The Court recently issued its findings of facts and conclusions of law following a 7 day bench trial in an ANDA case related to alleged infringement by Watson, Sandoz, and Paddock Laboratories of four patents (the ‘978, ‘359, ‘448, and ‘635 patents) that were listed in the Orange Book in connection with SANCTURA XR®, a once-a-day form of tropsium chloride used to treat overactive bladder. Allergan, Inc., et al. v. Watson Laboratories, Inc.-Florida, et al., C.A. No. 09-511 (GMS) (D. Del. Mar. 31, 2012). The Court directed the Clerk of Court to enter final judgment based on its findings that (1) the asserted claims of the patents-in-suit are invalid due to obviousness; (2) the asserted claims of the patents-in-suit are not invalid due to anticipation; (3) asserted claim 1 of the ‘978 patent and asserted claim 1 of the ‘449 patent are not invalid due to indefiniteness; (4) asserted claim 1 of the ‘359 patent is not invalid for failure to meet the written description requirement; and (5) the defendants’ proposed products infringe the asserted claims of the patents-in-suit assuming, arguendo, they are not invalid.
In XPRT Ventures, LLC v. eBay, Inc., et al., C.A. No. 10-595-SLR (D. Del. Mar. 26, 2012), after the completion of discovery and a couple weeks before the deadline for opening claim construction and summary judgment briefs, defendants filed an emergency motion to compel plaintiff to reduce the number of claims asserted in the case from sixty to twenty. Plaintiff opposed defendants’ motion arguing that, while it can and should reduce the number of claims, defendants’ motion was premature. Id. at 5. Plaintiff asked that the Court “permit XPRT the time to complete its analysis of the claims and to continue to assert all of the claims that do not contain duplicative issues of infringement or validity.” Id. at 6. Special Master White responded with the question, “if not now, then when? The time has come to present the issues in dispute to the Court in an orderly fashion.” Id. Because plaintiff “must know what claims will be pursued before preparing its claim construction brief[,]” Special Master White order plaintiff to disclose no more than 25 asserted claims by noon on the day plaintiff’s opening claim construction brief was due to be filed. Id.
In Cree, Inc. v. SemiLEDS Corporation, C.A. No. 10-866-RGA, Judge Andrews recently issued a claim construction opinion construing claim terms for five patents-in-suit involving semiconductor light emitting diode (“LED”) technology used for general lighting purposes. In the opinion, the Court construed the following terms:
“ohmic contact layer”
“conductive barrier layer”
“light extraction structures”
“wherein the metal contact forms on ohmic contact”
“is aligned with the non-transparent feature”
“in a region other than a reduced conductivity area of the surface of the p-type semiconductor layer”
“photon absorbing wire bond pad”
In St. Clair Intellectual Property Consultants, Inc. v. Hewlett-Packard Co., C.A. No. 10-425-LPS (D. Del. Mar. 28, 2012), Judge Stark clarified the pleading standard for an allegation of willful infringement. The defendant moved to strike the plaintiff’s willfulness allegations as insufficiently pled, prompting the plaintiff to move to amend its complaint. Id. at 1. The defendant argued that amendment would be futile because the plaintiff’s proposed amended willfulness allegations still failed to allege both the defendant’s “knowledge of the asserted patents and knowledge of the infringement.” Id. at 4. The Court rejected that argument, and clarified that a willfulness allegation is sufficiently pled if it “plead[s] facts giving rise to ‘at least a showing of objective recklessness’ of the infringement risk.” Id. (citing In re Seagate Technology, LLC, 497 F.3d 1360, 1371 (Fed. Cir. 2007)). Finding that the proposed amended complaint sufficiently pled willfulness under Seagate, the Court granted the plaintiff’s motion to amend and denied the defendant’s motion to strike as moot. Id. at 6.
In a recent memorandum opinion, Judge Stark denied a plaintiff’s motion to supplement its expert reports to address new infringement theories, and granted defendants summary judgment of non-infringement. St. Clair Intellectual Property Consultants, Inc. v. Matsushita Elec. Indus. Co., Ltd., et al., C.A. Nos. 04-1436-LPS, 06-404-LPS, 08-371-LPS (D. Del. Mar. 26, 2012). In November 2009, the Court issued a Report and Recommendation construing claims relating to digital camera technology which was consistent with the plaintiff’s proposed construction. The defendants filed objections to the Report and Recommendation, and before a decision was made whether to adopt the Report and Recommendation, the case was stayed pending the resolution of an appeal to the Federal Circuit in a related case where construction of the same claims was to be reviewed de novo. Id. at 4-5.
