Line design
HetliozĀ® (tasimelteon)
GENERICally Speaking

Case Name: Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., Nos. 22-7528, 22-7529 (CCC), 2023 WL 1883357 (D.N.J. Feb. 10, 2023) (Cecchi, J.) 

Drug Products and Patent(s)-in-Suit: Hetlioz® (tasimelteon); U.S. Patent No. 11,285,129 (“the ’129 patent”)

Nature of the Case and Issue(s) Presented: Vanda is a pharmaceutical company incorporated in Delaware with its principal place of business in Washington, D.C. Prior to this action, the parties engaged in lengthy litigation concerning multiple patents related to tasimelteon in the federal district court in Delaware. That litigation culminated in a four-day bench trial before Chief Judge Connolly in March 2022, who found in favor of Defendants. The Delaware litigation involved the same parties, the same products, the same ANDAs, the same product labels, the same patent specification, and similar prior art. Vanda appealed the Delaware court decision, and because Teva’s ANDA had been approved just one day that ruling came down, Vanda also petitioned the Federal Circuit to immediately enjoin Defendants from commercial marketing and sale of their generics pending appeal. The Federal Circuit denied Vanda’s request for an injunction. Vanda then sought a temporary injunction from this court to prevent Defendants from going to market with their generics. After conferring with the parties, Defendants filed their cross-motion to transfer, which Vanda opposed.  The court granted Defendants’ motion to transfer and transferred the case to the District of Delaware.

Why Defendants Prevailed: Defendants argued that “the District of Delaware has already familiarized itself with the factual, technical, and patent-related complexities through its handling of litigation concerning tasimleteon and patents in the same family as the one asserted here” and that because Vanda selected a forum that is not its home state, the deference afforded to the plaintiff’s choice of forum is minimal. Vanda responded that “there is no judicial economy to be gained by transfer, because the issues that will be raised in this patent dispute differ from those raised in the case that was previously tried in the District of Delaware” and that any efficiency benefits are limited when the related litigation in the proposed transferee district is not concurrently pending.

After finding that the case could have been brought in Delaware, the court next addressed the issue of whether transfer to Delaware is in the interests of justice and convenience. The court found that all the private interest factors were either neutral or favored transfer. It is undisputed that D.N.J. is not Vanda’s home forum, therefore Vanda’s choice of forum is accorded less weight. Defendants and Vanda are all incorporated in Delaware, “and Chief Judge Connolly has already heard extensive evidence and testimony in a related litigation over the same products.” The remaining factors are all neutral. “Accordingly, the Court finds that factors four, five, and six are neutral, and therefore, on balance, the private interest factors weigh slightly in favor of transfer.”

Next, the court addressed the public interest factors, finding that most were neutral with the exception of factor two: practical considerations that could make the trial easy, expeditious, or inexpensive, which weighed “decidedly in favor of transfer.” Again, relying on the District of Delaware’s substantial familiarity with the operative facts and issues of this matter offered strong support that transfer was in the interests of justice.

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