The Competing Cases

In the last blog post, I highlighted two competing PIV cases involving the same product, patent, and legal issue. The West Virginia District Court had found claims of the patent invalid due to lack of written description. This case is currently on appeal.

Meanwhile, a case in Delaware District Court had already completed its bench trial months before, and the parties were simply waiting for a court decision. After the favorable West Virginia decision issued in June, the ANDA filers in Delaware asked its Court to simply accept the decision under the legal doctrine of collateral estoppel.

Delaware Court Decides Tecfidera® Case

Last week, the Delaware Court agreed. It issued its Opinion that it did not need to decide the case. Collateral estoppel, Judge Noreika reasoned, applied to this situation: the case involved the same patent, same legal issue, and same data and evidence. Moreover, patent holder Biogen had ample opportunity to present its case in West Virginia. No real need to issue a decision.

However, the Delaware Court did acknowledge two important twists. First, the case in Delaware had already been tried. The only thing left was to decide. So, there would be no real duplication of tasks or a chance for the losing party (Biogen) to have a second chance to try the same case — the heart of the collateral estoppel doctrine. But the Court did not view this fact as preventing her decision not to issue a decision.

Not Necessarily the End

Second, Biogen pointed out that the parties presented other legal defenses in the Delaware trial. As such, if the Court of Appeals reverses the Mylan decision, it would mean that the Delaware Court would then have to issue a decision on the other legal defenses. There would be an efficiency benefit in issuing a decision on all of the legal issues so that the Court of Appeals could consider them all in one appellate case.

Judge Noreika seemed to agree that Biogen made a solid point. However, the Court declined to accept this argument. The Judge reasoned that the Court of Appeals could just as easily affirm the West Virginia decision. If so, the invalid claims would remain invalid, leaving the other defenses irrelevant. The Court also concluded that the possible loss of court efficiency was not that big of a deal.