By Jason Rantanen

While this might not be the most newsworthy federal document archives story this week, it’s something that patent practitioners and others who practice before the Federal Circuit might want to take note of.  Today the Federal Circuit issued an order in Miscellaenous Docket 2022-160, “In re: Unsealing of Court Case Records.” The order reads:

The court is in the process of accessioning its remaining paper case records to the National Archives and Records Administration for permanent retention. These records predate the court’s transition to its electronic case management filing system in 2012 and once transferred to the National Archives will remain in only paper format and will not be made available online. Pursuant to Federal Circuit Rule 25.1(a)(1), “[a]fter five years following the end of all proceedings in this court, the court may direct the parties to show cause why confidential filings (except those protected by statute) should not be unsealed and made available to the public.” Through the review of these records, the court has identified several cases containing confidential filings that remain under seal more than five years following the end of all proceedings.

The order goes on to direct parties to the identified cases to this order to show cause within 60 days as to why confidential material in those cases should not be unsealed, along with instructions for what to do. The order is followed by 60 pages of case docket numbers and names. Almost all of them arise from the district courts, but there are a few from other origins. You can access it here: https://cafc.uscourts.gov/wp-content/uploads/22-160.pdf (archived version: 22-160).

For context, in 2012 the Federal Circuit switched from an older version of the court electronic records system to a newer version. As a result, appeals filed prior to the transition without subsequent case activity are only in the older system. (Appeals filed before the transition but with activity after the transition show up in both systems.) Many of the older materials are only available in paper form, and if you’ve ever tried to get them you know that it is very expensive and difficult.

I was curious about what portion of appeals this order applied to, so I plugged the docket numbers from the order into the Federal Circuit Dataset Project to get a sense of what portion of cases this applied to. (The list of docket numbers from the order is linked here: https://doi.org/10.7910/DVN/FRHXWT). In total, there are 1,151 appeal  numbers listed in the order (plus 3 duplicates). Of these, 1,122 matched an appeal docketed in 2000 or later that’s available in PACER; 16 don’t match a record that shows up in PACER (likely because the entire docket is confidential) and 13 involve appeals filed before 2000. The latest appeal was docketed in 2012, and most of the appeals listed were docketed between 2003 and 2010. Out of the 12,225 appeals docketed between 2000 and 2011, 977 show up on this list (about 8%).

However, most of the appeal dockets on the court’s list are appeals from the district courts, and those are only a portion of the court’s cases. Because these are records from the older generation of PACER, we don’t have as much information about them as for later appeals. (See this forthcoming article for details: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4162979.)  However, when I combined the list in the court’s order with our document dataset, which goes back to late 2004, and limited it to opinions and Rule 36 summary affirmances issued between 2005 and 2012, it turned out that about 25% of appeal dockets arising from the district courts that resulted in an opinion or Rule 36 in those years were listed on the court’s order (517/1,459), with about the same percentage for appeals arising from the ITC (79 out of 305). This isn’t exclusive; there are some numbers on the list that didn’t result in an opinion or order. But there’s a good chance that if you had an appeal in a patent infringement case that resulted in an opinion or Rule 36 affirmance between 2000 and 2011, it’s on the court’s list.

Bottom line: this is a lot of appeal dockets, both just in raw numbers and as a fraction of appeals in patent infringement cases and from the CIT.  The appeals were filed over a decade ago, and likely haven’t had any actions since 2012, but it may be worth a ctrl-F on the order to see whether your clients are impacted.

One thing that I do hope is that the court doesn’t de-accession the existing PACER docket search for pre-2012 cases. It provides only limited data and access to documents, but it’s the only publicly accessible directory or index for that information. As far as I know (and I’d love to be wrong!), there’s no existing paper analog.

