By Michael Borella –

More than a decade after Alice Corp. v. CLS Bank Int’l, the two-step framework for patent eligibility under 35 U.S.C. § 101 remains as contentious as ever.  Courts, commentators, and the U.S. Patent and Trademark Office have all acknowledged the difficulty of applying a test that turns on undefined terms such as “abstract idea,” “directed to,” and “significantly more.”  But within this legal wreckage, a specific and recurring failure mode deserves closer attention than it has received.  Particularly, how a challenger can readily neutralize a patentee’s otherwise strong eligibility argument for a software invention (i.e., a claimed technical improvement described as such in the specification) by asserting in a conclusory fashion that the improvement is to an abstract idea recited by the claim.

The sleight of hand works like this.  The patentee points to Enfish, LLC v. Microsoft Corp. and its progeny, argues that the claims are directed to an improvement in computer functionality, and sets forth the specification’s disclosure of the technical problem and its solution.  The challenger, rather than disputing that the claims recite an improvement at all, responds that whatever improvement exists is merely an improvement an underlying abstract idea.  Invoking SAP America, Inc. v. InvestPic, LLC and BSG Tech LLC v. BuySeasons, Inc., for example, the challenger merely states that an advance an abstract idea cannot confer eligibility no matter how innovative the claimed invention.  With that single unreasoned characterization, the patentee’s entire pro-eligibility argument often evaporates.

In many cases, notably those involving software inventions that reduce computational resource usage, this characterization is analytically improper.  A claimed invention that reduces processor cycles, memory consumption, bandwidth, or latency is directed to a change in the physical operation of a machine.  Calling that change an improvement to an abstract idea does not make it one.  Yet the current § 101 framework allows the assertion to succeed with remarkably little scrutiny, both in the courts and at the USPTO.

The Federal Circuit has repeatedly held that improvements to computer functionality are not abstract.  In Enfish, the Federal Circuit found claims to a self-referential database table eligible because they were “directed to a specific improvement to the way computers operate.”  The Court cautioned against describing claims at “a high level of abstraction and untethered from the language of the claims,” warning that doing so would render the “directed to” inquiry meaningless because “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.”

McRO, Inc. v. Bandai Namco Games America Inc. extended this reasoning to claimed rules that improved an existing technological process for animating lip synchronization.  Finjan, Inc. v. Blue Coat Systems, Inc. and Ancora Technologies, Inc. v. HTC America, Inc. found improvements to computer security eligible, with Ancora emphasizing the specific placement of a verification structure in a memory location not previously used for that purpose.  Core Wireless Licensing S.A.R.L. v. LG Electronics, Inc. and Data Engine Technologies LLC v. Google LLC held that improved user interfaces can constitute technical improvements.  And in Koninklijke KPN N.V. v. Gemalto M2M GmbH, the Federal Circuit found claims to an improved error-checking technique eligible because they recited a specific implementation that improved the functionality of the error detection process itself.

More recent decisions have characterized the pro-eligibility argument as having two parts – the improvement must be described in the specification, and the claims must reflect it.  In Contour IP Holding, LLC v. GoPro, Inc., the Court reversed a summary judgment of ineligibility where the claims recited a point-of-view camera generating high- and low-quality video streams in parallel, with the lower-quality stream enabling real-time wireless preview on a remote device.  The specification described the technological problem of streaming video from a resource-constrained camera, and the claims recited the specific means of solving it; that combination placed the claims on the Enfish side of the line.  Conversely, in Recentive Analytics, Inc. v. Fox Corp., the Court held claims applying generic machine learning to television scheduling ineligible precisely because neither the claims nor the specification explained how any improvement to the underlying technology was accomplished.  And in U.S. Patent No. 7,679,637 LLC v. Google LLC, No. 24-1520 (Fed. Cir. Jan. 22, 2026), the Court stated that while the eligibility inquiry focuses on the claims, “the claim itself need not explicitly recite the improvement,” and endorsed looking to the written description to understand the problem addressed and whether a technological improvement is embodied in the claims.  Taken together, these decisions confirm that the specification’s technical disclosure is not window dressing, but rather evidence the challenger or tribunal is expected to consult.

The USPTO codified this line of authority in the 2019 Revised Patent Subject Matter Eligibility Guidance, now reflected in M.P.E.P. § 2106.04(d).  Under Step 2A, Prong Two, a claim that integrates a judicial exception into a practical application is not directed to that exception.  The first and most prominent example of such integration is “an improvement in the functioning of a computer, or an improvement to other technology or technical field.”  M.P.E.P. § 2106.04(d)(1) and § 2106.05(a) instruct examiners to evaluate the specification to determine whether it describes a technical problem and explains how the claimed invention solves it.  An August 2025 memorandum to the examining corps reinforced the point, reminding examiners that the claim need not explicitly recite the improvement described in the specification and directing them to consult the specification and confirm that the claim reflects the disclosed improvement.

On paper, then, one with a genuine technical improvement described in the specification and represented in the claim should be well positioned.  In practice, the picture is far murkier.

The countervailing argument used by challengers traces back to two 2018 decisions.  In SAP America, the court held claims to improved statistical analysis of investment data ineligible, stating that even assuming the techniques were “groundbreaking,” a pioneering abstract idea is not enough.  In BSG Tech, the Court held that “a claimed invention’s use of the ineligible concept to which it is directed cannot supply the inventive concept,” and that an alleged advance that lies entirely in the realm of abstract ideas cannot confer eligibility.

