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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Spotlight on Upcoming Oral Arguments – February 2017

Spotlight on Upcoming Oral Arguments – February 2017

Authors: Caitlin O’Connell
Editor: Lauren J. Dreyer

Wednesday, February 8, 2017

Allergan v. Sandoz, No. 16-1085, Courtroom 201

In this appeal, the Federal Circuit will determine whether collateral estoppel can bar a party from asserting an infringement claim when, in previous litigation between the parties, a patent in the same family and covering the same product was held invalid.  Allergan argues that collateral estoppel should not apply in this case because the issue of the validity of the eyelash growth and eyelash darkness claims is not “identical.”  Sandoz argues that collateral estoppel should apply in this case because the two sets of claims are “substantially similar,” thus the issue is “identical.”
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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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