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Spectrum Pharmaceuticals, Inc. v. Innopharma, Inc.

United States District Court, D. Delaware

May 22, 2015

SPECTRUM PHARMACEUTICALS, INC. and UNIVERSITY OF STRATHCLYDE, Plaintiffs,
v.
INNOPHARMA, INC., MYLAN TEORANTA, MYLAN INSTITUTIONAL LLC, and MYLAN INSTITUTIONAL INC., Defendants.

REPORT AND RECOMMENDATION

CHRISTOPHER J. BURKE, Magistrate Judge.

Pending before the Court in this patent infringement action are three summary judgment motions. Defendants Mylan Teoranta, Mylan Institutional LLC, and Mylan Institutional Inc. (collectively, "Defendants") filed a Motion for Summary Judgment of Noninfringement of Claims 5 through 14 of U.S. Patent No. 6, 500, 829 (the "'829 patent") ("Defendants' Non-infringement Motion"), (D.I. 197), and a Motion for Summary Judgment of Invalidity of Claims 1 and 2 of the '829 Patent ("Defendants' Invalidity Motion"), (D.I. 196). Plaintiffs Spectrum Pharmaceuticals, Inc. ("Spectrum") and the University of Strathclyde (collectively, "Plaintiffs") filed a single motion, entitled Motion for Summary Judgment that Rees 1986 Does Not Invalidate the '829 Patent ("Plaintiffs' Validity Motion"), (D.I. 204). During the pendency of these motions, a parallel District of Nevada action on the '829 patent proceeded to trial, involving the same Plaintiffs and similar accused products, and the District of Nevada held that certain claims of the '829 patent are invalid or not infringed. ( Spectrum Pharms., Inc. v. Sandoz Inc., Civil Action Number 12-111-GMN-RJJ (D. Nev.) (the "Nevada Action"), D.I. 313, 365) In light of that development, both Plaintiffs and Defendants have submitted letter briefs arguing that the pending motions cannot be heard on their merits, and that the Court must instead resolve this action on collateral estoppel grounds. ( See D.I. 263, 264, 266, 267) For the reasons that follow, the Court recommends that Defendants' Non-infringement Motion be GRANTED on collateral estoppel grounds as to claims 5-9 of the '829 patent and DENIED as moot with regard to claims 10-14 of the '829 patent, that Defendants' Invalidity Motion be GRANTED on collateral estoppel grounds, that Plaintiffs Validity Motion be DENIED as moot, and that judgment be entered in favor of Defendants.

I. BACKGROUND

A. The Patent-in-Suit

Plaintiffs assert infringement of the '829 patent, entitled "Substantially Pure Diastereoisomers of Tetrahydrofolate Derivatives[.]" (D.I. 1, ex. A) The patent issued on December 31, 2002. ( Id. ) At the time of its issue, the '829 patent was assigned to the University of Strathclyde, who subsequently issued an exclusive license to Spectrum. (D.I. 100 at ¶ 13)

The present invention centers on 5-formyltetrahydrofolic acid, a chemical compound commonly known as leucovorin. ('829 patent, col. 1:28-29) The leucovorin compound is composed of equal amounts of two diastereoisomers, referred to as the "(6S)" and "(6R)" diastereoisomers. (D.I. 47 at 2; D.I. 52 at 1) The '829 patent asserts, however, that a report from 1981 found that only the (6S) diastereoisomer - also known as levoleucovorin - is responsible for leucovorin's beneficial clinical effects. ('829 patent, col. 1:57-61; D.I. 52 at 2) Other reports suggested that the (6R) diastereoisomer might actually inhibit the beneficial effects of the (6S) diastereoisomer. ('829 patent, cols. 1:62-2:12) Accordingly, the present invention relates to the preparation of a substantially pure form of the desired (6S) diastereoisomer from leucovorin. ( Id., Abstract; id., Fig. 4; see also D.I. 52 at 3)

B. The Co-Pending Nevada Action

On January 20, 2012, prior to filing the present action, Plaintiffs brought an action for infringement of the '829 patent against Sandoz Inc. ("Sandoz") in the District of Nevada (the "Nevada Action"). (Nevada Action, D.I. 1 at ¶¶ 1, 22, 24) The Nevada Action has since proceeded through summary judgement, (Nevada Action, D.I. 313), and a bench trial, culminating in a judgment in favor of Sandoz, (Nevada Action, D.I. 365). The Nevada District Court held that claims 5-9 of the '829 patent were not infringed by Sandoz, (Nevada Action, D.I. 313 at 25), and that claims 1-2 of the '829 patent are invalid as obvious, (Nevada Action, D.I. 365 at 44-45). The Nevada Action is currently on appeal to the United States Court of Appeals for the Federal Circuit. (D.I. 270)

C. The Present Motions

This action was referred to the Court by Judge Richard G. Andrews on May 23, 2012, to hear and resolve all pretrial matters, up to and including the resolution of case-dispositive motions. Briefing on the pending motions for summary judgment was completed on December 9, 2014, (D.I. 242, 243, 245), and oral argument was requested on December 12, 2014, (D.I. 246). The Court held oral argument on the pending motions on March 10, 2015. Subsequent to the hearing, at the request of the parties, (D.I. 262), the Court issued an oral order allowing them to submit supplemental letter briefing regarding the issue of collateral estoppel in light of the decisions in the Nevada Action.[1]

II. STANDARD OF REVIEW

A. Summary Judgment

A grant of summary judgment is appropriate where "the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a). The moving party bears the burden of demonstrating the absence of a genuine issue of material fact. See Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 585-86 (1986). If the moving party meets this burden, the nonmovant must then "come forward with specific facts showing that there is a genuine issue for trial." Id. at 587 (emphasis in original) (internal quotation marks omitted). If the nonmoving party fails to make a sufficient showing on an essential element of its case with respect to which it has the burden of proof: the moving party is entitled to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986). During this process, the Court will "draw all reasonable inferences in favor of the nonmoving party, and it may not make credibility determinations or weigh the evidence." Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150 (2000).

However, in order to defeat a motion for summary judgment, the nonmoving party must "do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita, 475 U.S. at 586-87; see also Podobnik v. U.S. Postal Serv., 409 F.3d 584, 594 (3d Cir. 2005) (party opposing summary judgment "must present more than just bare assertions, conclusory allegations or suspicions to show the existence of a genuine issue") (internal quotation marks and citation omitted). The "mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986) (emphasis in original). Facts that could alter the outcome are "material, " and a factual dispute is genuine only where "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Id. at 248. "If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted." Id. at 249-50 (internal citations omitted). A party asserting that a fact cannot be - or, alternatively, is - genuinely disputed must support the assertion either by citing to "particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or ...


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