Past Webinars

  • December 2, 2015
Navigating Patent Potholes Along the FDA's Proposed ANDA / 505(b)(2) Pathway

Please join Fitch, Even, Tabin & Flannery LLP for a complimentary webinar, “Navigating Patent Potholes Along the FDA’s Proposed ANDA / 505(b)(2) Pathway,” presented by Kendrew H. Colton and James A. Zak. The webinar will take place on Wednesday, December 2, 2015, at 9:00 am PST / 10:00 am MST / 11:00 am CST / 12:00 noon EST.

The FDA has released new rules regarding the procedures for approval of ANDA and 505(b)(2) applications 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.

During our webinar, we will discuss 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

Our speakers will be Fitch Even attorneys Kendrew H. Colton and James A. Zak. Ken has extensive IP counseling and litigation experience, with a focus on designing strategies to achieve market exclusivity and freedom to operate for clients working with chemical and biochemical technologies. James chiefly focuses his practice on the intersection of intellectual property and FDA law, often working with startups in FDA-regulated industries to develop and align their IP and FDA market approval strategies while simultaneously developing robust patent portfolios. 

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