The Federal Circuit construed the claims consistently with the defendants’ proposals in this case, leading the defendants to move for summary judgment of non-infringement. Id. at 5-6. In response, the plaintiff moved to supplement its expert reports to address why the defendants infringed even under the Federal Circuit’s construction. Id. The Court viewed the plaintiff’s motion to supplement as a motion to add infringement contentions far beyond the deadline under the scheduling order. Id. at 8. Accordingly, the Court considered whether the plaintiff should be permitted to add infringement contentions based on the “good cause” standard of Rule 16. Id. at 9.
The Court concluded that the plaintiff could not show good cause, explaining that the plaintiff “made a tactical decision to not assert its infringement theories under Defendants’ proposed claim constructions … despite the fact that … the PTO applied the Defendants’ construction during the reexamination” in the related case, the plaintiff knew that its preferred construction was being appealed to the Federal Circuit in that related case, and claim construction in this case had not been resolved as of the deadline for expert reports or infringement contentions. Id. at 10. The Court explained, in denying the motion to supplement, “[a] strategic mistake does not equate to a showing of good cause under Rule 16.” Id. at 11. The Court next explained that exclusion of the plaintiffs’ expert reports, although an extreme sanction, was appropriate under Rule 37 and Pennypack because “the fact remains that [the plaintiff] violated the Scheduling Orders when it failed to raise all of its infringement contentions at the appropriate time.” Id. at 13. The Court also emphasized the prejudice to the defendants that would result from allowing the plaintiff to assert new infringement contentions at this stage, a prejudice that could not be cured completely, and that allowing supplementation would significantly prolong the litigation. Finally, and perhaps most critically, the Court noted the lack of a valid explanation for the plaintiff’s failure to timely disclose its infringement contentions. Id. at 13-15.
Because the plaintiff included its new infringement contentions in expert declarations filed in response to the defendant’s motions for summary judgment, the Court had opportunity to consider them. The Court found that the defendants would have been entitled to summary judgment of non-infringement even under the plaintiff’s new theories, lessening the ultimate severity of the Court’s decision. Id. at 23-26.
After a recent bench trial in a Hatch-Waxman infringement suit, the court entered a judgment of infringement with respect to two patents and noninfringement and invalidity with respect to two other patents. The court then denied cross-motions to amend judgment, finding that the parties had not met the high burden of showing a “manifest error of law or fact.” Alcon Research Ltd. v. Barr Laboratories Inc., C.A. No. 09-318-LDD (March 16, 2012) at 2.
Looking first at the arguments of Alcon Research, the court rejected the contention that it should not have made findings that neither party’s experts requested. This position, the court explained, was incorrect because a District Court has discretion to make findings of fact relevant to its decision and it “would not act prudently by merely parroting the position of one expert or another, especially when [it has] concerns about those experts.” Id. at 3. The court also refused to amend findings that it found were supported by the facts and rejected arguments that were not advanced at trial, as a motion to amend findings does not allow a party a “second bite at the apple.” Id. at 4-7.
The court then turned to the arguments of ANDA product manufacturer Barr Laboratories. Barr argued that, although Alcon had never actively litigated two patents during the course of the trial, Alcon also had not dismissed those patents from its complaint. The court had denied judgment as a matter of law of noninfringement on these two patents at the close of Alcon’s case because Alcon had never placed them at issue. Barr argued then and on its motion to amend the judgment that because the patents had never been formally dismissed, it needed a judgment of noninfringement in order to launch its generic. Despite the “cursory manner” in which the issue was raised at trial, the court reached the merits of the motion and determined that under Tol-O-Matic Inc. v. Proma Produkt-Und Marketing Gesellschaft m.b.H., 945 F.2d 1546 (Fed. Cir. 1991) and 800 Adept, Inc. v. Murex Sec., Ltd., 539 F.3d 1354 (Fed. Cir. 2008), it had been correct to deny Barr’s motion for judgment of noninfringement. Under these cases, the court found, “a complaint alone cannot support a judgment on claims not actually placed in issue at trial.” Rather, a counterclaim or declaratory judgment claim is necessary to keep “the involved patent claims ‘at issue’ and give the patentee fair notice that he must introduce evidence of infringement at trial or risk an adverse judgment.” Id. at 13-19.
