A Blog About Intellectual Property Litigation and the District of Delaware


Entries for tag: anda

Earlier today, Judge Burke unsealed an interesting order addressing the applicability of the common-interest doctrine to communications between a generic pharmaceutical company and its API manufacturer.

No attorneys directly participated in most of the underlying communications, but the defendants argued that they shared "a common legal interest" with their API manufacturer in avoiding a lawsuit "and that their communications furthered that interest." Although Judge Burke found that this "argument has some initial, superficial appeal[,]" in that "the subject of these communications is in some sense legal in nature[,]" he concluded that any shared legal interest came too late:

when one contextualizes the communications with regard to what was happening in the relevant time period, Defendants have not met …

Pigs
Kenneth Schipper Vera, Unsplash

Judge Andrews recently rejected the requests of several defendants in a Hatch-Waxman (or "ANDA") case to file an early motion for summary judgment, calling the request a "pig in a poke."

Judge Andrews, like most judges in this District, does not as a matter of course permit dispositive motions in ANDA cases or early dispositive motions in general. Nonetheless, two defendants in Astrazeneca AB v. Alembic Pharms. Ltd., C.A. No. 20-202-RGA, sought leave to file an early motion for summary judgment of no infringement under the doctrine of equivalents (plaintiff's only infringement theory).

Judge Andrews made short work of the request, first noting that the

defendants do not make a …

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.

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. …