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In a recent Memorandum Opinion, Chief Judge Leonard P. Stark issued a claim construction construing claim terms across seven of the eight patents-in-suit in this ANDA litigation. Forest Laboratories, Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al., C.A. Nos. 14-121, 14-200, 14-508, 14-686, 14-1058, 14-1271-LPS (D. Del. Jan. 5, 2016). Among the terms construed, Judge Stark found two terms indefinite. First, Judge Stark found the term “change in memantine concentration as a function of time (dC/dT) that is less than 50% that of an immediate release dosage form comprising the same dose of memantine as the composition” indefinite. Judge Stark explained that “[a]s indicated in the claims, memantine concentration must be observed ‘as measured in a single-dose human PK study.’” Id. at 16. Judge Stark found that “[a] person of ordinary skill in the art would not know, with reasonable certainty, which ‘human PK study’ on which to rely when considering whether a formulation of memantine might infringe the [patents at issue].” Id. Judge Stark explained that the patents at issue “provide[] no guidance, other than non-limiting examples, regarding which concentration profile (or set of profiles) should be used when assessing potential infringement.” Id. at 16-17. Indeed, as Judge Stark noted, “[t]he specifications of the [patents at issue] do not disclose any human PK study. Rather, they disclose memantine concentration data generated from computer simulations.” Id. at 17. Judge Stark also found the term “change in plasma concentration as a function of time (dC/dT) in a defined time period of 0 to 6 hours after administration … that is less than about 50% of the dC/dT provided by the same quantity of an immediate release form of memantine in said defined time period” indefinite for the same reasons discussed above with respect to the “memantine concentration…” term. Id. at 20. Specifically, “the ‘human PK study’ limitation (which is present in all of the claims containing this term) does not give a POSA the required ‘reasonable certainty.’” Id. at 20.

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In Vehicle Interface Technologies, LLC v. Jaguar Land Rover North America, LLC, C.A. Nos. 12-1285-RGA & 14-339-RGA (D. Del. Dec. 28, 2016), Judge Richard G. Andrews concluded that the case was exceptional, but requested additional information from the parties in order to assess the appropriate time period for calculating fees.

The Court concluded that Plaintiffs’ attempt to assert seven additional products at the close of fact discovery supported a finding that the case was exceptional due to improperly motivated litigation conduct, given that the new contentions were largely based on public information that had long been available to Plaintiffs prior to their assertion of the additional products. Id. at 4-5. The Court also found that a portion of plaintiffs’ claim construction position, in their opposition to Defendants’ motion for summary judgment of anticipation based on a certain reference, had been objectively baseless, which also supported an exceptional case finding. See id. at 5-6.

Having found the case exceptional, the Court then determined that Defendants should be awarded fees from “the date [Plaintiffs] had full notice that its case was objectively baseless in light of” that same anticipatory reference, which had been disclosed in Defendants’ initial invalidity contentions. Id. at 9. The Court concluded that, until that time, there was a reasonable basis for Plaintiffs to pursue the case. But the Court requested additional information from the parties as to “whether the invalidity contentions narrowly focused on the [key reference] as anticipatory prior art or listed it among voluminous contentions,” in order for the Court to assess “at what point after [service of those contentions Plaintiffs] should have realized that its infringement claims were objectively baseless.” Id. at 9. The Court also requested that the parties “comment upon the significance of the fact that” earlier references in discovery to (what appeared to be) the key anticipatory art differed from the Court’s references in deciding summary judgment (i.e., earlier references were “2000 Mercedes ” whereas later references were “2001 Mercedes”). Id. at 9-10.

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In a recent memorandum opinion, Judge Richard G. Andrews denied motions for summary judgment of non-infringement and invalidity, but granted a motion for summary judgment of no willful infringement and no infringement by products shipped abroad.  M2M Solutions LLC v. Motorola Solutions, Inc., et al., C.A. No. 12-33-RGA (D. Del. Jan. 6, 2016).  The plaintiff’s willfulness claim was based entirely on the post-litigation assertion of what the plaintiff characterized as objectively unreasonable defenses.  Judge Andrews explained, “Plaintiff presents no evidence of pre-suit knowledge or conduct tending to establish objective recklessness.  Plaintiff simply argues the merits of Defendants’ post-suit defenses.  It has therefore not provided the necessary clear and convincing evidence to meet the objective first prong of Seagate.”  Id. at 35.  In a footnote, Judge Andrews added that “Defendants’ potentially dispositive claim construction arguments were reasonable, which in itself also prevents Plaintiff from proving the objective prong of Seagate.”  Id. n. 14.

