Administrative law is famously labyrinthine. And not the fun kind of labyrinth with awesome bull-headed dudes.
"You totally rule Asterion" "I totally already know that"AI-Generated, displayed with permission
Today's case deals with an FDA practice -- not even a regulation! -- that had an outsized effect on an ANDA.
Mylan Pharmaceuticals Inc. v. Bayer Intellectual Property GMBH, C.A. No. 23-556-RGA (D. Del. Jan. 31, 2024) (R&R) was a declaratory judgment action spawned from an earlier ANDA dispute. In that earlier case, Mylan had filed given a Paragraph IV certification as to several of Bayer's orange book patents for Xarelto, and a Paragraph III certification as to another.
(Eds. Note - if you're wondering what a paragraph IV certification is, you should probably just stop here, this one gets pretty weedsy and the jokes are mostly over).
When all was said and done in that earlier case, one of the patents was invalid, and another Bayer never sued on at all, apparently conceding the product did not infringe. Mylan thus should have been able to launch as soon as the paragraph III patent expired.
Shh. They're not "invalid," they're "canceled" and "in the public domain"Kristina Flour, Unsplash
Yesterday Nate wrote about Judge Bryson's opinion that a plaintiff was not bound by its prior allegation that a product infringed two claims, because plaintiff's statement deals with an issue of law, not fact.
Today, I think it's worth discussing another aspect of the same decision, where Judge Bryson addressed a motion by plaintiff to preclude the defendant from discussing the same two invalid claims, claims 9 & 9 of the two asserted patents.
The the PTAB canceled claims 9 and 9 in an IPR, and plaintiff now asserts only claims that depend on those two canceled claims. It moved to prevent defendant from …
Watch out for what may be in that draft scheduling order...AI Generated, displayed with permission
In International Business Machines Corporation v. Zynga Inc., C.A. No. 22-590-GBW (D. Del.), the parties agreed in the scheduling order to a rather vague set of case narrowing provisions:
On November 30, 2023, Plaintiff shall perform a first narrowing of the number of asserted claims. On December 7, 2023, Defendant shall perform a first narrowing of the number of asserted invalidity references.
. . . On February 28, 2024, Plaintiff shall perform a second narrowing of the number of asserted claims. On March 5, 2024, Defendant shall perform a second narrowing of the number of asserted invalidity …
"What do you mean, attorney argument! This is unbiased expert testimony about how awesome our positions are."Braydon Anderson, Unsplash
Well, this is a new one for me. In Wirtgen America, Inc. v. Caterpillar, Inc., C.A. No. 17-770-JDW-MPT (D. Del. Jan. 16, 2024), the plaintiff had previously brought an action in the ITC against the defendant, and won—achieving an exclusion order that stood up (in part) on appeal.
Now, in a District of Delaware action on the same patents, plaintiff argues willfulness based in part on the previous ITC ruling. Defendant tried to offer an expert who would testify about how great its defenses were at the ITC:
Caterpillar offers Mr. Bartkowski to opine on how …
We've talked a lot about "plain meaning" constructions, and how our judges havesometimespushedback against parties who offer plain meaning constructions without any indication of what the actual meaning of the term is.
Magistrate Judge Fallon issued an R&R today on an offshoot of this issue. In PPC Broadband, Inc. v. Charles Industries, LLC, C.A. No. 22-1517-GBW-SRF (D. Del. Jan. 8, 2024), the parties disputed the construction of only a single term, "drop cable." Plaintiff proposed not construing the term at all, and offered a generic definition as an alternative. The defendant proposed a specific construction that added limitations to the claim.
The patent at issue is directed towards a wall-mounted box that …
The ITC is just, constantly issuing opinions. It's always "import this" and "don't export that." Frankly, I don't have the time for it.
That sands through the hourglass, so are the [copyrighted material redacted]Nathan Dumlao, Unsplash
On this historic day, however, Judge Wolson struck back against the relentless tide of ITC opinions. An act for which we at IP/DE will forever be grateful.
The issue came up in the context of a summary judgment opinion in Wirtgen America, Inc. v. Caterpillar, Inc., C.A. No. 17-770-JDW-MPT (D. Del. Jan 4, 2024) (Mem). The plaintiff there had previously prevailed at the ITC on one of the patents, and the ITC had issued (sigh) an exclusion order.
The plaintiff then moved for summary judgment of infringement, citing in support only the ITC's written decision. Judge Wolson, denied the motion:
The ITC’s decision is not factual evidence. It is, instead, a decision that weighs evidence and applies the law. Wirtgen’s reliance on the ITC decision as the sole evidence to support its argument means that I could deny the motion just for a failure of proof. But there are other problems as well.
