Recent Case Highlights

2023 Q2 Patent Defenses Update

Highlights and Strategies from April – June appellate decisions on substantive Patent Law.

Sec. 112(f) is Ready to Do Much More: Both sides in patent litigation under-utilize Sec. 112(f).

  1. Patent owners could apply Sec. 112(f) as a statutory (provisional) safe harbor against Alice patent-ineligibility, “full-scope” Sec. 112(a), and “indefiniteness” challenges based on facially functional claiming.
  2. Alleged infringers could argue that genuine ambiguity on whether a claim element triggers Sec. 112(f), renders the claim “indefinite” under Nautilus like any other genuine ambiguity about claim scope.
  3. Each side could apply Sec. 112(f) to method claims as readily as to non-method claims.
  4. Each side could apply Sec. 112(f) much more often in life sciences patent litigation.

Points 1 and 4 are illustrated by what was not argued in Amgen.

Functional Genus Claims at the Supreme Court: Amgen v. Sanofi

Here’s how our post-Argument predictions in our 1st Quarter update ( fared:

Enablement at the Supreme Court—Predictions

Amgen v. Sanofi concerns functionally defined genus claims on antibodies.

Based on the March 27th Argument, the Court’s Opinion likely will: (1) affirm or remand for clarification of the Federal Circuit’s analysis, (2) be narrowly limited to enablement, without discussing written description, indefiniteness, functional claiming, or the statutory provision governing functional claim elements, 35 U.S.C. § 112(f), and (3) endorse with minor clarification existing Federal Circuit enablement principles, including: only reasonable enablement is required, i.e., only “undue” experimentation defeats enablement; a claim’s full scope must be enabled and a broader claim normally requires a broader disclosure; the Wands factors are relevant; and the time needed to identify and make non-disclosed species is relevant but not dispositive.

The Court affirmed that Amgen’s disclosure of a few dozen antibodies did not provide the required “full-scope” enablement of its functional genus claims that might encompass millions of antibodies, but required trial-and-error experiments to determine, one candidate at a time, which had the claimed functionality. Amgen (U.S. 05/18/2023).

As interesting, is what the courts and parties did not say: these functional claims trigger Sec. 112(f) because they recite functions without particular acts, materials, or structures sufficient to perform the function. Amicus briefs by Eli Lilly and High Tech Inventors Alliance made this point.

Sanofi—which of course gets credit for prevailing in the end—could have argued for application of Sec. 112(f) in support of non-infringement (instead of admitting infringement as it did, and then losing non-enablement before the jury). Amgen could have argued that its “composition” claims qualified as “combination” claims and triggered Sec. 112(f), to avoid invalidity under Sec. 112(a) (or Sec. 112(b)) arising from its facially purely functional claims. Then it could have argued that the “acts” performed by Sanofi’s antibodies were equivalent to the “acts” performed by the patent’s disclosed antibodies. (The accused antibody structures were not equivalent.)

More claims failed last week for lack of full-scope enablement:

  • Medytox (Fed. Cir. 06/27/23) (aff’g PTAB that substitute claim’s element of “50% or greater” (construed as range of 50% to 100%) effect, lacked full-scope enablement, where Spec. disclosed “at most three examples of responder rates above 50% at 16 weeks: 52%, 61%, and 62%,” citing Amgen).

Narrow Construction of Open-Ended Claim Limitation to Save Claim from Non-Enablement

Patent owners sometimes can save a claim by narrowing its scope without resorting to Sec. 112(f).

  • Full-scope of open-ended claim limitation may be enabled “if there is an inherent, albeit not precisely known, upper limit and the specification enables one of skill in the art to approach that limit.” (Fed. Cir. 04/20/23) (aff’g ITC finding of enablement of limitations “a fiber optic connection density of at least ninety-eight (98) fiber optic connections per U space” and “…at least one hundred forty-four (144) …,” where upper limit established by evidence that as of priority date artisans would have understood densities substantially above 144 “were technologically infeasible” so claims were construed to not encompass densities exceeding that upper limit).

