In United Therapeutics Corp. v. Sandoz, Inc., Judge Peter G. Sheridan of the District of New Jersey ruled that Sandoz’s proposed label for a generic version of UTC’s anti-hypertensive Remodulin (treprostinil sodium) injection did not induce infringement of various UTC method patent claims.  (Civil Action No. 3:13-cv-1617-PGS-LHG, Dkt. No. 364).  As a way to reduce the risk of bloodstream infections associated with chronic IV use, UTC’s patent claimed the use of treprostinil sodium in conjunction with a glycine buffer solution.  Initially, the Sandoz proposed label included instructions to dilute the drug with sterile water, sodium chloride or glycine buffer solution.  Sandoz later amended the label to omit all references to dilution with glycine buffer solution.  Thus, nowhere in the Sandoz label was there any instruction for physicians to dilute the drug with glycine buffer solution.

At trial, UTC argued that other parts of the label served as an “implicit” instruction to physicians to dilute the drug with glycine buffer solution. One such part of the label was the warnings section, which stated that “[a]dministration of IV Remodulin with a high pH glycine diluent … has been associated with a lower incidence of [bloodstream infections] when compared to neutral diluents (sterile water, 0.9% sodium chloride) when used along with catheter care guidelines.”  UTC argued that the label’s warnings and references to clinical trials about the risk of bloodstream infections would lead physicians to want to learn more to reduce the incidence of such infections in their patients.  That in turn would cause physicians to find literature about the use of the drug with glycine buffer solution.

Judge Sheridan found that the Sandoz label did not induce infringement of the method claims. After noting that there Sandoz’s proposed label gave no actual instruction to infringe, he highlighted the tenuousness of UTC’s theory of intent to induce:

UTC’s theory would suggest that the absence of an instruction should be discounted in this instance, on the theory that a scholarly scavenger hunt—which may be incited by a reference in Sandoz’s proposed label, which may be undertaken by some physicians, and may ultimately result in a discovery which leads some physicians to prescribe [the buffer] as a diluent … —may constitute evidence of Sandoz’s intent to induce physicians to engage in infringing conduct.

Judge Sheridan concluded that there is a “rather significant difference” between a warning and an instruction, and Sandoz’s label warnings and clinical trial references were not instructions to infringe.

While Judge Sheridan purported to decide the case based in part on the credibility of the witnesses, the opinion seems to give such short shrift to UTC’s theory of induced infringement that one wonders why this issue was not appropriate for summary judgment. Judge Sheridan previously denied Sandoz’s earlier motion for summary judgment, however, despite the clear lack of instructions to infringe in the label and the speciousness of UTC’s induced infringement theory.