On Wednesday, Judge Andrews issued an order in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals, Inc., C.A. No. 20-430-RGA (D. Del. May 17, 2023) rejecting an attempt to evade judgment in an ANDA action based on the filing of an amended ANDA.
The defendant in the case had won on one method of treatment, and lost on the other. It filed an amended ANDA seeking to remove the infringing treatment from the label:
Defendant filed an ANDA seeking to make and market a drug for two different methods of treatment-the IBS-D indication and the HE indication. I had a bench trial. After trial, I ruled in Defendant's favor on the IBS-D indication (as …
Today Chief Judge Connolly addressed a motion to dismiss a combined trade dress, federal unfair competition, copyright infringement, and design patent infringement action.
The parties apparently agreed that the defendant in the action did not meet the TC Heartland venue test for the patent portion of the action:
Argento is a New York corporation with its principal place of business in New York. . . . It is undisputed that Argento does not own, rent, or maintain any offices, physical property, addresses, or bank accounts in Delaware and does not employ any Delaware-based employees, agents, or representatives. It is also undisputed that venue of Globefill's patent claim against Argento does not lie …
Yesterday, the Judicial Conference announced the end to the exception permitting remote public access during COVID-19:
The COVID-19 emergency is no longer affecting the functioning of the federal courts, the Judicial Conference’s Executive Committee has found, setting in motion a 120-day grace period in which federal courts may continue to provide the same remote public audio access to civil and bankruptcy proceedings as they did during the emergency.
The Executive Committee finding takes effect May 24. The grace period, which ends Sept. 21, relates only to the Judiciary’s temporary broadcasting exception for remote audio public access to civil and bankruptcy proceedings. …
When a party asks to do something outside of the time limits set by the scheduling order, the Court looks to whether there is "good cause" under FRCP 16(b)(4) to modify the scheduling order. Good cause requires diligence, generally meaning that the movant could not have reasonably met the deadline it's trying to move.
Last week we got two examples of diligence analyses from the Court, one that found that a party was diligent, and one that didn't. I thought it would be interesting to line them up and compare them.
"Immediately" = Good Cause
First, Judge Fallon found good cause where a plaintiff sought to depose a third-party witness after the close of fact discovery, after the …
Most judges in the District of Delaware limit the parties to three motions in limine per side. Visiting judges sometimes permit more, but I get the sense that this limit is something native D. Del. judges generally don't want the parties to change when submitting a proposed scheduling order.
But I can't recall a patent case where the parties did not use all of their motions in limine, and want more (even if they didn't ask the Court). These evidentiary issues can just have a large effect on trial. Plus, with a mountain of work bearing down on you in the leadup to trial, it's great to think you might knock out some opposing …
The objection in question actually failed under the rules on two counts—both failing to cite the relevant standard of review, and failing to include the certification that new arguments were not being raised. Judge Andrews found both failures fatal:
The first question on review is, what is the standard of review? The Local Rules recognize this: "Objections . . . shall identify the appropriate standard of review." I note that requiring the statement of a standard of review is helpful to the reviewing court. It might also help the disappointed party to consider whether it should even file objections. Barry does not identify a standard of review. . . . Barry did not comply with the Standing Order. His objections are thus overruled. I need proceed no further. . .
The Court has a standing order that states: "Any party filing objections . . . must include . . . a written statement either certifying that the objections do not raise new legal/factual arguments, or identifying the new arguments and describing the good cause for failing to previously raise [them] before the Magistrate Judge." Barry did not file such a written statement with his objections. Seaspine pointed this out. . . . Seaspine asserts that Barry has raised arguments that he did not raise before the Magistrate Judge. Had Barry filed the required statement, I would know what his position on Seaspine's assertion is. Even after Seaspine raised the issue, Barry did not seek leave to file a statement providing the required information. This is not some arcane requirement. It is a practical one, designed to make referrals to magistrate judges as efficient as the referral system can be. Barry' s objections are thus overruled. I need proceed no further
Barry v. Stryker Corporation, C.A. No. 20-1787-RGA (D. Del. May 4, 2023) (Mem. Order)
At this time, the bloggers code of ethics requires me to call this a trend. Stay safe out there.
It's no secret that the Court is busy, and it's only getting busier. Time being such a limited resource, requests for special (expedited) treatment are particularly fraught.
