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In March 2013, plaintiffs Bayer Healthcare Pharmaceuticals Inc., Intraserv GmbH & Co. KG, and lntendis GmbH filed this patent infringement case following defendant Glenmark Pharmaceuticals Limited’s filing of an Abbreviated New Drug Application to market a generic azelaic acid hydrogel.  lntendis GmbH, et al. v. Glenmark Pharmaceuticals Limited, et al., C.A. No. 13-421-SLR (D. Del. July 27, 2015).

Plaintiff Bayer is the the holder of the New Drug Application for Finacea® Gel, 15%, indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Plaintiff lntraserv is the assignee of the patent-in-suit, U.S. Patent No. 6,534,070 titled “Composition with Azelaic Acid.”  Plaintiff Intendis is the exclusive licensee of the ‘070 patent.

Following a bench trial in February 2015, the Court recently issued its Findings of Fact and Conclusions of Law.  Judge Sue L. Robinson found the ‘070 patent valid and infringed by Glenmark’s proposed ANDA product.

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Judge Sue L. Robinson recently considered plaintiff’s renewed motion to dismiss defendant’s counterclaim of inequitable conduct.  Quest Integrity USA, LLC v. Cokebusters USA Inc., C.A. No. 14-1483-SLR (D. Del. July 22, 2015).  Judge Robinson previously denied defendants’ request to transfer to the Southern District of Texas and plaintiff’s motion for a preliminary injunction.

Plaintiff’s motion argued that defendant’s counterclaim did not adequately show “but-for materiality” or “intent to deceive.”  Id. at 7.  As a preliminary matter, in their opposition, defendant argued that because plaintiff attached an exhibit to its motion containing a portion of the prosecution history, plaintiff’s motion to dismiss was converted to a summary judgment motion.  Id. at 2 fn.4.  Judge Robinson disagreed, noting that the prosecution history is a “public record,” and public records can be considered on a motion to dismiss.  Id. 

As to the merits of the motion, Judge Robinson noted that because the counterclaim was based on nondisclosure of prior art, defendant had to prove by clear and convincing evidence that “the applicant knew of the information, ‘knew that it was material, and made a deliberate decision to withhold it.'”  Id. at 7 (quoting Therasense v. Becton, Dickinson & Co., 649 F.3d 1276, 1290 (Fed. Cir. 2011).  Defendant alleged that the invention claimed in the patent in suit “was not new, was obvious from existing technology, and had been sold before the bar date.”  Id. at 8.  If the PTO had known of the prior art, it would not have issued the patent.  Id.  Judge Robinson, noting that the Court need not decide “the merits of the claim, only whether materiality had been alleged with sufficient particularity[],” found that defendant’s claims passed muster.  Id. at 8-9.  Regarding intent to deceive,  Judge Robinson also found the pleading sufficient because defendant pled adequate evidence of lack of candor with the PTO, from which intent to deceive “is the ‘single most reasonable inference [] to be drawn from the evidence.”  Id. at 10 (quoting Therasense 649 F.3d at 1290).

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After allowing additional discovery and further briefing, Judge Gregory M. Sleet recently granted a Rule 12(b)(1) motion to dismiss a declaratory judgment action seeking to invalidate the defendants’ patents.  Comba Telecom, Inc. v. Andrew LLC, et al., C.A. No. 12-311-GMS (D. Del. July 15, 2015).  The plaintiff argued that the defendants’ patents “present a barrier to [the plaintiff’s] entering the US market” and that the defendants “have taken steps to legally enforce U.S. patents in foreign litigation and by way of public and private threats.” The plaintiff highlighted to examples of such threats: (1) a 2011 press release stating that the defendants would defend their patents from infringement, including specific reference to infringement by the plaintiff; and (2) a letter to a third party manufacturer that, the plaintiff argued, was a “veiled threat” targeting the plaintiff.  The defendants argued that the press release referred to disputes in Brazil and China, not the United States, and denied that the letter to the third party manufacturer was intended as a threat to the plaintiff.  The Court found that the plaintiff’s arguments did not support declaratory judgment jurisdiction, explaining, “[i]mplied threats such as the type alleged by Comba cannot be considered a substantial step toward legal action for patent infringement.”  The Court added that, in any event, the plaintiff had not yet “taken meaningful steps to conduct patent-infringing activity” in the United States, further undercutting the plaintiff’s argument that an actual controversy existed to support declaratory judgment jurisdiction.

