Novartis and Accord Healthcare, Inc. are embroiled in a patent infringement suit concerning Novartis’ blockbuster multiple sclerosis drug Gilenya. Our previous articles Sound of Silence: Claiming Negative Limitations, and Sound of Silence: Take Two discussed two related decisions: Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., 21 F.4th 1362 (Fed. Cir. 2022) (“Original ”) and Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., 38 F.4th 1013 (Fed. Cir. 2022) (“Rehearing”), respectively.
The issue in dispute is whether a negative limitation recited in the Novartis patent claims meets the written description requirement when the specification is silent as to that limitation. The Original panel said on January 3, 2022, that implied disclosure was sufficient and ruled in Novartis’ favor, but the Rehearing panel said June 21, 2022, that without express disclosure, inherent disclosure is required for support of a negative limitation and reversed the first decision. After losing the Rehearing, Novartis filed a petition for a writ for certiorari on January 18, 2023, asking the Supreme Court to review not only the substantive patent law issue but also whether it is proper to allow a panel change to undo already-entered decisions.
The questions presented in the petition are below:
1. Whether 28 U.S.C. § 46 and principles of sound judicial administration preclude a court of appeals from adding a new judge to form a new panel and redecide a case after an original three-judge panel has already decided the case and entered its judgment.
2. Whether 35 U.S.C. § 112 should be interpreted consistent with its plain text as requiring that a patent specification contain a “written description of the invention” in a form that need only be understandable to “any person skilled in the art,” or whether the court of appeals properly read in a heightened requirement that allows it to deem the specification inadequate on de novo review and displaces the perspective of a person skilled in the art.
The first question addresses the unusual procedural twist in the cases: the judge who authored the Original opinion, Judge Kathleen M. O'Malley, retired and was replaced with Judge Hughes, who sat on the rehearing panel decided the Rehearing case. The dissenting judge on the Original Panel, Judge Moore, authored the decision in the rehearing case, delivering the blow to Novartis. Novartis argues that procedurally there was no rehearing – only replacement of a judge in the majority with a judge who agreed with the original dissenter, Judge Moore. The second question addresses the substantive, controversial issue in patent law relating to whether and when a disclosure that is silent as to the negative limitation nonetheless can meet the written description requirement.
It appears that the outcome of the Rehearing upset not only Novartis but also a particular group: retired judges who are concerned about their legacy after they leave the bench. On February 21, 2023, five (5) Retired Federal Appeals Ct. judges1 filed an amicus brief, siding with Novartis. The retired judges argued that a rehearing should be performed by the same judges who sat on the Original panel to reconsider their own earlier decision. The judges also argued that allowing judges to swap out (replacing O'Malley in the original panel with judge Hughes in the rehearing panel) under the pretense of panel rehearing to change already-published decisions undermines public confidence in the judiciary.
This case raises an interesting procedural issue: after a judge leaves the bench, can a losing party obtain a rehearing with the same court? While it is unclear whether the Supreme Court will decide on either question raised in Novartis’ petition, the sound of debate on these interesting issues is loud and clear.
Yifan Mao is a counsel at Kilpatrick Townsend & Stockton, LLP. She can be reached at email@example.com; 650-324-6311.
Allison W. Dobson is a partner at Kilpatrick Townsend & Stockton, LLP. She can be reached at: firstname.lastname@example.org; 336-607-7405.
The opinions expressed are those of the authors and do not necessarily reflect the views of the firm, its clients, or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
While we are pleased to have you contact us by telephone, surface mail, electronic mail, or by facsimile transmission, contacting Kilpatrick Townsend & Stockton LLP or any of its attorneys does not create an attorney-client relationship. The formation of an attorney-client relationship requires consideration of multiple factors, including possible conflicts of interest. An attorney-client relationship is formed only when both you and the Firm have agreed to proceed with a defined engagement.
DO NOT CONVEY TO US ANY INFORMATION YOU REGARD AS CONFIDENTIAL UNTIL A FORMAL CLIENT-ATTORNEY RELATIONSHIP HAS BEEN ESTABLISHED.
If you do convey information, you recognize that we may review and disclose the information, and you agree that even if you regard the information as highly confidential and even if it is transmitted in a good faith effort to retain us, such a review does not preclude us from representing another client directly adverse to you, even in a matter where that information could be used against you.