Category Archives: Other Challenges

FDA Request for Justification Found to Provide a Mere Research Suggestion—Not Conception of Claimed Formulation

Author: Thomas J. Sullivan
Editor: Jeff T. Watson

In Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC, Nos. 16-1115, -1259 (Fed. Cir. Jan. 26, 2017), the Federal Circuit affirmed the lower court’s holding that a patent covering a chelating-agent-free drug formulation was not derived from someone at the FDA.

Mylan’s derivation argument centered around communications between the inventor and the FDA regarding Cumberland’s application to market a pharmaceutical formulation that included the chelating agent EDTA. Specifically, the FDA requested that Cumberland provide justification for including EDTA in the formulation. Mylan argued that the FDA request (along with other exchanges) established conception of the claimed chelating-agent-free formulation by the FDA. Continue reading

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Affirmed Preliminary Injunction Leaves Water Balloon Infringer All Wet

Authors: Jonathan J. Fagan
Editor: Kevin D. Rodkey

In Tinnus Enterprises, LLC v. Telebrands Corp., No. 16-1410 (Fed. Cir. Jan. 24, 2017), the Federal Circuit affirmed the district court’s grant of a preliminary injunction, finding no clear error in that decision.

Tinnus sued Telebrands for infringement of Tinnus’s patent directed to a hose attachment that fills multiple water balloons at once. Tinnus moved for a preliminary injunction, which was granted by the district court. Continue reading

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Procedural Missteps Lead to Default Judgment

Authors: Thomas J. Sullivan
Editor: Lauren J. Dreyer

In United Construction Products, Inc. v. Tile Tech, Inc., No. 2016-1392 (Fed. Cir. December 15, 2016), the Federal Circuit affirmed the district court’s entry of default judgment against Tile Tech. The panel noted that, throughout the course of the litigation, Tile Tech repeatedly failed to comply with discovery requests—including an order to compel. Applying Ninth Circuit precedent on default judgments, the Court found that four of the five Malone factors favored dismissal: (1) the public’s interest in expeditious resolution of litigation; (2) the lower court’s need to manage its docket without routine noncompliance; (3) Tile Tech’s failure to comply with discovery requests prejudicing the plaintiff’s ability to adjudicate the matter fairly; and (4) the lack of availability of less drastic sanctions. The Court held that the last factor—public policy favoring disposition of cases on their merits rather than dismissal by default judgment—always weighed against default judgment. Continue reading

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