A Blog About Intellectual Property Litigation and the District of Delaware


Entries for tag: anda

Trials in ANDA cases (also known as Hatch-Waxman cases) are usually very efficient matters. There is no jury, and the judges, lawyers, and witnesses that regularly try and participate in ANDA cases are well-practiced at maximizing the amount of evidence presented in each trial day (even where the issues are quite complicated and the parties numerous). So ANDA trials are often short, sometimes just a few days from start to finish.

Occasionally, however, even ANDA cases are too complicated to fit into a one-week-or-less trial. For example, Judge Stark recently stated that he may allocate up to 25 hours per side in an ANDA case set to go to trial later this week.

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. …