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by Dennis Crouch

The defense of assignor estoppel has been in flux. The Federal Circuit had previously broadly applied the non-statutory doctrine to prevent a prior owner of patent rights (the “assignor”) from later challenging the validity of those rights. The basic idea was that the assignment of rights includes an implicit warranty.  In a 2021 decision, the Supreme Court shrunk the doctrine by creating important caveats. Minerva Surgical, Inc. v. Hologic, Inc., 141 S. Ct. 2298 (2021).  Although the Court retained the doctrine generally, it concluded that assignor estoppel is limited to situations where “the assignor’s claim of invalidity contradicts explicit or implicit representations made in assigning the patent.” Id.  The court noted potential situations of no-estoppel: (1) assignment made prior to the inventor even seeing the patent document; (2) a change in the law that renders the patent invalid; and (3) after the assignment, the new owner changes the scope of the patent claims that goes “beyond what the assignor intended to claim as patentable.” A key example of this would be claim changes that result in scope that is “materially broader” than those originally assigned.

On remand, the Federal Circuit concluded that estoppel still applies despite the Supreme Court’s added limitations. Hologic, Inc. v. Minerva Surgical, Inc., 19-2054, — F.4th — (Fed. Cir. 2022). In particular, the appellate court found that the claims at issue in the  litigation are not materially broader than what the assignor intended to claim at the time of the assignment.

The invention here relates to “an endometrial ablation device used to treat abnormal uterine bleeding (menorrhagia) by destroying targeted cells in the lining of the uterus.” Slip Op.  The invention generally proposed use of a “fluid permeable elastic member” for moisture removal; except that one claim in the application did not require the use of the permeable member.  (Claim 31).

Prior to the assignment at issue, the examiner had a restriction requirement and the patentee cancelled Claim 31 so that all of the remaining claims required the permeable member.  The patent application was in this state — with only permeable member claims — when the assignment at issue took place. Later, the patentee obtained a patent covering the invention without the permeable member and then sued the assignor who had formed a competing company.  In the litigaiton, the defendant challenged the broader claims as lacking written description, but the district court barred those challenges.

On appeal, the Federal Circuit found that in this context, the cancelled claim should still be considered part of the invention that the assignor expected to be patented.

[T]his 2002 cancelation in response to the Examiner’s restriction requirement says nothing, implicitly or explicitly, about the patentability of claim 31. Put another way, Mr. Truckai canceled claim 31 for reasons other than patentability. Indeed, an assignee would have understood that the restriction requirement and subsequent cancelation in response to the restriction requirement meant that the patent applicant could later prosecute claim 31’s subject matter. . . . Although claim 31 was canceled for purposes of further prosecution of the ’072 application, cancelation did not nullify the claim, as it remained viable for further prosecution in a divisional application filed by whomsoever owned the ’072 application. . . . The 2004 assignment assigned not just the rights to the ’072 application, but also the rights to any continuation, continuation-in-part, or divisional patent applications not yet filed. For certain, canceled claim 31 traveled with the ’072 application and its assignment to Hologic.

Slip Op.  Thus, to understand changes in the patent claims, the court will delve into the prosecution history to uncover the reasons for any changes to claim scope and then make some conclusions about whether those reasons fit within the assignor’s implicit intent-to-claim.  In a footnote, the opinion reserves the particulars for another day:

Our holding in this regard is limited to the facts of this case. We do not address whether a claim canceled for  reasons other than to comply with a restriction requirement would be part of the 2004 assignment.

Slip Op., Note 4.

I’ll note that the facts of Hologic do not reflect an ordinary patent case.  The assignment at issue was part of a $300 million company sale and thus was highly lawyered.  The assignment particularly included an express warranty that the IP rights being assigned were both valid and enforceable.  In the ordinary case, the inventor will be assigning rights to their employer pre-filing without the particular warranty or level of knowledge.

by Dennis Crouch

Every year, law schools advertise open faculty positions via a Faculty Appointments Register sponsored by the American Association of Law Schools (AALS).  This year’s list was just released, and lots of schools are looking to hire patent and IP professors. The list includes:

Akron, American University, Barry University, Baylor, Chicago-Kent, Drake, Duquesne, Florida A&M, GWU, Hawaii, Louisville, New England, New York Law School, Northern Kentucky, Oklahoma, Ole’ Miss, Seattle, Stetson, Suffolk, Suffolk, Texas Tech, U Florida, U Mass, UC Davis, UC LA, UIC (Chicago), UNH (Franklin Pierce), USC, & U San Francisco.

