As we previously mentioned, the Court has suspended all non-emergency jury trials until April 5, 2021, and has stated that, at least initially, it will permit only one jury trial to proceed at a time.
The Court tried repeatedly to re-start jury trials in November and continuing through early February—and got so far as jury selection—but ultimately all of the cases scheduled for trial either resolved or were delayed, mostly due to coronavirus concerns among the parties. At this point, the Court has recognized that, once jury trials restart, the trial calendar is looking extremely congested.
The Court Has Not Canceled All April Jury Trials (Yet)
When should a patentee have to disclose the date of invention? The defendant would prefer a date before invalidity contentions so they don't waste time vetting reams of recent prior art only to have the plaintiff produce the inventor's 4th grade journal showing conception in the early 1930's. The plaintiff, on the other hand, would prefer not to go digging through lab notebooks to try and prove a conception date, only to find that all of the relevant prior art was carved on stone tablets by cabal of renaissance alchemists long before the inventor was born.
No Answer In The Rules
Neither the Delaware Default Standard for Discovery, nor the form scheduling orders of any of our judges address when …
Chief Judge Stark on Friday scheduled the first post-COVID-19 patent jury trial that I've seen, in Guardant Health, Inc. v. Foundation Medicine, Inc., C.A. No. 17-1616-LPS-CJB, D.I. 487 (D. Del. Oct. 16, 2020). (The potential Judge Noreika trial I mentioned recently is not going forward).
The Court had offered the November 30 date late last month. The defendant objected to it due to a conflict. The defendant also argued that the jury pool will not be representative, lacking older jurors, and that holding a trial would go against CDC guidance.
The Court was not persuaded. It did, however, set the following restrictions:
No live witnesses: The Court accepted a proposal that since not all witnesses can …
Chief Judge Stark today denied an emergency request by defendants to delay a remote bench trial scheduled to start next week.
The Court had previously solicited the parties' preferences on how to handle trial and, before the pretrial conference, ordered that the trial would be fully remote. At the pretrial conference, neither party objected to that ruling.
Last week, however, Defendants sought emergency relief to delay the trial in order to convert it to a "partially remote" trial, submitting a declaration from their client that they had not authorized their now-former in-house counsel to agree to a fully virtual trial.
They cited due process rights and the importance of in-person testimony …
A recent decision from Judge Stark highlights an often-overlooked aspect of motions to compel: explaining why the documents are relevant in the first place.
Judge Williams issued an interesting opinion yesterday on a motion to strike.
This is becoming my standard pitcture when I don't have anything more clever. Let me know if you would like me to replace it with a series of cartoons of Andrew and I shruggingBilly, Unsplash
The issue in Cisco Systems, Inc. et al v. Ramot at Tel Aviv University Ltd., C.A. No. 21-1365-GBW (D. Del. Jan. 15, 2025) was the form of the briefing. The case had previously been assigned to Judge Stark, before passing to the vacant judgeship, then Judge Burke. The parties' scheduling order thus followed judge Burke's form order which contained a specific letter briefing procedure for motions to strike with 3-page opening, a 5 page answering and 2-page reply briefs. When the case was reassigned to Judge Williams, the parties kept the old scheduling order.
The parties ultimately raised the motion to strike through Judge Williams' dispute procedures. He issued an oral order that allowed for only 3-page opening and answering briefs without reference to the procedures in the scheduling order:
Having reviewed the parties' joint letter requesting a discovery teleconference (D.I. 146), IT IS HEREBY ORDERED that, by no later than 5:00 p.m. on Tuesday, December 10, 2024, any party seeking relief shall file with the Court a letter, not to exceed three (3) pages, outlining the issues in dispute, its position on those issues, and supporting authority for its position(s). By no later than 5:00 p.m. on Thursday, December 12, 2024, any party opposing the request for relief may file a letter, not to exceed three (3) pages, outlining that party's reasons for its opposition and supporting authority.
The movant (Plaintiff) filed a 3 page letter (the correct procedure under either the scheduling order the later oral order). The defendant, however, filed a 5-page answering brief -- allowed under the scheduling order but exceeding the limit set in the oral order.
Judge Williams thus declined to consider any of the argument after page 3 of the brief:
While the Operative Scheduling Order sets default page limits for motions to strike, the parties were both instructed to submit letter briefs not exceeding three pages. Cisco complied with that instruction. Ramot did not. Accordingly, the Court will exercise its discretion and give no weight to the text beyond page three of Ramot's brief.
