A Blog About Intellectual Property Litigation and the District of Delaware


Entries for tag: ANDA

Simon Didn't Say

Nathan R. Hoeschen, July 22, 2025
ANDA

Many years ago now, when I was still in the full flagrant flower of youth (38), I wrote a post discussing the relative rates at which various drug patents—compound, method of treatment, and formulation—were found invalid in Delaware.

Not analyzed at the time (because who has the time?) was the question of how often these various types of drug patents are found to be infringed in ANDA cases. I'll have a fuller post on this later in the week, but my guess is that it goes compound > method of treatment > formulation. If it turns out I am wrong, you will never be able to prove it because I will edit this post immediately.

AI-Generated, displayed with permission

In any case, method of treatment patents often follow trends with certain themes going into and out of vogue, so I suspect today's opinion from Chief Judge Connolly in Novo Nordisk, Inc. v. Mylan Pharms. Inc., C.A. No. 23-101-CFC (D. Del July 22, 2025), will be of general interest to our audience.

The patent there—for blockbuster drug Wegovy—required that the drug be administered "without another therapeutic agent," which the Court construed to mean "administered without another therapeutic agent as part of the method for reducing body weight, or for treating the conditions of diabetes or hypertension."

Mylan argued that their ANDA label could not induce infringement because, although it cautioned against using the drug with other GLP-1 inhibitors, it was agnostic as to any other weight loss drugs, merely saying that "[t]he safety and efficacy of coadministration with other products for weight loss have not been established."

Plaintiff argued that the this was sufficient to establish inducement because "the proposed label does not require patients to receive other treatment beyond a reduced-calorie diet and physical activity, 'physicians will inevitably prescribe Mylan's ANDA Product without another therapeutic agent.'"

The Court, however, ...

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Short and Sweet

Nathan R. Hoeschen, April 10, 2025
Motion Practice ANDA

Anyone who's ever heard a judge speak, be it at the Bench and Bar conference, a luncheon, or in the drive-thru of your local Arbys, will have heard them say that a shorter brief is often better.

I only need one horsey sauce, any more is just gilding the lily
I only need one horsey sauce, any more is just gilding the lily Mahavir Shah, Unsplash

Law being what it is, however, this advice isn't often taken. Looking at the last 7 motions to dismiss filed in the district (look, I got bored)—with the usual 20-page limit—the average length was about 18 pages.

And so, on this slow news day, I bring you what may be the shortest successful motion I have ever seen, so that we may all be inspired to similar brevity:

Dear Judge Andrews:
We write on behalf of MSN to respectfully request an emergency teleconference and a temporary restraining order restraining Novartis from forwarding today's final judgment to the FDA. MSN' s motion to delist the '659 patent is scheduled for oral argument on April 29, 2025, and if the Court grants the motion, then Novartis' loses its pediatric exclusivity and there would be no basis to re-set MSN's ANDA's FDA approval date. If Novartis were to forward the order to the FDA, FDA re -sets MSN's ANDA's approval date, and MSN is successful on its motion, then MSN would be irreparably harmed because it would not be able to launch its ANDA product even though Novartis would lose its pediatric exclusivity. In that regard, there is no harm to Novartis by granting MSN's requested TRO because the final judgment enjoins MSN from launching its product.
We respectfully request interim relief at the Court's earliest convenience.

Novartis Pharmaceuticals Corporation v. Dr. Reddy's Laboratories, Inc., C.A. No. 19-2053-RGA. D.I. 518 (D. Del. Apr. 1, 2025).

That little motion—which was actually emailed to chambers—won the defendant a short-lived TRO that very day:

MSN's request for temporary emergency relief is granted. Novartis and its agents are ORDERED to maintain the status quo. That is, Novartis is directed not to provide the final judgment entered today to the FDA. I do not see any harm to Novartis from brief delay, because MSN cannot launch. But Novartis can certainly respond to MSN's letter, and I will reconsider the issue after receiving any response from Novartis.

Id., D.I. 509.

As it happened, the whole thing ...

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The Sky Is Falling

Nathan R. Hoeschen, April 3, 2025
Chicken Little ANDA

You are all of course familiar with the classic tale of chicken little. You may be less familiar with the plot of if the ill-fated Disney move of the same name. They both start the same, chicken sleeping under a tree has something fall on him, tells everyone the sky is falling and starts a panic.

Sahad Babali, Unsplash

Here the stories diverge. In the folktale, chicken little and his panicked friends meet a while fox, who tricks them into taking shelter in his cave, and then eats them. You can see the lesson.

In the film, chicken little is scorned, but later redeems himself by helping the local baseball team win the pennant (?). Afterwards, he is again hit by a piece of the sky, which turns out to be high tech camouflage used to hide alien spaceships in low orbit. The ships descend upon the hapless town, and the whole thing turns out to be a big misunderstanding. The lesson is somewhat less clear. This film made 300 million dollars.

Those of you who read Law360 (who somehow scooped me on this, but whose article does not recount the plot of a 20-year-old children's movie in unnecessary detail) will have guessed that this is all leading up to Judge Andrews' Oral Order yesterday in Novartis Pharmaceuticals Corporation v. Dr. Reddy's Laboratories, Inc., C.A. No. 19-2053-RGA. D.I. 512 (D. Del. Apr. 2, 2025):

Yesterday, MSN said the sky was falling and it needed emergency relief. I granted it. Today, MSN has filed an emergency motion requesting additional relief for essentially the same falling sky. I decline to enter any additional relief at this time or to consider the motion on an emergency basis.

