Roche Palo Alto LLC v. Apotex, Inc.

• Decision Date: 11 September 2007
• Docket Number: No. C05-02116 MJJ.,C05-02116 MJJ.
• Citation: 526 F.Supp.2d 985
• Parties: ROCHE PALO ALTO LLC et al, Plaintiff; v. APOTEX, INC. et al, Defendant
• Court: U.S. District Court — Northern District of California

526 F.Supp.2d 985

ROCHE PALO ALTO LLC et al, Plaintiff; v. APOTEX, INC. et al, Defendant

No. C05-02116 MJJ.

United States District Court, N.D. California.

September 11, 2007.

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Alexander L. Brainerd, Nathan E. Shafroth, Samuel F. Ernst, Christine Saunders Haskett, Keith Robert Weed, Heller Ehrman LLP, Duane Daniel Bryon Nash, Heller Ehrman White & McAuliffe LLP, San Francisco, CA, for Plaintiff.

Alan H. Bernstein, Manny D. Pokotilow, Mona Gupta, Robert S. Silver, William J Castillo, Caesar Rivise Bernstein Cohen & Pokotilo, Philadelphia, PA, David Eric Goldman, Wendel Rosen Black & Dean LLP, Oakland, CA, Ronald Scott Lemieux, Paul Hastings Janofsky & Walker LLP, Palo Alto, CA, for Defendant.

Before the Court is Plaintiffs Roche Palo Alto LLC and Allergan, LLC's Motion For Summary Judgment. (Docket No. 52.)

For the following reasons, the Court GRANTS the Motion, as described in more detail below,

ORDER GRANTING PLAINTIFFS' MOTION FOR SUMMARY JUDGMENT

MARTIN J. JENKINS, District Judge.

INTRODUCTION

FACTUAL BACKGROUND

This case involves the same parties, and the same patent, as a previous matter litigated to judgment before this Court: Syntex v. Apotex, Case No. 3:01-cv-02214 MJJ ("Syntex"). As with Syntex, this case is about Defendants' proposal, in an Abbreviated New Drug Application ("ANDA") filed with the FDA, to make and sell a ketorolac tromethamine ("KT") ophthalmic solution, and whether that solution would infringe U.S. Patent No. 5,110,493 ("the '493 Patent") under 35 U.S.C. § 271(e)(2).

A. The Prior Syntex Litigation.

In the earlier Syntex litigation, Plaintiffs filed a complaint alleging that Defendants' ANDA 76-109 formulation infringed the '493 Patent. The drug for which Defendants sought approval pursuant to ANDA 76-109 was a 0.5% KT ophthalmic solution that was a generic copy of a 0.5% KT ophthalmic solution marketed by Plaintiffs known as ACULAR®. In Syntex, Defendants disputed whether their ANDA 76-109 formulation infringed the '493 Patent, and also argued (in the form of both affirmative defenses and counterclaims) that the '493 Patent was invalid and unenforceable. Specifically, with respect to invalidity, Defendants contended that the '493 patent was invalid on the grounds that it lacked utility, lacked enablement, failed to disclose the best mode, was indefinite, and was obvious. With respect to unenforceability, Defendants contended that Plaintiffs had committed inequitable conduct in prosecuting the '493 Patent.

After issuing a claim construction order, this Court granted summary judgment of infringement in favor of Plaintiffs in Syntex. The. Court then conducted a bench trial on the issues of invalidity and unenforceability of the '493 Patent, and issued Findings of Fact and Conclusions of Law that determined that the '493 Patent was valid and enforceable.

On an appeal brought by Defendants, the Federal Circuit affirmed this Court's claim construction and determination that there was no inequitable conduct, but remanded the case to this Court for further consideration of obviousness. See Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371 (Fed.Cir.2005). After further briefing and hearing on remand, this Court issued further Findings of Fact and Conclusions of Law in which it found, for a second time, that the '493 patent was not invalid based on obviousness. On a second appeal by Defendants, the Federal Circuit subsequently affirmed, in an April 9, 2007 order, this Court's determination that the '493 Patent is not invalid and is non-obvious.

On April 30, 2007, the Supreme Court issued its decision in KSR International Co. v. Teleflex Inc., ___ U.S. ___, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007) addressing the standards by which obviousness should be adjudicated. On May 3, 2007, contending that the KSR decision constituted a change in the law of obviousness, Defendants filed a motion with the Federal Circuit requesting that the Federal Circuit recall and stay its mandate in Syntex and accept a petition for rehearing by panel or en banc. The Federal Circuit summarily denied Defendants' motion on June 5, 2007. On July 9, 2007, Defendants filed a petition for a writ of certiorari with the United States Supreme Court, seeking to have the Federal Circuit's April 9, 2007 decision summarily Vacated and remanded. That petition is still pending.