Note that top ranked law schools rarely advertise for particular subject matter areas.  For the most part, new tenure-track law professors will have already published law review articles and have some sort of teaching experience.  A number of schools though are also considering clinical and administrative positions that would have different expectations.  The hiring process is a bit cumbersome at most schools because the faculty as a whole typically vote on whether to extend an offer.  At Mizzou, we begin the recruitment process in late August and then usually vote in early December.  The new hire then starts work the following summer.  We’re not hiring in IP this year, but are looking to hire several candidates folks — primarily focusing on the areas of Criminal Law/Procedure; Evidence; Constitutional Law courses (including First Amendment); Contracts; Dispute Resolution; and Veterans benefits (clinic).

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).

Documents:

• Petition for Rehearing
• Hricik Brief
• Morris Brief

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.

by Dennis Crouch

Section 101 has some magic to it.  The short provision has remained essentially unchanged since it was originally handwritten in the 1700s and signed into law by President George Washington.

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

35 U.S.C. 101.  But the courts have taken the general provision and given it substantial meaning beyond the text.

Senator Tillis has introduced legislation that would re-write Section 101 — taking back authority from the courts and detailing the scope of eligibility as broadly extending to technology-based innovation.  Because the Supreme Court’s interpretation of Section 101 is largely atextual, the proposed amendment does not change the core text cited above. Rather, the Bill adds detail in the form of “eligibility exclusions” and notes that the broad provisions of Section 101 are subject “only to” the statutory exclusions.”  In his press release, Senator Tillis indicates that the proposal “is the product of almost four years of consensus driven stakeholder conversations from all interested parties.”

Unfortunately, due to a series of Supreme Court decisions, patent eligibility law in the United States has become confused, constricted, and unclear in recent years. This has led to inconsistent case decisions, uncertainty in innovation and investment communities, and unpredictable business outcomes. This has resulted in a wide range of well-documented negative impacts.

Tillis.  The Bill does not include a statement about whether its impact would be retroactive to apply to already issued patents and pending applications.  If it is retroactive, the legislation would have an immediate impact on many thousands of of patents and pending applications.

The Bill lists four particular eligibility exclusions that would be codified within a new Section 101(b)(1).  In particular, the statute would deny patent protection “for any of the following, if claimed as such:”

(A) A mathematical formula, apart from a useful invention or discovery.

(B) A process that— (i) is a non-technological economic, financial, business, social, cultural, or artistic process; (ii) is a mental process performed solely in the human mind; or (iii) occurs in nature wholly independent of, and prior to, any human activity.

(C) An unmodified human gene, as that gene exists in the human body.

(D) An unmodified natural material, as that material exists in nature.

These four exclusions are the only exceptions to Section 101’s broad text. The provision goes on with additional “CONDITIONS” that endeavor to ensure that the exclusions are narrowly read:

(2) CONDITIONS.—

(A) CERTAIN PROCESSES.—Notwithstanding paragraph (1)(B)(i), a person may obtain a patent for a claimed invention that is a process described in such provision if that process is embodied in a machine or manufacture, unless that machine or manufacture is recited in a patent claim without integrating, beyond merely storing and executing, the steps of the
process that the machine or manufacture perform.

‘(B) HUMAN GENES AND NATURAL MATERIALS. … a human gene or natural material that is isolated, purified, enriched, or otherwise altered by human activity, or that is otherwise employed in a useful invention or discovery, shall not be considered to be unmodified [i.e., is patentable].

The Bill would also add a process for determining whether or not an invention is eligible.

(c) ELIGIBILITY.—

(1) IN GENERAL.—In determining whether, under this section, a claimed invention is eligible for a patent, eligibility shall be determined—

(A) by considering the claimed invention as a whole and without discounting or disregarding any claim element; and

(B) without regard to—(i) the manner in which the claimed invention was made; (ii) whether a claim element is known, conventional, routine, or naturally occurring; (iii) the state of the applicable art, as of the date on which the claimed invention is invented; or (iv) any other consideration in section 102, 103, or 112.

