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Venue in Hatch-Waxman Cases Limited to District Where ANDA Is Submitted

The US Court of Appeals for the Federal Circuit found that in cases brought under the Hatch-Waxman Act, for purposes of determining venue, infringement occurs only in districts where actions related to the submission of an abbreviated new drug application (ANDA) occur, and not in all locations where future distribution of the generic products specified in the ANDA is contemplated. Valeant Pharmaceuticals North American LLC v. Mylan Pharmaceuticals Inc., Case No. 19-2402 (Fed. Cir. Nov. 5, 2020) (O'Malley, J.). Valeant holds a new drug application for the brand name drug Jublia®, which is used to treat toenail fungal infections. In 2018, Mylan Pharmaceuticals Inc. (MPI) executed an ANDA seeking approval to market a generic version of Jublia®. MPI sent the ANDA from its West Virginia corporate office to the US Food and Drug Administration, located in White Oak, Maryland. The ANDA included a Paragraph IV certification that the Orange-Book-listed patents for...

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First-to-File Rule Must Be Followed Unless Compelling Circumstances Justify Exception

Vacating and remanding a district court's decision not to transfer a case, the US Court of Appeals for the Federal Circuit granted a petition for a writ of mandamus because the district court did not consider whether the first-to-file rule favored keeping the case in the second-filed court. In re: Nitro, Case No. 20-142 (Fed. Cir. Oct. 28, 2020) (Reyna, J.). In 2018, Cameron International filed a suit against Nitro in the Southern District of Texas alleging that Nitro's fracturing-fluid delivery systems infringed three of Cameron's patents. In February 2020, Cameron filed a second suit against Nitro in the Western District of Texas, alleging that the same accused products infringed two of Cameron's other related patents. Relying on the first-to-file rule, which generally dictates that the court in which an action is first filed is the appropriate court to determine whether subsequently filed cases involving substantially similar issues should proceed, Nitro...

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Overcoming Heavy Burden Required to Succeed on Venue-Related Writ of Mandamus

Addressing a venue challenge, the US Court of Appeals for the Federal Circuit denied a petition for a writ of mandamus because the challenger did not demonstrate it had no adequate alternative means to obtain desired relief since meaningful review could occur after final judgment was entered. In re. Google, Case No. 20-144 (Fed. Cir. Sept. 18, 2020) (Reyna, J.). Personalized Media Communications (PMC) sued Google in the Eastern District of Texas for infringement of six patents related to adaptive video streaming. PMC initially asserted venue was proper based on the presence of several Google Global Cache (GGC) servers at facilities owned by internet service providers (ISPs) located within the district. Google moved to dismiss for improper venue. While Google’s motion was pending, the Federal Circuit issued its decision in In re. Google, rejecting a venue argument asserted by a different plaintiff against Google that was also premised on the presence of GGC...

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