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In a recent Order, Judge Gregory M. Sleet granted defendants’ motion for leave to amend its answer to include allegations that the asserted patent is unenforceable due to inequitable conduct. Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC, C.A. No. 13-2088-GMS (D. Del. Jul. 10, 2015). As Judge Sleet explained, plaintiff opposed the motion solely on the grounds that “permitting the defendants to include such allegations would be futile.” Id. at 1. Judge Sleet was unpersuaded by plaintiff’s argument, noting that “plaintiff essentially asks the court to evaluate the merits of the defendants’ inequitable conduct accusations, pointing to specific statements in the record and explaining why they do not evidence deception. These arguments are untimely and better suited for the summary judgment stage.” Id. at 2. Judge Sleet found that “the court cannot say that the defendants’ allegations are baseless,” and ultimately concluded that “defendants have adequately alleged the necessary elements of inequitable conduct.” Id.
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In a recent Memorandum Opinion, Judge Sue L. Robinson denied defendants’ motion to transfer venue to the Southern District of Texas. Quest Integrity USA, LLC v. Clean Harbors Industrial Services, Inc., C.A. Nos. 14-1482, 14-1483-SLR (D. Del. Jul. 8, 2015). As Judge Robinson explained, plaintiff “is a limited liability company organized and existing under the laws of the State of Texas and having its principal place of business in Seattle, Washington.” Judge Robinson further explained that “Defendant Clean Harbors is a corporation organized and existing under the laws of the State of Delaware and having its principal place of business in Norwell, Massachusetts,” and “Defendant Cokebusters is a corporation organized and existing under the laws of the State of Delaware and having its principal place of business in Houston, Texas.” Id. at 1-2

In denying the motion to transfer, Judge Robinson first explained that because “‘convenience’ is separately considered in the transfer analysis, the court declines to elevate defendants’ choice of venue over the choice of the plaintiff.” Id. at 4. Judge Robinson found that “plaintiffs have historically been accorded the privilege of choosing their preferred venue for pursuing their claims remains a significant factor.” Id. Further, as Judge Robinson noted, “Defendants admit to engaging in infringing conduct in Delaware,” and “[t]hat fact negates the argument that the alleged infringement is focused in the Texas Gulf Coast region.” Id. Judge Robinson went on to observe that “[a]s is usual in these cases, the convenience factors do not weigh in favor of transfer because discovery is a local event and trial is a limited event.” Id. at 8. Additionally, as Judge Robinson explained, “[a]lthough Delaware is not the locus of any party’s business activities, it is a neutral forum.” Id. Judge Robinson thus concluded that transfer was not warranted in the interests of justice. Id.

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Judge Richard G. Andrews recently granted in part a defendant’s motion to dismiss for failure to claim patent-eligible subject matter under § 101.  Pragmatus Telecom, LLC v. Genesys Telecomm. Labs., Inc., C.A. No. 14-26-RGA (D. Del. July 9, 2015).  At issue were four patents sharing a common specification relating to “controlling communication between customers and organizations using certain computer systems.”  As Judge Andrews explained, the “specification demonstrates that the claims [of the purportedly representative ‘314 Patent] are directed to the abstract idea of connecting customers to call centers.”  Id. at 11.  In describing the claims, the Court drew an analogy to a customer calling a business and identifying himself, then dialing certain numbers to be transferred either to “help” or an “operator” or to leave a voicemail.  Id. at 12-13.  Judge Andrews explained, “[t]o allow such a claim would preempt the fundamental concept of customers communicating with businesses, and more specifically customers communicating with call center agents.”  Id. at 14.  The Court added, “the claim does not contain an inventive concept to transform the abstract idea into patent-eligible subject matter.”  Id.  The defendant sought to also invalidate the three other patents, based on the invalidation of the purportedly representative ‘314 Patent, but Judge Andrews explained, “the Court will only deal with the patent eligibility of the claims of the ‘314 Patent.  If Defendants wish to challenge the other patents under § 101, they must actually provide analysis for this position.”  Id. at 9.

