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In a recent memorandum order, Chief Judge Leonard P. Stark ruled on several pre-trial in limine motions and provided guidance on trial issues.  Masimo Corp. v. Philips Elec. N. Am. Corp. et al., C.A. No. 09-80-LPS (D. Del. Aug. 27, 2014).  Chief Judge Stark first denied a motion seeking to exclude evidence that a third party’s  product received FDA clearance pursuant to §510k, finding such evidence relevant to whether the product is an acceptable alternative to the plaintiff’s own product, and not unfairly prejudicial.  The Court also excluded, sua sponte, any evidence of reexamination of any of the patents-in-suit, finding that the risk of jury confusion and waste of the jury’s time outweighed any probative value such evidence may have.

Chief Judge Stark also provided some guidance on objections at trial to the scope of an expert’s testimony, and to the manner in which certain evidence could be presented during the jury trial, which was to precede a bench trial on equitable issues.  First, the Court granted the parties’ request that the Court rule on objections to the scope of an expert’s testimony during trial, rather than simply preserving the objections for post-trial briefing.  Chief Judge Stark explained that he “views the ‘scope’ of what has previously been disclosed to include anything that was disclosed by an expert in any expert report, any expert declaration, and/or any expert deposition testimony.”  With respect to equitable issues, in this case one relating to laches, Chief Judge Stark made clear that “no evidence that is solely admissible with respect to the issues to be tried to the bench will be presented to the jury.  Such evidence will be presented only to the bench. . . . The Court will rule at trial on objections to evidence that is arguably relevant both to issues being tried to the jury and to the bench.”

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In the case of Idenix Pharms., Inc., et al. v. Gilead Scis., Inc., et al., Chief Judge Stark referred a motion to dismiss counterclaims to Magistrate Judge Burke on May 20, 2014. Judge Burke heard oral argument on the motion on August 14, 2014 and issued his decision on August 25, 2014. Judge Burke’s report and recommendation considered plaintiff Idenix’s motion to dismiss certain of defendant Gilead’s counterclaims for non-infringement, invalidity, and patent interference with claims of one of the Gilead’s patents. Idenix Pharms., Inc., et al. v. Gilead Scis., Inc., et al., C.A. No. 13-1987-LPS, Report and Recommendation at 1-3 (D. Del. Aug. 25, 2014).

Idenix first challenged Gilead’s declaratory judgment counterclaims of non-infringement and invalidity for lack of subject matter jurisdiction. Calling the issue “a close one,” Judge Burke nevertheless concluded that Gilead did not meet its burden of establishing the existence of a case or controversy. Id. at 5. As Judge Burke explained, there are “a number of facts that raise understandable concern as to whether [Defendants] might face further suit from Plaintiff . . . [including] that ‘the parties have plainly been at war over patents involving [the same general subject matter implicated by the declaratory judgment claims] and are likely to be for the foreseeable future’ [and] the fact that there are a number of undeniable similarities between the [declaratory judgment] patents on the one hand, and the patents Plaintiffs have asserted in [their complaint] on the other.” Id. at 5-6.

Judge Burke found all of these facts were outweighed by Idenix’s countervailing facts indicating that it had “never taken any steps to threaten Defendants with litigation” and there were “noticeable differences” between the declaratory judgment patents and the patents asserted in the complaint. Id. at 8-9. “In the end,” Judge Burke concluded, “this close decision is swung by two primary factors. The first is that in nearly all of the key patent cases cited by the parties in which courts have found subject matter jurisdiction to exist regarding a declaratory judgment claim, the patent holder took far clearer, hostile action related to the patent at issue than have Plaintiffs here. And the second is the nature of the burden – it is Defendants’ burden to convince the Court why, though they have never been threatened with litigation over these two patents, circumstances suggest an imminent and real threat in the future.” Id. at 10-11.

Interestingly, Judge Burke also explained that under Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329 (Fed. Cir. 2008) and Microsoft Corp. v. Datatern, Inc., 755 F.3d 899 (Fed. Cir. 2014), “since the Court’s ultimate decision here is that Defendants have not demonstrated that subject matter jurisdiction existed as to [the declaratory judgment counterclaims] at the time of the filing of the counterclaims, the post-filing, covenant-related activity between the parties does not affect the Court’s calculus.” Id. at 7-8 n.3.

