1. Home
  2. |Insights
  3. |Federal Circuit Affirms Extension of The 30 Month Hatch-Waxman Stay Preventing FDA Approval of Generic Version of Evista

Federal Circuit Affirms Extension of The 30 Month Hatch-Waxman Stay Preventing FDA Approval of Generic Version of Evista

Client Alert | 1 min read | 02.27.09

For the first time, the Federal Circuit has affirmed the extension of a thirty month stay under the Drug Price Competition and Patent Term Restoration Act (known as the "Hatch-Waxman Act"). The U. S. District Court for the Southern District of Indiana extended the stay because the generic company recast its product, disclosing new samples only eight months before trial was to commence and produced documents after the discovery cut-off. But a vigorous dissent claims that what the majority had done is to "effectively eliminate the statutorily required finding."

At issue in Eli Lilly & Co. v. Teva Pharms. United States, Inc ., 2009 U.S. App. LEXIS 3526 (Fed. Cir. 2009) was when, under the Hatch-Waxman Act, a trial court has the discretion to extend the thirty month stay that prevents the FDA from approving a generic drug for distribution while the branded and generic companies litigate any patent infringement issues.

Chief Judge Paul R. Michel and Judge Randall R. Rader held that District Judge Sarah Evans Barker had acted within her discretion in granting the extension, emphasizing that "Teva altered its generic [Evista] tablets late in the litigation."

Judge Sharon Prost dissented, arguing that the thirty month stay period was "a hard-won compromise" that "ceases to have meaning when district courts are able to modify the stay without articulating why the narrow circumstances described in the statute are present."

Under the ruling, Teva has seven days to file a petition for panel rehearing or rehearing en banc.

Contacts

Insights

Client Alert | 4 min read | 08.07.25

File First, Facts Later? Eleventh Circuit Says That Discovery Can Inform False Claims Act Allegations in Amended Complaints

On July 25, 2025, the Eleventh Circuit Court of Appeals issued its decision in United States ex. rel. Sedona Partners LLC v. Able Moving & Storage Inc. et al., holding that a district court cannot ignore new factual allegations included in an amended complaint filed by a False Claims Act qui tam relator based on the fact that those additional facts were learned in discovery, even while a motion to dismiss for failure to comply with the heightened pleading standard under Federal Rule of Civil Procedure 9(b) is pending.  Under Rule 9(b), allegations of fraud typically must include factual support showing the who, what, where, why, and how of the fraud to survive a defendant’s motion to dismiss.  And while that standard has not changed, Sedona gives room for a relator to file first and seek out discovery in order to amend an otherwise deficient complaint and survive a motion to dismiss, at least in the Eleventh Circuit.  Importantly, however, the Eleventh Circuit clarified that a district court retains the discretion to dismiss a relator’s complaint before or after discovery has begun, meaning that district courts are not required to permit discovery at the pleading stage.  Nevertheless, the Sedona decision is an about-face from precedent in the Eleventh Circuit, and many other circuits, where, historically, facts learned during discovery could not be used to circumvent Rule 9(b) by bolstering a relator’s factual allegations while a motion to dismiss was pending.  While the long-term effects of the decision remain to be seen, in the short term the decision may encourage relators to engage in early discovery in hopes of learning facts that they can use to survive otherwise meritorious motions to dismiss....

View All Insights