argument, see CivLR 7.1.d.1.

Defendants ask the Court to reconsider three aspects of its February 27, 2014 order:

1. The Court's reading of Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2012), and Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012), as standing for the proposition that, "regardless of the stage of the regulatory process in which a patented invention is used to obtain information, the information derived from using the patented invention must be reasonably related' to the type of information required by the FDA at some point during the regulatory process."
2. The Court's conclusion that Santaris's act of entering into contracts with U.S. pharmaceutical companies to discover and develop drugs that the pharmaceutical companies may submit to the FDA does not, as a matter of law, fall within the safe harbor.
3. The Court's conclusion that the term "patented invention, " as used in 35 U.S.C. § 271(e)(1), means inventions that would be eligible for a patent extension under 35 U.S.C. § 156 or inventions that are themselves subject to regulatory approval.

(ECF No. 258-1.)

In the alternative, Defendants ask the Court to certify its February 27, 2014 order for interlocutory appeal.

1. Reconsideration

a. Legal Standards

District courts have the discretion to reconsider interlocutory rulings until a final judgment is entered. Fed.R.Civ.P. 54(b); United States v. Martin, 226 F.3d 1042, 1048-49 (9th Cir. 2000). While the Federal Rules of Civil Procedure do not set forth a standard for reconsidering interlocutory rulings, the "law of the case" doctrine and public policy dictate that the efficient operation of the judicial system requires the avoidance of re-arguing questions that have already been decided. See Pyramid Lake Paiute Tribe of Indians v. Hodel, 882 F.2d 364, 369 n.5 (9th Cir. 1989).

As such, most courts adhere to a fairly narrow standard by which to reconsider their interlocutory rulings. This standard requires that the party show: (1) an intervening change in the law; (2) additional evidence that was not previously available; or (3) that the prior decision was based on clear error or would work manifest injustice. Id .; Marlyn Natraceuticals, Inc. v. Mucos Pharma GmbH & Co., 571 F.3d 873, 880 (9th Cir.2009); Sch. Dist. No. 1J v. ACandS, Inc., 5 F.3d 1255, 1263 (9th Cir.1993).

Reconsideration is an "extraordinary remedy, to be used sparingly in the interests of finality and conservation of judicial resources." Kona Enters., Inc. v. Estate of Bishop, 229 F.3d 877, 890 (9th Cir. 2000). "A motion for reconsideration is not an opportunity to renew arguments considered and rejected by the court, nor is it an opportunity for a party to re-argue a motion because it is dissatisfied with the original outcome.'" FTC v. Neovi, Inc., 2009 WL 56130, at *2 (S.D. Cal. Jan. 7, 2009) (quoting Devinsky v. Kingsford, 2008 WL 2704338, at *2 (S.D.N.Y. July 10, 2008)).

In addition to these substantive standards, Civil Local Rule 7.1.i.1 requires a party moving for reconsideration to submit an affidavit or certified statement of an attorney

setting forth the material facts and circumstances surrounding each prior application, including inter alia: (1) when and to what judge the application was made, (2) what ruling or decision or order was made thereon, and (3) what new or different facts and circumstances are claimed to ...

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