The proposed amendment makes clear that invalidity via eligibility is still potentially available via motion to dismiss.

Finally, the provision also modifies and adds definitions to Section 100 of the Patent Act:

 (b) [Amended] The term “process” means process, art or method, and includes a new use, application, or method of manufacture of a known or naturally occurring process, machine, manufacture, composition of matter, or material.

(k) [New] The term ‘useful’ means, with respect to an invention or discovery, that the invention or discovery has a specific and practical utility from the perspective of a person of ordinary skill in the art to which the invention or discovery pertains.

Read the legislation yourself here.

Editor’s Note: Avery Welker is a rising 3L at Mizzou and likely a future patent attorney. He authors a series linking law school canonical cases with intellectual property counterparts, and the views expressed are his own. You can email ideas for future posts to avery@patentlyo.com.  – Dennis Crouch

By Avery Welker

TecSec, Inc. v. Adobe Inc., 978 F.3d 1278 (Fed. Cir. 2020) [decision link]

Last semester, I took a class on the Federal Rules of Evidence. We began the course by learning about relevance. As we progressed through the semester, relevance continued to stay, well, relevant! Many evidentiary analyses ended with the great gatekeeper of Federal Rule of Evidence 403, and our professor said that Rule 403 requires the dangers listed in Rule 403 to substantially outweigh the probative value of the evidence.[1] Our professor taught us that the Rule can limit relevant evidence but doesn’t always result in a sweeping exclusion, much to TecSec, Inc.’s delight during a 2020 appeal to the Federal Circuit.[2]

In 2010, TecSec asserted several patents against Adobe covering file-encryption methods transmitted over a data network.[3] The district court construed several terms in the patents on March 3, 2011, resulting in a judgment of noninfringement for Adobe.[4] However, the Federal Circuit reversed the judgment and construction of a term, remanding for further proceedings under the new term construction.[5] The case bounced up and down from the district court to the Federal Circuit.[6]

In October 2018, before trial, Adobe submitted a motion in limine to exclude any evidence of Adobe’s intent or willfulness to infringe TecSec’s patents between March 3, 2011 and October 18, 2013 unless TecSec agreed to allow the March 3, 2011 stipulation of noninfringement, order, and judgment, which Adobe argued were relevant to determining an infringer’s state of mind.[7] The district court granted Adobe’s motion and barred the evidence, stating that allowing TecSec to argue inducement of infringement is too prejudicial to Adobe without allowing Adobe to introduce the three documents it requested, and, if the court admitted the evidence, it would prejudice TecSec and confuse the jury.[8] Finally, the dispute went to a jury trial in late 2018.[9] After entering final judgment for Adobe (see a previous Patently-O post regarding this judgment here), TecSec (among other issues) appealed Adobe’s previous motion in limine.[10]

On appeal, Adobe attempted to protect the district court’s ruling on the motion in limine by arguing that the court was permitted to exclude the evidence because Rule 403 allowed the court to prevent unfair prejudice and avoid confusing the jury.[11] However, the Federal Circuit noted that Adobe’s presented applications of the Rule did not support such a sweeping exclusion of evidence.[12] The district court erroneously excluded an entire class of evidence (evidence of induced infringement after March 3, 2011) instead of excluding a piece or fixed set of evidence that would allow TecSec to present any other relevant and admissible evidence on the issue of induced infringement.[13]

Adobe’s motion scope addressed only whether Adobe could admit the March 3, 2011 claim construction results and TecSec’s stipulation; it did not bring up TecSec finding all evidence of inducement intent to determine a triable issue of infringement inducement after March 3, 2011.[14] The Federal Circuit found that Adobe’s motion in limine did not give the district court the basis to take the extreme measure of preventing the admission of all evidence of infringement inducement after March 3, 2011.[15]

Additionally, the Federal Circuit found that the district court determined that admitting the documents Adobe requested would unduly prejudice TecSec, but TecSec never indicated that it would drop its inducement claim after March 3, 2011 if the documents were introduced into evidence.[16] The Federal Circuit noted that the district court should have listened to whether TecSec would drop its inducement suit for the post–March 3, 2011 time frame before determining that the evidence would be too prejudicial to TecSec.[17] The Federal Circuit reversed the district court’s decision to exclude evidence of infringement inducement post–March 3, 2011.[18]

[1] Fed. R. Evid. 403.

