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

This CLE course 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?

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.