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In late 2013, Chief Judge Stark granted a motion to stay this case pending an inter partes review by the PTO based, in part, on the argument that the stay would not exceed 18 months, given the statutory deadlines for IPRs, and the defendant’s withdrawal of its prior opposition after the IPR was instituted. Zoll Medical Corp. v. Respironics, Inc., C.A. No. 12-1778-LPS, Memo. Or. at 1-2 (D. Del. July 8, 2015). Recently, the PTO confirmed patentability of eight claims of the patent-in-suit, with one claim having been cancelled in the IPR. Plaintiff Zoll sought to lift the stay of this litigation and Defendant Respironics opposed, arguing that it would appeal the finding of patentability to the Federal Circuit. Id.

As Judge Stark explained, “[u]nderstandably, Zoll now wishes to proceed with the litigation it filed more than 2 ½ years ago . . . . The proper exercise of the Court’s discretion under these circumstances is to lift the stay and proceed with the litigation, just as the parties (and the Court) envisioned at the time the unopposed motion to stay was granted. The IPR proceeding is complete and the stay has been in place nearly 19 months. Respironics has pointed to no new, unforeseeable events to cause the Court to depart from the path that was set when the stay was imposed. As Zoll puts it, ‘Having taken its shot in the USPTO and failed, Respironics should not be able to preclude Zoll from pursuing its claims in this court for an indeterminate period of time.’” Id. at 2.

Respironics’ appeal to the Federal Circuit was not a persuasive reason to keep the stay in place: “The pendency of an appeal from the IPR, and the possibility that the Federal Circuit may reverse the PTO (and thereby simplify this litigation by, presumably, making it disappear), is not, in and of itself, a sufficient basis to make the patentee here continue to wait to enforce patent rights that it currently holds.” “Had Respironics initially been seeking a stay that would extend to the period during which any appeal from the IPR would be pending, it is likely Zoll would have continued to oppose the motion, and the Court’s calculus might very well have differed too.” Id. at 2-3.

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In a declaratory judgment action brought by Draeger alleging non-infringement and invalidity, Judge Sue L. Robinson granted My Health’s motion to set aside the clerk’s entry of default and motion for extension of time to answer, and denied Draeger’s motion for default judgment as moot. Draeger Medical Systems, Inc. v. My Health, Inc., C.A. No. 15-248-SLR (D. Del. July 1, 2015). Draeger had filed the action after My Health’s affiliate had contacted it to potentially negotiate a license for the patent-in-suit. My Health had not responded to Draeger’s complaint, but explained that its general counsel had been suffering from neurological problems at the time process was served and had no memory of seeing the complaint. Id. at 2-3.

The Court granted My Health’s motion. While Draeger argued that it would suffer prejudice “if the default is set aside, given that it is a developing company and the ‘specter of litigation’ is detrimental to its sales, market share, business decisions, and investment from third parties,” the Court concluded that these concerns were “more suited to establishing subject matter jurisdiction than precluding litigation on the merits.” Id. at 4-5. The Court also rejected Draeger’s arguments that My Health’s conduct was willful or in bad faith, accepting as credible that the general counsel’s health problems had caused the lack of response, especially where Draeger had rejected My Health’s request for a short extension acompanyied with an explanation as to these “extenuating medical circumstances.” Id. at 6.

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Magistrate Judge Fallon recently issued a report and recommendation in litigation between Merck and Teva over Teva’s proposed generic version of mometasone furoate nasal spray, marketed by Merck as Nasonex®. Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc., C.A. No. 14-874-SLR-SRF, Report and Recommendation at 1-2 (D. Del. July 1, 2015). Judge Fallon addressed several motions at once, recommending denying Teva’s motion to transfer to the District of New Jersey based on the Third Circuit’s Jumara factors, which indicated that Delaware was “a legitimate forum based on Teva’s state of incorporation” and would not be unduly burdensome (id. at 3-8); denying as moot Teva’s motion for judgment on the pleadings (id. at 16); and granting Teva’s motion to dismiss Count II of the complaint with leave to amend (id. at 8-16).

