Amgen Files Reply Brief in Sandoz v. Amgen

On April 14, Amgen filed its reply brief in Sandoz v. Amgen. We have previously reported on Sandoz’s response and reply brief, Amgen’s consolidated opening and responsive brief and Sandoz’s opening brief.

As we have previously covered, Sandoz, in response to the cross-petition, argued that when Congress specified that a biosimilar “shall” provide its application and manufacturing information to the reference product sponsor, it only meant that the applicant “shall” do so if it “wishes to engage in the information exchange.”

In their reply brief, Amgen argues that this is a “surpassingly strange interpretation of the word “shall” that would create an “entirely separate dispute-resolution pathway.” Amgen argues that Sandoz’s early disclosure of its application and manufacturing information would permit the sponsor to determine which patents are at issue and “enable the parties to narrow their disputes, and streamline the necessary litigation.”

Amgen ultimately concludes that “[w]hen Congress provides that a person “shall” do something, it is generally imposing a command, not offering a choice. That mandatory construction is reinforced where an opt-out construction would create absurd results. And it is doubly reinforced where complying with the mandate would be straightforward. The Court should reject Sandoz’s contrary approach, which would eviscerate the statutory scheme for no reason other than Sandoz’s desire not to be bound by it.”