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 https://klarquist.com/patent-defenses/enablement-sec-1121a/#b-enable-full-scope-of-claim.
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.
- Best Medical (Fed. Cir. 08/29/22) (aff’g PTAB non-obviousness finding and finding that POSITA must have “formal computer programming experience,” and discounting of challenger’s expert who lacked that experience, where alleged invention implemented on a computer and named inventors had that experience.). See https://klarquist.com/patent-defenses/person-having-ordinary-skill-in-the-art-phosita/
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 https://klarquist.com/patent-defenses/271a-direct-infringement-of-non-method-claim/
2022 Q2 Patent Defenses Update
Highlights and Strategies from Apr. – June Fed. Cir. Decisions on Substantive Patent Law.
This quarter’s most interesting decisions concerned Sec. 112. The Fed. Cir. continued its robust enforcement of Sec. 112(a)’s written description mandate, made questionable decisions uncharacteristically narrowing the scope of Sec. 112(f), and continued its generally weak enforcement of Sec. 112(b)’s mandate for particular and distinct claims.
The most interesting non-decision was the Supreme Court denying certiorari in the Sec. 101 patent eligibility case, American Axle, on June 30, despite the Solicitor General urging that the Court revisit and revise Alice.
Generic Claim Element Loses Entitlement to Ancestor Application’s Filing Date
To be entitled to an ancestor application’s filing date, a claim must, of course, encompass something described in that application. But, under Sec. 112(a), it also must not claim beyond the scope of that ancestor’s disclosure, such as claiming a genus where the ancestor criticized a species within the genus.
- Arthrex (Fed. Cir. 05/27/22) (aff’g PTAB finding that claims not entitled to priority date of ancestor’s filing date where generic claim element encompassed both flexible and rigid eyelets but ancestor application criticized flexible eyelet design described in incorporated parent application and instead touted rigid eyelet as solving problems associated with flexible eyelets).
A Negative Limitation Must Be Disclosed Expressly, Such as a Reason to Exclude That Element, or Inherently
Having a Fed. Cir. panel reverse itself on rehearing is exceedingly rare … unless one of the two Judges in the split decision against you, retires. After J. Hughes replaced retiring J. O’Malley, a Fed. Cir. panel reversed itself on rehearing and held claims invalid under Sec. 112(a) for lack of written description support, with a lengthy discussion of what’s required to support a negative claim limitation.
- Novartis (Fed. Cir. 06/21/22) (2-1) (rev’g D. Ct. finding that negative limitation was disclosed; where claim recited “administering fingolimod ‘at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen’”: “The question is not whether the patentee intended there to be a loading dose; the question is whether the patentee [in the specification] precluded the use of a loading dose.” Probabilities are insufficient.), vacating Novartis (Fed. Cir. 01/03/22) (2-1).
“Code” Configured to Perform Function Does Not Trigger Sec. 112(6/f) Where Conventional Code Available to Perform the Function
The Federal Circuit generally has strictly applied Williamson, with 13 post-Williamson opinions finding claim terms not using “means,” triggering Section 112(6/f). But in a precedential opinion on a claim reciting “code” “configured to” perform specific functions, it seems to ask the wrong question, namely did skilled artisans know of existing code for performing the function. The correct question is whether the claim recites particular structures, materials or acts for performing the function so that the claim does not encompass all possible ways of performing the function. 23 IP Professors have filed an Amici brief supporting a petition for rehearing en banc.
- Dyfan (Fed. Cir. 03/24/22) (rev’g indefiniteness; the claim limitations (“system comprising … code, when executed, further configured to …,” “application [configured to …],” and “system [configured to …]”) do not trigger 112(6/f) where challenger’s expert testified that skilled artisans would have understood that “conventional” “off-the-shelf” applications and code were available to perform the functions), petition for rehearing en banc (05/02/22) (treating “code” as structure is contrary to Williamson). See IP Professors’ Amici in support of rehearing (05/16/22) (“If software patentees can avoid Williamson and write purely functional claims merely by using the word ‘code’ in place of actual structure, this Court will have rendered Williamson a dead letter.”).
