All posts by Holman

Federal Circuit Flips “Negative Claim Limitation” Decision after Change in Panel Composition

By Chris Holman

Novartis Pharms. Corp. v. Accord Healthcare, Inc., 2022 WL 2204163, — 4th —  (Fed. Cir. June 21, 2022)

Here we have a case in which a petition for rehearing by the Federal Circuit leads to a flipped decision that appears to be the consequence of a change in panel composition.

In the original decision, authored by Judge O’Malley and decided January 3, a divided panel upheld a district court’s determination that the patent claims at issue were not invalid for failure to satisfy the written description requirement. The Federal Circuit agreed to rehear the case, but the composition of the panel rehearing the case was altered by the replacement of Judge O’Malley (who retired in March) with Judge Hughes. The reconfigured panel flipped the result of the earlier decision, this time reversing the district court.  The second decision was authored by Judge Moore, the dissent in the original decision. Judge Linn, who sided with Judge O’Malley in the original decision, found himself writing in dissent the second time round.

The relevant issue before the court was whether a negative claim limitation was adequately supported by the priority patent application. The claims are directed towards methods of treating relapsing-remitting multiple sclerosis (RRMS) through the administration of fingolimod (an immune suppressant) “at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.”  The “no loading dose” limitation was added by amendment during prosecution in order to overcome an obviousness rejection.  A loading dose is a “higher-than-daily dose,” usually given as the first dosage in a dosing regimen.   It was undisputed that loading doses were well-known in the medical field generally, and that loading doses have been used with some medicaments used in the treatment of MS.

The priority application does not explicitly mention loading doses, let alone the absence of a loading dose, but the district court nonetheless found implicit support for the negative claim limitation in two examples provided in the specification (one a prophetic human clinical trial, the other an experiment conducted in rats) which disclosed dosage regimens that did not involve the use of an initial loading dose. There was expert testimony to the effect that a person of skill in the art (POSA) reading the examples would have understood them as being “complete,” and as such the fact that the examples do not mention a loading dose implicitly discloses a dosage regimen that is not preceded by a loading dose.

In the original decision upholding the district court’s decision as not erroneous, Judge O’Malley emphasized that the majority was not instituting a “new and heightened standard for negative claim limitations,” and acknowledged that the disclosure need not describe a limitation in haec verba.  Writing in dissent, Judge Moore argued that the “no loading dose” limitation could not possibly find adequate support in a patent specification that fails to even mention loading doses.

Writing for the majority in the second opinion, Judge Moore reiterates her position that the district court clearly erred in finding written description support for the “no loading dose” limitation. While she acknowledges that a negative claim limitation does not necessarily require explicit written description support when the specification describes a reason to exclude the relevant element, e.g., when the specification identifies disadvantages of using that element, or “distinguishes among” the element and alternatives to it, she maintains that the element must at least be disclosed in some form, given that “the hallmark of written description is disclosure.” Judge Moore does not dispute that the written description requirement can be satisfied if a skilled artisan would have understood that the specification inherently discloses the negative limitation, but she found no evidence on the record in this case that a skilled artisan would understand silence regarding a loading dose to “necessarily exclude” a loading dose.

In his dissent, Judge Linn does not so much disagree with Judge Moore’s characterization of the law of written description, as with the way the majority applied that law to the facts of this case. In particular, he complains that majority improperly required the priority application to disclose that the negative limitation in question was “necessarily excluded”.  He argues that it can be sufficient for the specification to merely provide a “reason to exclude” the negative claim limitation.


Induced Infringement and the Section 286 Statute of Limitations

By Chris Holman

Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC, 2022 WL 1052320, — 4th —  (Fed. Cir. Apr. 8, 2022)

Through its acquisition of BioVeris Corporation, Roche Diagnostics became the owner of various patents relating to immunoassays employing electrochemiluminescence (“ECL”). In spite of its ownership of the patents, however, a jury found that a predecessor of BioVeris (IGEN) had exclusively licensed the patents to Meso Scale Diagnostics, and that Roche was liable to Meso for directly infringing one of the patents, and for inducing infringement of two others. On appeal, a divided Federal Circuit affirmed the jury’s decision with respect to direct infringement, but reversed the judgment of induced infringement, remanding for a new trial on damages. Writing in dissent, Judge Newman would have found that Meso did not have an exclusive license in the patents, and therefore Roche was not liable for either direct or induced infringement. The decision raises interesting issues relating to induced patent infringement and the interpretation of a licensing provision.