For those wondering about the context here, the Federal Circuit just recently issued its mandate in the case ruling that the asserted patent was valid and infringed. Judge Andrews then promptly entered a final judgment, which included an order setting the effective date for approval of MSN's ANDA until after the end of Novartis' pediatric exclusivity period.

It's unclear from the docket exactly what happened next, but it appears that MSN emailed chambers ...

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Injunction Junction

Nathan R. Hoeschen, Feb. 13, 2025
Preliminary Injunction ANDA

I hope some of you saw the musical video Andrew posted yesterday before it was taken down in a copyright strike by the Prince Estate due to his eerily pitch perfect parody. The costumes alone were worth the price of admission.

Honestly the photo doesn't do it justice
Honestly the photo doesn't do it justice AI-Generated, displayed with permission

Hopefully tomorrow's video—Injunction Junction—fairs better.

Mallinkrodt Pharms. Ireland Ltd. v. Airgas Therapeutics LLC, C.A. No. 22-1648-RGA (D. Del. Feb 12, 2025). presented an interesting twist on the tried and true preliminary injunction formula.

The likelihood of success analysis was pretty standard (although it touched on one of my favorite issues—drug interaction). Ditto for irreparable harm, with the Court finding allegations of lost sales and …

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Court Grants Rule 12(c) Judgment on the Pleadings of No Contributory Infringement

Andrew E. Russell, Jan. 13, 2025
FRCP 12(c) Motion for Judgment on the Pleadings

Pills
HalGatewood.com, Unsplash

Defendants are always on the lookout for ways resolve patent cases (and other cases) early. One potential avenue is an FRCP 12(c) motion for judgment on the pleadings—but it only works in uncommon circumstance that the pleadings themselves show a lack of infringement or validity.

It's an uncommon circumstance—but not unheard of. Last week, the Court granted an FRCP 12(c) motion of no contributory infringement in Boehringer Ingelheim Pharma. Inc. v. Apotex Inc., C.A. No. 23-685-CFC (D. Del.), after a plaintiff's own complaint showed a lack of infringement.

Boehringer is an ANDA action. The patent claims a drug used to treat a disease in patients who—critically—are ineligible to receive a second drug. The label …

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No-Look Suit

Nathan R. Hoeschen, Oct. 8, 2024
ANDA OCA

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 …

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Stipulation, Smipulation

Nathan R. Hoeschen, June 18, 2024
ANDA Judgment

In a modern patent case—with dozens of claims and zillions of similar accused products—there are innumerable possible permutations of infringement and invalidity outcomes.

This can make it pretty difficult to craft a stipulation on undisputed issues.

The image generator I was using is now behind a paywall so I'm trying out new ones. Expect some more cursed illustrations like this for the next little while
The image generator I was using is now behind a paywall so I'm trying out new ones. Expect some more cursed illustrations like this for the next little while AI-Generated, displayed with permission

This was the hard lesson in Janssen Pharms, Inc. v. Tolmar, Inc., C.A. No. 21-1784-WCB, D.I. 198 (D. Del. June 13, 2024). In that ANDA case, the defendant had stipulated that "if any of claims 1–7, claim 15, and claims 17–21 (as dependent from claims 1 and 4) of the ’906 patent are not found to be invalid in this Action, Tolmar will agree to entry of a judgment of infringement and order pursuant to 35 U.S.C. 271(e)(4)(A) with respect to such claim.” Id. at 7 (quoting D.I. 86).

The whole thing went to trial and all of those claims were found not to be invalid. However, each of the above claims required a specific dosage strength, while Tolmar's ANDA covered several other doses in addition to the claimed ones. So, after trial they amended their ANDA to remove the infringing dosage and subsequently moved to amend the judgment to all the FDA to approve the amended ANDA for the (allegedly) non-infringing dosages.

Judge Bryson denied the motion however, holding that ...

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Longstanding FDA Practice

Nathan R. Hoeschen, Feb. 1, 2024
ANDA Subject Matter Jurisdiction

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.

But there was a twist. Bayer was ...

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ANDA 'Nother Thing . . .

Nathan R. Hoeschen, Jan. 9, 2024
ANDA Motion to Dismiss

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 seeds
mmm . . . dark seeds AI-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.

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Judge Wolson Rejects Attempt to Limit Deposition Discovery & Force Remote Depositions in ANDA Action

Andrew E. Russell, Sept. 10, 2023
Remote Depositions Depositions

An attorney's view after many a deposition—if you're lucky enough to catch a flight back that night.
An attorney's view after many a deposition—if you're lucky enough to catch a flight back that night. Eva Darron, Unsplash

This On Friday, Judge Wolson addressed—and rejected—an effort by an ANDA defendant to limit deposition discovery on the basis that discovery is, in its view, just not that important in an ANDA action. As set they put it:

This is an ANDA case. Black letter law holds that the infringement issues in an ANDA case are controlled by the ANDA itself. . . . Months ago, Defendants produced the ANDA and ANDA product samples from which the relevant infringement analysis must be derived. Plaintiff has now noticed the deposition of both Defendants and seven individuals. But the information that …
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