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In a recent opinion, Judge Gregory M. Sleet denied defendant Mylan Pharmaceutical, Inc.’s (“Mylan”) motion to dismiss plaintiff AstraZeneca AB’s (“AstraZeneca”) ANDA action for lack of personal jurisdiction pursuant to Fed. R. Civ. P. 12(b)(2).  AstraZeneca AB v. Mylan Pharmaceuticals, Inc., C.A. No. 14-696-GMS (D. Del. Nov. 5, 2014).  AstraZeneca alleged that the Court maintained jurisdiction over Mylan because (i) Mylan “consented to jurisdiction in Delaware”; (ii) Mylan is “subject to specific jurisdiction in Delaware”; and (iii) Mylan is “subject to general jurisdiction in Delaware.” Id. at 5. Judge Sleet concluded that the Court maintained jurisdiction over Mylan only on the grounds that Mylan is subject to specific jurisdiction in Delaware.

First, Judge Sleet determined that AstraZeneca failed to demonstrate that Mylan “is properly subject to general jurisdiction in Delaware.”  Rejecting jurisdiction on this ground, Judge Sleet explained that “AstraZeneca notes only that Mylan is registered to do business in Delaware and has a broad network of third-party contacts within the state,” and that “[u]pholding jurisdiction on these allegations alone would permit the ‘exercise of general jurisdiction in every [s]tate.’” Id. at 7. Judge Sleet also noted that “Mylan’s litigation history in Delaware fail[ed] to rise to [a] level” that would subject Mylan to general jurisdiction.  Id. at 8.

Next, Judge Sleet rejected AstraZeneca’s argument that Mylan “consented to be subject to Delaware’s general jurisdiction by registering to do business in the state and by appointing a registered agent to accept service of process.” Id. at 8.  First acknowledging there “is a circuit split as to whether this type of ‘statutory consent’ is an adequate basis on which to ground a finding of personal jurisdiction,” Judge Sleet ultimately concluded that “Mylan’s compliance with Delaware’s registration statutes-mandatory for doing business within the state-cannot constitute consent to jurisdiction.” Id. at 9-11. In reaching this determination, Judge Sleet relied on the Supreme Court’s decision in Daimler AG v. Bauman, 134 S. Ct. 746, 761 (2014), which held that “‘continuous and systematic contacts’ alone are insufficient to establish general jurisdiction,”  and thus rejected “the idea that a company could be haled into court merely for ‘doing business’ in a state.” Id. at 11. Judge Sleet additionally noted that “[f]inding mere compliance with such statutes sufficient to satisfy jurisdiction would expose companies with a national presence (such as Mylan) to suit all over the country, a result specifically at odds with Daimler.” Id.

Judge Sleet did find, however, that AstraZeneca demonstrated that Mylan is subject to specific jurisdiction in Delaware.  Judge Sleet first noted that “specific jurisdiction has historically been disfavored by courts as a basis to exercise jurisdiction over generic drug company defendants in ANDA cases.” Id. at 12.  Judge Sleet explained that “ANDA litigation is unlike other patent infringement litigation: The injury is abstract, making it difficult to point to a location out of which the injury ‘arises’ for jurisdictional purposes.” Id. at 14.  Nevertheless, Judge Sleet ultimately concluded that Mylan was subject to personal jurisdiction in Delaware, reasoning that “Mylan’s contact with Delaware is not illusory . . . . Mylan sent its paragraph IV certification to AstraZeneca U.S. in Delaware, thus triggering the forty-five-day countdown for AstraZeneca to file a lawsuit-a ‘real act with actual consequences.’” Id. at 15. Judge Sleet also found that “Mylan cannot plausibly argue that it could not ‘reasonably anticipate being haled into court’ in Delaware when patent litigation is an integral part of a generic drug company’s business.” Id.

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In EMC Corp., et al. v. Pure Storage, Inc., C.A. No. 13-1985-RGA (D. Del. Nov. 5, 2014), Judge Richard G. Andrews recently struck affirmative defenses of inequitable conduct and unclean hands against prosecuting attorneys of one of the patents-in-suit, but denied plaintiffs’ motion to strike these defenses against the inventors of this patent.  Defendant alleged that the patent’s inventors and two prosecuting attorneys failed to disclose a certain prior art patent to the PTO with the intent to deceive.  The focus of plaintiffs’ motion was on what defendant had alleged with respect to intent to deceive.

