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SCOTUS Unravels Some of the BPCIA Enigma But Questions Remain

USA - June 13 2017 Reference product sponsors (RPSs) and biosimilar manufacturers were hoping the Supreme Court of the United States would clarify two aspects of the...

Tasha M. Francis.


The Last “Cabilly” Challenge Quietly Settles

USA - May 25 2017 U.S. Pat. No. 6,331,415, commonly referred to as “Cabilly II,” has been called one of the most-litigated patents of all time, having been challenged...

Tasha M. Francis, Casey Kraning-Rush.


How Soon Can A Biosimilar Applicant Be Sued for Patent Infringement?

USA - April 24 2017 Biosimilar manufacturers proceeding under the abbreviated approval pathway laid out in the Biologics Price Competition and Innovation Act ("BPCIA")...

Tasha M. Francis.


Protective Agreements Before and During BPCIA Litigation: Prosecution and Regulatory Bars

USA - April 20 2017 Protective orders that regulate the disclosure and use of confidential information exchanged during patent litigations are commonplace. However, the...

Noorossadat Torabi.


First Biosimilar Monoclonal Antibody in Oncology Granted EU Approval: Implications for the U.S. Market

European Union, USA - March 14 2017 Recent developments in Europe may augur a new push for oncology biosimilars in the United States. On February 22, 2017, the European Commission...

Tasha M. Francis, Ron Vogel.