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

Recording of a 90-minute premium CLE webinar with Q&A

Conducted on Thursday, August 9, 2018

Recorded event now available

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Program Materials

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.


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?



  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


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?


Cyr, Shana
Shana K. Cyr, Ph.D.

Finnegan Henderson Farabow Garrett & Dunner

Dr. Cyr represents clients in complex patent litigations, contentious proceedings before the USPTO, and appeals related...  |  Read More

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

Finnegan Henderson Farabow Garrett & Dunner

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

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