A Blog About Intellectual Property Litigation and the District of Delaware


ANDA
Abbreviated New Drug Application

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.

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 …

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. …