[2] TecSec, Inc. v. Adobe Inc., 978 F.3d 1278 (Fed. Cir. 2020).

[3] Id. at 1282–83.

[4] Id. at 1283.

[5] Id.

[6] Id. at 1283–85.

[7] Id. at 1284.

[8] Id. at 1284–85.

[9] Id. at 1283–85.

[10] Id. at 1286. The motion in limine resulted in the court excluding TecSec’s expert witness deposition testimony of Adobe’s alleged induced infringement after March 3, 2011. Id.

[11] Id. at 1288.

[12] Id.

[13] Id.

[14] Id.

[15] Id. at 1288–89.

[16] Id. at 1289.

[17] Id.

[18] Id.

by Dennis Crouch

The basic issue in Novartis v. Accord is quite familiar. A new limitation was added to the claims during prosecution that is not found expressly in the specification, but would be expected by someone of skill in the art.  Does the claim violate the written description requirement of 35 U.S.C. 112? In its most recent statement, the Federal Circuit finds failure of written description unless the invention is either expressly or inherently disclosed in the original specification. Novartis Pharm. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013 (Fed. Cir. 2022) (rehearing decision). One quirk here is that the court identifies the particular limitation as a “negative claim limitation” and there are wide ranging policy views on how those limitations should be treated. However, the Novartis court explained that its express-or-inherent holding here applies regardless of whether claim limitations are expressed in positive or negative form.  Novartis has no petitioned for en banc rehearing.

• Novartis En Banc Petition
• Chris Holman, Federal Circuit Flips “Negative Claim Limitation” Decision after Change in Panel Composition, Patently-O (June 23, 2022)

The appellate procedure in this case is strange and important to its current status: The district court sided with Novartis (infringed + not-invalid) and the Federal Circuit affirmed on appeal in a January 2022 decision.  That original CAFed decision was penned by Judge O’Malley and joined by Judge Linn.  Chief Judge Moore wrote in dissent — arguing that the majority had been way too lenient.

By January 2022, Judge O’Malley had already announced her plans to retire from the judiciary in early March 2022. The appellant’s rehearing petition would have ordinarily been due on Groundhog Day, February 2, but HEC requested and was granted a 21-day delay and that meant that Novartis’s response would not be due until after Judge O’Malley’s retirement.  Rather than waiting for the deadline, Novartis  filed its responsive brief with a four-day turn around.  But to no avail; Judge O’Malley retired before acting on the rehearing petition.

After Judge O’Malley’s retirement, the court added Judge Hughes to the panel to decide the rehearing.  Of any judge that might have been added, Judge Hughes was one very likely to find against the patentee in this situation.  My understanding is that the court did not announce Judge Hughes addition to the panel until it issued a revised panel opinion on June 21, 2022.  Presumably in this case, there was some randomness in Judge Hughes’ selection, but the rules don’t expressly require that.

The panel re-composition flipped the outcome.  Chief Judge Moore had previously written in dissent, but now Judge Hughes joined her opinion–putting her in the majority. With the loss of Judge O’Malley, Judge Linn’s position flipped to the dissent.  Thus, the new opinion sided with the accused infringer–concluding that the district court “clearly erred” in finding the claims not invalid.   The decision here is apparently the first time that a Federal Circuit panel has flipped the outcome following a change in panel composition.

Now, Novartis has filed its petition for rehearing.  The petition raises two issues: one on the merits of the written description issue; and a second focusing on the unusual appellate procedure.

1. Patent Law Merits: Whether 35 U.S.C. §112 and this Court’s precedent require that, to have adequate written description, a claim limitation must be either expressly disclosed in the specification or necessarily present in some express disclosure, even if a skilled artisan would otherwise read the specification to disclose possession of the limitation.
2. Appellate Procedure: Did the court procedurally err by issuing the new decision on rehearing.

