United Therapeutics Corp. v. Sandoz, Inc. (D.N.J.) (4/16/14)

Summary judgment of non-infringement denied because amended ANDA label may still implicitly instruct physician and patients to practice claimed limitation.

Summer 2014

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: United Therapeutics Corp. v. Sandoz, Inc., Case No. 12-cv-01617, 2014 U.S. Dist. LEXIS 52353 (D.N.J. Apr. 16, 2014) (Sheridan, J.)

Drug Product and Patent(s)-in-Suit: Remodulin® (treprostinil sodium); U.S. Patent No. 7,999,007 (“the ’007 patent”)

Nature of the Case and Issue(s) Presented: The ’007 patent covers pharmaceutical preparations in which treprostinil or treprostinil sodium is diluted with a high pH glycine buffer, and the methods of using those preparations in order to facilitate safer intravenous use of Remodulin for patients with pulmonary arterial hypertension. Remodulin’s drug label provides that the drug “must be diluted with either Sterile Water for Injection, or 0.9% Sodium Chloride Injection, or Flolan Sterile Diluent for Injection” prior to intravenous infusion.

Initially, Sandoz’s proposed ANDA product labeling copied the instructions from the Remodulin labeling. Sandoz however submitted a proposed amendment to its ANDA, in which it revised its proposed label to delete all references to dilution with the sterile diluent for Flolan. Sandoz also submitted a Section viii statement, stating that the ’007 patent does not claim uses for the treprostinil sodium ANDA products for which Sandoz is seeking FDA approval, namely use of treprostinil sodium diluted with sterile water or 0.9% sodium chloride for intravenous administration. Following this carve-out, Sandoz’s amended label instructs physicians and end-users that its ANDA product can either be administered as supplied for subcutaneous infusion or diluted “with Sterile Water” or “0.9% Sodium Chloride” for intravenous infusion; it does not instruct users that its ANDA product can or should be diluted with the sterile diluent for Flolan.

Sandoz moved for summary judgment of non-infringement on the basis that its label initially recommends subcutaneous infusion in which a buffer is not used, and secondly it recommends aseptic techniques when preparing/administering treprostinil (wiping hands with alcohol as opposed to using the Flolan diluent). The court denied Sandoz’s motion.

Why United Therapeutics Prevailed: The Court denied summary judgment because there was a question of fact as to infringement. Sandoz had removed all references to use of a diluent like Flolan. Nevertheless, the Sandoz label referred to a CDC survey regarding bloodstream infections for precautionary measures. This survey, according to the court, would lead a medical practitioner to review the medical research on the issue. This research includes articles that recommend using Flolan as a diluent with treprostinil. Thus, the court denied summary judgment because a question of fact existed as to whether the amended Sandoz label would implicitly instruct the use of Flolan.

Ryan M. Schultz


Pronouns: he/him

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