Here is an update on recent en banc activity at the Federal Circuit in patent cases. Since our last update, one new petition for en banc rehearing was filed raising several questions related to attorney’s fees. One new response to a petition was filed in a case a case raising a question related to the Hatch-Waxman Act. A response to a notice of supplemental authority was filed in the same case. And, finally, one petition was denied in a case raising questions related to standing. Here are the details.
New Petition
Since our last update, one new petition was filed.
In Extremity Medical, LLC, v. Nextremity Solutions, Inc., Nextremity Solutions asked the en banc court to review the following questions:
- “If a patentee brings a District Court action for patent infringement when it knew or should have known that the asserted patent claim in that action was invalid, can attorney fees, which are awarded by the District Court under 35 U.S.C. § 285, include the attorney fees incurred in a related parallel Inter Partes Review (‘IPR’) before the Patent Trial and Appeal Board (‘PTAB’) when the District Court deemed the case ‘exceptional’ and dismissed the action based upon the result of the IPR?”
- “Does the United States Supreme Court’s decision in Sullivan v. Hudson, 490 U.S. 877 (1989) allow for an award of attorney fees incurred in a parallel IPR under § 285, when the parallel IPR was ‘intimately tied’ to the District Court action regardless of whether the IPR was voluntarily or involuntarily participated in by the patent challenger defending a claim of patent infringement?”
- “Is the decision in this case and in Dragon Intellectual Property, LLC v. Dish Network, L.L.C., 101 F.4th 1366 (Fed. Cir. 2024), which precludes an award of attorney’s fees incurred in a parallel IPR under 35 U.S.C. § 285 because the IPR was ‘voluntary’ by the patent challenger, contrary to the Supreme Court’s decision in Sullivan v. Hudson, 490 U.S. 877 (1989)?”
- “If an award of attorney’s fees incurred in a parallel IPR requires that the IPR be ‘voluntary’ by the patent challenger, is the patent challenger’s participation in an IPR voluntary or involuntary when the patentee makes a motion to amend the patent claim within the IPR, in light of 35 U.S.C. § 315(e) which requires that the patent challenger successfully oppose the motion to amend to avoid being estopped from challenging the validity of the amended patent claim thereafter including before the District Court?”
Response
Since our last update, one new response brief was filed.
In its petition in Corcept Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc., Corcept Therapeutics asked the court to consider the following question:
- Whether “[t]he panel erroneously relied on Genentech, Inc. v. Sandoz Inc., 55 F.4th 1368 (Fed. Cir. 2022), when Genentech conflicts with prior Federal Circuit precedent and is therefore not controlling.”
Now, in its response, Teva Pharmaceuticals argues the Federal Circuit’s “holding in Genentech, Inc. v. Sandoz Inc., that the infringement inquiry in a Hatch-Waxman case requires consideration of ‘all the relevant evidence,’ including physician practice, follows from decades of precedent.” Teva contends Corcept would have the Federal Circuit “jettison that settled approach and adopt a regime that would categorically forbid courts from analyzing evidence outside the label.” Teva argues “[t]hat breathtaking expansion of liability finds no support in precedent or sound policy.”
Response to Supplemental Authority
Since our last update, a new response to supplemental authority was filed.
In the same case just discussed, Corcept Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc., Corcept Therapeutics cited supplemental authority. According to Corcept, the Supreme Court’s recent decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. “confirmed Corcept’s understanding of the Hatch-Waxman Amendments.” Corcept further argued the decision “confirms that this Court should overrule Genentech and provides a strong basis for the Court to reconsider its broader jurisdictional-only approach” to 35 U.S.C. § 271(e)(2).
Now, in response, Teva Pharmaceuticals argues Hikma “neither states nor implies anything about the extent to which outside-the-label evidence should be considered when evaluating a § 271(e)(2) claim.” Teva contends, moreover, that “Hikma’s description of the Hatch-Waxman framework is fully consistent with the long line of precedent—including . . . Genentech, Inc. v. Sandoz Inc.—holding that a Paragraph IV certification provides a jurisdictional hook that allows a lawsuit to proceed before the generic product has been marketed without altering the substantive standards for infringement under 35 U.S.C. §§ 271(a), (b), and (c).” Teva further argues that, “[t]o the extent Hikma is relevant, it confirms that plaintiffs alleging induced infringement need to prove direct infringement—which Corcept failed to do here.”
Denial
Since our last update, the Federal Circuit denied one petition for en banc rehearing: