by Dennis Crouch
The Federal Circuit is now considering a pending en banc petition in Novartis Pharm. Corp. v. Accord Healthcare, Inc., Docket No. 21-1070; petition from 38 F.4th 1013 (U.S. Fed. Cir. 2022). The case involves a negative limitation added to a drug treatment method claim during prosecution, and substantive question on appeal is whether the claim limitation lacks written description support. The original Federal Circuit opinion penned by Judge O’Malley sided with the patentee; Chief Judge Moore wrote in dissent. Judge O’Malley subsequently retired and Judge Hughes was added to the panel to consider Accord’s rehearing petitioning. The new panel flipped the outcome with Judge Hughes joining the Chief’s position that the claims are invalid. We already have several posts on the case in Patently-O:
- Dennis Crouch, The Sound of Silence and the Inherency Doctrine for Written Description, Patently-O (July 29, 2022)
- Chris Holman, Federal Circuit Flips “Negative Claim Limitation” Decision after Change in Panel Composition, Patently-O (June 23, 2022)
Two groups of law professors have each filed an amicus brief in support of the petition. The first focuses on substantive written description issues and the second focuses on problematic appellate procedure presented by the panel recomposition.
Substance: The key substantive controversy centers on Chief Judge Moore’s restatement of the written description doctrine–that it requires all claim limitations be disclosed in the original specification either (a) expressly or (b) inherently in a fashion where the “particular limitation would always be understood by skilled artisans as being necessarily” present in the disclosure. The patentee in the case argues that inherency is too strict a standard and that it goes beyond what is required by the statute and prior precedent.
The Novartis patent claims a particular long-term drug dosage for a chronic disease. During prosecution the examiner rejected the claims based upon a prior art reference that began with a loading dosage before dropping down to a similar long-term dosage. The patentee amended the claims to state that its dosage does not follow a loading dose. “[A] daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.” Prior to that amendment, the specification had not previously disclosed any information about loading dosages. But loading doses were already known to be useful for this particular class of drug, and four experts testified that the original specification implicitly disclosed no-loading dose examples. On appeal though, the Federal Circuit concluded that implicit disclosure does not rise to the level of inherent disclosure.
I substantive amicus was is signed by a number of law professors with all-but-one having ongoing ties to George Mason University’s Antonin Scalia Law School. Professor Emily Michiko Morris was a primary author and so I’m calling it the “Morris Brief.” The Morris Brief argues that that the panel opinion reflects a new standard for the written description requirement:
[T]he Federal Circuit—until now—has never suggested that, absent in haec verba disclosure, the written description requirement can only be met through inherent disclosure, wherein the specification “necessarily” or “always” includes a positive limitation or excludes a negative one.
Morris Brief. The brief argues that a more flexible approach allowing for patentees to claim a non-expressed invention if PHOSITA would find the invention sufficiently disclosed based upon the “text, structure and technological context of the specification” and “without wooden rules.” The brief also argues that the decision “erroneously places the burden of proving validity upon the owner of an issued patent.”
This case is typical of written description arguments centered on whether amendments to avoid prior art were sufficiently disclosed. The Morris Brief notes that the ability to amend claims using negative limitations is an important feature of the patent system, and the decision here will limit the ability of applicants to make those amendments. The brief finally argues that the new panel improperly disregarded fact finding by the district court and instead effectively treated written description as an issue of law. Written description is a question of fact, and that the panel made a number of factual findings based upon evidence presented at the bench trial. On appeal though, the Moore court rejected these conclusions based upon its legal determination of no inherency and that “testimony from a skilled artisan as to possibilities or probabilities that the recited element would be excluded would not suffice, lest such testimony could effectively eliminate the written description requirement.” Slip op.
Procedure: The second brief focuses on appellate procedure and was filed by a group of CivPro / IP professors including Prof. David Hricik. The Hricik Brief spells out the arguments as follows:
This case presents an extraordinary circumstance in which, after a three-judge panel issued a 2-1 decision affirming the district court, a new panel was created for purposes of rehearing. That panel, with one new judge, reached a result opposite from the first. In effect, the majority opinion became the dissent, and the dissent the majority. This series of procedural events was contrary to this Court’s rules and precedent. The events here also run against longstanding tradition in the federal courts that panel rehearing may be granted only with the vote of at least one judge in the original majority. Numerous decisions from around the country show that where the departure of one of a panel’s original members leaves a 1-1 split, a petition for rehearing must be denied unless the remaining judge who had been in the majority changes his or her mind. In addition, the second opinion in this case violates the law-of-the-circuit doctrine, which provides that one three-judge panel must abide by prior panel decisions, absent en banc or Supreme Court rulings. . . .
The result here is all the more concerning because of a lack of transparency in the process. The second opinion did not acknowledge the change in panel, much less explain it. There was no notice to the parties as to why a different panel was needed to decide a petition for rehearing, let alone how the law authorized a different panel to address the petition.
The panel should grant rehearing and vacate the June 21 decision, thereby restoring the January 3 decision. Alternatively, the Court should grant rehearing en banc.
Hricik Brief. Accord is unlikely to file a responsive brief unless requested by the Court. FRAP 35(e).
Claim at issue:
1. A method for reducing or preventing or alleviating relapses in Relapsing-Remitting multiple Sclerosis in a Subject in need thereof, comprising orally administering to said Subject 2-amino-2-2-(4-octylphenyl)ethylpropane-1,3-diol, in free form or in a pharmaceutically acceptable salt form, at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.