Even if I treated the ITC’s decision as evidence, it would not suffice to carry Wirtgen’s burden. The decision is not binding on me. And the decision came in a different procedural posture. The ITC weighed the parties’ evidence and reached a conclusion, much like I would do after a bench trial. But, at this stage of the proceedings, I can’t weigh the evidence. Instead, I have to credit any contrary evidence that Caterpillar offers, and it has offered evidence . . .
Wirtgen, C.A. No. 17-770-JDW-MPT, at 10.
Let this serve as a reminder that we all have to keep fighting the good fight.
(Eds. Note - the ITC is actually pretty cool by the standards of IP courts and practitioners)
"Not invalid" may be a double negative, but it's definitely not the same as "valid."Markus Spiske, Unsplash
Chief Judge Connolly issued a short opinion this morning denying a motion for summary judgment that a patent was not patent ineligible, in C.R. Bard, Inc. v. Angiodynamics, Inc., C.A. No. 20-1544-CFC-SRF (D. Del. Jan. 3, 2024).
In short, the patentee had previously succeeded on the issue of § 101 ineligibility at the Federal Circuit, which reversed a lower-court finding of ineligibility and held that:
[T]he asserted claims in Bard’s three patents are directed to eligible subject matter under § 101.
C.R. Bard, Inc. v. Med. Components, Inc., C.A. Nos. 2022-1136, 2022-1186, 2023 U.S. App. LEXIS …
The District of Delaware's Default Standard for Discovery requires contentions in patent cases.
One common Delaware counsel question is: what level of detail is required for contentions?
The answer varies on what the concern is. There is a certain level of detail that will probably preclude the Court from ordering you to supplement your contentions—but providing just that bare level of detail may not be enough to preserve all arguments that you later want to make.
On Monday, Judge Burke denied a motion to strike invalidity contentions where a party had disclosed an obviousness theory as to a patent based on modification of a prior art reference, but had not disclosed their intent to cite and rely on their own product as evidence that the modification was obvious.
The plaintiff had moved to strike the discussion of the defendants' own product from their expert reports, on the theory that their contentions failed to to disclose their intent to use that product in their obviousness analysis. Judge Burke denied the motion, and explained that a party need not disclose all evidence in support of its contentions:
Although this is a difficult issue, the Court is not prepared to say that Defendants' actions amounted to an untimely disclosure. This is because Defendants have affirmatively represented that they are not relying on the direct aortic Engager system as prior art itself; instead, they rely on it only as a piece of evidence that will be used to "show that a direct aortic version would have been an obvious modification to Engager 3.0 at the relevant time." (D.I. 361 at 2) In other words, Defendants are relying on the system simply as evidence in support of a theory that was itself timely disclosed. And as Defendants note, courts generally hold that: (a) in validity-related or infringement-related contentions, a party is not required to cite to every piece of evidence that will be used to support a given theory; and (b) it is proper for an expert to expand upon such theories in his expert report. . . . The Court also notes that it is not as if Plaintiff had zero prior knowledge of the existence of the [Defendants'] system. As Defendants point out, they produced documents in discovery regarding this system, and their engineers testified at some length about the device during depositions. . . . (4) In light of the above, the Court cannot say that Defendants' conduct amounts to untimely disclosure that should be stricken.
Speyside Medical, LLC v. Medtronic CoreValve LLC, C.A. No. 20-361, D.I. 447 (D. Del. Dec. 18, 2023).
In my view, the Court is not saying that no evidence at all needs to be disclosed in support of the contentions—just that this particular evidence went beyond what was necessary, under the facts of the case.
It's impressive when an attorney files a short letter and gets the Court to do something that it is not often inclined to do.Immo Wegmann, Unsplash
The District of Delaware generally suspended its mediation program in 2021, and mediations before a magistrate judge rarely happen in patent cases these days (although they do sometimes happen in some other cases, such as employment cases).
Since then, parties have sometimes moved to private mediations—especially when ordered to—but generally in my experience the overall number of cases that go through mediation has declined, and there aren't a huge number of local patent-case mediators.
When we last discussed this, we noted from comments at the 2023 Bench and Bar conference that …
Chief Judge Connolly's scheduling order requires parties to rank their Daubert motions, and gives the Court the discretion to automatically deny all lower-ranked motions if it denies any one motion. In other words, if a party files five Daubert motions, and the Court grants the first-ranked motion but denies the second, the Court can then deny motions three, four, and five:
If the Court decides to deny a motion filed by the party, barring exceptional reasons determined sua sponte by the Court, the Court will not review any further Daubert motions filed by the party.
It has a similar provision for summary judgment motions Thus, it's important that parties split up their motions and rank them. …
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.
![That sands through the hourglass, so are the [copyrighted material redacted]](https://bd6f.s3.amazonaws.com/media/images/nathan-dumlao-5Hl5reICevY-unsplash.max-640x360.webp)
