IP Law Daily Tecfidera® infringement suit barred by collateral estoppel
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Thursday, September 17, 2020

Tecfidera® infringement suit barred by collateral estoppel

By Randall Holbrook, J.D.

Patent-in-suit was found invalid by another court in a prior lawsuit.

The manufacturer of a drug for multiple sclerosis and the owner of a related patent were collaterally estopped from litigating the validity of its patent, the federal district court in Wilmington, Delaware, has held. A bench trial on validity of the patent in a parallel suit by the same plaintiffs against a potential generic manufacturer in a West Virginia federal court reached a conclusion before the court in Wilmington issued its findings and ruling; that trial had resulted in a determination that patent was invalid. The present court determined that collateral estoppel prevented the patent owners from revisiting the issue of validity and dismissed the case (Biogen International GmbH v. Amneal Pharmaceuticals LLC, September 16, 2020, Noreika, M.).

Biogen International GmbH and Biogen MA Inc. (collectively, Biogen) owned U.S. Patent No. 8,399,514 (the ’514 Patent), which was directed at methods of treating multiple sclerosis with about 480 mg of dimethyl fumarate, monomethyl fumarate, or a combination thereof. Biogen sued several defendants for filing applications to produce generic medications that allegedly infringed on that patent. The defendants contended that claims 1-4, 6, 8-13, 15, and 16 of the ’415 Patent were invalid for inadequate written description and other reasons. The court held a five day bench trial on validity of the patent. After the conclusion of the bench trial but before the court made its findings of fact and issued its rulings, a similar case between Biogen and another potential generic manufacturer in a West Virginia federal court concluded. The West Virginia court determined that the patent was invalid because the written description did not match the claims, as the claims had been updated to reflect the results of studies completed after the initial filing of the patent, while the description was left untouched in order to attempt to preserve the priority date. The Delaware court began by considering the four factors of collateral estoppel.

Identity of issues. The general issue of invalidity was the same in both cases, and the specific issue of the invalidity of the same claims for the same lack of adequate written description was also the same. The court concluded that Biogen’s arguments were addressed to the correctness of the West Virginia decision, not to whether the issues were identical, so this factor supported collateral estoppel.

Actual litigation. Because the issue was identical and proceeded to judgment on the merits in the West Virginia matter, there was no dispute that the issue was actually litigated.

Necessary to the judgment. It was undisputed that the validity of the patent was essential to the judgment in the West Virginia case.

Full representation. The West Virginia case was heard in a multi-day bench trial and Biogen was represented there by the same counsel as represented them in the present case, so the court determined that the plaintiffs were fully represented and had every possible opportunity to litigate the validity of the patent in West Virginia.

Other considerations. The plaintiffs argued that equitable considerations should have prevented the court from relying on collateral estoppel. The trial on the issue of validity had already occurred, and it would save no time or resources to deny the parties a decision on the merits at that point. However, the court determined that there was no basis for denying application of collateral estoppel when the four elements had been met. Existing Third Circuit precedent limited the analysis to the four elements which the court considered, and there was no discretion in the trial court to rule otherwise on equitable grounds.

This case is No. 1:17-cv-00823-MN.

Attorneys: Steven J. Balick (Ashby & Geddes, P.A.) for Biogen International GmbH and Biogen MA Inc. Anne Shea Gaza (Young Conaway Stargatt & Taylor, LLP) for Amneal Pharmaceuticals LLC.

Companies: Biogen International GmbH; Biogen MA Inc.; Amneal Pharmaceuticals LLC

MainStory: TopStory Patent GCNNews DelawareNews

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