Inducement:  In 2003, prior to acquiring BioVeris (and its ECL patents), Roche obtained a nonexclusive license to the patented ECL technology from IGEN in the field of “human patient diagnostics.”  This license required Roche to note this field restriction on its product packaging. Later, in 2007, a Roche affiliate acquired BioVeris (including over 100 patents) for approximately $600 million. Roche announced this acquisition in a press release stating it would now “own the complete patent estate of the [ECL] technology,” giving it “the opportunity to fully exploit the entire immunochemistry market” and ensuring its ability to “provide unrestricted access to all customers.” Roche also prepared a customer letter indicating that the field-restriction labels were “now obsolete” and would be “removed as soon as possible,” but that in the interim customers should “please ignore the restrictions.” Roche subsequently began selling the products without field restrictions.  Meso argued that these actions induced customers to use the patented technology outside of the licensed field of use, i.e., “human patient diagnostics.”

Writing for the majority, Judge Prost explained that the decision to reverse the district court’s judgment with respect to induced infringement rested on two independent grounds: (A) absence of intent, and (B) absence of an inducing act that could support liability during the six-year statute of limitations on collecting back-damages, as set forth in 35 U.S.C. § 286.  (In a 2019 post, Dennis explains why it is correct to refer to the Section 286 limitation on damages as a “statute of limitations.”  For the record, Judge Newman uses the term in her  Roche Diagnostics dissent.)

Regarding absence of intent, the court found that the district court had, in denying JMOL, “incorrectly applied a negligence standard rather than requiring specific intent for inducement.” Judge Prost explained that:

While it’s true that we previously applied a “knew or should have known” formulation, we’ve since made clear that, “to the extent our prior case law allowed the finding of induced infringement based on recklessness or negligence, such case law is inconsistent with Global-Tech and no longer good law.”  …  Under the proper standard, the jury’s inducement conclusion is unsupportable.

The majority went on to explain that a finding of induced infringement was fundamentally inconsistent with the district courts conclusion (made in the context of a JMOL of no willful infringement) that “at no time did Roche have a subjective intent to infringe (or induce infringement of) Meso’s patent rights.”  In particular, the district court found that Roche had reasonably (albeit ultimately incorrectly) concluded that Meso did not have an exclusive license in the patents, and thus that Roche had no liability to Meso for patent infringement. Judge Prost explained that:

In some respects, the intent standard for inducement is akin to the one for willfulness, as both rest on the subjective intent of the accused infringer. … Here, the jury’s verdict of inducement couldn’t have survived JMOL under the proper intent standard because it contradicts the court’s express findings regarding Roche’s subjective belief that it wasn’t infringing or inducing infringement.

The majority further found that Meso had not proven that Roche had committed inducing acts within the Section 286 patent-damages limitations period, which began in April 2011. In particular, Roche’s allegedly inducing acts, i.e., its press release, customer letter, and decision to stop affixing field-restriction labels, occurred solely in 2007.

In sustaining the jury’s verdict of induced infringement, the district court had posited that acts occurring before the damages period could support a finding of inducement if they “continued to have an impact and caused third parties to use the products-at-issue outside of the licensed patient-diagnostics field after April 2011.”  The majority rejected the district court’s “continuing-impact” standard, citing Standard Oil Co. v. Nippon Shokubai Kagaku Kogyo Co., 754 F.2d 345 (Fed. Cir. 1985), and finding that “Roche’s press release, customer letter, and removal of field restrictions cannot support the jury’s induced-infringement verdict because the evidence indicates—and Meso doesn’t dispute—that none of these acts occurred within the damages period.”

Meso argued that Roche had committed inducing acts during the damages period because Roche “sold the products without restrictive labels throughout the damages period.” But the majority found that “sales without restrictive labels are not acts of inducement where, as here, the products have both in-field (non-infringing) and out-of-field (infringing) applications.”

