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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.

Dismissal Demonstrates Need for Clarity on BPCIA Disclosure Steps

USA - March 13 2017 On March 1, Judge Sleet of the District of Delaware granted Amgen’s Motion to Dismiss for lack of subject matter jurisdiction Genentech’s Complaint...

Gina Nellesen.

Rituxan Patents Resurface at the PTAB

USA - March 10 2017 Two patents related to methods of treating rheumatoid arthritis (RA) patients with rituximab have been brought before the PTAB for a third time - with...

Tasha M. Francis, Casey Kraning-Rush.