Fed. Cir. Continues Mixed Enforcement of Mandate That Claims Have Clear Boundaries
In two decisions finding claims not indefinite, the Court was satisfied that the specification disclosed examples inside the claims’ scope without analyzing, expressly at least, whether the skilled artisan could reasonably identify a clear boundary between what’s outside the claim vs. inside the claim.
- Clearone (Fed. Cir. 06/01/22) (aff’g PTAB that substitute claim’s “microphones arranged in a self-similar configuration” is not indefinite where Spec. provides examples showing “that self-similar configuration refers to repeating or fractal-like configurations, such as concentric rings, ovals, or other shapes”).
- Niazi (Fed. Cir. 04/11/22) (where claim recited a double catheter comprising an outer “resilient catheter having shape memory” and inner “pliable catheter,” rev’g Markman order finding “resilient” and “pliable” indefinite; claims (including dependent claims identifying materials from which catheter can be made), Spec. (which, e.g., “provides an exemplary material that can be used to make a pliable inner catheter, explaining that the inner catheter is more flexible than the outer”) and dictionary definitions provided sufficient description and boundaries for the terms, e.g., skilled artisan would know “of exemplary materials that can be used to make a resilient outer catheter, i.e., one that has shape memory and stiffness such that it can return to its original shape”).
Indirect Infringement Damages Limited to Extent of Direct Infringement
A reasonable royalty must account for non-infringing uses of sold devices. Niazi (Fed. Cir. 04/11/22) (aff’g exclusion of expert opinion because he failed “to limit damages to a reasonable approximation of actual infringing uses of the claimed method.” “Damages should be apportioned to separate out noninfringing uses, and patentees cannot recover damages based on sales of products with the mere capability to practice the claimed method.”).
2022 Q1 Patent Defenses Update
Highlights and Strategies from Jan. – Mar. Fed. Cir. Decisions on Substantive Patent Law.
Another Application of Williamson
We now have 13 examples of claim language not using the word “means” but nevertheless invoking Sec. 112(6/f) in Federal Circuit opinions. See https://klarquist.com/patent-defenses/1126f-claim-language/#a-whether-sec-1126f-treatment-invoked
- Kyocera (Fed. Cir. 01/21/22) (rev’g ITC construction and remanding for determination of corresponding structure; “a lifter member which exhibits a contact surface that, at predetermined locations along said contact surface, makes contact with said plurality of spaced-apart protrusions of said driver member such that, when said lifter member is moved in a first direction, it causes a return stroke of an operating cycle and moves said driver member from a driven position toward a ready position, and when said lifter member is moved to a holding position, it temporarily holds said driver member at said ready position by use of a holding contact between said lifter member and said driver member” invokes 112(6/f) because (1) “lifter member” is “a non-structural generic placeholder (member) modified by functional language (lifter),” (2) “the only thing a skilled artisan could glean from the claim language is that the lifter member is moved by the prime mover and lifts the driver member. That is a purely functional description,” (3) the term has no plain meaning in the art, and (4) while Spec. gives examples of “lifter member” it does not give “a clear and unambiguous definition” thereof).
Information Now is “Structure”?
35 U.S.C. § 112(f) provides “An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof.” While “structure, material, or acts” is broad it presumably does not encompass mere information. Per USPTO Legal Training Module guidance (08/02/13): “Terms that represent only non-structural elements such as information, data, instructions, and software per se would not serve as substitutes for ‘means’, because the terms do not serve as placeholders for structure or material.”
But a week ago, the Federal Circuit issued a precedential decision on application of Section 112(f) to claim elements recited as program code configured to be executed by a processor. The decision is questionable in several respects including equating information with structure.
