Law360, New York (January 6, 2017, 5:16 PM EST) -- Michael B. Cottler
Joshua A. Whitehill
In 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Affordable Care Act. The BPCIA established an abbreviated regulatory pathway for biosimilars and unique litigation mechanisms for resolving patent disputes between biosimilar applicants and reference product sponsors (RPSs).
In practice, a new BPCIA complaint stems from the U.S. Food and Drug Administration acceptance of a biosimilar application filed under subsection (k) of the BPCIA (i.e., an “abbreviated Biologics License Application,” or “aBLA”), which triggers a cascade of exchanges between the applicant and RPS that is commonly...
Stay ahead of the curve
In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.
Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
Create custom alerts for specific article and case topics and so much more!