This week, Judge Bryson issued his findings of fact and conclusions of law following trial in Janssen Pharmaceuticals, Inc., v. Tolmar, Inc., C.A. No. 21-1784-WCB (D. Del. Feb. 26, 2024), and ANDA action. The opinion is long and thorough, and I thought the section on enablement was worth noting.
The patent at issue covers a "dosing regimen" for giving an anti-psychotic drug "to a psychiatric patient in need of treatment for psychotic disorder." According to the method, two loading doses of the drug are given, and then a maintenance dose is given between 21 and 38 days later (a "17-day window").
Defendant argued that the patent was not enabled, first because a person of …
I'm going in to trial soon so today's post will be light on jokes. Just the facts.
They were supposed to look like Dragnet (#best show if the '50s?) but instead they just look like they're on a fashionable date.AI-Generated, displayed with permission
(Eds. note: not the most informative post on the blog, just the most informative one Nate wrote)
(Other eds. note: rude.)
(Same eds. note: OK, 1 joke.)
You're probably aware that we've got a new judge in town. Just yesterday she issued an order cancelling a Markman hearing where the only issues raised in …
The text of the District of Delaware Local Rules require non-pro se parties to meet-and-confer on every non-dispositive motion:
RULE 7.1.1. Statement Required to be Filed with Nondispositive Motions.
Except for civil cases involving pro se parties or motions brought by nonparties, every nondispositive motion shall be accompanied by an averment of counsel for the moving party that a reasonable effort has been made to reach agreement with the opposing party on the matters set forth in the motion. Unless otherwise ordered, failure to so aver may result in dismissal of the motion. For purposes of this Rule, “a reasonable effort” must include oral communication that involves Delaware counsel for any moving party and Delaware …
Look, I get it. We write about redactions alot. Andrew wrote about redactions yesterday. I begged him not to, but he was like "shut up, I do what I want" before threatening me with the broken end of a bottle.
Actual reenactmentAI-Generated, displayed with permission
But alas, I have lived long enough to see myself become the villain of this blog. Judge Andrews issued an opinion the other day that had some guidance on redactions that was too helpful not to share (if a bit disheartening for the budding redactors). Both parties in Regenxbio Inc. f/k/a ReGenX v. Sarepta Therapeutics, Inc., C.A. No. 20-1226, D.I. 249 (D. Del Feb 22, 2024) (Oral Order) filed timely notices of …
Once you stop groaning, you can use this image of "sealing the courtroom" to help you remember to move to seal next time.AI-Generated, displayed with permission
Most filings in the District of Delaware can be made under seal without a motion. The Court requires a motion to seal certain things, however, including hearing transcripts—and the burden on those motions can be high.
I've noticed that out-of-town counsel sometimes forgets just how involved it is to file a motion to seal. It's not a form motion that you can draft up quickly. It's a substantive filing, that also requires a meet-and-confer, and that is best supported by a client declaration.
Visiting Judge Wolson, of the Eastern District of Pennsylvania, reminded …
In Exeltis USA, Inc. v. Lupin Ltd., C.A. No. 22-434-RGA-SRF (D. Del.), plaintiff asserted infringement of claims from six patents. Back in July, 2023, Judge Andrews ordered the plaintiff to narrow its case to seven asserted claims across all of the patents prior to trial, which is set for Monday, February 26, 2024.
On Tuesday of this week, the Court issued its ruling on several pre-trial claim construction disputes. Plaintiff lost some of the disputes and, apparently, decided that it needed to stipulate to non-infringement of that claim.
With one of its seven claims out of the case, and with less than a week to go before trial, Plaintiff sought leave to re-assert one …
When I was maybe 12, my class took a trip to the public library and we were told to pick up books on our likely future careers. This was before blogs were invented, so I had to find something else. I ended up getting a book on electrical engineering and a book on screenwriting -- which I suppose adds up to within a rounding error of patent blogger.
I don't remember much of the electrical engineering (obvs) but I vividly recall the chapter on capturing your characters' vernacular. There was an example scene of a clandestine drug purchase, wherein the dealer refused to sell due to nearby police. Looking back, I think the author had a problem. It went like …
Goodbye, inconvenient 30(b)(6) testimonyAI-Generated, displayed with permission
FRCP 30(b)(6) allows a party to notice the deposition of a corporation or other organization on a list of topics. That organization then presents one or more designees to testify on its behalf at deposition. The designee's testimony is treated as that of the corporation.
