Last month, the Federal Circuit affirmed per curium U.S. District Judge Colm F. Connolly’s order denying Genentech’s request for either a temporary restraining order or a preliminary injunction.  Genentech sought a preliminary injunction to prevent Amgen from selling a generic version of Genentech’s blockbuster cancer drug, Herceptin^®.  Amgen launched on the same day the district court issued its order.

The district court held that Genentech’s delay was fatal to its request for a preliminary injunction.  Genentech’s request was filed nearly fourteen months after receiving a notice of commercial marketing, three months after Amgen announced its launch date, and four weeks after Amgen received FDA approval.  In addition, the court noted that Genentech granted licenses to Mylan, Celltrion, and Pfizer, allowing other biosimilars to enter the marketplace.  These licenses indicated that Genentech was able to place a value on its patents and would be able to recover any potential damages if it succeeded on its infringement claims.

This case highlights the importance of timeliness in seeking preliminary injunctions and temporary restraining orders.  It also shows the significant impact prior licensing efforts may have on biologic companies’ efforts to obtain injunctive relief against future biosimilar defendants.  Biosmilar companies facing a motion for a preliminary injunction should leverage any evidence showing that Plaintiffs were on notice of their plans to launch, as well as prior licensing efforts.