New first-inventor-to-file patent system takes effect in the United States on March 16, 2013 *

USA - February 13 2013
On February 13, 2013, the USPTO issued Final Rules and Examination Guidelines to assist in implementation of the First-Inventor-To-File changes of…

Co-authors: Brian Landry, Ralph A. Loren.

New post-grant review procedures for challenging patent validity go into effect September 16, 2012 *

USA - July 19 2012
Beginning September 16, 2012, two new procedures under The America Invents Act will be available to allow third party post-issuance challenges to a patent.

Co-authors: Christine A. Dudzik, Ralph A. Loren.

FDA issues guidance for Final Rule on the Submission of Summary Bioequivalence Data for ANDAs *

USA - May 20 2011
Earlier this month, the US Food and Drug Administration (FDA) issued its Guidance for Industry governing the Final Rule on the "Submission of Summary Bioequivalence Data" ("the BE data rule"), which now requires ANDA applicants to "submit data from all BE studies the applicant conducts on a drug product formulation submitted for approval."

Co-authors: Peter J. Manso, Jennifer L. Dereka.

FDA hears testimony on approval pathway for biosimilar and interchangeable follow-on biologics *

USA - November 10 2010
On November 2-3, 2010, the FDA held an important hearing relating to a new piece of legislation intended to allow for market entry of "follow-on" biologic drug products.

Co-authors: Thomas H. Wintner, Elizabeth N. Spar.