In the latest hearing over Zarxio’s alleged patent infringements, interpretation of the wording of the BPCIA was debated.
After failing twice to block Zarxio’s market entry since 2014, Amgen won an 11th-hour reprieve in May 2015, when the U.S. Court of Appeals for the Federal Circuit in Washington, granted the company an injunction – scheduling oral arguments in the case, which were heard on June 3.
Detailing proceedings, a National Law Review article reported that Nick Groombridge, representing Amgen, first questioned whether the disclosure of a biologics license application and certain manufacturing information by a Section 351(k) applicant (the biosimilar applicant, or ‘K applicant’) to the reference product sponsor was mandatory or optional.
Amgen’s interpretation of the word “shall”, in particular, caused some confusion, prompting one of the three presiding judges, Alan D. Lourie to remark: “What you are going to tell us Mr. Groombridge is that ‘shall’ means ‘shall’ and in fact, it means ‘must’ and usually that is true, and, this is a statute that is a multifaceted statute and I’m thinking that perhaps it is entitled to a Pulitzer [Prize] for complexity or unclarity or something.”