One of the hallmarks of the Hatch-Waxman Act is the "offer of confidential access," wherein the generic manufacturer must offer the NDA holder, you guessed it, confidential access to the ANDA before the deadline to file suit.
AI-Generated, displayed with permission
One of the lesser explored implications of the OCA is the effect of a patentee declining the offer and bringing suit without reviewing the actual ANDA. In particular, how does that decision effect the attorney's fees inquiry if the NDA holder is ultimately unsuccessful at trial?
This was the question Judge Goldberg addressed on Friday in Silvergate Pharms., Inc. v. Bionpharma Inc., C.A. No. 18-1962-MSG (D. Del. Oct. 4, 2024) (Mem. Op.). Bionpharma had prevailed …
As defenses go, there's few better than "I don't infringe." Unfortunately, it's quite difficult to prove at the motion to dismiss stage. It is, after all, the rare complaint that contains the dark seed of its own demise on this front.
mmm . . . dark seedsAI-Generated, displayed with permission
You might think that a motion to dismiss based on non-infringement would be a little bit easier in the ANDA context. After all, you have this giant document listing everything in your product and what it does. You would be wrong.
Such was the lesson of Judge Fallon's opinion in Allergan, Inc. v. Mankind Pharma Ltd., C.A. No. 23-272 (D. Del. Dec. 21, 2023), unsealed last week. The patent there required (amongst dozens of assorted buffers, reagents, uppers, downers, and excipients) a phosphate buffer. The defendant responded by pointing out that none of the 3.2 trillion ingredients listed in their ANDA contained any phosphorus.
(Eds. Note—for the liberal arts majors amongst you, phosphorous is a pretty big part of anything "phosphate")
They thus moved for judgment on the pleadings of no literal infringement, reasoning that the ANDA controlled the infringement inquiry. Judge Fallon denied the motion however, holding that it was possible future evidence might contradict the ANDA:
Mankind Pharma insists that the ANDA specification controls the infringement inquiry. However, the case law cited by Mankind Pharma in support of this proposition explains that the infringement inquiry is based not only on the ANDA filing, but also on "other materials submitted by the accused infringer to the FDA, and other evidence provided by the parties." The Federal Circuit explained "[i]t is ... possible, at least in theory, that other evidence may directly contradict the clear representations of the ANDA and create a dispute of material fact[,]" even if "[s]uch circumstances [are] unlikely to arise in practice[.]" Consistent with this recitation of the applicable standard, each case cited by Mankind Pharma was decided on a fully developed record, either on summary judgment or following a bench trial.
Allergan, Inc. v. Mankind Pharma Ltd., C.A. No. 23-272, at 5-6 (D. Del. Dec. 21, 2023) (internal citations omitted).
This case follows several similar decisions in the district, Novartis Pharmaceuticals Corp. v. Alembic Pharms. Ltd, C.A. No. 22-1395-RGA, 2023 WL 6387975, at *5 (D. Del. Sept. 29, 2023) and InfoRLife SA v. Sun Pharm. Ind. Ltd, C.A. No. 21-1740-WCB, D.I. 153 at 4-5 (D. Del. Nov. 21, 2022), which the opinion discusses at some length. Neither of those cases however were quite as factually stark as the one presented here, where the claims clearly require phosphorus, and the ANDA includes . . . no phosphorus.
Motions to strike are tough in Delaware. Although the reign of Pennypack seems to be slowly entering its dotage, the door remains open for the late-disclosed.
With exclusion so rare, its a bit odd we don't see more of Rule 37's lesser sanction -- fees.
But visiting Judge McCalla gave us one on Monday in Invacare Corp. v. Sunrise Medical (US) LLC, C.A. No. 21-823-JPM (D. Del. May 22, 2023) (Oral Order). The facts there were pretty stark.
The defendant had an inequitable conduct claim based on the patentee's failure to inform the PTO that identical claims had previously been rejected. Plaintiff's prosecution counsel testified that the failure was due to an error in an internal spreadsheet they kept of related applications that omitted the relevant application. Plaintiff had previously withheld the spreadsheet as privileged but eventually waived privilege and produced it.
Unfortunately, it came out during expert discovery that the spreadsheet actually contained the relevant application. This was probably a bad day for a lawyer somewhere. Plaintiff then went back to see if there were other versions of the spreadsheet that did omit the application -- they eventually found and produced some, but by then it was 4 months after the close of fact discovery.
Defendant moved to exclude these new references. Judge McCalla denied the motion but ordered plaintiff to pay what will surely be a hefty sum to cover the ...
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