A Blog About Intellectual Property Litigation and the District of Delaware


DED
United States District Court for the District of Delaware

Uncertain Times (ANDA Amendments)

Nathan R. Hoeschen, Aug. 5, 2021
ANDA Stay

ANDA litigation can be an odd beast. You file a case based on a product that a defendant has only applied to manufacture—what then, when the FDA requires an amendment? What of the litigation that may be years in the making and heading into the home stretch?

The somewhat tortured history of Biodelivery Sciences International, Inc. et al. v. Chemo Research, S.L., C.A. No. 19-444-CFC-CJB, gives us several examples of exactly how the Court deals with this situation.

An Early Change to an ANDA Does Not Warrant a New Trial Date

Early on in that case (about 6 months after the scheduling order was entered) one of the defendants—Chemo—received a complete response letter ("CRL") from the FDA requiring them …

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Judge Stark Bars Late-Disclosed Witnesses from Trial

David M. Fry, Aug. 4, 2021
Pennypack MIL

Ref
Nathan Shively, Unsplash

We've written several times about the Pennypack factors—the Third Circuit standard for determining whether to exclude late-disclosed evidence. Although the standard itself is fairly lenient (focusing on prejudice and whether it can be cured), the D. Del. judges have shown an increasing willingness to exclude evidence under Pennypack in recent years.

Earlier today, for example, Judge Stark applied Pennypack to preclude four witnesses from testifying at an upcoming jury trial (two from each side). The witnesses were disclosed months after the close of fact discovery, and Judge Stark refused to force the parties to use their limited trial prep time for clean-up discovery: "there is not sufficient time in the 12 remaining days before trial …

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D. Del. Permits "Novel Theory" of Induced Patent Infringement Against Health Insurer on a Method-of-Use Claim for a Generic Drug

Andrew E. Russell, Aug. 3, 2021
Generic Drug

Pills
Christina Victoria Craft, Unsplash

Magistrate Judge Hall issued an R&R today recommending that the Court deny a motion to dismiss an inducement claim against a health insurer relating to a method-of-use claim for a generic drug.

The complaint alleges that, despite knowing that the plaintiff had a method-of-use claim for a specific treatment, the insurer nonetheless covered the patented treatment at a lower cost to patients than treatment with the name-brand drug:

The thrust of the allegations against [the insurer] Health Net are (1) that it provides coverage and payment for [co-defendant] Hikma’s generic product even in cases where Health Net actually knows that a particular beneficiary is using the generic version for an unapproved—and allegedly infringing . . …
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Judge Andrews Gives His Thoughts on Privilege of Pre-Litigation Scientific Testing Results, Strikes "Unsolicited" Declarations

Andrew E. Russell, Aug. 2, 2021
Privilege Litigation

Science!
Hans Reniers, Unsplash

On Friday, Judge Andrews issued an opinion adopting a Special Master opinion, which held that certain pre-litigation testing documents were not covered by attorney privilege.

Pre-Litigation Testing Not Protected by Attorney-Client Privilege If Not Provided to Attorneys

The Court found that the pre-litigation scientific testing was not covered by attorney-client privilege, even though they may have been done "at the direction of" a law firm, because the core purpose was for the client's understanding rather than for facilitating legal advice:

I do not think [plaintiff] First Quality has shown that the attorney-client privilege applies to any of the [relevant] disputed . . . documents. Plaintiff's position is that everything [the expert] Dr. Malburg did falls "well …
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Chief Judge Connolly Declines to Apply First-to-File Rule

David M. Fry, July 30, 2021
MTD

Chief Judge Connolly issued an interesting opinion on Friday, denying a motion to dismiss a DJ complaint in favor of an earlier-filed infringement action in the Western District of Texas.

The DJ case is the second Delaware action between these parties. After Judge Connolly found the claims in the first case invalid under § 101, the patentee brought an infringement action in Texas on a "virtually identical" continuation patent.