Judge Andrews recently issued a claim construction opinion in Shire LLC’s case against Teva Pharmaceuticals regarding a generic form of the pediatric ADHD drug Intuniv. Shire LLC v. Teva Pharmaceuticals USA Inc., C.A. No. 10-329-RGA (March 22, 2012). Judge Andrews construed the following terms of the three patents-in-suit:
- “without inducing excessive sedation”
- “readministering the dose at an interval required to obtain a desired level and duration of behavioral inhibition”
- “non-pH dependent sustained release agent”
- “pH dependent agent that increases the rate of release of said at least one pharmaceutically active agent from the tablet at a pH in excess of 5.5”
- “enteric agent”
- “agent that increases the solubility of said at least one pharmaceutically active agent at a pH of greater than 5.5”
- “agent that maintains an acidic microenvironment in the composition”
- “reducing the likelihood of side effects associated with the administration of guanfacine”
In AstraZeneca UK Limited, et al. v. Watson Laboratories, Inc., C.A. No. 10-915-LPS (D. Del. Mar. 13, 2012), Judge Stark recently granted Watson Laboratories, Inc.’s and EGIS Pharmaceuticals PLC’s motions to dismiss AstraZeneca’s claims of infringement of its ‘618 and ‘152 Patents under Section 271(e)(2). In a previous suit brought by AstraZeneca against different generic drug manufacturers, the Federal Circuit affirmed the district court’s dismissal of similar claims because the defendants “had not sought FDA approval for the method of use indications covered by the ‘618 and ‘152 patents.” Id. at 6. Judge Stark found that Watson had done the same thing here, i.e., “filed a Section 505(b)(2)(B) Statement certifying that it is not seeking FDA approval for the indications covered by the ‘618 and ‘152 patents.” Id.
Judge Stark also granted EGIS’s motion to dismiss AstraZeneca’s declaratory judgment claims that EGIS will induce infringement of the patents-in-suit upon FDA approval of Watson’s NDA. Id. at 10. Judge Stark found that the there was no substantial controversy of sufficient reality to warrant a declaratory judgment. Specifically, the “potentially infringing subject,” i.e., Watson’s proposed NDA label, “has not remained substantially fixed over time.” Id. at 11. Thus, “Watson’s label . . . does not provide the basis for a justiciable Article III controversy of sufficient ‘reality.’” Id.
In Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc., et al., C.A. No. 08-309-LPS (D. Del. Mar. 13, 2012), Judge Stark construed the following claim terms of the patents-in-suit:
“a feedback circuit coupled to receive a feedback signal”
“a control circuit coupled to generate a control signal in response to an output of the comparator and in response to an output of the feedback circuit”
“an oscillator for generating a signal having a switching frequency, the oscillator having a control input for varying the switching frequency”
“a controller to generate the switching signal in response to a first feedback signal associated with a voltage control loop and a second feedback signal associated with a current control loop in the primary-side of the transformer”
Judge Stark also denied plaintiff’s motion for summary judgment of infringement and defendants’ motions for summary judgment of non-infringement and invalidity because the Court concluded that there were genuine issues of material fact as to each motion.
In a recent opinion, Chief Judge Simandle of the District of New Jersey, sitting by designation pursuant to 28 U.S.C. § 292(b), held in connection with a motion to dismiss a declaratory judgment action for lack of subject matter jurisdiction that discovery requests in a case between the parties in another forum created an actual controversy. W.L. Gore & Assocs., Inc. v. AGA Medical Corp., C.A. No. 11-539 (JBS-KMW) (D. Del. Mar. 13, 2012). AGA filed suit against Gore in the District of Minnesota alleging that Gore’s occluder device for treating heart defects infringed the ‘738 patent. In that action, AGA sought discovery relating to a new Gore occluder device that was not accused in the Minnesota action. Id. at 5. Gore responded by filing a declaratory judgment action in the District of Delaware seeking a declaration that its new occluder device did not infringe the ‘738 patent, or the related ‘552 patent. Id. at 6. The Court found, with respect to the ‘738 patent, that “a substantial controversy existed at the time the action was commenced” because AGA served a discovery request in the Minnesota action relating to Gore’s new device and expressly told the Minnesota court that the discovery was justified because AGA might need to amend its complaint to include a claim based on the new device. Id. at 16. However, the Court held it lacked subject matter jurisdiction with respect to the ‘552 patent because it was not at issue in the Minnesota action and was not the subject of AGA’s discovery requests there. Id. at 15-16. Finally, the Court found it could not exercise personal jurisdiction over AGA because its Delaware sales amounted to less than 0.5% of its total sales, and it otherwise lacked continuous contacts with Delaware. Id. at 22. The Court rejected Gore’s argument that AGA was subject to specific personal jurisdiction in Delaware because it filed suit against Gore, a Delaware corporation, in Minnesota. The Court distinguished the situation before it from others where, for example, the patentee sends cease and desist letters into the forum state satisfying the forum’s long-arm statute. Here, in contrast, AGA did nothing to enforce its patent against Gore “in Delaware.” Id. at 24. As an alternative to dismissal under Rule 12(b)(2), the Court transferred the case to the District of Minnesota, AGA’s home state where the parties were litigating over the same patent. Id. at 25.