The Court first held that the prosecuting attorneys’ appointment of power of attorney for the prosecution of the patent (along with five other lawyers) was insufficient to show their “substantial[] involve[ment]” in the prosecution of that patent, nor was this fact sufficient to adequately plead an intent to deceive by these individuals.  Id. at 3.

However, as to the patent’s inventors, the Court denied the motion to strike these defenses, finding that the allegations were sufficient.  Defendant had alleged that the inventors of the patent not disclosed to the PTO were colleagues of the inventors of the patent-in-suit and that both “sets of inventors worked on the same family of products at the same company.”  Id. at 4.  Furthermore, defendant also alleged that the patent-in-suit’s inventors were familiar with and cited other works by at least one of the prior art patent’s inventors.  Id. As a result, the Court granted the motion to strike in part and denied it in part.

In the Order, the Court also clarified that the legal standard for intent to deceive at the pleading stage was governed by Exergen Corp. v. Wal-Mart Stores, Inc., 575 F. 3d 1213 (Fed. Cir. 2009) rather than the higher standard articulated at a bench trial in Therasense, Inc. v. Becton, Dickinson Co., 649 F.3d 1276 (Fed. Cir. 2011).  Plaintiff had cited Therasense for the legal standard.   Id. at 2 n.2.

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As previously reported here, Judge Andrews granted a motion for attorneys’ fees and costs under Section 285 and the Supreme Court’s Octane Fitness decision. Judge Andrews ordered the parties to make further submissions of “supporting documentation necessary to justify their fees as well as a brief explanation of those documents.” Having received those submissions from the parties, Judge Andrews determined last week that the defendants were entitled to a substantial portion of the fees they sought. Chalumeau Power Sys. LLC v. Alcatel-Lucent USA Inc., et al., C.A. No. 11-1175-RGA, Memo. Or. at 1-4 (D. Del. Nov. 6, 2014). Under the Lodestar approach, Judge Andrews determined that the “forum rate” for the case “must be governed by the rate for Delaware intellectual property attorneys” and that the “limited exception to the forum rule cannot apply because a number of Delaware attorneys can, and do, capably litigate patent matters.” Id. at 3.

Judge Andrews therefore concluded that “attorneys’ fees and expenses should be governed by the prevailing Delaware market rates for patent litigation” and that the calculation should not be adjusted up or down because these prevailing market rates reflect the “specialized skill that patent litigators possess, as argued by Defendants.” Id. His Honor was “not convinced that Defendants have demonstrated that there is an exceptional circumstance with respect to the result obtained or the amount involved” sufficient to justify an adjustment, nor should the rates “be adjusted downward simply because Defendants did not win on a dispositive motion or at trial.” Id. at 3-4. Finally, Judge Andrews rejected the plaintiff’s argument that fees prior to the Court’s granting of Defendants’ motion to amend to assert a licensing defense were unnecessary: “Because the licensing agreement predates the litigation, and this Court determined the licensing defense was not untimely, it is not clear why the recovery should exclude fees and expenses from before [the Court’s determination]. Defendants had to litigate the case until they learned of the licensing defense. It makes no sense (and perhaps that is why the argument is limited to a footnote) to say that defending the case was not reasonably necessary.” Id. at 4.

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Judge Richard G. Andrews recently denied-in-part plaintiff CallWave Communications, LLC’s motion for leave to amend its complaints against defendants in a series of related cases.  CallWave Communications, LLC v. AT&T Inc., et al., C.A. Nos. 12-1701-RGA, 12-1702-RGA, 12-1704-RGA (D. Del. Nov. 5, 2014).  Previously, Judge Andrews granted Defendants’ motion to dismiss CallWave’s willfulness and indirect infringement claims.  In its motion to amend, CallWave sought to remove the portions of its complaints no longer relevant in light of Judge Andrews’ previous order, but also sought to add new factual allegations.  Id. at 3.  Judge Andrews granted CallWave’s motion to permit it to remove allegations related to willfulness and indirect infringement, but denied the motion as to the new factual allegations because the proposed amendments would be futile.  Id.  The proposed amendments related to a meeting between CallWave and defendant Google that, according to CallWave, would be relevant to Google’s pre-suit knowledge of the patents-in-suit.  Id. at 4.  Judge Andrews found that the new allegations “serve no purpose.”  Because the only claims “successfully pled” by CallWave relate to direct infringement, the new allegations relate to no existing claim and cannot “form the basis for CallWave successfully re-plead[ing] willful infringement against Google at some point in the future.”  Id.  