Both holdings are defensible on their facts.  The claims in SAP America were directed to mathematical analysis of financial information with the results displayed, and the claims in BSG Tech recited a method of indexing information in a database using conventional structures.  Neither specification credibly described an improvement to the operation of a computer.

The problem is what happened next.  These cases handed challengers and examiners a template that can be deployed against any software claim, regardless of what the specification actually discloses.  In district court briefing, the pattern is now routine.  The defendant frames the abstract idea broadly, characterizes every claimed benefit as flowing from that idea, and cites SAP America and BSG Tech for the proposition that such benefits are irrelevant.  At the USPTO, the corresponding move appears in countless Office actions as a single conclusory sentence, something to the effect of “the alleged improvement is an improvement to the abstract idea itself, not to the functioning of a computer or to another technology.”

Note the asymmetry.  To establish a technical improvement, the patentee must engage with the claim language, the specification, and often expert testimony explaining the state of the art and the nature of the advance.  To defeat that showing, the challenger needs only a characterization.  No claim construction, no engagement with the written description, no explanation of why a reduction in memory usage or processing time is not a change in how the machine operates.  The characterization (often a mischaracterization) does all the work, and decision makers too frequently accept it at face value.

A pronounced flaw in the “improvement to the abstract idea” argument is its circularity, and this flaw is most visible in cases involving computational resource efficiency.  Consider a claim to a data structure, encoding scheme, or scheduling technique that measurably reduces processor load, memory footprint, or network bandwidth.  These are physical, measurable phenomena.  A processor that executes fewer instructions consumes less power and completes tasks sooner.  A memory system that stores a compressed representation of data uses less silicon.  Reducing network utilization increases throughput and reduces delay for all communications carried by that network.

These effects occur in a machine, not in the mind of a mathematician.  The Federal Circuit recognized as much in Enfish, where the claimed self-referential table achieved “increased flexibility, faster search times, and smaller memory requirements,” and in Uniloc USA, Inc. v. LG Electronics USA, Inc., where a reduction in communication latency was held to be a patent-eligible improvement to computer functionality.  Similarly, in Cellspin Soft, Inc. v. Fitbit, Inc., allegations that the claimed arrangement reduced the hardware and power requirements of the capturing device were credited.

Now observe how the challenger’s argument operates against such a claim.  First, the challenger defines the abstract idea at a level of generality high enough to encompass the improvement.  If the claim reduces memory usage through a novel indexing arrangement, the abstract idea becomes “organizing and storing data.”  If the claim reduces bandwidth through a selective transmission protocol, the abstract idea becomes “sending only necessary information.”  Second, having drawn the abstract idea to swallow the technical contribution, the challenger points out that the claimed benefit flows from that contribution, and therefore from the abstract idea.  Third, the challenger concludes that under BSG Tech or similar authority that the improvement “lies entirely in the realm of abstract ideas.”

This reasoning is entirely circular.  The conclusion that the improvement is abstract depends on the premise that the abstract idea includes the improvement, and that premise was constructed by the challenger for exactly that purpose.  Any invention can be dissolved this way.  The claims in Diamond v. Diehr improve upon “the abstract idea of curing rubber at the right time.”  The claims in McRO improve upon “the abstract idea of matching mouth shapes to sounds.”  The claims in Ancora improve upon “the abstract idea of verifying a license.”  The Federal Circuit warned against precisely this maneuver in Enfish and again in Thales Visionix Inc. v. United States, yet the “improvement to the abstract idea” formulation invites decision makers to commit the error while appearing to apply binding precedent.

The tell, in resource-efficiency cases, is that the claimed benefit is verifiable on hardware.  One can run the prior art technique and the claimed technique on the same machine and measure the difference in cycles, watts, bytes, or time.  Where a computer merely executes an unchanged process faster than a human could, as in Bancorp Services, L.L.C. v. Sun Life Assurance Co. of Canada, the improvement is attributable to the computer, not the invention.  In these situations, eligibility is properly denied so long as the process was not reasonably performable by a human in the first place.[1]  When the specification describes, and the claims capture, a change to the physical behavior of a computing system that results in a technical improvement, the SAP America line of cases simply does not fit.  That the improvement can be described in abstract terms proves nothing, because as Enfish reminds us, every invention relies on underlying judicial exceptions.

If the circularity problem is troubling in litigation, where the patentee at least has briefings and oral arguments to expose it, it is worse in prosecution.  Examiners operating under time constraints frequently dispose of an applicant’s eligibility arguments with the conclusory sentence described above, without addressing the specification’s description of the technical problem or explaining why the asserted benefit is not technical.  This practice sits uneasily with M.P.E.P. § 2106.04(d)(1), which directs the examiner to evaluate whether the specification sets forth an improvement and whether the claim reflects it.  A bare assertion that the improvement is to the abstract idea evaluates nothing.

PTAB review of such rejections has been inconsistent, with some panels demanding that examiners engage with the disclosed improvement and others affirming on the same conclusory rationale.  The practical consequence is perverse.  Applicants can respond by overloading claims with hardware recitations and implementation minutiae that add nothing inventive but make the claims look less abstract.  Claim quality degrades, prosecution costs rise, and the resulting patents protect the invention less faithfully than the original claims would have.