The court further found that:

Even if Standard Oil doesn’t foreclose the district court’s “continuing-impact” standard, we reach the same conclusion because Meso didn’t provide evidence of causation between the allegedly inducing acts (before the damages period) and the direct infringement (within the damages period). Specifically, Meso put forward no evidence that any customers purchasing Roche’s products during the damages period received the 2007 communication and, in reliance on it, used the products out-of-field. …  For similar reasons, Meso’s argument that Roche induced infringement because it “never withdrew” its 2007 guidance also fails, at least because Meso didn’t show that this omission caused customers to infringe.

Readers might find it interesting to compare Judge Prost’s opinion in this case with her dissent in the Federal Circuit’s recent “skinny label” decision, Glaxosmithkline v. Teva, 7 F.4th 1320 (Fed. Cir. 2021) wherein she discusses induced infringement, and particularly her interpretation of the causation element of inducement.

License Scope:  Meso’s exclusive license in the ECL patents arose out of a joint venture agreement between IGEN and Meso Scale Technologies, a company owned by Jacob Wohlstadter (son of IGEN CEO Samuel Wohlstadter).  The agreement specified a “Research Program” for Meso to perform and included the following license provision:

2.1. IGEN Technology. IGEN hereby grants to [Meso] an exclusive, worldwide, royalty-free license to practice the IGEN Technology to make, use and sell products or processes (A) developed in the course of the Research Program, or (B) utilizing or related to the Research Technologies; provided that IGEN shall not be required to grant [Meso] a license to any technology that is subject to exclusive licenses to third parties granted prior to the date hereof. In the event any such exclusive license terminates, or IGEN is otherwise no longer restricted by such license from licensing such technology to [Meso], such technology shall be, and hereby is, licensed to [Meso] pursuant thereto.

With respect to the directly infringed patent, the majority affirmed the district court’s determination that the patent was “developed in the course of the Research Program,” and therefore, under “prong A” of the provision, Meso had exclusive rights in the asserted claim.  The court noted that “the work that was done in this patent was part of the research program,” and that Roche had not provided any persuasive reason why the asserted claim wasn’t “developed in the course of the Research Program.”  According to the majority:

The most Roche offers on this score is a footnote arguing generally that “the evidence at trial was insufficient for the jury to find that Meso held exclusive rights to the entirety of the ‘939 patent claim” and citing further course-of-conduct evidence. But this argument, “made in passing only in a footnote, is not sufficient under our precedents to preserve an argument for review.”

The majority found it unnecessary to decide whether Meso had an exclusive license in the patent claims that were only infringed indirectly, given that the district court’s finding of induced infringement had been reversed.

Writing in dissent, Judge Newman argued that Roche was not liable for infringement of any of the patents, since, under her interpretation of the license provision, Meso did not have an exclusive license to any of them.  She found the jury’s verdict to be “contradicted by the activity of all parties at the time of the 1995 license and the ensuing twenty-two years (citing Old Colony Tr. Co. v. City of Omaha, 230 U.S. 100, 118 (1913) (The practical interpretation of a contract by the parties to it for any considerable period of time before it comes to be the subject of controversy is deemed of great, if not controlling, influence)).”

Judge Newman also took issue with what she she saw as the majority’s decision to “disregard[] the undisputed evidence of [Meso]’s acceptance of Roche’s rights, because Roche mentioned that evidence in a footnote.” In her view:

Although presented in footnotes, these arguments were fully developed. The majority’s holding that Roche forfeited this issue defeats “the orderly administration of justice,” instead presenting a trap for the unwary. The judicial obligation is to seek truth and justice, even from footnotes.

Clearly, an attorney addressing the court should think twice before using a footnote to make a substantive point.

The Definiteness Implications of Using “Examples” to Define Claim Terms

by Chris Holman

ImmunoGen, Inc. v. Hirshfeld, 2022 WL 885774, (Fed. Cir. Mar. 25, 2022) (nonprecedential)

The patent application at issue in this case claims a method of treating a cancer patient by administering mirvetuximab (an immunoconjugate drug) “at a dose of 6 milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient.” The purported invention arose out of the discovery that administration of mirvetuximab at the recited dosage significantly reduces the severe ocular side effects that were observed during Phase 1 clinical trials when the drug was administered at a dose of 7 mg per kg of the patient’s total body weight (“TBW”).  After the Patent Trial and Appeal Board (“Board”) affirmed the examiner’s rejection of the pending claims for obviousness and obviousness-type double patenting, the applicant (ImmunoGen) filed a § 145 suit in the Eastern District of Virginia challenging the rejections.  The district court determined on summary judgment that the claims are “fatally indefinite and fatally obvious” as a matter of law.  On appeal, the Federal Circuit vacated the grant of summary judgment and remanded for further proceedings.