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In a recent Memorandum Opinion, Chief Judge Leonard P. Stark granted defendants’ motion to dismiss with respect to claim 1 of U.S. Patent No. 5,612,179 (“the ’179 patent”), after finding that claim to be directed toward a natural phenomenon, a category of unpatentable subject matter. Genetic Techs. Ltd. v. Bristol-Myers Squibb Co., C.A. No. 12-394-LPS (D. Del. Oct. 30, 2014). Judge Stark denied defendants’ motion to dismiss without prejudice to renew as the remaining asserted claims of the ’179 patent and the asserted claims of the other patent-in-suit, U.S. Patent No. 5,851,762 (“the ‘762 patent”).

While acknowledging that it was not precedential at the time of the Court’s decision, Judge Stark was nevertheless persuaded by the Federal Circuit’s decision in Ultramercial, Inc. v. Hulu, LLC, 722 F.3d 1335 (Fed. Cir. 2013), which stated that “to grant dismissal of a patent infringement suit at the pleading stage for lack of patentable subject matter, ‘the only plausible reading of the patent must be that there is clear and convincing evidence of ineligibility.’” Id. at 6-7. Claim 1 of the ’179 patent was directed to a method of “amplifying and analyzing correlations between different regions of DNA sequence.” Id. at 10. Relying on the two-step framework set forth in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012), Judge Stark first determined that claim 1 recites a natural phenomenon, explaining that a “correlation that preexists in the human body is an unpatentable phenomenon.” Id. at 11. Next, Judge Stark considered whether there existed “additional steps in the claim . . . sufficient to satisfy patent eligibility.” Judge Stark found that the claim’s additional steps did not give rise to an “inventive concept” as to satisfy patent eligibility:

The asserted claim recites a series of steps to manifest the natural law – that is, to detect the natural correlations between coding and noncoding sequences. The added steps used to discern these correlations consist only of routine and conventional techniques. The patent specification states this outright, making this one of the (perhaps rare) occasions in which further factual development and claim construction are not necessary and invalidity can properly be determined at the 12(b)(6) stage.

 Id. at 13. Judge Stark therefore concluded that “the only plausible reading of claim 1 of the ’179 patent is that its additional steps, which consist only of routine and conventional techniques, fail to give rise to an ‘inventive concept,’ such that when, taken as a whole, the claim does not provide meaningful limitations that restrict the natural correlation to an application.” Id. at 14. Given the parties’ limited analysis in their briefing and during oral argument, Judge Stark stated that “the Court will require additional assistance from the parties to apply the foregoing analysis to the ’762 patent (and to the remaining claims of the ‘179 patent as well).” Id. at 20.

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In a recent decision, Judge Sue L. Robinson granted in part a defendant’s motion to dismiss claims relating to a “method of supplying in-room beverage service to a lodging establishment” using “a novel single-use, disposable brew basket for an electric coffee maker.”  Courtesy Prods., L.L.C. v. Hamilton Beach Brands, Inc., Civ. No. 13-2012-SLR (D. Del. Nov. 5, 2014).  The Court dismissed the plaintiff’s claim for direct infringement of an asserted method claim, finding that the plaintiff failed to allege that the defendant performed all steps of the method claim – i.e. that it “supplies its ‘system’ to lodging establishments or provided any factual information regarding the performance of the last three steps of the claim,”  which related to supplying individual hotel rooms with disposable brew baskets and filter packs.  The Court also dismissed the willful infringement claim, finding that the plaintiff  “offered no factual information to establish ‘awareness’ or ‘full knowledge’ of the patents-in-suit, sufficient to evidence pre-suit knowledge of the patents-in-suit.  Moreover, the complaint contains no facts establishing ‘objective recklessness of the infringement risk.’”  Id. at 10 (quoting Intellectual Ventures I LLC v. Toshiba Corp., 2014 WL 4365235 (D. Del. Sept. 3, 2014)).

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On Tuesday, the jury in Interdigital Communications, Inc., et al. v. ZTE Corporation, et al., C.A. No. 13-009-RGA (D. Del. Oct. 28, 2014) returned a verdict for the plaintiffs, finding all asserted claims of the three patents-in-suit infringed and not invalid.

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This week, the jury returned a verdict for plaintiff in Comcast IP Holdings I, LLC v. Sprint Communications Company L.P., et al., C.A. No. 12-205-RGA-CJB (D. Del. Oct. 15, 2014).  The jury found that plaintiff had proven infringement of all asserted claims and awarded $7.5 million in damages.