Alice: the Name of the Game is the Claim

Many Fed. Cir. decisions explain that an alleged technical improvement disclosed in the specification but absent from the claims cannot save the claim under Alice. The same is true of an alleged technical problem the patent supposedly solves:

  • (Fed. Cir. 04/07/23) (rejecting argument that claims’ data structure solved technical problem with some CRM systems because claims not limited to CRMs so “there is no evidence of a technological problem with the claimed systems of record”).

Patent Owner Hoist on Own Petard

Not infrequently the publication of an ancestor application in a patent family qualifies as prior art—because the later-drafted claims cannot be backdated to the ancestor’s filing date for lack of Sec. 112(a) support—and anticipates or otherwise contributes to invalidity of the claims over the prior art. See Another example this quarter:

  • Parus Holdings (Fed. Cir. 06/12/23) (aff’g PTAB finding that continuation patent claims obvious over references including published ancestor application, which ancestor application lacked sufficient written description for those claims).

Class on Inventorship

Two precedential decisions this quarter provide a comprehensive course on co-inventorship and correcting inventorship.

  • Blue Gentian (Fed. Cir. 06/09/23) (aff’g correction of inventorship to add co-inventor; in determining whether contribution significant, consider combination of elements contributed not each element individually; good summary of governing law).
  • “To qualify as joint inventor, a person must make a significant contribution to the invention as claimed [under three-part Pannu test:] (1) contributed in some significant manner to the conception of the invention; (2) made a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention; and (3) did more than merely explain to the real inventors well-known concepts and/or the current state of the art.” HIP (Fed. Cir. 05/02/23) (rev’g finding of joint inventorship, under second Pannu factor, as heating in infrared oven mentioned only once in Spec. and once in claims in a Markush group, as distinct from focus on microwave ovens).

Scope of Estoppel from Unsuccessful Patentability Challenge in IPR

The Fed. Cir. began to clarify the scope of estoppel in district court against an alleged infringer who has lost a PTAB IPR final written decision on claim unpatentability.

  • Sec. “315(e)(2) estops a petitioner as to invalidity grounds a skilled searcher conducting a diligent search reasonably could have been expected to discover, as these are grounds that the petitioner ‘reasonably could have raised’ in its petition.” Ironburg (Fed. Cir. 04/03/23) (remanding for district court to apply this standard; “The inquiry into what a skilled and diligent searcher would reasonably have discovered is ultimately concerned with what the searcher of ordinary skill would find through reasonable diligence and not what an actual researcher in fact did find through whatever level of diligence she exercised.”).

2023 Q1 Patent Defenses Update

Highlights and Strategies from Jan. – Mar. appellate decisions on substantive Patent Law.

Delisted from Orange Book: A System Claim is Not a Method Claim

  • “[M]ethod claims require the performance of steps; claims that describe physical components of a whole are system, or apparatus, claims.” Jazz Pharm. (Fed. Cir. 02/24/23) (affirming injunction requiring that patent be delisted from Orange Book; patent with only system claims is not patent on “method of using the drug” as that phrase is used in statute on listing of patents in the Orange Book, 21 U.S.C. § 355(b)(1)(A)(viii) of Hatch-Waxman Act).

Claim Encompassing Isolated Vitamin Ineligible Because Isolated Form Not Structurally or Functionally Different From Natural Form

  • Chromadex (Fed. Cir. 02/13/23) (affirming Summ. J. patent ineligibility under Chakrabarty, Myriad, and Natural Alternatives where only difference between natural milk and at least one claimed embodiment of dietary supplement containing nicotinamide riboside (“NR”) (a form of vitamin B3 naturally present in trace amounts in non-isolated form in natural milk) is that the claimed embodiment’s NR is isolated, because “the isolated NR is no different structurally or functionally from its natural counterpart in milk”).