Also at issue were certain counts seeking a declaration of invalidity, which Idenix argued were insufficiently pled under Twombly and Iqbal. Judge Burke found that the Twombly standard had not been met by Gilead’s “bare-bones legal conclusions.” Id. at 14. In doing so, Judge Burke decided between divergent authority in the District of Delaware on the question of whether patent counterclaims are subject to the Twombly pleading standard. Compare Bayer CropScience AG v. Dow AgroSciences LLC, Civil No. 10-1045 RMB/JS, 2011WL6934557, at *2-3 (D. Del. Dec. 30, 2011) with Senju Pharm. Co., Ltd. v. Apotex, Inc., 921 F. Supp. 2d 297 (D. Del. 2013). Id. at 11-14.

Finally, Idenix moved to dismiss Gilead’s counterclaim of interference, which did not allege that Gilead believed the two patents at issue were interfering, but that Idenix had asserted that they are interfering. Id. at 17-18. Judge Burke found that this did not meet the pleading standard because Gilead had not alleged that the two patents claim the same or substantially the same subject matter, and “[t]he Court cannot conceive of a circumstance in which a party could be said to have met its burden to state a claim-not by affirmatively asserting that facts exist that would plausibly satisfy a claim element-but instead by contending only that someone else thinks that they do.” Id. at 18-19.

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In Comcast IP Holdings I, LLC v. Sprint Communications Company L.P., et al., C.A. No. 12-205-RGA (D. Del. Aug. 22, 2014), Judge Richard G. Andrews recently construed a single disputed term (“parsing”) found in U.S. Patent Nos. 7,012,916 and 8,204,046.  The Court explained that “[u]ntil recently, the parties had agreed that ‘parsing’ had a plain and ordinary meaning,” but now had submitted competing constructions.  Id. at 1.  Having heard oral argument on this issue on August 20, the Court did not adopt either party’s construction in full, but its construction (“An automated process of analyzing a string according to a set of rules of a grammar”) was closer to what plaintiff had proposed.  Id. at 3.

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Judge Andrews recently issued a claim construction opinion in Alltech Associates., Inc. v. Teledyne Instruments, Inc., C.A. No. 13-425-RGA (D. Del. Aug. 25, 2014).  The following terms from the plaintiff’s patents, U.S. Patent Nos. 8,115,930, 8,305,581, 8,305,582, and 8,314,934, were construed by the Court:

  • “during a/the/said chromatographic run”
  • “collecting the one or more components from the stream in a faction collector during the chromatographic run in response to a change in the composite signal during said chromatographic run”
  • “a fraction collector operatively adapted to collect a fraction in response to a change in the composite signal during said chromatographic run”
  • “collecting the one or more components from the stream in a fraction collector during the chromatographic run in response to a change in at least one of said signals during said chromatographic run”
  • “a fraction collector to collect at least one fraction corresponding to one of said components in response to a change in at least one of said signals during said chromatographic run”
  • “composite signal”
  • “obliterate”
  • “actively controlling fluid flow”
  • “active splitter”
  • “actively moving”

The following terms from the defendant’s patents, U.S. Patents Nos. 7,419,598 and 8,414,773, were construed:

  • “solvent-level indicating signal”
  • “initiating a replenishment process”
  • “immersing a solvent compatible portion of a pressure sensor or bubbler for generating the solvent-level indicating signal in the solvent reservoir before the chromatographic run”
  • “target time of run resolution”
  • “gradient profile”
  • “performing chromatography on the sample with the at least one gradient run for samples in which the target resolution and target time of run resolution were met with the at least one gradient run”
  • “pilot run”

 

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Judge Sue L. Robinson recently construed several claims of U.S. Patent No. 7,243,004, entitled “Self-configuring controls for heating, ventilating and air conditioning systems.  Carrier Corp. v. Goodman Global, Inc., et al., Civ. No. 12-930-SLR (D. Del. Aug. 14, 2014).  The following terms were construed:

 

  • “HVAC units”
  •  “data bus”
  • “central control”
  • “control algorithms”
  • “optimal control strategy”
  • “characteristic(s)” and “characteristic information”
  • “said control”
  • “connectivity kit”

Judge Robinson found that the following terms did not need to be construed by the Court, explaining that in light of the Court’s other claim constructions the jury would understand the limitations based on their plain and ordinary meaning:

  • “indoor unit” and “outdoor unit”
  • “determining an optimal control strategy for said indoor unit and said outdoor unit”
  • “selecting a particular one of said optimal control strategies”
  • “selecting one of said plurality of control algorithms”
  • “determine optimum control algorithms”

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On September 30, 2014 DuPont and Widener University School of Law will sponsor a day-long Intellectual Property CLE Seminar at the DuPont Country Club in Wilmington, Delaware.  Click HERE to register.  The keynote speakers, Judge Leonard P. Stark of the District of Delaware and Judge Leonard Davis of the Eastern District of Texas, will discuss the current state of patent litigation.   Andrew Byrnes, Chief of Staff of the USPTO, will present on the perspective of the USPTO.  Additional plenary and breakout sessions include IP due diligence, non-practicing entities, ethics, patent drafting, and trademark/copyright highlights.