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Judge Gregory M. Sleet recently issued an opinion construing the disputed terms of U.S. Patent No. 5,980,940 (“the ’940 Patent”), entitled “Pharmaceutical Combination Preparation for Hormonal Contraception.” Bayer Intellectual Property GmbH et al. v. Warner Chilcott Co., LLC et al., C.A. No. 12-1032-GMS (D. Del. Oct. 9, 2014). As to the phrase “effective estrogen content,” defendants’ construction was founded on “the lowest level disclosed in a preferred embodiment, and requires ethinyl estradiol in an amount of at least 15 [micrograms] in the combined pill and at least 2 [micrograms] in the unopposed pill.” Id. at 2. Defendants argued that “given the patent’s objective to provide a daily estrogen content that was ‘as low as possible in each individual dosage unit,’ the inventors would have preferred and described lower respective doses if they believed that such estrogen content would be ‘effective.’” Id. Judge Sleet found, however, that “the subjective intent of the inventor when he used a particular term is of little or no probative weight in determining the scope of a claim,” and that “when a claim term is expressed in general descriptive words, [the court] will not ordinarily limit the term to a numerical range that may appear in the written description or in other claims.” Id. at 2. The Court thus found that the term “effective estrogen content” captures “pharmaceutical combinations with ethinyl estradiol levels below 15 [micrograms] in the combined pill and below 21 [micrograms] in the unopposed pill.” Id.

As to the disputed phrase “high contraceptive reliability, low incidence of follicular development, and satisfactory cycle control, with reliable avoidance of intracyclic menstrual bleeding and undesirable side-effects,” Judge Sleet found that the “disputed phrase should not be construed as a single term because it includes five distinct requirements that cover different oral contraceptive concepts/characteristics.” Id. at 3. However, Judge Sleet was ultimately unable to construe this disputed phrase. After rejecting both parties’ proposed constructions, Judge Sleet provided the following explanation:

The plain meaning of the claim language leaves the court with numerous questions, the answers to which are necessary to complete an infringement analysis regarding when the claim limitations are met. For example, how high must the contraceptive reliability be? What incidence of follicular development would be considered low? What constitutes satisfactory cycle control? And even more problematic are the reliable terms. What level of avoidance is necessary for intracyclic menstrual bleeding, and is it evaluated after the first 28 day administration cycle or after prolonged use? The uncertainty is compounded for side effects. The specification discusses various side effects ranging from headaches to cardiovascular disease. What constitutes an unacceptable avoidance of headaches is a thoroughly different question than what would constitute unacceptable avoidance of cardiovascular disease, yet the two are linked together in a single characteristic in the disputed phrase. Finally, even if the court did have individual standards against which the limitations are measured, the intrinsic record does not indicate what analytical tools or processes should be used to make the measurements.

 Id. at 7-8. Judge Sleet went on to further explain that “[t]he Supreme Court has recently held that the proper test for whether a patent is indefinite is ‘if its claims, read in light of the patent’s specification and prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.’” (citing Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, *6 (2014)). Judge Sleet concluded that “[t]he difficulty the court has encountered in construing the terms may unavoidably present an indefinite issue that will need to be addressed at summary judgment.” Id. at 8.

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In an open letter to Delaware counsel, Chief Judge Leonard P. Stark has provided clarification on the Court’s new 6 p.m. EST deadline for the filing and service of papers, which will become effective Thursday, October 16. Judge Stark explained that “the 6:00 p.m. Eastern Time deadline applies to every filing and service deadline in every case in the District of Delaware, other than initial pleadings.” Accordingly, “the 6:00 p.m. deadline applies to the exchange among parties of discovery requests and discovery responses, and it applies even if such requests or responses are made by hand delivery.”

Notably, Judge Stark also clarified that “[p]arties will not be permitted to alter the new deadline on a case-by-case basis.” To that end, Judge Stark further explained that “[w]hile each individual Judge retains the discretion to set a different deadline in a specific case with respect to a particular paper, the Judges of the Court agree that this discretion will be exercised rarely (most likely during trial).”

Judge Stark also noted that the new deadline does “not apply to proceedings pending in Bankruptcy Court,” but it “does, of course, apply to bankruptcy appeals and any other bankruptcy-related cases to the extent those cases are on the District Court’s docket.”

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