A Blog About Intellectual Property Litigation and the District of Delaware


ANDA
Abbreviated New Drug Application

Chief Judge Connolly Warns ANDA Plaintiff to Cut Back from 16 to 4 Asserted Claims Before Trial or Face Consequences

Andrew E. Russell, May 16, 2022
ANDA Congestion

Four
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 …
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Judge Connolly Issues New Standing Orders, Including Requirement to Disclose Litigation Funding

Andrew E. Russell, April 18, 2022
Standing ANDA

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 …

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Judge Hall Denies Attorneys' Fees, Rejects Argument That ANDA Suit Triggering 30-Month Stay Was Unreasonable

Andrew E. Russell, June 23, 2021
ANDA 30-Month Stay

Pills
HalGatewood.com, Unsplash

Judge Hall today issued an R&R on attorneys fees in In Re Kerydin (Tavaborole) Topical Solution 5% Patent Litigation, MDL No. 19-md-2884-RGA (D. Del. June 23, 2021), an ANDA case.

There, the plaintiff filed suit on four patents even though the PTAB had previously found an earlier patent in the family invalid in an IPR, and even though IPRs were pending on each of the four patents-in-suit.

Filing suit triggered the 30-month stay of FDA approval. Shortly after the suit was filed, one of the defendants moved to stay; plaintiff did not oppose, and actually filed a cross-motion to stay its own action against the other defendants (who opposed).

The Court granted the …

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Judge Stark Resolves Pretrial Disputes About Courtroom Sealing, Cross Exhibits

Jeff Castellano, Jan. 26, 2021
ANDA Trial Procedure

Somewhere between the filing of the pretrial order and the pretrial conference, Judge Stark typically issues an order resolving pretrial disputes and allocating trial time. These orders - while usually short - provide a wealth of insight into his trial practices and preferences, and (often) his views on substantive evidentiary issues. They also serve to remind litigants of longstanding trial management practices (including those codified in his form pretrial order).

On Friday, Judge Stark issued a 3-page pretrial memorandum order in a set of consolidated Hatch-Waxman ("ANDA") actions, Silvergate Pharmaceuticals, Inc. v. Bionpharma, Inc. et al., C.A. Nos. 18-1962, 19-1067, 19-678. The order contained decisions on sealing the courtroom during the bench trial, obviousness proofs, disclosure of exhibits to be used on cross examination, and others.

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Judge Stark Dismisses ANDA Case For Reasons that Now Seem Obvious

Andrew E. Russell, June 29, 2020
Paragraph III ANDA

Judge Stark today dismissed an ANDA claim after the defendant converted their ANDA in such a way that it simply did not infringe, and plaintiff was left with no claim and no remedy.

What Is an ANDA? (The Short Short Version)

ANDA cases make up a fair portion of the Court's docket. If you're not already familiar, ANDA cases are brought by patent holders after a drug manufacturer files an ANDA seeking approval to manufacture a generic version of a drug.

As part of the ANDA, if there are unexpired patents listed with the FDA as covering the drug, the manufacturer may certify either that the patents are invalid, unenforceable, or won't be infringed (paragraph IV), or …

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Judge Andrews Draws Clear Line on ANDA Inducement Claim

Andrew E. Russell, June 22, 2020
Inducement ANDA

Pill Bottle
Sharon McCutcheon, Unsplash

Judge Andrews today granted a rare Rule 12(c) motion in an ANDA action, entering judgment against the plaintiffs on their inducement claim based on the pleadings alone.

The method claim at issue requires administering a drug "from about 3 hours to about 1 hour" before a colonoscopy.

The accused product's label includes instructions to administer the drug "start[ing] approximately 5 hours prior to [a] colonoscopy," and then to "drink at least three 8-ounce cups . . . of clear liquids . . . at least 2 hours before" the procedure.

Judge Andrews held that those allegations—even if true—cannot show inducement of infringement, even if in practice some amount of infringement would occur. …

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