Count II of the complaint dealt with Merck’s claim of contributory infringement. As the Court explained, “[p]ursuant to Merck’s conversion theory of contributory infringement, Teva would be liable for infringement even if the generic copy of Nasonex® nasal spray sold by Teva contains only anhydrous mometasone furoate, because at least some of the mometasone furoate contained in Teva’s product converts to the allegedly infringing monohydrate form during the proposed shelf life of the product.” Id. at 2-3.

Teva argued that the complaint did not include sufficient allegations supporting Merck’s “conversion theory,” which was more fully expressed in its briefs, including that Teva had knowledge of such a conversion or that its product was made especially for such a conversion. Judge Fallon rejected this argument, however, finding that the contributory infringement theory met the plausibility requirement of Twombly and Iqbal. Id. at 12-14. Similarly, Judge Fallon found that Merck had adequately plead the absence of a substantial non-infringing use and adequately identified a component of the invention as allegedly infringing. Id. at 14-15.

Judge Fallon agreed, however, with Teva’s assertion that “Merck’s cause of action for contributory infringement is facially deficient because it fails to specifically reference or make factual allegations regarding materiality,” i.e. that the complaint does not set out that the allegedly infringing component constitutes a material part of the invention as required by § 271(c). Thus, “Merck’s cause of action for contributory infringement is facially deficient and should be dismissed on this basis.” Id. at 11-12. Judge Fallon recommended, however, that dismissal be with leave to amend the complaint to address the materiality requirement. Id. at 15-16.

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In Andrulis Pharmaceuticals Corp. v. Celgene Corp., C.A. No. 13-1644-RGA (D. Del. June 26, 2015), Judge Richard G. Andrews construed terms in claim 2 of U.S. Patent No. 6,140,346, finding three sets of related terms to be indefinite.  The patent relates to a “novel method for treating cancers with thalidomide alone or in combination with other antiangiogenic and anti-cancer agents.”  Id. at 1 (citation and internal quotation marks omitted).

The terms found indefinite were: “enhanced” and “enhanced combination”; “enhanced therapeutically-effective amounts of thalidomide”; and “said neoplastic diseases are sensitive to said enhanced combination.”  Defendant argued that “enhanced” required degrees that the patent never articulated.  Id. at 7.  The Court found the “central issue” to be whether “enhanced means greater than additive,” as Plaintiff claimed the addition of “enhanced” was needed for the claim to overcome prior art, “or whether it renders the claim indefinite.”  Id.

The Court concluded that the term was indeed indefinite.  There was no evidence narrowing its meaning, id. at 8, and the patent provided very little guidance as to the meaning, id.  at 8-9.  The Court also found that the prosecution history did not support Plaintiffs’ contention that “enhanced” necessarily meant “greater than additive” in light of the prosecution history.  Id. at 9.  In fact, “[t]he prosecution history demonstrates that the applicant did not simply adopt the examiner’s position that the claims require a greater than additive effect.”  Id. at 10.  “It cannot be the case that ‘enhanced’ is merely a synonym for ‘greater than additive’ when read within the context of the examiner’s rejection, and the applicant’s amendment and response.”  Id.  The inventor’s own testimony supported the interpretation that “enhanced” was not synonymous with “additive effect,”  id. at 12, although the Court did not find the inventors’, or proffered experts’, testimony on this subject particularly probative.  See id. at 12, 13.  It concluded that “[b]ecause ‘enhanced’ can mean less than additive, additive, or greater than additive, the term is indefinite because it does not inform a person skilled in art of the invention with reasonable certainty of its meaning in the patent-in-suit.”  Id. at 13.

As to “enhanced therapeutically-effective amounts of thalidomide,” the Court concluded that its “grammatical structure adds a second reason for a finding of indefiniteness.”  Id. at 14.  Plaintiffs attempted to argue “enhanced” did not modify “therapeutically-effective amounts of thalidomide,” but the Court found this would result in “grammatical gymnastics.”  Id. at 15.  The larger term was indefinite because it was “unclear what an ‘enhanced’ amount of thalidomide . . . would be.”  Id.  The Court also found the third term “said neoplastic diseases are sensitive to said enhanced combination” indefinite “[f]or the reasons offered int eh analysis of the [other two] terms.”  Id. at 17.

The Court also construed the terms “administering” and “neoplastic diseases.”

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