Hatch-Waxman Litigation and 30-Month Stays: Multiple Stays, Late-Listed Patents, and More

A live 90-minute premium CLE webinar with interactive Q&A


Thursday, October 29, 2020

1:00pm-2:30pm EDT, 10:00am-11:30am PDT

Early Registration Discount Deadline, Friday, October 2, 2020

or call 1-800-926-7926

This CLE webinar will guide patent counsel on the 30-month stay in Hatch-Waxman Act litigation. The panel will discuss the circumstances where the FDA will grant a stay--and those where it will not. The panel will discuss when a stay may extend beyond 30 months and when it may be shortened.

Description

Under the Hatch-Waxman Act, the owner of an Orange Book-listed patent covering an innovative pharmaceutical product is entitled to a 30-month stay if it sues a generic drug applicant within 45 days of receiving a Paragraph IV notice letter. When the stay is in place, the FDA will not grant final approval of the generic product.

While this procedure seems relatively straightforward, a surprising number of questions regarding 30-month stays can and do arise. What are the requirements for filing suit to trigger a stay? Can pharmaceutical companies get multiple stays, for example, by listing multiple patents in the Orange Book? Will reissue of the patent during litigation or challenges at the USPTO affect the stay?

Listen as our authoritative panel explains the 30-month stay in Hatch-Waxman Act litigation. The panel will discuss when the FDA will grant a stay--and when it will not. The panel will review when a stay may extend beyond 30 months and when it may be shortened.

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Outline

  1. Triggers
    1. Requirements
    2. Defective complaint
    3. Multiple stays
  2. Potential impacts
    1. Additional listing
    2. Paragraph III or IV certifications
    3. Change in product
    4. Expiration with pending litigation
    5. Reissue during litigation
    6. Challenges at USPTO

Benefits

The panel will review these and other crucial issues:

  • Can a "defective" complaint trigger the stay?
  • Can a late-listed patent give rise to a stay?
  • Is a generic drug applicant subject to a second 30-month stay if it converts a Paragraph III certification to a second Paragraph IV?
  • What is the impact of the stay expiring while the litigation is pending?
  • What is the impact of the litigation ending while the stay is in place?
  • What impact does a USPTO decision or pending USPTO proceedings have on a stay?

Faculty

Feldstein, Mark
Mark J. Feldstein, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and...  |  Read More

Rudolph, Barbara
Barbara R. Rudolph, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Rudolph has successfully litigated complex Hatch-Waxman Paragraph IV Abbreviated New Drug Application and...  |  Read More

Weingarten, M. David
M. David Weingarten, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Weingarten has a diverse intellectual property practice focusing on patent litigation before U.S. district courts...  |  Read More

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