Naked Functional Claims Alice’d

A naked functional claim element recites a function without reciting how it is performed, either directly or, as construed, under Section 112(f), and is easy target under Alice. See

  • Hawk Tech. (Fed. Cir. 02/17/23) (affirming R. 12(b)(6) dismissal of complaint under Alice; claims “are directed to a method of receiving, displaying, converting, storing, and transmitting digital video ‘using result-based functional language,’” including “receiving video images,” “digitizing any of the images not already in digital form,” “displaying one or more of the digitized images,” “converting one or more of the video source images into a selected video format,” “storing at least a subset of the converted images,” “providing a communications link,” “receiving . . . a request to receive one or more specific streams of the video images,” “transmitting . . . a version of one or more of the video images,” and “displaying only the one or more requested specific streams of the video images”).

Enablement at the Supreme Court—Predictions

Amgen v. Sanofi concerns functionally defined genus claims on antibodies.

Based on the March 27th Argument, the Court’s Opinion likely will: (1) affirm or remand for clarification of the Federal Circuit’s analysis, (2) be narrowly limited to enablement, without discussing written description, indefiniteness, functional claiming, or the statutory provision governing functional claim elements, 35 U.S.C. § 112(f), and (3) endorse with minor clarification existing Federal Circuit enablement principles, including: only reasonable enablement is required, i.e., only “undue” experimentation defeats enablement; a claim’s full scope must be enabled and a broader claim normally requires a broader disclosure; the Wands factors are relevant; and the time needed to identify and make non-disclosed species is relevant but not dispositive.

2022 Q4 Patent Defenses Update

Highlights and Strategies from Oct. – Dec. appellate decisions on substantive Patent Law.

Functional Claiming and Amgen: The slides for our January 12, 2023, CLE on functional claiming and the Amgen v. Sanofi case pending before the Supreme Court of the United States, are here.

Oyez! Oyez! Oyez! … Antibodies!

The Supreme Court’s only other Section 112 case was the Nautilus case, in 2014, concerning Section 112(b)’s mandate of particular and distinct claiming. Klarquist represented Nautilus in that case. Now the Supreme Court returns to Section 112 in the context of naked functional claims on antibodies, by which we mean the claims recite functions performed by the antibodies but not their structure.

  • Amgen (Sanofi) II (Fed. Cir. 02/11/21) (aff’g JMOL of no enablement of full scope of claims covering any isolated monoclonal antibody that binds to at least two identified amino acid residues on the naturally occurring protein PCSK9 and blocks PCSK9 from binding to LDL receptors in the liver, having millions of possible antibody embodiments, where Spec. disclosed roughly two dozen antibodies within the scope of the claims), granted (U.S. 11/04/22) (Question Presented: “Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ’make and use’ the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art ’to reach the full scope of claimed embodiments’ without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort.’””).

While Amgen, the patents’ owner, frames the case as concerning Section 112(a)’s full-scope enablement mandate, the lurking issues include functional claiming, Section 112(f), and whether Section 112(b) permits claims whose potentially millions of embodiments can be identified only via experimentation.

Amgen’s Dec. 27 Brief on the merits is here, arguing in part:

Under the Federal Circuit’s decision: “It is no longer sufficient that the patent enable skilled artisans to ‘make and use’ the invention. Instead, skilled artisans must be able to ‘reach the full scope of claimed embodiments’—i.e., to cumulatively identify and make all, or nearly all, possible variations of the invention—without ‘substantial time and effort.’”

The Patent Act nowhere imposes that standard. There may be myriad variations on James Watt’s steam engine or the Wright Brothers’ airplane. But the law has never required that, for those inventions to be patentable, skilled artisans must be able to cumulatively identify and make every variation without substantial time and effort.

