Paroxetine mesylate – USA

Paroxetine mesylate – USA

On Apr. 20, 2021, Federal Circuit denied an unusual appeal from Sebela in a Hatch-Waxman litigation.

 

Sebela appealed the decision of New Jersey court which found US 8,658,663 and US 8,946,251 patents invalid under obviousness. Previously, Sebela filed suit against Defendants, Actavis & Prinston for infringement of these patents which are listed in Orange Book (OB) for BRISDELLE product. New Jersey district court found patents obvious and also made contingent finding on utility & lack of written description support.

 

During appeal, Sebela did not challenge obviousness ruling but instead asked Federal Circuit to affirm it. The objective was to avoid any preclusive effect on other invalidity issues such as utility & lack of written description support in different suit involving different patent i.e .U.S. Patent No. 9,393,237. Defendants asserted that Sebela lacks standing in this appeal because Sebela has not sought to overturn the district court’s judgment for obviousness and issue preclusion concerns are an insufficient basis for standing to appeal.

 

Federal Circuit said that it need not address the correctness of Sebela’s standing theory because it rests on an erroneous premise—that the district court made alternative invalidity holdings based on written description and utility grounds. While the district court briefly discussed those two potential invalidity grounds, it did so in an inconclusive, contingent manner that did not result in additional, alternative holdings. Several aspects of the district court’s opinion affirm this finding. The district court only briefly discussed utility and written description, and the district court’s final conclusion refers only to obviousness. Therefore, Sebela lacked constitutional standing and thus, the appeal was dismissed.

 

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