Three corrective principles would go a long way.  First, the party asserting that an improvement encompasses the abstract idea should bear the burden of engaging with the specification and articulating, with specificity, why the asserted benefit is not a technical one.  A characterization unsupported by analysis should carry no weight.

Second, measurable reductions in computational resource usage should be treated as presumptively technical.  This is not a radical proposition, as it follows directly from Enfish, Uniloc, KPN, and Cellspin.  A challenger remains free to show that the claims fail to capture the improvement or that the specification’s assertions are implausible, but the physical nature of the benefit should not be in serious dispute.

Third, decision-makers should heed Diehr‘s instruction to consider the claim as a whole, rather than first filtering out the allegedly abstract components and then asking what remains to be improved.  The filtering approach guarantees the circular result, because the improvement is always found among the components that were filtered out.

The Alice framework has always tolerated a certain amount of rhetorical gamesmanship, but the “improvement to the abstract idea” gambit is a particularly corrosive example.  It targets the one doctrine, the Enfish technical-improvement line, that gives software patentees a principled path to eligibility. Until courts and the USPTO require those who invoke SAP America, BSG Tech, and the like to actually demonstrate that a claimed improvement is abstract, rather than merely to assert it, inventors of genuinely technical advances, including those that make computers demonstrably faster, smaller, and more efficient, will remain exposed to a one-sentence dismissal of their strongest argument.

Thus, the irony is complete.  A doctrine allegedly created to weed out patents that claim inventions too abstractly is now enforced through arguments that reason too abstractly.

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[1] Put another way, a resource-intensive task like training a large language model is not something that a human ever has performed or even could perform.  Therefore, it is deeply reliant on the computing hardware on which it executes, without which there would be no model.  Alternatively, a computer performing an unchanged human process is almost certainly to fail as obvious under § 103, so why bother using the vague and problematic analysis of § 101 for this purpose?

By Kevin E. Noonan –

The Federal Circuit affirmed a District Court determination that method claims reciting administration of a modification of an established antibiotic by adding magnesium to the composition were infringed and not invalid in Melinta Therapeutics, LLC v. Nexus Pharmaceuticals, Inc.

The case arose as ANDA litigation over Nexus Pharma’s generic version of Melinta’s antibiotic formulations comprising magnesium cations used in a claimed method for treating bacterial infections that reduced hemolysis of red blood cells at the injection site, compared with such methods using antibiotics without the addition of magnesium, as claimed in U.S. Patent Nos. 9,084,802 and 9,278,105.  Claim 1 of the ‘805 patent and claim 1 of the ‘105 patent are reproduced in the opinion as being representative:

The ‘802 patent:

1.  A method of treating a bacterial infection in a subject, wherein the method consists of:

administering a therapeutically effective amount of a composition to a subject in need thereof via an intravenous route of administration,

wherein the composition consists of an aqueous solution consisting of minocycline or a salt thereof, a salt that comprises a magnesium cation, and a base,

wherein the molar ratio of magnesium cation to minocycline is greater than about 4:1, and

wherein the composition has a pH that is no less than 4 and no greater than 6,

whereby injection site hemolysis of red blood cells is reduced relative to intravenous administration of a composition that does not include magnesium.

The ‘105 patent:

1.  A method of treating a bacterial infection in a subject, wherein the method comprises administering a therapeutically effective amount of a composition to a subject in need thereof via an intravenous route of administration, wherein the composition comprises an aqueous solution of a 7-dimethylamino-tetracycline antibiotic and a magnesium cation, wherein the molar ratio of magnesium cation to 7-dimethylamino-tetracycline antibiotic is greater than 3:1 and wherein the solution does not comprise a pharmaceutically acceptable oil, has a pH greater than 4 and less than 7, and has an osmolality less than about 500 mOsmol/kg.

Melinta’s product, Minocin, is an aqueous solution of minocycline and magnesium and, as the opinion notes, had been marketed since 1972 but had been reformulated to include magnesium, as well as having an increase pH and a reduced six of the administered dose.

The District Court found that Nexus Pharma’s generic formulation would infringe the patented method claims of the ‘802 and ‘105 patents and issued a permanent injunction.  The District Court also held that Nexus had failed to establish invalidity of the claims on “obviousness, indefiniteness, inadequate description, or lack of enablement” grounds.  This appeal followed.

The Federal Circuit affirmed with regard to the asserted claims of the ‘802 patent and did not reach the issues raised for the ‘105 patent, in an opinion by Judge Bryson, joined by Judges Prost and Reyna.  With regard to the District Court’s findings concerning the ‘802 patent Nexus raised two arguments on appeal.  First, Nexus argued that the District Court erred in construction of the terms “composition” and “administering.”  Regarding the “composition” term, District Court construed the term to mean (as recited in the claim) the combination of minocycline, magnesium, and a base prior to the addition of the diluent needed to produce the formulation (the “admixture” as recited in the claim) actually administered to a patient in need thereof.  The construction of the term “administering” by the District Court referred to the diluted composition given to the patient.

Nexus argued that the phrase as a whole in the claim (“administering . . . a composition”) required the administered composition not to include a diluent, because claim 1 recites that the composition “consists of” the three listed named ingredients and did not include a diluent (“wherein the composition consists of an aqueous solution consisting of minocycline or a salt thereof, a salt that comprises a magnesium cation, and a base”).  Because Nexus Pharma’s composition does contain a diluent administration thereof is not infringing according to their argument.  Melinta argued that the term “composition” should be construed to the “”concentrated, reconstituted solution prior to further dilution” and that what was administered was the composition after the diluent was added.

