ANDA litigation can be an odd beast. You file a case based on a product that a defendant has only applied to manufacture—what then, when the FDA requires an amendment? What of the litigation that may be years in the making and heading into the home stretch?
The somewhat tortured history of Biodelivery Sciences International, Inc. et al. v. Chemo Research, S.L., C.A. No. 19-444-CFC-CJB, gives us several examples of exactly how the Court deals with this situation.
An Early Change to an ANDA Does Not Warrant a New Trial Date
Early on in that case (about 6 months after the scheduling order was entered) one of the defendants—Chemo—received a complete response letter ("CRL") from the FDA requiring them to add a specification for the pH range of various films layers in their product, which Judge Burke described as a "key infringement issue in the case." Id., D.I. 372 at 2 n.2. Plaintiffs moved to stay the case a few weeks later, until " Defendants obtain tentative approval of their ANDA or it appears likely that Defendants will receive tentative approval of their ANDA but for any minor deficiencies." Id., D.I. 132.
Judge Burke denied this motion shortly after briefing on the motion completed, noting that the scheduled trial was still 11 months away in February 2021. Id., D.I. 193. He went on to order some related discovery and required the parties to submit status reports related to that discovery and Chemo's response to the CRL. Id., D.I. Nos. 251, 262, 274. Although he allowed plaintiffs to propose some modifications to the schedule, he was clear that the infringement trial date would not be moved.
A Late Change to an ANDA is Cause to Delay Trial, but not Indefinitely
About a year later, Chemo had still not responded to the CRL and plaintiffs again moved to stay the case until "the FDA is able to review and weigh in on Chemo's amended ANDA." Judge Burke declined to issue such an open-ended stay noting that:
there is some level of inherent uncertainty as to the nature of the final accused product in many Hatch-Waxman cases, since the relevant statute provides for pre-FDA approval adjudication of pharmaceutical patent disputes. (D.I. 352 at 6; D.I. 368 at 3 & n.4) Here, the Court is willing to say only that there is a bit more uncertainty than in the average case, simply in light of the fact that the FDA has issued a CRL. But the current record does not indicate a level of unpredictability that is so outsized as to warrant a stay
Id., D.I. 372 at 3.
Instead, he ordered the parties to submit proposals for new case schedules to accommodate these regulatory delays. The parties did so, and Judge Burke chose plaintiffs' proposal which moved out the trial date by approximately 5 months—3 months after the earliest date the FDA was expected to respond to Chemo's new ANDA. Id., D.I. 389. Chemo had proposed trial before the FDA was to respond to its amended ANDA.
If you enjoyed this post, consider subscribing to receive free e-mail updates about new posts.
