The recent back and forth between Amgen and Sandoz took another dramatic turn on December 5, 2014, when the Federal Circuit affirmed the district court’s dismissal of Sandoz’s declaratory judgment lawsuit against Amgen because Sandoz’s alleged injury did “not meet the requirements of immediacy and reality” necessary for standing. Regarding immediacy, Judge Taranto noted that Sandoz had brought the suit at a time when it was years away from completing its Phase III clinical trials for its Enbrel® biosimilar. Obtaining FDA approval would further push back the earliest possible date on which Sandoz could hope to market its drug. Regarding reality, Judge Taranto further opined that it was possible that Sandoz’s biosimilar would never infringe the patents licensed to Amgen. For example, Sandoz’s drug could fail completely in Phase III trials and never be approved by the FDA; the drug might also require modifications making it dissimilar enough from Enbrel® as to prevent infringement, even while remaining biosimilar. For those reasons, Judge Taranto concluded Sandoz could not demonstrate that either of these possibilities was “so unlikely to arise” that Sandoz could show it had a concrete injury in the pipeline.
While seemingly fact-specific, the Federal Circuit’s decision may have larger ramifications for future cases involving the BPCIA. Judge Taranto noted in his opinion: “The biosimilarity approval standard is new; indeed, the FDA has not yet applied the new standard to complete its review of and approve any product under the BPCIA.” Yet elsewhere in the opinion, Judge Taranto suggested that the Federal Circuit, at least, had an idea of how courts should evaluate BPCIA cases. He wrote: “Our conclusion is consistent with our cases under the Hatch–Waxman Act. As noted above, we have found no justiciability where a declaratory-judgment plaintiff had not filed an application for the FDA approval required to engage in the arguably infringing activity. On the other hand, where we have found a case or controversy in the Hatch–Waxman setting, we have focused on the presence of an application for the required FDA approval.” Thus Sandoz’s failure to submit a biosimilar application to the FDA before filing seeking its declaratory judgment seems to have played a role in the outcome of the case.
The Federal Circuit’s decision to consider this BPCIA ruling’s conformity with Hatch–Waxman may be due to the fact that the BPCIA provision under which Sandoz’s brought suit was directly “borrow[ed] from” Hatch–Waxman. Whether other courts hearing BPCIA cases will look to Hatch–Waxman or view this part of the Federal Circuit opinion as dicta remains to be seen.
The Federal Circuit ultimately declined to review the district court’s alternative grounds for dismissal involving Sandoz’s failure to comply with BPCIA procedures, limiting the extent of its holding. While Sandoz may appeal this decision to the Supreme Court, it is clear for now that parties must continue to carefully evaluate standing prior to bringing a patent infringement suit under the BPCIA.
For more information on this topic, please contact David A. Fazzolare.