The District Court construed these terms consistent with Melinta’s argument and the Federal Circuit affirmed based on the intrinsic and extrinsic evidence.  This included a description in the specification that the three-component composition was diluted prior to administration; the testimony of three expert witnesses to the same effect; and the prescribing information that instructs reconstitution and further dilution.  Nexus Pharma’s proposed construction was inconsistent with this evidence, according to the opinion, and a person having ordinary skill in the art would know adding a diluent to the composition was necessary.  The panel affirmed the District Court’s finding that Nexus Pharma’s generic, diluent- and magnesium-containing antibiotic composition would infringe.

The second basis for Nexus Pharma’s challenge to the District Court’s decision was that the specification did not satisfy the disclosure requirements under 35 U.S.C. § 112(a) because the relevant claim limitation (“injection site hemolysis of red blood cells is reduced relative to intravenous administration of a composition that does not include magnesium”) did not make clear that the comparison would be made against compositions that contained no divalent cations or ones containing a different divalent cation (such as calcium, for example).  Nexus contended that to be consistent with satisfaction of the written description requirement the comparison must be between compositions having magnesium and that do not.  The inventors failed to show that they had possession of reduced hemolysis when the comparison was made with compositions having calcium cations.

Melinta first argued that Nexus had waived this argument because it had appeared in only a single sentence of Nexus Pharma’s post-trial brief (which the Court rejected based on, inter alia, expert trial testimony by the parties on this issue).  Melinta also argued that the correct comparison would be between compositions with magnesium and those without.  Regarding this argument the Federal Circuit held that the District Court did not err and considered it to be the most natural comparison” between the same composition with and without magnesium (wherein the latter was Melinta’s prior formulation).  The specification sets forth comparisons between formulations having divalent cations (including those with magnesium or calcium) and those without (i.e., lacking any metal cations).  However, “[n]othing in the specification is directed to comparing the effect of magnesium with that of calcium [but r]ather, the focus of the specification is the reduction of hemolysis resulting from the inclusion of magnesium or calcium, as compared to prior art formulations, which did not include metal cations at all.”

The panel conceded that the District Court’s construction “does not expressly exclude a formulation that lacks magnesium but includes a different cation, such as calcium, in place of the absent magnesium.”  Nevertheless, the panel opined that the construction argued by Nexus Pharma “would be contrary to the overwhelming evidence that the invention of the ‘802 patent was directed to the advantage of adding magnesium to a minocycline formulation lacking divalent cations, and not to any advantage magnesium might have compared to other metal cations.”  It did not escape the panel’s notice that the prior art Minocin product included a warning against administering formulation including a calcium-containing diluent which may form a precipitate.

 Having affirmed the District Court’s decisions on infringement and non-invalidity, the opinion explains that the parties had stipulated that the district court’s infringement finding would be upheld if either the ‘802 or ‘105 patents were found not invalid and thus the Court did not address validity of the ‘105 patent.

The outcome in this case is somewhat in contrast to that in Enanta Pharmaceuticals inc. v. Pfizer Inc.  In that case, the patentee lost priority to its earliest-filed provisional application (U.S. Patent Application No. 63/054,048) for reciting alternatives for a substituent as being “NHC(O)—C₂-C₁₂-alkyl” whereas U.S. Patent No. 11,358,953 at issue before the Court recited “NHC(O)—C₁-C₁₂-alkyl.”  The District Court’s decision was affirmed by the Federal Circuit, but it is just as easy to see that the decision could also have readily rested on a finding that the lack of disclosure in the ‘048 provisional precluded Enanta from a finding that Pfizer infringed by including a species (nirmatrelvir) in its product Paxlovid^Ò) that had a C₁ substituent (-CH₃), and permitting Enanta to retain the scope of the C₂-C₈ alkyl species disclosed in the provisional application to which they were arguably entitled.  Here the District Court and the Federal Circuit somewhat overlooked Nexus Pharma’s distinction that although the specification disclosed the need to add a diluent to the magnesium-containing composition prior to administration that wasn’t what was recited in the asserted claims of either patent-in-suit.  Maybe that is because the asserted claims were method claims and the “invention” was inclusion of magnesium to a well-known antibiotic that reduced an important drawback, injection site hemolysis of red blood cells, rather than the composition of matter claims in Enanta. But it seems prudent to recognize the distinctions.

Melinta Therapeutics, LLC v. Nexus Pharmaceuticals, Inc. (Fed. Cir. 2026)
Nonprecedential disposition
Panel:  Circuit Judges Prost, Bryson, and Reyna
Opinion by Circuit Judge Bryson

By Michael Borella –

By Donald Zuhn –

The U.S. Patent and Trademark Office has published a final rule in the Federal Register (an unpublished version of the notice, which will be published on June 24, can be found here), in which the Office states that it is “revising its practice of requiring additional information for delays in taking certain actions in patent applications and patents from requiring additional information for delays exceeding two years to requiring additional information for delays exceeding one year.” 

