IP Hatch-Waxman Act Team Has Important Victory on Behalf of Torrent Pharmaceuticals, Ltd.

Tuesday, July 20, 2021

On Tuesday, July 13, a Windels Marx IP Hatch-Waxman Act team achieved an important victory on behalf of firm client Torrent Pharmaceuticals, Ltd. (“Torrent”) against Almirall, LLC (“Almirall”), winning a case dispositive motion for judgment on the pleadings.

The case arose when Torrent filed an Abbreviated New Drug Application (“ANDA”) seeking regulatory approval to market a generic version of Almirall’s dapsone product, brand name ACZONE®. Almirall filed a patent suit in the U.S. District Court for the District of Delaware against Torrent, alleging that Torrent's ANDA product infringed its patent.

After Almirall answered Torrent’s counterclaims, Torrent immediately filed a motion for judgment on the pleadings before any fact discovery in the case had taken place, arguing that Almirall was legally barred from asserting that Torrent’s formulation infringed under the doctrine of equivalents, as a result of argument based estoppel. Under the argument-based estoppel doctrine, a patentee can disclaim an equivalent by clear and unmistakable surrender of subject matter. The standard is whether a competitor would reasonably believe that the applicant had surrendered the relevant subject matter, regardless of whether the argument was required to secure allowance of the patent. Torrent explained that Almirall had clearly and unmistakably surrendered equivalents of a particular chemical, “A/SA,” and thus Torrent could not infringe the asserted patent under the doctrine of equivalents.

Almirall made several arguments opposing the application of argument based estoppel. First, it contended that its complaint properly pleaded a claim of infringement. Second, it contended that fact discovery, expert discovery, and claim construction would be required to rule on Torrent’s claims. Third, it contended that Torrent’s motion relied on selective, self-serving portions of its ANDA and prosecution history that the Court may not properly consider at this stage.

The Court, however, rejected Almirall’s arguments. With respect to Almirall’s first argument, the Court explained it may grant a 12(c) motion in an ANDA case, and that the statutory basis for the cause of action in this case does not, by itself, preclude the grant of Torrent’s motion. Concerning Almirall’s arguments about discovery and claim construction, the Court noted that Almirall had failed to raise claim construction or factual disputes which would preclude dismissal. Finally, the Court concluded that Almirall had failed to direct it to any portions of the file history supporting its position, and that it was allowed to consider the ANDA and file history in a 12(c) motion.

Accordingly, the Court granted Torrent’s motion.

Andrew Miller, Constance Huttner, Ajay Kayal, Stuart Sender, James Barabas and Amit Singhai represented Torrent.

Read the Decision regarding Motion For Judgment on the Pleadings.

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