Ferring Pharmaceuticals Inc. v. Serenity Pharmaceuticals, LLC

Background

Ferring Pharmaceuticals Inc., Ferring B.V., and Ferring International Center S.A. (collectively, “Ferring”) moved under Federal Rule of Civil Procedure 60(b) to vacate this court’s earlier collateral-estoppel order. The defendants and counterclaimants are Serenity Pharmaceuticals, LLC, Reprise Biopharmaceutics, LLC, and Avadel Specialty Pharmaceuticals, LLC.

The dispute involves four patents concerning pharmaceutical formulations of desmopressin. Two patents, the ’203 and ’321 patents, were held by Dr. Seymour Fein as the named inventor. Ferring held the ’429 and ’654 patents. In an earlier related proceeding, Ferring sought to replace Dr. Fein as the named inventor of the ’203 and ’321 patents. Judge Robert W. Sweet dismissed those inventorship claims based on equitable estoppel, meaning that Ferring’s earlier conduct and delay prevented it from asserting the claims. Judge Sweet found that Ferring had not acted for more than seven years while others invested resources in developing and commercializing Dr. Fein’s patents.

Ferring later filed this action seeking declarations that the ’203 and ’321 patents were unenforceable or invalid, including on the ground that Dr. Fein was not the actual inventor. Serenity and Reprise moved for judgment on the pleadings based on collateral estoppel, also called issue preclusion. This court granted that motion and dismissed Count One to the extent it relied on Ferring’s assertion that it, rather than Dr. Fein, was the true inventor of the ’203 and ’321 patents. Counts Two, Three, and Four and the defendants’ infringement counterclaims remained pending.

Ferring’s Rule 60(b) Motion

Ferring sought relief under Rule 60(b)(2), (5), and (6). Those provisions address, respectively, qualifying newly discovered evidence, certain changes affecting a judgment, and extraordinary circumstances justifying relief from a final judgment or order. Ferring relied on Judge P. Kevin Castel’s findings after a bench trial concerning whether Dr. Fein contributed to the inventions covered by Ferring’s ’429 and ’654 patents.

The court held that the motion failed for both procedural and substantive reasons. First, Rule 60(b) applies only to a final judgment, order, or proceeding. The court’s collateral-estoppel order was interlocutory, not final, because it dismissed only Count One and left other claims and counterclaims unresolved.

Second, the court explained that Judge Castel’s findings were not newly discovered evidence. They were findings based on facts that Ferring had known about and used throughout the earlier related proceeding. The court also concluded that the findings would not have changed the collateral-estoppel ruling because they concerned Dr. Fein’s contribution to the ’429 and ’654 patents, while the earlier estoppel ruling concerned Ferring’s delay and conduct regarding the ’203 and ’321 patents.

The court further held that Rule 60(b)(5) did not apply because the collateral-estoppel order had not been satisfied, released, discharged, reversed, or vacated, and was not being applied prospectively in the relevant legal sense. Rule 60(b)(6) also did not provide a basis for relief because Ferring had not shown extraordinary circumstances or undue prejudice.

Scope of the Earlier Order

The court emphasized that the collateral-estoppel order was narrow. It barred Ferring from affirmatively asserting that it, rather than Dr. Fein, should be listed as the inventor of the ’203 and ’321 patents. It did not decide whether Ferring could assert Dr. Fein’s alleged lack of inventorship as an affirmative defense to Serenity and Reprise’s infringement counterclaims.

The court distinguished defensive issue preclusion, where a defendant uses a prior decision to block a plaintiff’s claim, from offensive issue preclusion, where a plaintiff seeks to use a prior decision against a defendant. Serenity and Reprise had used issue preclusion defensively to defeat Ferring’s affirmative claim. They had not moved to strike Ferring’s affirmative defense to the infringement counterclaims. The court therefore did not decide whether that defense would be barred if the issue were later presented.

Disposition

Judge Colleen McMahon denied Ferring’s motion to vacate the collateral-estoppel order. The clerk was directed to remove the motion from the list of open motions. The court also noted that Ferring’s appeal from Judge Sweet’s equitable-estoppel order was pending in the Federal Circuit and that the appeal could affect some issues in the upcoming trial, but the court did not postpone the trial in this order.