Wednesday, November 18, 2015

December 3: Webcast - Navigating Patent Potholes Along the FDA’s Proposed ANDA / 505(b)(2) Pathway

The FDA has released new rules regarding the procedures for approval of an Abbreviated New Drug Application (ANDA) and a 505(b)(2) application implementing the Medicare Prescription Drug, Improvement, and Modernization Act (MMA). The U.S. Patent and Trademark Office in turn has created new procedures and other ways by which they cancel, modify, and administer patent rights. The USPTO’s actions have created potholes along the FDA-proposed pathways for pharmaceuticals companies and generics manufacturers attempting to maintain monopolies. These USPTO activities may also provide an express lane for new startups in the pharmaceutical space.
The webinar will cover these topics and more:
  • Newly listed patents in the Orange Book and the ability to catch up to first applicants
  • Breaking through settlement roadblocks with AIA post-grant procedures
  • Newly listed and issued patents downshifting ANDAs into tentative approvals
  • Express lane for 505(b)(2) applicants.
Title:
Navigating Patent Potholes Along the FDA’s Proposed ANDA / 505(b)(2) Pathway
When/Where:
December 2, 2015
9:00 am PST / 10:00 am MST / 11:00 am CST / 12:00 noon EST.
Live webcast; registration required.
Speakers: Fitch Even attorneys Kendrew H. Colton and James A. Zak
Presented by: Fitch, Even, Tabin & Flannery LLP
Credit: 1 hr CLE CA/IL/NE; Other states may also reward credit upon attendee request.
Cost: 
Free. Registration required.