In the wake of the Federal Circuit’s 2024 Orange Book delisting decision in Teva v. Amneal, Hatch-Waxman practitioners have been left to grapple with several unanswered questions. Although the decision clarified what is required for some patents to qualify for listing in the Orange Book, the case was voluntarily dismissed before downstream effects of the delisting could come to a head in the litigation.

Thus, questions remain about what happens in ongoing Hatch-Waxman litigation when the asserted patents are delisted. The answers to these questions may have important tactical and practical implications for stakeholders. This article addresses three of those questions.

Can Hatch-Waxman claims be dismissed when the asserted patent is delisted?

If all asserted patents are delisted during litigation, dismissal of the corresponding infringement claims has some logical appeal. After all, if the patents had not been listed improvidently in the Orange Book, there would not have been any legal basis to initiate the litigation. Moreover, and as a practical matter, the NDA holder would not have known until much later that an ANDA had even been submitted.

Complicating this question is the common practice in Hatch-Waxman litigation of pleading parallel Hatch-Waxman infringement claims and declaratory judgment infringement claims. One court has appeared willing, at least in theory, to allow declaratory judgment claims to survive delisting of the parallel Hatch-Waxman claims. Teva Branded Pharm. Prods. R&D, Inc. et al v. Deva Holding AS a/k/a Deva Holdings AS, Case No. 2:24-cv-04404, ECF No. 29 (D.N.J. Aug. 28, 2024).

As a practical matter, litigants may or may not want to try to un-ring the Hatch-Waxman litigation bell, even if the patents have been delisted. There may be scenarios where dismissal serves the interests of the defendant. But some defendants might prefer to proceed in the litigation, rather than dismiss and proceed under the specter of damages liability when they later obtain FDA approval and launch their ANDA products. For various reasons beyond the scope of this article, a preference to proceed in the litigation may be strong when the ANDA is eligible for first-to-file generic exclusivity.

If the case proceeds after delisting, are Hatch-Waxman remedies still available?

Even if the litigation is not dismissed, delisting raises a substantial remedies question. A patentee prevailing on a Hatch-Waxman infringement claim is statutorily entitled to an order preventing final FDA approval until after the patent expires. Because the accused ANDA product cannot be sold until after final approval, such an order is effectively an automatic permanent injunction against sales.

This remedy is unique to patents listed in the Orange Book. A patentee prevailing on any other infringement claim cannot obtain a permanent injunction unless the situation satisfies the equitable test under eBay. eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006). Depending on the factual scenario, such a showing can be difficult or impossible to make, leaving damages as the primary remedy.

Thus, Hatch-Waxman defendants may seek to persuade the court that Hatch-Waxman remedies are not available once the asserted patents have been delisted. It remains to be seen whether courts will agree.

Does the substantive infringement analysis change after delisting?

Delisting also raises a substantial question about the kinds of evidence that may be required to show infringement. In ANDA cases, if the controlling portion of the ANDA (the so-called “specification”) speaks directly to the factual infringement question, then infringement can essentially be decided on what the ANDA “says.” Sunovion Pharms., Inc. v. Teva Pharms. USA, Inc., 731 F.3d 1271, 1279 (Fed. Cir. 2013). The infringement inquiry only shifts to tests or observations of the physical ANDA product itself when the ANDA does not squarely answer the question of whether a claim limitation is met. Ferring B.V. v. Watson Lab’ys, Inc.-Fla., 764 F.3d 1382, 1387-88 (Fed. Cir. 2014). Sometimes, this can lead to a finding of infringement where the ANDA expressly permits the ANDA product to exhibit the claimed characteristic, even if real world testing or observation shows that the actual ANDA product does not exhibit the claimed characteristic.

Delisting arguably makes Sunovion-type infringement arguments inapplicable, even if the litigation proceeds. Depending on the facts, this could significantly shift the merits of the (non)infringement arguments and may lead to a shift in the evidence required to prevail.

Conclusion

Teva v. Amneal answered a high‑level statutory interpretation question about listing of patent in the Orange Book. But important questions linger, and Hatch-Waxman practitioners and stakeholders must continue to wrestle with these issues as they formulate strategies for triggering and resolving these disputes.