- “In determining whether software limitations … recite sufficient structure, we can look beyond the initial ‘code’ or ‘application’ term to the functional language to see if a person of ordinary skill would have understood the claim limitation as a whole to connote sufficiently definite structure.” Dyfan (Fed. Cir. 03/24/22) (rev’g indefiniteness; the limitations (“system comprising … code, when executed, further configured to … cause to be output, via the at least one mobile device, the second visual information based on the second location-relevant information.…,” and “application [configured to ….]”) recite sufficient structure where challenger’s own expert testified that skilled artisans would have understood that “code” is “a bunch of software instructions” and “conventional” “off-the-shelf” applications and code were available to display whatever information the developer chooses, which “demonstrates that the ‘code’/’application’ limitations here connote a class of structures to a person of ordinary skill”).
Two En Banc Rehearing Denials Divide Fed. Cir.: Skinny Label and Disclosure Support for End Point of a Range
- Last year, GlaxoSmithKline (Fed. Cir. 02/23/21) (2-1) reversed a JMOL of non-infringement where FDA’s “skinny label” approval of the generic drug required it to include infringing use, and generic marketed its drug as comparable to brand name drug that doctors already knew had that infringing use. In February, the Court, seven to three, denied en banc rehearing, with a 6-Judge Concurring opinion noting that the dissent’s fairness concerns tracked elements of equitable estoppel. Rehearing en banc denied (Fed. Cir. 02/11/22) (7-3) (6-Judge Concurring Op.).
- Last November, Biogen (Fed. Cir. 11/30/21) (2-1) affirmed written-description invalidity of a claim reciting a particular dosage even though the Spec. had disclosed that dosage as the end point of range of dosages. In March, the Court, six to three, denied en banc rehearing, with a dissent from Judge Lourie outlining asserted errors in the analysis. Rehearing en banc denied (Fed. Cir. 03/16/22) (6–3) (Lourie, J., dissenting) (error to (1) compare amount of disclosure of the claimed species versus the unclaimed subject matter, (2) put burden on patentee to prove efficacy, (3) import considerations of operability, best mode and inventorship, (4) improperly use extrinsic evidence beyond understanding what disclosure would have disclosed to skilled artisan).
Fed. Cir. Divided on Whether Alleged Priority Application, or Issued Application, is Subject of Written Description Invalidity Analysis
Sometimes the Federal Circuit perpetuates two lines of conflicting precedents without acknowledging the divide. That’s the case on this basic question: if claims are unsupported by the application the patent owner asserts for the claim’s effective filing date, does that invalidate the claims under section 112(a)? At least four times in the past 11 years, the Court has assumed Yes. And at least four times, it has assumed No, the latest in January. So, when asserting invalidity under Sec. 112(a), it’s best to challenge both the “priority” application and the issued application.
- “Both parties wrongly assume that, if the 2006 priority application lacks sufficient written description of the ’405 patent’s claims, those claims are invalid. If the 2006 priority application lacks sufficient written description for the ’405 patent’s claims, the ’405 patent’s claims are not automatically rendered invalid; they are merely deprived of the 2006 priority date.” Novartis (Fed. Cir. 01/03/22) (2-1).
Obviousness: Carefully Compare Skilled Artisan’s Field of Endeavor to Reference’s Field
As plaintiff or defendant, it’s tempting to focus only on comparing the claims at issue to the most relevant excerpts from the prior art reference. But remember to also compare the respective fields of endeavor. Even an exact-match disclosure may not help the patent’s challenger if the skilled artisan would not have considered the reference in the first place.
- Broadcom (Fed. Cir. 03/08/22) (aff’g PTAB non-obviousness; “a skilled artisan’s field of endeavor is ‘power management and processor clock control’ …. [E]ven if Van Hook did disclose this limitation, Van Hook relates to processor performance, not power management and processor clock control, so a skilled artisan would not have been motivated to combine Van Hook and Kiuchi.”).
Oops!: Our Expert is Less Than Ordinary
- The Federal Circuit excluded all infringement testimony of the patent owner’s expert witness, in an ITC proceeding, because he lacked the design experience the parties accepted as part of the definition of a person having ordinary skill in the art. Kyocera (Fed. Cir. 01/21/22).