An Amicus Brief (here) that Klarquist filed today for two high-tech trade associations urges caution:

This case is an exceptionally poor vehicle for disturbing existing law under Section 112 because (1) Petitioners have not challenged longstanding full-scope enablement law, (2) the Question Presented is based on a false premise that the claims have been construed to identify the “claimed embodiments,” (3) the claims are naked functional claims which plague the computer, electronics, telecommunications, and software fields much more so than life sciences, and (4) neither the Patent Office nor the lower courts have analyzed, or construed, these claims under this Court’s precedents banning naked functional claims, or the limited safe harbor of Section 112(f) enacted in response to those precedents. Moreover, no certiorari-stage brief mentioned Halliburton Oil, General Electric, or Section 112(f).

The Court therefore should either dismiss certiorari or expressly circumscribe its Opinion to apply solely to the claims and peculiar procedural posture before the Court. Any broader ruling risks serious harm to innovation across a broad range of industries and a vast swath of the American economy.

Respondent Sanofi’s brief is due February 3, with supporting amici briefs to follow Feb. 10. The case will be argued in March or April, and decided most likely in June.

We hope you join our discussion of the case on January 12.

Requirements For Showing Inducement Infringement By An ANDA

Proving inducement infringement requires showing direct infringement that the defendant induced with specific intent. Filing an Abbreviated New Drug Application (“ANDA”) on a patented product or method is an act of infringement for jurisdiction purposes. If the label proposed by the ANDA recommends the claimed method, that often supplies the evidence of the required specific intent. But is it always enough to show the direct-infringement element? No.

  • Genentech (Sandoz) (Fed. Cir. 12/22/22) (2-1) (aff’g no inducement infringement because no showing that direct infringement of the method claim would occur if the defendant’s drug were put on the market, despite proposed label recommending claimed methods, based on evidence of past conduct of physicians).

Alice and Data Structures

A mid-December precedential decision was a pleasant addition for patent owners to the relatively short line of decisions rejecting Alice challenges to computer-based patent claims. The issue, as it often is with such claims, was whether the focus of the claim was merely useful information (patent ineligible) or an improved computer or other improved technology (patent eligible). The claims here were directed to data structures, and approved as patent eligible in an opinion authored by Chief Judge Moore.

  • Not Directed To Abstract Idea Or Law of Nature: Adasa (Fed. Cir. 12/16/22) (aff’g Summ. J. that claims are not directed to an abstract idea, but “to a specific, hardware-based RFID serial number data structure designed to enable technological improvements to the commissioning process,” which “is not a mere mental process, but a hardware-based data structure focused on improvements to the technological process by which that data is encoded”).

Alice and Naked Functions

This quarter also added to the longer line of Federal Circuit decisions invalidating computer-related claims under Alice in part because the claims recite mere functions or results without a particular way (structures, materials, or acts) to perform the function or achieve the result.

  • IBM (Zillow) (Fed. Cir. 10/17/22) (aff’g R. 12(c) judgment and finding that Alice Step Two was not satisfied by adding “generic computer components” and “merely restat[ing] their individual functions—i.e., selecting, identifying, matching, re-matching, applying, determining, displaying, receiving, and rearranging—without describing how any of those functions are performed”).

Issue Preclusion: When Ripe? When Forfeited?

In patent litigation, often related matters are litigated in parallel. So, when does a decision in one proceeding trigger possible issue preclusion (aka “collateral estoppel”) and when does delay asserting such issue preclusion, forfeit it?

A judgment triggers issue preclusion when it becomes final in the tribunal issuing it, despite a right to appeal, but a party may wait to assert issue preclusion until the judgment is affirmed on appeal, without forfeiting it, sometimes. (It remains safest to assert issue preclusion as soon as it becomes available.)