Access the full agenda here:  http://www.dupontlegalmodel.com/wp-content/uploads/2014-cle-agenda2.pdf

 

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In Carrier Corp. v. Goodman Global, Inc., C.A. No 12-930-SLR (D. Del. Aug. 14, 2014), Judge Sue L. Robinson considered several motions for summary judgment, and defendants’ motions to strike and exclude certain expert testimony. First, Judge Robinson denied defendants’ motion for summary judgment of non-infringement. Regarding defendants’  argument that they did not practice the “selecting” limitation of the asserted patent, Judge Robinson explained that defendants presented only “attorney argument . . . without explanation from [their] expert or citation to an expert report.” Id. at 9. Judge Robinson also denied defendants’ non-infringement argument that they only sell individual HVAC units, not HVAC systems, as required by the asserted patents. Id. at 10-12. Judge Robinson explained that defendants did not supplement their contentions with this theory until “11:19 p.m. on the last day of fact discovery,” and also “failed to articulate [their] position with any clarity so that [plaintiff] could respond and give the court the opportunity to adjust the schedule to accommodate discovery on an important issue.” Id. at 10-11. Judge Robinson thus concluded that defendants “did not play the rules” and therefore “must suffer the consequences,” and denied their motion for summary judgment in this regard. Id. at 11-12. Judge Robinson also denied defendants’  motion for summary judgment of non-infringement with respect to indirect infringement, finding that there were disputed issues of fact. Id. at 12.

Judge Robinson next addressed the parties’ motions for summary judgment of invalidity. Judge Robinson denied defendants’ motion for summary of indefiniteness as to the term “optimal control strategy,” explaining that “one of ordinary skill in the art is apprised with reasonable certainty that the claims focus on whether a manufacturer has predetermined control strategies that it deems optimal for a given set of HVAC units.” Id. at 13. Judge Robinson also denied defendants’ motion for summary judgment of anticipation, explaining that “[t]he court respectfully disagrees with [defendants’] argument that no expert opinion is needed to support [their] anticipation argument. The present technology involves complex technology, i.e., controlling HVAC systems using algorithms loaded into a central control. The court concludes that attorney argument is not sufficient to meet the burden of persuasion on invalidity at the summary judgment motion stage.” Id. at 16. Judge Robinson also denied plaintiff’s cross-motion for summary judgment of no anticipation, explaining that the Court was “left without the essential analysis (or citation thereto), that is, [plaintiff’s] demonstration of the absence of a genuine issue of material fact regarding [defendants’] anticipation arguments, to determine whether the limitation at issue . . . is . . . not found in the prior art.” Id. at 17. Judge Robinson denied defendants’  motion for summary judgment of obviousness, finding that defendants relied only “on attorney argument.” Id. at 20. Judge Robinson also denied plaintiff’s cross-motion for summary judgment of non-obviousness, finding that there were genuine issues of material fact in view of expert disagreement. Id. at 22-23.

Judge Robinson denied defendants’ motions to strike with one exception. That is, Judge Robinson granted defendants’ motion to strike plaintiff’s expert opinions on secondary considerations to the extent that the experts “attribute commercial success to the ease of installation due to the single data bus, an invention disclosed in the ’452 patent, not the [asserted patent].” Id. at 24. Judge Robinson also excluded a certain invalidity theory from trial based on a prior art reference that was not asserted by defendants until nine months after the deadline to do so, explaining that it “was not properly vetted through discovery and it is unreasonable at this late stage to require [plaintiff] to respond to such allegation.” Id. at 23-24.

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Judge Mitchell S. Goldberg, sitting by designation from the Eastern District of Pennsylvania, recently denied plaintiff Transcend Medical, Inc.’s request to modify the stipulated Protective Order governing the exchange of confidential information in this case “to allow one attorney and one expert from each side to participate in certain Patent and Trademark Office (‘PTO’) proceedings or similar proceedings in other countries[.]”  Transcend Medical, Inc. v. Glaukos Corp., C.A. No. 13-830-MSG (D. Del. Aug. 12, 2014).  Transcend argued that its counsel had “gained extensive knowledge” over the course of representing Transcend and that counsel would not draft claims or use confidential information.  Id. at 2.  Further, the significant prejudice to Transcend would outweigh any risk of inadvertent disclosure of confidential information.  Id. at 2-3.  Glaukos objected noting that both parties knew of the potential of PTO proceedings at the time they agreed to the prosecution bar and that it would be “impossible to meaningfully participate in the [PTO] proceedings without advising or opining on the scope of patents, or without inadvertently using confidential materials.”  Id. at 3.  Judge Goldberg agreed, noting that the parties acknowledged the risks associated with allowing those with access to confidential information to participate in PTO proceedings when they agreed to the prosecution bar less than six months before Transcend requested the modification.  Id. at 3-4.