Judge Andrews also granted a motion for summary judgment that offers made in the United States for foreign sales of infringing products, absent evidence that those infringing products ended up being imported into the United States, could not be the basis for a finding of infringement.  The Court explained that the Plaintiff “offers no evidence through which a jury could quantify, for purposes of calculating damages, how many of those products shipped abroad actually made it into the United States, if any. . . . Rather than providing an estimate of how many of these products enter the U.S. based on some reasonable projection grounded in facts, Plaintiff seeks to include all products shipped abroad in its damages calculation without proving that a single product shipped abroad actually made it into the U.S. . . . [B]ecause Plaintiff has failed to offer a shred of evidence that a single product shipped abroad, let alone all of them, made it into the U.S., the presumption against extraterritorial application of U.S. patent law must govern.”  Id. at 47.

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Judge Gregory M. Sleet recently considered defendant Roxane Laboratories, Inc.’s letter request to file a motion for summary judgment of invalidity for lack of patentable subject matter under 35 U.S.C. § 101.  Vanda Pharmaceuticals Inc. v. Roxane Laboratories, Inc., C.A. No. 13-1973-GMS (consol.) (D. Del. Dec. 30, 2015).  Judge Sleet denied the request finding disputed issues of material fact to be “properly determined at trial,” such as whether the asserted claims involve a law of nature combined with steps that are “routine and conventional,” and whether the claims at issue are analogous to those at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289, 1294 (2012).  Id. at 1 n.1.

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Judge Robinson previously granted a permanent injunction in this case in March 2014. The defendants have now moved for relief from continued application of that injunction, arguing that the rationale for the injunction has changed warranting modification of the injunction. Invista N.Am. S.A.R.L., et al. v. M&G USA Corp., et al., C.A. No. 11-1007-SLR, Memo. Or. at 1-2 (D. Del. Dec. 28, 2015).

Judge Robinson began her analysis of defendants’ request by rejecting the contention that the PTO’s invalidiation of the patent in suit during reexamination was grounds to modify the injunction because “the PTO’s determination is far from a final one, and . . . the Federal Circuit has already reviewed the ‘216 patent on appeal and affirmed the jury’s verdict of validity. Therefore, while the reexamination proceeding may be one factor to review in connection with defendants’ request for relief, it is by no means dispositive.” Id. at 3.

“With respect to the ‘different competitive reality’ that exists now,” however, Judge Robinson found that “the record before the court reflects several significant factors which have changed since (or were not apparent to the court in) March 2014.” Id. The Court’s prior determination that there were only two suppliers of products covered by the patented technology in the market (the plaintiff and the defendant) was no longer true in light of at least two other suppliers. “Moreover, the fact that plaintiffs have made no commercial in-roads with its . . . product since March 2014 indicates that the patented technology is not plaintiffs’ primary revenue source and calls into question whether such technology actually drove customer demand for defendants’ . . . product.” Id. at 3-4.

Overall, therefore, Judge Robinson found that the analytical framework for a permanent injunction had changed: “As to the first prong of the test, likelihood of success on the merits, the PTO’s finding of invalidity on reexamination – while not final – certainly adds an element of ambiguity to the analysis, when there was none in March 2014. The second prong of the analysis is irreparable harm. As noted, the harm advanced by plaintiffs in 2014 was ‘lost sales and market share, leading to the loss of research and development activities, a loss of goodwill in the market, and a forced loss of their patent exclusivity.’ Plaintiffs have had more than 18 months to generate market share for their PolyShield product and have failed to do so. Without sales in the first instance, it is difficult to justify imposition of injunctive relief based on lost sales and market share.” Id. at 4. Moreover, the balance of hardships weighed in favor of the defendants given that the plaintiff could be adequately compensated by a royalty (which Judge Robinson ordered be deposited in escrow in case the patent-in-suit survived appeal) and the “public interest is evenly balanced at best, with the ‘216 patent’s validity under scrutiny and its legal monopoly reducing competition.” Id. at 5.

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In a recent Memorandum Order, Chief Judge Leonard P. Stark granted defendants’ cross motion for partial judgment on the pleadings based on lack of subject matter jurisdiction over the parties’ declaratory judgment claims and affirmative defenses relating to the existence of an implied license (“implied license claims”), and thus dismissed the implied license claims without prejudice. S3 Graphics Co., Ltd. v. ATI Technologies ULC, et al., C.A. No. 11-1298-LPS (D. Del. Dec. 11, 2015). As Judge Stark explained, “[a]n implied license is an affirmative defense to a claim of patent infringement,” and “the parties agree[d] that this case does not involve any allegations of patent infringement.” Id. at 3. Accordingly, Judge Stark concluded that “there is no case or controversy, and the Court must dismiss the parties’ implied license claims.” Id. Judge Stark reached a similar conclusion with respect to “the implied license portion of [plaintiff’s] claim for injunctive relief.” Id. at 4. That is, just as the Court lacks subject matter jurisdiction to determine whether defendants have an implied license to the patents at issue, Judge Stark also found that the “Court lack[s] subject matter jurisdiction to provide [plaintiff] the remedy it requests relating to that claim.” In the same Memorandum Order, Judge Stark also denied plaintiff’s motion for reargument and motion to inspect as moot.

