Opinion Denying TRO/PI in Genentech v. Amgen Released on Public Docket

As we previously reported, last week the U.S. District Court for the District of Delaware denied Genentech’s motion for a preliminary injunction against Amgen in the BPCIA litigation concerning Amgen’s Kanjinti (trastuzumab-anns).  A redacted version of the court’s opinion has now been posted to the public docket.  As set forth in the opinion by Judge Connolly, the court denied Genentech’s motion because it had failed to establish that it would suffer irreparable harm if the injunction did not issue.

The court first found that Genentech delayed in filing its motion for preliminary injunctive relief.  In particular, Amgen had served its notice of commercial marketing for Kanjinti on May 15, 2018 and Genentech had learned during discovery that Amgen expected FDA approval and intended to launch Kanjinti by July 2019.  The FDA then approved Kanjinti on June 13, 2019, but Genentech did not file its motion until July 10, 2019.  These delays, the court found, tended to negate the notion that Genentech was facing irreparable harm if Amgen were permitted to launch prior to a decision on the merits of Genentech’s patent infringement claims.  In coming to this conclusion, the court noted that Genentech’s delay was “contrary to the spirit and purpose of the BPCIA,” under which the 180-day period for notice of commercial marketing was “designed to prevent” this kind of “hurried motion practice.”

The court further found that Genentech’s licensing practices for the patents on which it based its motion supported the court’s finding of no irreparable harm.  Specifically, Genentech had already granted licenses to the patents, which cover methods of treating cancer with a specific trastuzumab dosage regimen, to Mylan, Celltrion, and Pfizer.  Based on the license agreements, the court found that “Genentech has been able to place a value on the patents and has approved competitors entering the market….”  Therefore, the court held that any harm caused by Amgen’s market entry to Genentech for infringement of those patents could be quantified and compensated with reasonable royalty damages.

In view of its finding that there was no irreparable harm, the court did not provide a detailed analysis on any of the other preliminary injunction factors.  However, in a footnote, the court noted that the public interest would not be served by preventing access to an affordable drug.  Moreover, the court explained that Genentech’s patent on the trastuzumab composition had already expired and only two of the four indications on Kanjinti’s label are alleged to infringe the dosing regimen patents upon which Genentech based its motion.  Thus, the court stated that an injunction would not serve the public interest in that it would deprive access to a “large number of non-infringing features.”