  • Uniloc (Motorola) (Fed. Cir. 11/04/22) (aff’g plaintiff lacked standing based on district court findings in another action by plaintiff against a different defendant (Apple) with whom plaintiff settled and then dropped appeal; “collateral estoppel can be applied based on a district court decision that is still pending on appeal, and we have affirmed the application of issue preclusion even when the preclusive judgment was pending appeal.” But, issue preclusion defense not forfeited by waiting to assert it until earlier ruling is no longer subject to appeal).
  • Google (Hammond) (Fed. Cir. 12/08/22) (finding Google did not forfeit a collateral estoppel argument based on a PTAB FWD about another patent that issued about two months before the FWD on the patent on appeal, even though it did not raise the argument until the appeal).

2022 Q3 Patent Defenses Update

Highlights and Strategies from July – Sept. appellate decisions on substantive Patent Law.

Supreme Court Report

S. Solicitor General Urges Denial of Cert. in Amgen Full-Scope Enablement Case

The S. Ct. has decided only one case under Sec. 112 of the 1952 Patent Act: its Nautilus Sec. 112(b) decision changing the test for patent claim “indefiniteness.” Last week, the Solicitor General urged the Court to deny certiorari on Amgen’s petition challenging the Federal Circuit’s law that a disclosure must enable the full-scope of a claim. U.S. Amicus (09/21/2022) (“where a patentee purports to invent an entire genus, it must enable the entire genus”; “disclosing how to produce some antibodies that perform a specified function is not equivalent to disclosing how to produce all such antibodies—and it is the latter that petitioners claim as their invention”). See

Chief Justice Stays Mandate in Novartis “Negative Limitation” Written Description Case

On Sept. 29, Chief Justice Roberts granted Novartis’s emergency application for a stay of the mandate in Novartis (Fed. Cir. 06/21/22) (2-1) (J. Hughes replaced J. O’Malley on rehearing) (rev’g D. Ct. finding that negative limitation (without immediately preceding loading dose) was disclosed; “The question is not whether the patentee intended there to be a loading dose; the question is whether the patentee precluded the use of a loading dose.” Probabilities are insufficient.), vacating Novartis (Fed. Cir. 01/03/22) (2-1) (aff’g priority app. supported negative limitation).

Assignor Estoppel on Remand From S. Ct.

Fed. Cir. has applied the S. Ct.’s revised rules for evaluating assignor estoppel. Hologic II (Fed. Cir. 08/11/22) (assignor estoppel bars inventor’s later employer (and alleged infringer) with which he is in privity, from challenging validity of issued claim. Asserted issued claim not “materially broader” than broadest claim that was assigned by inventor’s company when it was acquired, i.e., claim that was cancelled two years earlier “without prejudice” in response to a restriction requirement and thus “traveled with” the application and its assignment to Hologic.)


Stop Short-Changing the Central Character in any Pretrial Patent Invalidity Movie

The central character doesn’t bill by the hour, get cross examined, or sit behind a bench. The central character to invalidity challenges under section 102, 103 and 112 of the Patent Act, pretrial, is the ordinarily skilled artisan, the POSITA. But too often patent litigants put too little thought into defining the POSITA. A patent owner recently saved its patent in the PTAB by not making this mistake.

Where Claim Requires Capability, Need to Show Accused Device Without Alteration Reasonably Capable of Such Use

Many patent claims recite a device having a capability. Unlike method claims, a product can infringe a device claim without the product being used. So, what does a patent owner asserting infringement have to show to satisfy the “capability” limitation in the patent claim? Reasonable capability without alteration of the device. A Federal Circuit panel discussed this a month ago for a software-related capability.

  • INVT (Fed. Cir. 08/31/22) (aff’g ITC non-infringement finding: “In contexts involving software functionality, we have never suggested that reasonable capability can be established without any evidence or undisputed knowledge of an instance that the accused product performs the claimed function when placed in operation…. Because we require claim limitations to have some teeth and meaning, proof of reasonable capability of performing claimed functions requires, at least as a general matter, proof that an accused product—when put into operation—in fact executes all of the claimed functions at least some of the time or at least once in the claim-required environment.”). See

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