Brand-name pharmaceutical companies employ a variety of strategies to preserve and extend their branded drug products’ monopolies. Challenges by generic drug manufacturers and consumers to those efforts as allegedly...more
We previously posted that Coherus had filed a motion to stay discovery in Amgen v. Coherus (involving pegfilgrastim) pending resolution of Coherus’s motion to dismiss. On September 13, Coherus withdrew its motion to stay. ...more
Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some...more
As we have discussed before, the first generation of biosimilar litigation under the Biologics Price Control and Innovation Act (BPCIA) addresses whether the BPCIA’s patent dispute resolution procedures – the “patent dance” –...more
As discussed previously in Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures, Amgen Inc. (“Amgen”) filed a Citizen Petition with the FDA requesting that...more