The notice indicates that in a prior Federal Register notice published a little more than six years ago, the Office had clarified its practice with respect to situations requiring additional information about whether a delay in seeking the revival of an abandoned application, acceptance of a delayed maintenance fee payment, or acceptance of a delayed priority or benefit claim was unintentional (see “USPTO Issues Clarification Regarding Petitions Based on Unintentional Delay“).  In particular, the prior notice indicated that the Office would require additional information when a petition to revive an abandoned application was filed more than two years after the date the application became abandoned, or when a petition to accept a delayed maintenance fee payment was filed more than two years after the date the patent expired for nonpayment, or when a petition to accept a delayed priority or benefit claim was filed more than two years after the date the priority or benefit claim was due.

In the final rule published today, the Office notes that it “has decided to shorten the two-year period for requiring additional information to one year,” explaining that “[i]f the period of delay is more than one year, there is a sufficient concern that the entire delay may not be unintentional and thus warrant a requirement for an additional explanation of the circumstances surrounding the delay.”  The Office also notes that the change from a two-year period to a one-year period “aligns with USPTO efforts to reduce application pendency and promote efficient patent operations by encouraging applicants to regularly monitor patent files and promptly take corrective actions when needed.”  The notice states that “[p]rompt, corrective actions are more likely to be associated with unintentional delay and assist in streamlining examination.”

The notice cautions stakeholders that “[n]othing in this notice should be construed as an indication that the USPTO will only require additional information in consideration of a petition” filed more than one year after the date an application became abandoned, the date a patent expired, the due date of a priority or benefit claim, or the expiration of the time limit in connection with the requirements pertaining to an international design application.

The new rule will take effect on August 13, 2026, and will apply to any new petition filed after the effective date.  The notice indicates that the two-year period triggering the fees under 37 C.F.R. §§ 1.17(m)(1) and 1.17(m)(2) will be changed to a one-year period.

By Kevin E. Noonan –

In a nonprecedential opinion, the Federal Circuit reviewed summary judgment granted to accused infringer Abiomed that claims asserted by Maquet Cardiovascular LLC were not infringed, in Abiomed Inc. v. Marquet Cardiovascular LLC.

The case arose over claims to intravascular blood pump systems and methods for using them to provide heart support.  U.S. Patent Nos. 7,022,100; 8,888,728; 9,327,068; 9,545,468; 9,561,314; and 9,597,437 were asserted; by the time the case came to trial, only claims 16 and 17 of the ‘100 patent were at issue.  Claim 1 of the ‘468 patent was also set forth in the opinion to further illustrate relevant claim terms construed by the District Court, wherein said construction was reversed at trial and upheld on appeal:

1.  An intravascular blood pump system, comprising:

     an intravascular blood pump adapted to be guided to a predetermined location within the circulatory system of a patient by a guide wire and configured to provide leftheart support, the intravascular blood pump comprising a rotor having a rotor hub tapering in the distal direction, at least one blade extending radially outward from the rotor hub,

     a catheter coupled to a proximal end of the intravascular blood pump, a purge lumen extending through the catheter and operatively arranged to deliver purge fluid towards the intravascular blood pump;

     a cannula coupled to a distal end of the intravascular blood pump, one or more first ports and one or more second ports establishing fluid communication between a lumen of therefrom and located distal to the at least one first port, the cannula is configured such that when the intravascular blood pump is positioned in the patient to provide leftheart support the distal end of the cannula and the at least one second port are positioned inside the patient’s heart and the proximal end of the cannula and the at least one first port are positioned in the patient’s aorta, the intravascular blood pump is configured to draw blood from the patient’s heart into the at least one second port through the cannula lumen and out the at least one first port to provide leftheart support while the cannula is positioned across an aortic valve of the patient;

     an elongate lumen associated with the cannula and sized to slidably receive the guide wire and dimensioned such that the guide wire passes slidably and coaxially through the elongate lumen, the elongate lumen is sized smaller cross sectionally than the cannula lumen, both the elongate lumen and the cannula lumen not extending through the rotor hub, the intravascular blood pump system configured for the guide wire to extend proximally away from the intravascular blood pump, the guide wire not passing through the rotor hub or the catheter, and the guide wire extending out of the intravascular blood pump system in a distal direction through the elongate lumen;

     a pressure sensing element configured to sense pressure proximate the intravascular blood pump;

     a housing connected to a proximal end of the catheter; and first and second conduits each connected to the housing, at least one of the first conduit and second conduit in fluid communication with the purge lumen.

16.  An intravascular blood pump system comprising:

     an intravascular blood pump having a cannula coupled thereto,

     a guide mechanism adapted to guide said intravascular blood pump and cannula to a predetermined location within the circulatory system of a patient, and

     a blood pressure detection mechanism to detect the pressure of the blood proximate

     at least one of the intravascular blood pump and cannula.

17.  The intravascular blood pump system of claim 16 and further, wherein said blood pressure detection mechanism comprises at least one of fluid filled column disposed within at least a portion of said cannula, a piezoelectric element coupled to at least one of the intravascular blood pump and cannula, and a strain gauge coupled to at least one of the intravascular blood pump and cannula.

(Wherein italicized text identifies the elements of the patent claims in dispute.)

Abiomed initially filed a declaratory judgment action that its intravascular blood pump systems did not infringe any of the claims of the asserted patents and that those claims were invalid; Maquet filed a counterclaim asserting infringement and demanding money damages.

