A Blog About Intellectual Property Litigation and the District of Delaware

Entries for tag: ANDA

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.

Drug patents are legion, and they are prone to flock together. In ancient times, a patent would describe A molecule that cured . . . the dancing plague (?) and that would be the end of that. But one bright fellow after another came up with new ways to extend the life of a drag patent, from formulation, to method of treatment, to the new hip thing -- interaction patents.

The gist of these patent claims is pretty basic

  • You've got a drug that you normally give in amount A.
  • You've got atypical patient with whose taking drug B, or has condition C (these pretty much always have something to do with the liver, don't ask me why, I was …

Undo Button
Sergi Kabrera, Unsplash

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 …

David Pisnoy, Unsplash

On Friday, Chief Judge Connolly issued an order in the lead-up to an ANDA bench trial compelling the plaintiff to reduce its number of asserted claims by 75% to 4 claims, or face consequences:

ORAL ORDER: WHEREAS, the parties filed the proposed pretrial order (D.I. 225) on May 10, 2022; WHEREAS, the bench trial in this case is 24 days away, and, according to the pretrial order, Plaintiffs are still asserting 15 claims across eight patents . . . ; and WHEREAS, Plaintiffs' assertion of 15 claims across eight patents at this juncture makes clear that Plaintiffs have yet to focus adequately on the relative strength of their various infringement claims, the limited resources of …

Delaware Memorial Bridge
Chintan Jani, Unsplash

Observant readers will have noticed that the new scheduling orders Chief Judge Connolly unveiled last week were specifically for non-Hatch-Waxman cases, and perhaps deduced that further orders for ANDA cases would be forthcoming. Well, the wait is over.

The new Hatch-Waxman case order, released yesterday, contains many of the same updates as the orders from last week, including a procedure for ranking Daubert motions, the tweaks to claim construction procedures, and the requirement for colored covers on courtesy copies. All to be expected given the changes last week.

Early Case Narrowing

The big change was that the new scheduling order includes a staged procedure for narrowing asserted claims and prior art. The first such stage begins just 7 days after the scheduling conference:

No later than seven days after the date of this Order, Plaintiff(s) shall serve Defendant(s) with a "Preliminary Disclosure of Asserted Claims" that lists each claim of each patent alleged to be infringed by Defendant(s), including for each claim the applicable statutory subsections of 35 U.S.C. § 271 asserted. Unless otherwise agreed to by the parties, Plaintiff(s) may assert no more than ...

Standing Stones
Andreas Brunn, Unsplash

Today, Judge Connolly issued four new standing orders. These orders include:

  1. A requirement to disclose third-party litigation funding arrangements on the docket;
  2. A requirement in diversity cases to disclose the name and citizenship of every individual and corporation with a direct or indirect interest in every party;
  3. An order expanding disclosure requirements under Federal Rule of Civil Procedure 7.1 for non-governmental joint ventures, LLCs, partnerships, and LLPs;
  4. A requirement for the defendant in ANDA cases where there was a Paragraph IV certification to produce the ANDA when responding to the complaint;

The above are numbered only for reference below.

Each of these orders explicitly applies only in Chief Judge Connolly cases.

Order 1: Litigation …

On Tuesday, Judge Andrews issued what I believe is the first opinion in the district regarding "skinny labels" since the Federal Circuit issued its decision in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021).

As anyone immersed enough in patent law to read this blog will know, skinny labeling is the practice of excluding certain indications from the generic drug's label and associated inserts, so as to avoid inducing infringement of method of treatment patents listed in the orange book. In Amarin Pharma, Inc. et al v. Hikma Pharmaceuticals USA Inc., C.A. No. 20-1630-RGA, D.I. 97 (D. Del. Jan. 4, 2022), for instance, the branded drug was indicated for treatment of severe …

Charting Goals and Progress, Isaac Smith, Unsplash

To give the reader a bit of a peak behind the curtain, it can sometimes be taxing to write 5 blog posts in a week. This is especially true on a week, like this one, where the Court issues fewer decisions than average. All of us at IP/DE have our own strategies for dealing with this -- my preferred method is to dig up some stats that I had always wondered about, but never bothered to figure out.

This week, my focus was on invalidity challenges in ANDA cases. In particular, what are the relative odds of invalidating a composition patent, vs. a method of treatment patent, vs. a formulation patent?

The …

In a post-trial Hatch-Waxman opinion issued this week, Chief Judge Connolly sided with the defendant regarding the sole infringement dispute: whether the defendant's ANDA product had an infringing pH. The plaintiffs' patents required that the claimed compositions have a pH of between 3.7 and 3.9. The defendant's ANDA undisputedly required that the defendant's generic product have a pH between 3.4 and 3.6. Importantly, the ANDA required that the product stay within the 3.4-3.6 range both upon release and during the stability testing period (24 months).

Given that the ANDA's requirements are binding on the manufacturer of the generic product, and given that the ANDA is the operative document for the purposes of the infringement inquiry in Hatch-Waxman cases, you might think that would be the end of the inquiry. Indeed, Judge Connolly noted that in these circumstances, a judgment of noninfringement "must necessarily ensue."

However, the plaintiffs challenged this conclusion...

ANDA litigation can be an odd beast. You file a case based on a product that a defendant has only applied to manufacture—what then, when the FDA requires an amendment? What of the litigation that may be years in the making and heading into the home stretch?

The somewhat tortured history of Biodelivery Sciences International, Inc. et al. v. Chemo Research, S.L., C.A. No. 19-444-CFC-CJB, gives us several examples of exactly how the Court deals with this situation.

An Early Change to an ANDA Does Not Warrant a New Trial Date

Early on in that case (about 6 months after the scheduling order was entered) one of the defendants—Chemo—received a complete response letter ("CRL") from the FDA requiring them …