Although the Texas case was filed first, Judge Connolly declined to apply the first-to-file rule. He based his decision not only on judicial economy (i.e., he had already devoted substantive attention to the earlier, "virtually identical" patent), but also on the patentee's "litigation gamesmanship":

Second, SmileDirectClub' …
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A Markman First for Judge Noreika

Nathan R. Hoeschen, July 29, 2021
Indefiniteness

All teed up
All teed up Will Porada, Unsplash

I come to you, loyal reader, with hat in hand. As a reporter on the indefiniteness beat, I pride myself on being on top of all the new developments in Delaware—but it looks like one slipped by me earlier this month—Judge Noreika has issued her first order finding a claim indefinite at Markman.

It should be noted that the claims at issue in Tracktime, LLC v. Amazon.com, C.A. No. 18-1518-MN, D.I. 89 (Mem. Order, July 7, 2021) were means-plus-function claims, which Judge Noreika found indefinite for lack of a corresponding structure in the specification. See id. at 14-15. These issues tend to be easier lifts at the Markman stage for all of …

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Chief Judge Connolly Dismisses NPE Complaint for Inadequate Detail

Andrew E. Russell, July 28, 2021
MTD FRCP 12(b)(6)

March of the Trolls
Paulo O, CC BY 2.0

Continuing our theme, another subject that often comes up in defending NPE complaints is whether the NPE's often-lackluster complaint may be vulnerable to an FRCP 12(b)(6) motion to dismiss (and whether that motion can be brought economically).

Judge Connolly today dismissed a complaint by Swirlate IP, an (alleged) IP Edge entity, because the complaint mostly parroted the language of the claims and offered an unspecific website URL.

Here is an example of a typical paragraph from the complaint, which mirrors the claim language but also offers slightly more:

21. Upon information and belief, the Accused Instrumentality performs the step of performing the second transmission by transmitting the second data symbols over a …
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Claim Construction Argument Costs Defendants Credibility

Jeff Castellano, July 27, 2021
IPR Claim Construction

In a short ruling issued in Deere & Co. v. AGCO Corp., 18-827-CFC, Judge Connolly rejected the defendants' motion for additional claim construction after IPR. The defendants had asked the Court to conduct further claim construction proceedings on three groups of terms, to account for allegedly inconsistent positions taken by the plaintiff during IPR proceedings on 8 of the 11 asserted patents. Judge Connolly explained that he entertained the motion for more claim construction "based on Defendants' repeated and emphatic representations that Plaintiff Deere & Company maintained . . . positions on claim construction [during IPR] that were 'diametrically opposed' to and 'fundamentally inconsistent' with positions Deere took during claim construction before me."

Judge Connolly, however, did not agree . . .

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Expert's On-the-Stand Admission That He Changed Opinion after Speaking to Attorneys, Resulting in $444,000+ in Fees, Insufficient to Render Case Exceptional

Andrew E. Russell, July 26, 2021
§ 285 Trial

"Oh god. What did our expert just say?" Jamie Haughton, Unsplash

More and more NPE cases have moved to Delaware over the last few years, following TC Heartland. Defendants often try to deal with NPE cases by threatening fees under 35 U.S.C. § 285, with varying degrees of success.

A § 285 fees opinion today by Judge Stark offers an interesting data point as to what kind of conduct is not sufficient to render a case as a whole exceptional under § 285, as well as a lesson on how to best to pursue a fees motion.

In Intellectual Ventures I LLC v. Trend Micro Inc., C.A. No. 12-1581-LPS (D. Del.), the patentee's …

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Judge Andrews: "Simply Needing More Time Is Not Good Cause" to Push Trial

David M. Fry, July 23, 2021
Scheduling Trial Calendar

As jury trials in Delaware continue to get back on track, the judges' trial calendars are jam packed for 2021 and 2022. What does this mean if you have an upcoming trial date and need to move it?

In some cases, you might be out of luck. Yesterday, Judge Andrews denied an unopposed motion to extend a case schedule that would have pushed trial from June 2022 to September 2022. The purpose for the request was to provide additional time to complete fact discovery.

In an oral order, Judge Andrews rejected the request outright:

The Parties say they need more time, but simply needing more time is not good cause. The Court's schedule is already completely full …
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