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# Protect 30-Month Stay During IPR, Lawyers Say
- URL: https://www.fdaweb.com/protect-30-month-stay-during-ipr-lawyers-say/
- Published: 2016-03-16T12:00:00.000Z
- Updated: 2026-09-15T02:44:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135109

> Four Faegre Baker Daniels attorneys say that two recent decisions involving Alcon and Lilly demonstrate that it may be difficult for branded drug companies to prevent a litigation stay in view of pending *inter partes* review (IPR) proceedings. (*Inter partes* reviewis a procedure to challenge a patent’s validity before the U.S. Patent and Trademark Office.)  
>  
> Writing in an online [post](http://www.faegrebd.com/tips-for-protecting-hatch-waxman-stay-after-lilly-alcon?ref=fdaweb.com), the attorneys say that one of the most important protections for innovator firms engaging in Waxman-Hatch litigation is the automatic 30-month stay of FDA approval of a generic drug ANDA. The stay “serves the important policy of minimizing risk of irreparable harm to the brand company by preventing the generic drug from launching until resolution of the underlying patent infringement suit,” they write. “However, recent federal district court decisions in *Lilly* and *Alcon* show that the increasing tendency of district courts to stay litigation in view of *inter partes* review proceedings poses a real risk to the protections of the 30-month regulatory stay.”  
>  
> They point out that if Waxman-Hatch litigation is stayed pending IPR but the 30-month regulatory stay is not extended, there is a significant risk that a generic could launch at-risk before the merits of the underlying litigation are resolved. Given that in both *Lilly* and *Alcon* company requests for regulatory 30-month extensions were denied, the attorneys say that the most effective strategy for protecting the 30-month regulatory stay may be to prevent a litigation stay in the first place.  
>  
> Strategies to successfully oppose motions to stay litigation in view of an IPR discussed in the post include picking up the pace and seeking a case schedule that expedites early fact discovery and claim construction deadlines, being upfront with the court about the reason for seeking such a schedule in light of the need to protect the 30-month regulatory stay, setting a trial date as early as possible given the venue in which the complaint is filed, filing suit in a venue that is likely to allow for early discovery and trial, and explaining why it is unduly prejudicial to the innovator company if it is forced to rely on preliminary injunctive relief to prevent an at-risk launch by a generic.