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In W.L. Gore & Associates, Inc. v. C.R. Bard, Inc. and Bard Peripheral Vascular, Inc., C.A. No. 11-515-LPS-CJB (D. Del. Aug. 8, 2014), Magistrate Judge Christopher J. Burke recently issued a Report and Recommendation construing six disputed terms of U.S. Patent Nos. 5,700,285 and 5,735,892, both entitled “Intraluminal Stent Graft.”

The Court construed the following terms:

“tubular, diametrically adjustable stent”/”diametrically adjustable stent”

“wall”

“multiplicity of openings”

“covering”

“affixed”/”affixing” and “the first tubular covering of porous expanded polytetrafluoroethylene is affixed to the second tubular covering of porous expanded polytetrafluoroethylene film through openings through the wall of the stent”

“collapsed diameter”/”enlarged diameter”

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Judge Robinson recently considered motions arising from Mylan’s at risk launch of a generic version of Anesta’s Amrix product. In 2011, Judge Robinson held a bench trial and determined that although the generic products infringed the patents-in-suit, certain asserted claims were obvious. Mylan launched its generic product the next day. A week later, Judge Robinson granted Anesta’s motion for a temporary restraining order and later issued a preliminary injunction pending appeal to the Federal Circuit. A few days later, Mylan filed an emergency motion with the Federal Circuit, seeking to stay the injunction pending briefing. The Federal Circuit granted the motion and Mylan began selling its generic product again. When it reached the merits of the motion shortly over a month later in July 2011, the Federal Circuit denied the motion in part, prohibition sale of Mylan’s product during the appeal, and granted it in part, staying a portion of Judge Robinson’s preliminary injunction that required Mylan to “take all reasonable steps to recall” its product. In April 2012, the Federal Circuit reversed the finding of invalidity and dismissed the appeal of the preliminary injunction. In April 2012, Judge Robinson entered a final judgment and permanent injunction. Against this background, Judge Robinson recently reviewed motions by Mylan for summary judgment of no lost profits and partial summary judgment of no willfulness. Anesta AG, et al. v. Mylan Pharms., Inc., et al., C.A. No. 08-889-SLR, Memo. Or. at 1-2 (D. Del. Aug. 14, 2014).

Her Honor denied the motion as to plaintiff’s claim for lost profits. Mylan’s argument was “that plaintiffs should be precluded from claiming lost profits because their expert . . . failed to consider price elasticity in his lost profits analysis. When asked at his deposition about price elasticity, [plaintiffs’ expert] explained that price elasticity under the circumstances at bar was ‘relatively modest’ and ‘offset’ by other factors.” Id. at 4. Judge Robinson explained that the Federal Circuit’s “demand for a ‘credible economic analysis’ can be met by a variety of evidence – both fact and expert – depending on the facts of the case and the nature of the markets at issue . . . [and] plaintiffs have presented plausible evidence that the case at bar presents an unusually complex set of facts vis a vis calculating lost profits, due in part to the unique nature of the relevant market and due in part to the brevity of the damages period. Having rejected defendants’ proposition that there are rigid standards applicable to every case, I decline to take the issue of lost profits damages away from the jury.” Id. at 6.

Judge Robinson granted Mylan’s motion for summary judgment of no willful infringement, however, stating “I agree with defendants that, although their launch was at risk, it was not illegal when it took place and, absent a directive from the Federal Circuit to recall their generic products, defendants had no legal obligation to do so. Having committed no illegalities vis a vis the launch, and willfulness generally being irrelevant in the context of ANDA cases, I grant defendants’ motion for partial summary judgment” of no willfulness. Id. at 4.

Finally, Judge Robinson denied Mylan’s motion to exclude a Dr. Steiner. Dr. Steiner had been allowed to testify during the liability phase of the bifurcated trial because it was recognized that he possessed clinical expertise regarding the products at issue. Accordingly, this expertise was relevant and admissible in the damages phase of the trial as well. Id. at 7.

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