Biologics milestone as court denies declaratory judgment

The US District Court for the Northern District of California has dismissed biosimilar maker Sandoz’s motion for declaratory judgment that its etanercept product does not infringe biopharmaceutical company Amgen’s arthritis drug Enbrel.

It is the first time the patent litigation provision of the Biologics Price Competition and Innovation Act (BPCIA), which passed into law in 2010, has been interpreted in court.

Roche owns two patents covering Enbrel active ingredient etanercept.

In June of this year, Sandoz filed for declaratory judgment of patent non-infringement and invalidity against Amgen and Swiss drugmaker Hoffman-La Roche.

In its complaint, Sandoz claimed that Amgen seeks to use the patents to block competition from its biosimilar and to extend Enbrel’s monopoly until 2029.

It added that Amgen’s patent position “places a cloud of legal uncertainty” over its etanercept product and business operations.

In August 2013, Amgen moved to dismiss Sandoz’s claims, and said that Sandoz’s action was premature “as it is just starting the determinative phase of the clinical trial process.”

“Many uncertainties remain as to if and when plaintiff’s alleged biosimilar will ever be approved and ready to market in the US,” it added.

The district court agreed, and in its ruling dated November 12 said that neither the reference product maker nor the biosimilar applicant may file a lawsuit “unless and until they have engaged in a series of statutorily-mandated exchanges of information” as laid out in the BPCIA statute.

Aaron Barkoff, a partner at McAndrews, Held and Malloy Ltd in Chicago, said that the court’s interpretation of the act is significant: “If other district courts interpret the act in the same way, certain litigation strategies will be off the table.”

He told LSIPR: “One strategy biosimilar companies have considered, such as Sandoz in this case, is filing a declaratory judgment action years before filing a biosimilar application with the FDA.

“Doing so could eliminate some patents from the brand company’s arsenal before the biosimilar company has fully invested in all of the clinical study work that the FDA requires before granting approval of a biosimilar drug.  If other courts follow this [case], the ‘early declaratory judgment’ option is off the table,” he explained.

Barkoff added that some biosimilar companies have suggested another strategy: by providing the “notice of commercial marketing” early, at the time of filing a biosimilar application with the FDA, they could file a declaratory judgment action against the innovator at their chosen venue.

“In other words, the biosimilar company would file suit against the innovator, seeking a declaration that any patents are invalid or not infringed, before the innovator could sue the biosimilar company for patent infringement,” he said.

“The fundamental message from this court is that biosimilar applicants must follow the process laid out in the BPCIA, and cannot stray from that.”