The district court’s indefiniteness ruling was based on the claims’ recitation of “AIBW,” a term which the court found was not defined in the application in manner that would inform a skilled artisan, with reasonable certainty, as to the scope of the invention (the Nautilus standard).  The application defines AIBW as “a size descriptor that accounts for sex, total body weight, and height.” It further defines ideal body weight (“IBW”), which is used to calculate AIBW, as “an estimate of weight corrected for sex and height, and optionally frame size.”  The AIBW and IBW definitions each includes a specific formula, introduced by the phrase “for example,” for calculating the respective values.

The formulas are reproduced below in the form of equations:

AIBW = IBW + 0.4(Actual weight in kg – IBW)

IBW (male) = 0.9(Height in centimeters) – 88

IBW (female) = 0.9(Height in centimeters) – 92

These “example” formulas were also reproduced in Example 4 of the application, which relates to the dosing of mirvetuximab.

In support of its decision finding the claims indefinite, the district court relied primarily on the fact that the definitions section of the application preceded the AIBW formula with the language “for example,” which the court found “ma[de] clear that there are multiple ways to calculate AIBW,” thereby “leav[ing] a skilled artisan to wonder or to guess whether the formula provided is the only one covered by the ’809 Application.” This uncertainty was, in the view of the district court, compounded by: (1) similar “for example” language accompanying the IBW formula; (2) the disclosure that IBW corrects “for sex and height, and optionally frame size”; and the incorporation by reference in its entirety of “Green,” an article that discloses several methods for calculating IBW and lists correction factors, each specific to a different drug, that can be used to adjust IBW to AIBW.

On appeal, the Federal Circuit found that the material factual findings underlying the district court’s definiteness ruling were far from undisputed. In particular, ImmunoGen had identified other intrinsic evidence a skilled artisan would consider in determining the scope of the claims, including that: (1) the claims and specification are drawn to a specific dosing regimen for a specific immunoconjugate, which is significant in light of expert testimony that the correction factor used to calculate AIBW is drug-specific; (2) Example 4 describes dosing mirvetuximab in accordance with the claimed method and uses the same AIBW and IBW formulas disclosed in the definitions section; and (3) during the prosecution of the ’809 Application, the USPTO never disputed the definiteness, or gave any indication it failed to understand the meaning, of the now-allegedly indefinite term. ImmunoGen also presented extrinsic evidence regarding the knowledge of a skilled artisan. For instance, both parties’ experts testified that AIBW dosing involves drug-specific formulas and correction factors.

The Federal Circuit also found that the district court had erred in concluding that there was no disputed question of material fact with respect to obviousness.  It was undisputed that AIBW dosing had not previously been used for mirvetuximab, or for that matter any other immunoconjugate drug.

If on remand the court ultimately finds the claims indefinite for defining a critical claim limitation in terms of an “example,” it would not be the first time that the Federal Circuit has flagged this as an issue.  In Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364 (Fed. Cir. 2014), the Federal Circuit held claims invalid for indefiniteness because the specification failed to adequately define the claim limitation “unobtrusive manner that does not distract a user.”  While “recognizing that a patent which defines a claim phrase through examples may satisfy the definiteness requirement,” the court “decline[d] to cull out a single “e.g.” phrase from a lengthy written description to serve as the exclusive definition of a facially subjective claim term.”  The court observed that “[h]ad the phrase been cast as a definition instead of as an example—if the phrase had been preceded by “i.e.” instead of “e.g.”—then it would help provide the clarity that the specification lacks.”

Still, I think that Interval Licensing can be readily distinguished over ImmunoGen, in that Interval Licensing’s “unobtrusive manner that does not distract the user” claim limitation seems much more “facially subjective” than ImmunoGen’s “adjusted ideal body weight.”