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Judge Richard G. Andrews recently issued a post-trial opinion in Novartis’s suit over the generic version of its Exelon® transdermal patch.  Novartis Pharmaceuticals Corp., et al. v. Par Pharmaceutical, Inc., et al., C.A. No. 11-1077-RGA (D. Del. Aug. 29, 2014).  Novartis alleged that Par’s Abbreviated New Drug Application (“ANDA”) for a “rivastigmine transdermal system” infringed its U.S. Patent Nos. 6,335,031 and 6,316,023.  Id. at 1.  After a two-day bench trial the Court determined that Novartis failed to prove that Par’s ANDA infringed the patents-in-suit.  Id. at 2.  Because defendant’s counterclaim of invalidity was “based upon a finding of infringement,” the Court did not reach the issue of invalidity.  Id. at 2 n.5.

Click through to read the Novartis opinion.

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Following a two day bench trial in Fresenius Kabi USA, LLC v. Dr. Reddy’s Laboratories Ltd. et al., C.A. Nos. 13-925, 13-1015-RGA (D. Del. Aug. 25, 2014), Judge Richard G. Andrews found that plaintiff failed to prove that defendants’ ANDA products infringe claims 1, 16, 36, an 37 of the patents-in-suit. Defendants certified that the only differences between plaintiff’s brand drug, Diprivan, and defendants’ ANDA products are the “antimicrobial agents” (i.e., “the preservatives”). Id. at 3. Additionally, plaintiff conceded that “there is no literal infringement, but claim[ed] that Defendants ANDA products infringe under the doctrine of equivalents.” Id. While plaintiff argued that “dipropofol” was the equivalent, Judge Andrews concluded that dipropofol was not actually the preservative in defendants’ ANDA products. Id. at 6-8. To this end, Judge Andrews noted that while plaintiff “was not under an obligation to prove that the ANDA products contained dipropofol, it would have been probative of whether the identified preservatives were responsible for antimicrobial activity.” Id. at 8 n.3. Judge Andrews also concluded that dipropofol does not function in substantially the same way as edetate, the preservative appearing in the asserted claims, and thus concluded that defendants’ ANDA products do not infringe. Id. at 8-11.

 

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In Art+Com Innovationpool GmbH v. Google, Inc., C.A. No. 14-217-RGA (D. Del.), Judge Richard G. Andrews had previously denied plaintiff’s motion for judgment on the pleadings as to defendant’s laches defense.  D.I. 33.  The Court now denied plaintiff’s motion to certify the case for interlocutory appeal.  Slip Op. (Aug. 26, 2014).

The Court explained that, even if the Federal Circuit accepted the Court’s certification (which was “seriously doubt[ful]”), the Court’s decision would either be affirmed or, if reversed, “the case would continue with only 91% of the asserted defenses.”  Id. at 1.  Therefore, the Court did not find the disputed issue “a controlling question of law,” nor would interlocutory appeal “materially advance the ultimate termination of the litigation.”  Id.

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Judge Richard G. Andrews recently considered defendants’ motion requesting the Court find certain terms of the patents-in-suit indefinite under 35 U.S.C. § 112.  IpLearn, LLC v. Blackboard, Inc., et al., C.A. Nos. 11-876-RGA, 11-1026-RGA (D. Del. Aug. 26, 2014).  Defendants argued that the claim terms at issue (“the user” and ” [considers/considering] at least a preference of the learner, other than the fact that the learner might prefer to learn the subject”) were indefinite under Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2124 (2014), because they did not provide “reasonable certainty” as to the scope of the invention.  Id. at 2.  Plaintiff, on the other hand, argued that the claim terms as construed by the Court were clear, and that the defendants’ did not meet their burden to present evidence to the Court “indicating whether a person of ordinary skill in the art (“POSITA”) at the time of the drafting of the claim would have reasonable certainty as to what the inventor claimed.”  Id. Judge Andrews agreed:

This lack of evidence was highlighted at oral argument when the Defendants were asked on several occasions what evidence they had regarding a POSITA’s understanding of the claim, and on each occasion failed to directly address the Court’s question. In fact, in one of the rare instances where Counsel did provide the Court with citations to the record, the citations did not provide the evidence the Court was asking for. For example, when asked by the Court if a POSITA would understand the claim, Plaintiffs counsel directed the Court’s attention to page 5 of their July 3rd, 2014 reply brief. However, when the Court examined that page, along with the reference to paragraph 172 of Dr. Kris Jamsa’s report, neither made any reference to a POSITA. Dr. Jamsa knew what a POSITA was. Dr. Jamsa referred to a POSITA in making other invalidity arguments. Thus, he knew how to refer to a POSITA when he thought it appropriate to do so.

Id. at 3.

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Judge Sue L. Robinson recently construed the following claim terms of U.S. Patent No. 6,037,319 titled “Water-soluble packets containing liquid cleaning concentrates”:

“[L]ess than 7.5 wt.% water”1 and “[less than 5.0 wt.% water]”

“Liquid cleaning concentrate”

“water soluble”

“film”

“a polyvinyl alcohol film”

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In TruePosition, Inc. v. Polaris Wireless, Inc., C.A. No. 12-646-RGA, Magistrate Judge Mary Pat Thynge had previously concluded that the means-plus-function term “means for detecting” was invalid as indefinite because a corresponding algorithm was not disclosed. Plaintiff filed an objection to this Report and Recommendation. Reviewing the Magistrate’s recommendation for claim construction de novo, Judge Richard G. Andrews concluded that the term was indeed indefinite, and thus adopted Judge Thynge’s Report and Recommendation. TruePosition, Inc. v. Polaris Wireless, Inc., C.A. No. 12-646-RGA (D. Del. Aug. 26, 2014).

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Chief Judge Stark recently denied motions filed by defendant Toshiba for summary judgment of non-infringement and for spoliation sanctions in a case brought by plaintiff St. Clair Intellectual Property Consultants. St. Clair Intellectual Prop. Consultants, Inc. v. Toshiba Corp., et al., C.A. No. 09-354-LPS, Memo. Or. at 1 (D. Del. Aug. 27, 2014).

Judge Stark first denied summary judgment of non-infringement with respect to one patent because there was a genuine dispute of material fact where a “jury could reasonably credit the expert opinion of [the plaintiff’s expert] and, thereby, find infringement.” Id. at 3-4. The expert’s opinion included the possibility of meeting the claim limitations by the doctrine of equivalents, which he opined on at his deposition after reserving the right to do so in his report. Id. at 4.

Judge Stark next denied summary judgment of non-infringement of a second patent because there were genuine issues of material fact involved in each of St’ Clair’s theories of infringement. Among the issues that could not be resolved on summary judgment were whether a fixed clock rate must necessarily have a fixed bandwidth, where the parties had not previously asked for construction of the term “bandwidth” and whether there could be direct infringement where Toshiba had sold or offered to sell all of the components of a claimed system, even if the components were sold separately to be assembled by the customer. Id. at 5-7.

Finally, Judge Stark denied Toshiba’s motion for spoliation sanctions based on the destruction of documents by a prior owner of the patents-in-suit. As Judge Stark explained, Toshiba did not “put forth sufficient evidence to support a finding of bad faith,” as required for a finding of spoliation. Id. at 8-9. Rather, the evidence suggested that a “benign explanation [was] more plausible” because the records destroyed by the predecessor-in-interest to St. Clair were destroyed under a standard record retention policy. Id. The more recent destruction of backup data was “more complex” because it more likely contained relevant information, it occurred after St. Clair had already commenced litigation and notified the prior owner that it would be subject to document requests and subpoenas, and St. Clair appeared to have control over the documents. Id. at 9-10. But here too there was no evidence of bad faith in destruction of the backup data. Accordingly, Judge Stark explained that although the “nearly complete destruction of many of [the prior owner’s] historic files is worrying (and potentially negligent), the record does not support sanctioning St. Clair for spoliation.” Id. at 10.

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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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