NEW YORK, June 5, 2012 -- In responding to one of the questions posed by Law360 editors recently, Baker Botts L.L.P. Partner Sandra Lee talked about major transitions taking place in her area of practice -- Intellectual Property (IP).
“Both the America Invents Act and the Biologics Price Competition and Innovation Act are paving the way for numerous changes,” Lee stated in response to a question concerning the aspect of her practice area most in need of reform. “The Biologics Act -- part of the Patient Protection and Affordable Care Act -- has created a pathway for the approval of follow-on biologics. Such follow-on biologics are already on the marketplace, for example in Europe, and the U.S. is now positioning itself to follow suit.
“Numerous guidelines will be issued during the course of this year, and will likely affect both prosecution aspects as well as litigation and regulatory practice.”
In addition to the reform question, Lee discussed her most challenging case, key issues and cases in the IP practice area, a lawyer who made a lasting impression on her and an early career mistake that she turned into a lesson well-learned.
The Law360 Q&A with Lee is available here.
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