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In a recent Memorandum Order, Judge Richard G. Andrews considered defendants’ request to “show that the suboxone film has not achieved commercial success.” Reckitt Benckiser Pharmaceuticals Inc., et al. v. Watson Laboratories Inc., et al., C.A. No. 13-1674-RGA (D. Del. Dec. 15, 2015). Judge Andrews first noted that “Plaintiffs are not claiming commercial success, but are asserting other secondary factors of nonobviousness.” Judge Andrews also noted that “[t]he absence of objective evidence is a neutral factor.” Judge Andrews explained that “marketplace failure could, under the right circumstances, be a ‘negative factor,’” as it “could rebut (in a roundabout way) ‘long-felt need.’” While Judge Andrews “was doubtful that Defendants [can] show marketplace failure,” or “even have a good shot at making commercial results a neutral factor,” Judge Andrews nevertheless found that “Defendants have to decide how to allocate their time. “ Accordingly, Judge Andrews concluded that “if Defendants believe the proffered . . . evidence [regarding commercial success] is a good use of their time, I will allow it.” Judge Andrews reached this conclusion despite the fact that “Plaintiffs unilaterally withdrew their commercial success expert, and Defendants’ expert was to respond to that now foregone evidence.” Judge Andrews did “not see Plaintiffs being unfairly prejudiced by allowing Defendants to put on their evidence.”

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In Reckitt Benckiser Pharmaceuticals Inc., et al. v. Watson Laboratories, Inc., et al., C.A. No. 13-1674-RGA; v. Par Pharmaceutical, Inc., et al., C.A. No. 14-422-RGA (D. Del. Dec. 16, 2015), Judge Richard G. Andrews granted-in-part Plaintiffs’ motion in limine to preclude Defendants from offering evidence at trial concerning the an inter partes review of a patent-in-suit.

Defendants were precluded from offering “the PTAB’s factual finding, decisions, and legal conclusions,” but would be allowed to offer opposing party statements admissible under FRE 801(d)(2).  Id. at 2.  The remainder of documents at issue appeared to be inadmissible hearsay, and the Court thus advised they should not be offered into evidence absent a exception.  Id.  The Court would permit Defendants at trial to lay a foundation for their expert to rely on a certain declaration from the proceedings (regarding another’s pH measurement), explaining that whether the expert could rely on such data was a factual question that was not amenable to resolution before trial.  Id.

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Special Master Seville recently decided several discovery disputes arising between plaintiff Callwave and defendants Google and Broadsoft in several related litigations pending before Judge Richard G. Andrews. Callwave Communications, L.L.C. v. AT&T Mobility LLC, et al., C.A. Nos. 12-1701-RGA, 12-1702-RGA, 12-1704-RGA, 13-711-RGA (D. Del. Dec. 17, 2015).

First, Special Master Seville vacated a prior order denying Callwave’s request regarding the production of an expert’s report and testimony from a prior litigation.  Id. at ¶ 1-2.  Special Master Seville found that the report and testimony related to “opinions on prior art asserted by Google in this litigation and are therefore relevant.”  Id. at ¶ 2.

Special Master Seville then considered Callwave’s motion to strike defendants’ expert and defendants’ counter motion to strike Callwave’s new validity opinions and portions of the reply report of its expert.  Id. at ¶ 4.  After a review of the relevant factors set forth in Meyers v. Pennypack Woods Home Ownership Ass’n, 559 F.2d 894, 904-05 (3d Cir. 1977), Special Master Seville denied both motions.  Special Master Seville found no prejudice that could not be cured, no disruption of a trial date (trial was not scheduled), and no bad faith or intentional conduct.  Id. at ¶ 10-12.

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In this patent litigation between Adidas and Under Armour, Judge Sleet held a Markman hearing on May 14, 2015 and issued a claim construction order on June 15, 2015. The Defendant, Under Armour, subsequently filed a motion to modify the claim construction order based on the fact that the Under Armour had proposed the same construction in filing an inter partes review that it had proposed in the litigation. Although the PTAB did not institute IPR, Under Armour argued that Judge Sleet should adopt the construction advocated before the PTAB because the PTAB had accepted that construction in its denial of IPR. Therefore, Under Armour reasoned, the PTAB’s reliance on that construction means that collateral estoppel should apply. Adidas AG v. Under Armour, Inc., et al., C.A. No. 14-130-GMS, Or. at 2 n.1 (D. Del. Dec. 15, 2015).

Judge Sleet rejected this argument, reasoning that “the PTAB’s choice not to institute and IPR is not the type of adjudication that leads to issue preclusion” because the PTAB adopted Under Armour’s construction only “for purposes of this decision.” Id. Moreover, “the patent owner [Adidas] did not present the PTAB with a different construction than the one it presented to the court. The fact that it did not provide the PTAB with any construction does not weigh in favor of issue preclusion in such a preliminary proceeding. Contrary to the defendants’ assertions, the patentee is not ‘trying to have its cake and eat too.’ The court is not bound by a preliminary claim construction used by the PTAB for the limited purpose of denying an IPR request.” Id.

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