The opinion recognizes that the asserted claims disclosed three “broad aspect[s] of the present invention,” each defined by a specific type of “guide mechanism:” (1) “an ‘over-the-wire’ type guide mechanism;” (2) “a ‘side-rigger’ or ‘rapid exchange’ type guide mechanism;” and (3) “a ‘guide catheter’ type guide mechanism.”  These embodiments were recited in claims with three claim limitations at issue: (1) “an elongate lumen associated with the cannula;” (2) “purge fluid;” and (3) “guide mechanism,” with the “guide mechanism” claim being recited in the asserted claims of the ‘100 patent.

The District Court issued a claim construction order wherein the limitation “an elongate lumen associated with the cannula” in the ‘468, ‘314, and ‘437 patents was construed to mean “a permanent elongate lumen formed along the side of the cannula.”  The term “purge fluid” in the ‘728, ‘068, ‘468, ‘314, and ‘437 patents was construed to require that “the purge fluid does not go through the rotor bearings and into the bloodstream.”  Finally, the District Court construed the limitation “guide mechanism” in the ‘100 patent to be in means-plus-function format.  Maquet limited the asserted claims to claims 16 and 17 of the ‘100 patent as set forth above as a result of the District Court’s claim construction.

The District Court held on summary judgment that Abiomed’s accused infringing intravascular blood pump systems did not infringe asserted claims 16 and 17.  This appeal followed.

The Federal Circuit affirmed-in-part, vacated-in-part, and remanded, rejecting the four arguments asserted by Maquet.  The first of these was that the District Court erred in construing the phrase “elongated lumen associated with the cannula” to be limited to those elongated lumens that are “formed alongside of the cannula.”  Maquet did not argue that there was error in the District Court’s determination that nothing in the plain language of the claims, the specification, or the prosecution history supported restricting the term to lumens found alongside the cannula.  Rather,  the District Court’s relied upon statements made by Maquet in inter partes proceedings, which Maquet argued was error.  The Federal Circuit panel agreed, citing Phillips v. AWH Corp., 415 F.3d 1303, 1313–14 (Fed. Cir. 2005) (en banc), for the canons of construction that claims are construed under their plain and ordinary meaning to the skilled artisan, the specification and the prosecution history.  There are two exceptions recognized by the Court: the first is when a patentee acts as their own lexicographer and provides express definitions; and the second is when a patentee disclaims the full scope of a claim in the specification or during prosecution.  The panel assessed each of the three Philips bases of claim construction and found no support for the District Court’s construction of this phrase in the claims.  For example, while there are species embodiments of this construction in the specification these are “exemplary only” and don’t limit the scope as construed by the District Court.

The inter partes review source of the District Court’s claim construction of this term was based on Marquet’s statements distinguishing its claims from a reference to Jegaden in those proceedings.  The District Court’s error, in the panel’s view, was interpreting these statements as constituting prosecution disclaimer.  Such an interpretation is not forbidden under Aylus Networks, Inc. v. Apple Inc., 856 F.3d 1353, 1360 (Fed. Cir. 2017), but in order for prosecution disclaimer to be properly invoked under these circumstances those statements must satisfy both of two requirements, specifically that the disclaimer be clear and unmistakable under Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1326 (Fed. Cir. 2003).  The Federal Circuit did not consider Maquet’s statements to have been “words or expressions of manifest exclusion or restriction” under Unwired Planet, LLC v. Apple Inc., 829 F.3d 1353, 1358 (Fed. Cir. 2016) (quoting Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002)), and were “far too slender . . . reed[s] to support the judicial narrowing of a clear claim term,” citing N. Telecom Ltd. v. Samsung Elecs. Co., 215 F.3d 1281, 1294 (Fed. Cir. 2000).  Thus, the panel held the District Court’s construction of this term was error.

Maquet’s second argument was that the District Court erroneously imported a negative limitation into the term “purge fluid,” specifically that the fluid “does not go through the rotor bearings and into the bloodstream.”  The panel rejected Abiomed’s support for this construction based on distinctions made to overcome the prior art (International Publication No. WO 99/02204) and disparagement thereof, and held that the District Court erred.  As in its analysis of the cannula term, the opinion parsed the Philips factors and found wanting the District Court’s construction using this assessment.  In fact, the panel found evidence from the specification that permitted the purge fluid to pass though the components of the claimed intravascular blood pump system and into the bloodstream.  The District Court, while recognizing these deficiencies nevertheless found that Maquet had “unmistakably disparaged” configurations permitting the purge fluid to enter the bloodstream, again arising from statements made during an IPR.  Once again, the panel held that the statements did not “amount to an instance ‘[w]here an applicant argues that a claim possesses a feature that the prior art does not possess in order to overcome a prior art rejection,’” citing Seachange Int’l, Inc. v. C-COR, Inc., 413 F.3d 1361, 1372–73 (Fed. Cir. 2005), and also Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1374 (Fed. Cir. 2007).  Under these circumstances, where in addition it was unclear on the record whether the argument was made to distinguish the prior art, the panel held the District Court erred in finding “clear and unmistakable” disclaimer and vacated this determination, remanding to the District Court “for proceedings consistent with [the] opinion.”

