Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
A closely watched and hotly debated life sciences patent dispute saw the U.S. Supreme Court affirm a narrow interpretation of patent enablement when filing for patent protection....more
The year 2016 has only just started, and we have already seen several important court decisions related to employee benefit plans and the Employee Retirement Income Security Act of 1974, as amended (ERISA). This Client Alert...more
On January 25, 2016, in Amgen, Inc. v. Harris, 2016 WL 280886, the Supreme Court sent a strong message to the lower courts, plaintiffs and ERISA fiduciaries that pleading standards for breach of fiduciary duty prudence claims...more
Two recent Supreme Court decisions, and a recent Sixth Circuit analysis on remand from the Supreme Court, offer a roadmap of sorts on ERISA litigation. In both decisions, the Supreme Court did away with presumptions, and at...more
There has been a lot of curiosity within the biologics industry regarding how the “patent dance” procedures of the Biologics Price Competition and Innovation Act (“BPCIA”) would operate. This interest was piqued in July 2014...more
After granting the plaintiffs’ Rule 23(f) petition, the Ninth Circuit reversed a denial of class certification, finding that the district court had improperly weighed the merits of the plaintiffs’ Rule 23(a)(2) commonality...more