On July 21, 2015, the Federal Circuit issued a split decision in the Amgen v. Sandoz appeal. As we anticipated in our analysis of the oral argument, Sandoz won with its interpretation of the first issue: an applicant can choose between disclosing its (k) application and manufacturing information, or not disclosing such information and instead facing immediate infringement action from the reference product sponsor (“RPS”). Amgen won on the notice issue: notice of commercial marketing can be given only after FDA approval of the biosimilar product.
Please join us on August 12, 2015 at 12:30 pm EDT for a lively discussion about the case as Goodwin Procter partners Elaine Herrmann Blais and Robert Cerwinski analyze the outcome and discuss what is likely to happen next, along with how the decision impacts biosimilars strategy going forward.
To register for the webinar, please click here.