Third, Maquet argued that the District Court erred in construing the term “guide mechanism” as being a means-plus-function term.  On this construction the panel agreed with Abiomed that the District Court had not erred.  The Federal Circuit recognized that the term did not contain the canonical “means for” terminology but also that under Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1346 (Fed. Cir. 2015), that language was not mandatory.  Under Williamson, the presence or absence of this phraseology raised a rebuttable presumption for or against (respectively) a finding that 35 U.S.C. § 112 ¶ 6 was to be applied in construing the claim.  In this case, the panel held the District Court had not erred because the claim did not recite sufficiently definite structure and the skilled worker would not have understood the claimed element (the guide mechanism) to possess “a sufficiently definite meaning as the name for a structure” under Williamson.  In the Court’s assessment, “mechanism” is nothing other than a “nonce” word and “guide” is a merely a “functional modifier,” citing Media Rts. Techs., Inc. v. Cap. One Fin. Corp., 800 F.3d 1366, 1373 (Fed. Cir. 2015).  The remaining claim language does not remedy these deficiencies according to the opinion as the claim only recited functional terms.  Nor did the Court find any “clear and unambiguous” definition for the term in the specification.

Having decided that the District Court had not erred in considering “guide mechanism” to be in means-plus-function format, the opinion determined that the specification was lacking in the required “sufficient structure” that “corresponds to the claimed function.”  The District Court held that the structural disclosures in the specification amounted to:

(a) a guide wire passing slideably through a central lumen extending through a drive cable assembly, blood pump, and cannula; (b) a guide wire passing slideably through a lumen extending through a guide carriage integrally formed along at least a portion of the cannula sidewall; or (c) a conduit assembly, including guide catheter, a rotor shroud, and a cannula, which is capable of docking to a separate pump assembly.

Maquet objected to this description by arguing that the District Court failed to include in this litany “(1) a ‘rapid exchange’ guide mechanism and (2) a guide mechanism that ‘includes a guide carriage 124.’”  The Federal Circuit rejected these objections because Maquet supported its argument with extrinsic evidence which the panel found insufficient under Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1584 (Fed. Cir. 1996).

Finally, Maquet argued that granting summary judgment in Abiomed’s favor was error because there remained genuine issues of material fact even if the Federal Circuit held that the District Court had properly construed the term “guide mechanism.”  Once again, here the Federal Circuit agreed with Abiomed, reciting the rubric that “[t]o literally infringe a means-plus-function limitation, ‘the accused structure must either be the same as the disclosed structure or be a section 112, paragraph 6 “equivalent,” i.e., (1) perform the identical function and (2) be otherwise insubstantially different with respect to structure,’” citing Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364 (Fed. Cir. 2000).  The District Court had properly considered summary judgment by viewing the evidence in light most favorable to non-movant Maquet and accepting Maquet’s specific factual contentions.  The basis for this reasoning was illustrated by drawings showing the arrangement of the disputed elements in the claimed device:

and stating “[s]pecifically, the parties dispute whether the structure of the Impella products meets structure (b) of the district court’s claim construction.  Maquet contends that ‘a jury could reasonably find that the Impella’s pigtail guide carriage is “integrally formed along at least a portion of the cannula sidewall.’”  However, as the District Court determined, “the pigtail is not attached to any portion of the cannula sidewalls.  Rather, it is attached to the threaded nub, which is attached to a flat surface, which is attached to the inlet cage at the distal end of the cannula[:]”

Because “[t]he cannula sidewalls lie entirely below (proximal) to that plane; the pigtail and threaded nub lie entirely above (distal) to it, . . . there is never any point in the structure where the pigtail or nub are ‘along’ even a ‘portion’ of the cannula sidewall.”

The opinion thus asserts that accordingly “the district court did not reversibly err in determining that the Impella pigtail is not ‘formed along at least a portion of the cannula sidewall.’”

Finally, in this regard, the opinion rejects Maquet’s assertion of expert testimony based on its characterization of that testimony as being “conclusory” and “insufficient to defeat summary judgment,” citing Traxcell Techs., LLC v. Sprint Commc’ns Co., 15 F.4th 1121, 1129 (Fed. Cir. 2021).

In sum, the Federal Circuit affirmed-in-part, vacated-in-part, and remanded to the District Court.

Abiomed Inc. v. Marquet Cardiovascular LLC (Fed. Cir. 2026)
Nonprecedential disposition
Panel: Circuit Judges Hughes, Cunningham, and Stark
Opinion by Circuit Judge Cunningham

By Kevin E. Noonan –

In a nonprecedential decision, the Federal Circuit recently affirmed a district court’s finding that innovator drugmaker Otsuka Pharmaceutical failed to show generic competitor Lupin infringed (or would infringe, if it marketed an FDA-approved generic version of Otsuka’s JYNARQUE® drug), the claims of U.S. Patent No. 8,501,730 and that Lupin had shown that Otsuka’s method of making the active pharmaceutical agent, highly pure tolvaptan, was obvious in Otsuka Pharmaceutical Co. v. Lupin Ltd.

In ANDA litigation, Otsuka asserted claims of U.S. Patent Nos. 8,501,730 and 8,273,735:

U.S. Patent No. 8,501,730:

1.  A highly pure 7-chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoylamino)benzoyl]-2,3,4,5-tetrahydro-1H-1-benzazepine having a purity of more than 99.5%, or a salt thereof, which is produced by the process which comprises reducing a benzazepine compound of the formula (1):

wherein X1 is a halogen atom, R1 and R2 are independently a lower alkyl group, or a salt thereof in the presence of a hydrogenating agent selected from the group consisting of lithium aluminum hydride, sodium borohydride, zinc borohydride, and diborane in an amount of 0.25 to 1 mole per 1 mole of the compound (1).