At trial, it's not unusual for a party to want to play the 30(b)(6) deposition testimony of an opposing party, even if the designee who gave the testimony also happens to be testifying as a fact witness.
Why? Because, often times, the party got exactly what they wanted out of the 30(b)(6) witness on some topic, and if they play the video they can be assured that …
I want you to take a deep breath and imagine yourself in the heady days of 2015. Every night you enjoy the newly released Doritos' loco taco. Every morning you practice the harlem shake. Game of Thrones has so much promise. Life is good.
This was really my peakAI-Generated, displayed with permission
For the patent litigator (e.g., everyone reading this), the law is in an interesting place. Form 18 is about to be abolished, and there is a great deal of of hemming and hawing about how much detail will need to be included in a complaint for patent infringement. Yours truly even jumped on the hype train and wrote an article on it for Landslide (other than the Alice Cooper reference in the title, which I think went largely unnoticed, it bears little resemblance to the current blog).
For defendants, things were trickier still. The question of what level of detail was required for pleading the usual counterclaims of noninfringement and invalidity was even more up in the air. Several Delaware decisions even held that greater particularity was required for counterclaims than infringement claims. For instance, Judge Robinson made the following statement in dismissing invalidity counterclaims in Senju Pharm. Co. v. Apotex, Inc., 921 F. Supp. 2d 297, 302 (D. Del. 2013):
the fact that Form 18 (rather than Twombly and Iqbal) remains the standard for pleading infringement claims is an insufficient justification for deviating from Twombly and Iqbal for pleading other causes of action . . . Therefore, the court concludes that the pleading standards set forth in Twombly and Iqbal apply to counterclaims of invalidity.
Judge Burke addressed a situation yesterday in BT Americas, Inc. v. Palo Alto Networks, Inc., C.A. No. 22-01538-CJB (D. Del.) where a defendant moved to stay pending IPR, but the patent-in-suit wasn't actually part of the IPR.
You may be thinking—huh? How did that situation come up?
The plaintiff apparently brought suit on two patents, and the defendant moved for IPRs on both. The PTAB instituted on the first one, and declined to institute on the second. When the defendant notified plaintiff of their intent to request a stay, the plaintiff immediately dismissed the first patent with prejudice—leaving only the second patent, which was not the subject of any IPR.
The defendant nonetheless charged ahead with its motion to stay, arguing that it should get a stay anyway:
A stay of the suit pending resolution of PAN’s instituted IPR petition on the ’641 patent will streamline the issues in this case, even if the ’641 patent is dismissed. . . . Regarding the ’237 patent [which is not subject to an IPR], a stay is appropriate regardless of whether the ’641 patent is dismissed because there is substantial overlap between the two Asserted Patents. Both patents share an identical specification and the claims of the ’237 patent substantially overlap with the claims of the ’641 patent. . . . Indeed, during motion to dismiss briefing, the parties and the Court treated claims 14 and 18 of the ’237 patent as representative of all asserted claims of both patents. . . . Even BT’s infringement contentions are replete with internal cross-references, repeatedly relying on the “mapping” of representative ’237 patent claims to argue infringement of the ’641 patent. . . . The PTAB’s institution decision on the ’641 patent relies on the same evidence to demonstrate a reasonable likelihood of success as the PTAB’s decision on the ’237 patent for corresponding claim limitations.
. . .
Because of this significant overlap, the PTAB’s final written decision as to the ’641 patent could dramatically simplify the case or, at the very least, would be highly instructive as to the ’237 patent. The reasoning and written record from the PTAB on the instituted IPR will be relevant to at least claim construction and invalidity of both Asserted Patents. Accordingly, a stay will remove the possibility of onerous, redundant, and potentially inconsistent rulings, and narrow the issues in this case. . . . A stay will thus conserve judicial and party resources as to validity of the Asserted Patents.
This blog is for general informational purposes. It is not an offer to perform legal services, and should not be considered a substitute for legal advice. Nothing in this blog should be construed as forming an attorney-client relationship. If you have legal questions, please consult counsel in your jurisdiction.