Lets start with procedure and panel dependence. The other circuits have an internal rule or practice that a panel rehearing will not be ordered unless at least one judge in the majority votes for the rehearing.  The idea behind a panel rehearing to raise issues that the majority can recognize that it “overlooked or misapprehended.” FRAP 40(a)(2). But, no one in the majority changed their outlook. Rather, the addition of Judge Hughes provided an end-run around the majority by adding a new panel member.

The Federal Circuit has previously written about this issue – but not in a self-reflective way. Rather the court was in its then supervisory role of the US Claims Court. Universal Restoration, Inc. v. U.S., 798 F.2d 1400 (Fed. Cir. 1986).  In Universal, one panel member of the Claims Court had been replaced following its original determination.  That recomposition resulted in a flipped the outcome on rehearing.   On appeal, the Federal Circuit reversed on the merits, but in a footnote explained that the recomposition was improper:

Where the original panel reconsiders and changes a decision, a member of the original majority must vote for the change. In the Supreme Court where less than a majority may order rehearing, a member of the original majority must vote for the rehearing. These procedures are readily acceptable as “fair.” Sup.Ct.R. 51.1 (1980); Ambler v. Whipple, 90 U.S. (23 Wall.) 278, 281–82 (1874). . . . What appears to be the case here is that there was in fact no reconsideration. A different panel simply disagreed with the first decision.

Id.  The Federal Circuit does have a rule regarding replacement of a missing panel member. Federal Circuit Rule 47.11. That rule calls for the Chief Judge to secure an additional judge in situations where “a judge of a panel that has heard oral argument or taken under submission any appeal, petition, or motion is unable to continue with consideration of the matter.”  If the remaining two judges are unable to resolve the matter,  then the chief judge should appoint another judge.  Id.  In its petition, the Novartis argues that this rule is inapplicable based upon the aforementioned general tradition and because panel rehearing petitions are not “argued” or “taken under submission.”

On the merits: The petition argues that the new majority opinion improperly creates an “express-or-inherent rule:” That the invention as claimed must be either expressly or inherently disclosed within the specification.  Chief Judge Moore explained:

[I]t is possible that the written description requirement may be satisfied when a skilled artisan
would understand the specification as inherently disclosing the negative limitation. . . [However], 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. If silence were generally sufficient, all negative limitations would be supported by a silent specification. If, however, a patent owner could establish that a particular limitation would always be understood by skilled artisans as being necessarily excluded from a particular claimed method or apparatus if that limitation is not mentioned, the written description requirement would be satisfied despite the specification’s silence.

Id.   The petition argues that Judge Moore has improperly created a bright-line rule in an area where “there are no bright-line rules.”

The new majority’s inflexible heightened standard conflicts with a substantial body of precedent. It makes written description turn not on what the specification “reasonably conveys to those skilled in the art,” but on what the specification expressly or necessarily discloses. And because the new majority expressly declined to limit its holding to negative claim limitations, that holding could be applied to reverse any written-description finding.

Novartis En banc Petition.

What is the invention: Fingolimod was a known immune suppressant.  In its patent, Novartis claims a method of treating multiple sclerosis (RRMS) by administering fingolimod at a particular daily dosage of 0.5 mg.

Many drug regimens begin with a loading-dose to quickly raise the blood-level. The dosage is then reduced to a lower maintenance dosage. During prosecution some prior art was uncovered that started with a loading dose and then reduced dosage down to a level close to that claimed by Novartis. But the Novartis invention did not require a loading dose.  Prosecutors amended the claims to make that clear: “a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.”

The Sound of Silence: The problem identified by Chief Judge Moore is that the Novartis patent application documents never mention loading doses or the absence of loading doses. They don’t say anything one-way-or-the-other.  Novartis provided evidence that loading doses in this area were common and that PHOSITA would have understood that silence regarding loading doses was actually a disclosure that no-such loading doses were required.  Judge Moore rejected this argument; holding instead that “Silence is not disclosure.”  Further, Judge Moore adopted the inherency doctrine as a limiting rule. That doctrine is quite tight and only finds  disclosures inherent if they necessarily flow from express teachings.