B. The Current Litigation.

In 2005, Defendants submitted a second ANDA (ANDA 77-308) to the FDA, seeking approval for an 0.4% KT ophthalmic solution which would be a generic copy of a 0.4% KT ophthalmic solution marketed by Plaintiffs known as ACULAR LS®. Plaintiffs filed the complaint in this action against Defendants in May 2005, alleging that the ANDA 77-308 formulation infringes the '493 Patent. In their amended answer, Defendants contend that the ANDA 77-308 formulation does not infringe. They also, again argue (in the form of both affirmative defenses and counterclaims) that the '493 Patent is invalid and unenforceable. With respect to invalidity, Defendants this time contend that the '493 patent is invalid on the grounds that it lacks utility, lacks enablement fails to disclose the best mode, is indefinite, is obvious, and constitutes obviousness-type double patenting. With respect to unenforceability, Defendants again contend that Plaintiffs committed inequitable conduct in prosecuting the '493 Patent,

LEGAL STANDARD

Rule 56(c) of the Federal Rules of Civil Procedure authorizes summary judgment if there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The moving party bears the initial burden of demonstrating the basis for the motion and identifying the portions of the pleadings, depositions, answers to interrogatories, affidavits, and admissions on file that establish the absence of a triable issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). If the moving party meets this initial burden, the burden then shifts to the non-moving party to present specific facts showing that there is a genuine issue for trial. Fed.R.Civ.P. 56(e); Celotex, 477 U.S. at 324, 106 S.Ct. 2548; Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586-87, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). The non-movant's bare assertions, standing alone, are insufficient to create a material issue of fact and defeat a motion for summary judgment. Anderson, 477 U.S. at 247-48, 106 S.Ct. 2505. An issue of fact is material if, under the substantive law of the case, resolution of the factual dispute might affect the case's outcome. Id. at 248, 106 S.Ct. 2505. Factual disputes are genuine if they "properly can be resolved in favor of either party." Id. at 250, 106 S.Ct. 2505, Thus, a genuine issue for trial exists if the non-movant presents evidence from which a reasonable jury, viewing the evidence in the light most favorable to that party, could resolve the material issue in its favor. Id. However, "[i]f the [nonmovant's] evidence is merely colorable, or is not significantly probative, summary judgment may be granted." Id. at 249-50, 106 S.Ct. 2505 (internal citations omitted).

ANALYSIS

A, Plaintiffs Are Entitled To Summary Judgment Of Infringement.

Submission of, an ANDA is an act of patent infringement if the ANDA seeks approval for a drug that is claimed in a patent or the use of which is claimed in a patent. 35 U.S.C. § 271(e). Determination of patent infringement is a two-step analysis. The first step is to construe, or interpret, a claim of the patent. See Gart v. Logitecli, Inc., 254 F.3d 1334, 1339 (Fed. Cir.2001). The second step is to determine whether every limitation of the properly construed claim is found in the accused device, either literally or under the doctrine of equivalents. See id.

1. Defendants Do Not Dispute That Each Limitation Of Claims 1-5, 15 & 16 Literally Reads On The ANDA 77-308 Formulation.

Plaintiffs contend that Defendants have admitted, in responses to requests for admission, that all of the claim limitations contained in claims 1-5, 15 and 16 of the 493 Patent literally read on, the ANDA 77-308 formulation. The Court agrees.

Determination of which terms in the '493 Patent claims constitute claim limitations, and construction of those terms deemed limitations, was previously addressed by this Court in Syntex. At that time, this Court determined that the Court determined that "stabilizing" and "antimicrobially effective" are not claim limitations, and arrived at constructions of the other limitations. Defendants do not challenge the correctness of this Court's prior claim construction rulings, here, and in any event, issue preclusion would prevent Defendants from relitigating these claim construction issues. See Del Mar Avionics, Inc. v. Quinton Instrument Co., 836 F.2d 1320, 1323 (Fed.Cir.1987). The Court's claim constructions from Syntex are binding on Defendants.

Defendants also do not dispute that their responses to Plaintiffs' requests for admission admit that each of the limitations of claims 1-5 & 15-16 of the '493 Patent is literally met by the ANDA 77-308 formulation. (See Shafroth Decl., Exh. 4, Admitted Request For Admission Nos. 1-5, 7, 12 (for claims. 1-4); id., Admitted Request For Admission. Nos. 1-5, 7, 12-14, 16-17, 19-20 (for claim 5); id., Admitted Request For Admission. Nos. 2-5, 7, 22 (for claims 15-16).) The Court therefore finds that it is undisputed that each of the limitations of claims 1-5 & 15-16 of the '493 Patent is literally met by the ANDA 77-308 formulation.

2. Because Defendants' Reverse Doctrine of Equivalents Argument Lacks Any Support In The Claims, Specification, Prosecution History or Prior Art, It Fails As A Matter Of Law.

Defendants contend that summary judgment of infringement is nonetheless inappropriate because they...