AI-Generated, displayed with permission
An important codicil (legal words for 200 Alex (#notmyAlex)) to this rule is that, once you receive this special treatment, you really can't change your mind. This rule was brought into sparkling clarity in Taiho Pharmaceutical Co., Ltd. v. Eugia Pharma Specialities Ltd., C.A. No. 19-2309-CFC (D. Del. May 1, 2023) (Oral Order), which really speaks for itself:
Plaintiffs have filed a motion to extend by two weeks the deadline for their posttrial brief and findings of fact. During these proceedings, both sides insisted on quickly proceeding to a bench trial on the validity of the '284 patent, even though that patent does not expire until 2029. The Court accommodated the parties' request, and it has repeatedly noted the importance of the parties adhering to the Court's schedule given the Court's high caseload. Plaintiffs now seek to extend their posttrial briefing schedule by an additional two weeks because they have chosen to hire additional counsel. Plaintiffs have significantly burdened the Court's resources to date and proceeded to trial knowing that they had to abide by the Courts post trial schedule. Now therefore, Plaintiffs' motion is DENIED.
So there you go—if you're going to go fast, go fast.
There was an interesting oral order from Judge Burke last week in Natera, Inc. v. CareDX, Inc., C.A. No. 20-38 (D. Del. Apr. 28, 2023). Defendant apparently asserted a large number of § 112 defenses based on lack of enablement or written description. The Court held that the defendant had to narrow it's defenses.
The parties further disputed whether the parties should count § 112 arguments by limitation or by claim. The Court held that they should be counted by claim limitation, not by claim:
With respect to the parties' dispute as to whether an argument that a claim is invalid under section 112 based on a particular claim limitation counts …
The defendants in Corteva Agriscience LLC v. Monsanto Company, C.A. No. 22-1046-GBW (D. Del. Apr. 27, 2023) moved to stay after a third party initiated an ex parte reexamination of the patents-in-suit.
To meet the "simplification" factor in moving to stay, defendants offered to drop their obviousness-type double patenting defense:
The first factor—whether granting the stay will simplify the issues for trial—disfavors a stay. Defendants assert a stay would simplify the case. First, Bayer claims it will agree to not argue that the '555 Patent is invalid for obvious-type double patenting ("OTDP") on the basis of U.S. Patent No. 11,149,283 ("the '238 patent" ) and that dropping this argument will simplify the issues for trial. D.I. 41 at 9.
The Court quickly dispatched with that idea, noting that it was essentially a throw-away argument:
However, Defendants recognize that Corteva can overcome the OTDP argument if Corteva files a terminal disclaimer. 3 Id. at 9-10. Because it is likely that this OTDP argument will not make it to trial anyway, the Court does not find that Bayer's offer to drop the argument will simplify the case.
The Court found that the factors did not favor a stay, especially considering the plaintiff had added two additional patents in the time since defendants filed their motion, and those two patents are not subject to re-examination. Beyond that, a stay would likely preclude injunctive relief (due to a patent expiration).
All told, it's not clear how they could have prevailed on this motion at all after the plaintiff asserted the two additional patents.
Parties can freely stipulate to many things in the District of Delaware, and often stipulations to extend deadlines are filed close to the last minute, especially where the parties are working toward agreement but ultimately cannot agree on the final filing in time (or else are having trouble connecting with the other side).
However, stipulations filed close to the Delaware witching hour (5:00PM EST) can be fraught with risk of the Court's denial, as we’ve seen in past heart-stopping examples. We’ve warned before that requests to move Court-scheduled conferences are in the “iffy” category, and combined with last minute filing, can end in disappointment for everyone, as shown in an oral order from Judge Noreika last week in Neurocrine Biosciences, Inc. v. Lupin Limited et al., C.A. 21-1042, D.I. 197 (D. Del. Jul. 16, 2021):
On April 17, 2023, the Court instructed the parties to talk to each other about their disputes so that a follow-up call with the Court (set for April 21, 2023) would be more productive than the prior call. On April 21, 2023, a few hours before the set call, the parties submitted a stipulation requesting the April 21 call be delayed. After further inquiries, it became clear that, in the five days after the Court directed the parties to TALK, they did not do so. The Court intended to address that during the April 21 call, but no counsel appeared for the call (notwithstanding that the Court had not granted the request for a delay). THEREFORE, IT IS HEREBY ORDERED that, should the parties not inform the Court that they have resolved their dispute in full by Tuesday April 25, 2023, lead trial counsel SHALL appear in person in Courtroom 4A on April 26, 2023 at 3:00 p.m. ORDERED by Judge Maryellen Noreika on 4/21/2023.
Judge Noreika previously indicated frustration with the magnitude of this particular discovery dispute (on search methods to find responsive documents), so the parties were on thin ice long before ...
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