U.S. Patent No. 8,273,735:

6.  A process for producing a 2,3,4,5-tetrahydro-1H-1-benzazepine compound of the formula(10):

wherein X1 is a halogen atom, R1 and R2 are independently a lower alkyl group, or a salt thereof, which comprises reducing a benzazepine compound of the formula (1):

wherein R1, R2 and X1 are as defined above, or a salt thereof in the presence of a hydrogenating agent selected from the group consisting of lithium aluminum hydride, sodium borohydride, zinc borohydride, and diborane in an amount of 0.25 to 1 mole per 1 mole of the compound (1).

7.  The process according to claim 6, wherein the hydrogenating agent is sodium borohydride which is used in an amount of 0.25 to 1 mole per 1 mole of the compound (1).

(wherein dependent claims 7, 8, and 10 were asserted).

Otsuka’s drug product and method for producing it had the benefit of reducing the percentage (to be less than 0.05%) of an impurity (termed “the dechlorinated impurity” in the opinion) for the tolvaptan used to treat Autosomal Dominant Polycystic Kidney Disease (ADPKD).  The District Court found that Lupin’s Drug Master File differed from Otsuka’s method because “where Otsuka’s claimed process generally uses 1 molar equivalent or less of hydrogenating agent such as sodium borohydride per 1 mole of precursor compound, Lupin’s process uses at least 1.2 molar equivalents of sodium borohydride per 1 mole of precursor” (emphasis in opinion).

In other differences in its commercial process, Lupin tested the progress of the synthesis reaction at 15 and 75 minutes after initiation to determine whether no more than 0.05% of the original amount of the precursor compound remained.  If that was the case, the reaction was quenched by the addition of hydrochloric acid and water, whereas if 0.05% of the original amount of the precursor compound or more remained additional reducing agent was added.  On the basis of these differences, the District Court held Lupin’s DMF method does not infringe Otsuka’s claimed (and approved) method.

Regarding invalidity, the District Court found that the asserted claims of the ‘735 patent were obvious over the cited prior art while the asserted claims of the ‘730 patent were not.

The Federal Circuit affirmed, in an opinion by Circuit Judge Hughes, joined by Circuit Judge Cunningham and the Honorable Allison D. Burroughs, District Judge, U.S. District Court for the District of Massachusetts, sitting by designation.

In its assessment of the District Court’s infringement determination, the panel reviewed the District Court’s conclusion for clear error regarding fact findings and its legal conclusions de novo, citing United Therapeutics Corp. v. Liquidia Techs., Inc., 74 F.4th 1360, 1367 (Fed. Cir. 2023), and Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC, 881 F.3d 1376, 1384 (Fed. Cir. 2018).  Otsuka argued that the District Court’s reasoning was disjointed with regard to the claim term “amount,” wherein the District Court adopted a “practical completion” for construction and a “different and contradictory” construction (“absolute completion”) in applying the terms to Lupin’s DMF.  Otsuka contended that “the reaction is practically complete before 1 molar equivalent of hydrogenating agent is added to the reaction mixture.”  The District Court had construed the term “amount” to mean “the amount [of hydrogenating agent] while the reaction is taking place.”  The panel also considered the differing definitions asserted by the parties during post-trial briefing, where Otsuka argued that the amount of hydrogenating agent recited in the claims was “the amount of hydrogenating agent added before the reduction reaction reaches ‘practical completion’ or is ‘complete in a practical sense,’” and Lupin’s position was that “so long as unreacted ketone precursor and sodium borohydride are present, the reaction will continue to proceed.”  Otsuka’s argument prevailed with the District Court, on the grounds that Lupin’s position was directed to “the ‘theoretical possibility’ of ‘absolute completion’ of the reaction.”

On the basis of this construction, the District Court found that Otsuka’s infringement contentions failed for two reasons.  First, Otsuka’s evidence did not establish that the reduction reaction was “practically complete” by the time the amount of unreduced precursor fell to 0.05% of the original amount in the reaction mixture when Lupin’s recipe ended the reaction by initiating the quenching step.  Second, should Lupin’s reaction reach that amount Otsuka failed to show the other limitations of the claims were satisfied, that “no more than 1 molar equivalent of sodium borohydride or less has been added by that point.”  The panel, in affirming these determinations, rejected Otsuka’s evidence to the contrary, which consisted of the results of two experiments performed by Lupin during the development of their synthetic process, and testimony from its own expert that “the reduction reaction will be complete long before the addition of 1 molar equivalent of sodium borohydride.”  The basis for the Court’s rejection of these arguments was that, for Otsuka’s first contention the data from the two experiments contained “anomalies” that could be accounted for by “some unspecified ‘margin of error’ or a lack of ‘appropriate quality control.’”  These anomalies were enough for the panel to agree with the District Court that reliance on these experiments by Otsuka’s expert was faulty because the data itself was “flawed.”

Otsuka’s second argument, based on its expert’s testimony, “that the reduction reaction will be complete long before the addition of 1 molar equivalent of sodium borohydride” was also unpersuasive to the Federal Circuit.  Because some of these conclusions relied on the flawed experiments from Otsuka’s first arguments the panel agreed with the District Court that that Lupin’s expert’s testimony was more reliable and consistent with the evidence than Otsuka’s evidence.

Another Otsuka argument that did not convince the panel was that the District Court had erred with regard to Lupin’s expert witness testimony and purported deficiencies thereof.  Specifically, Otsuka argued that Lupin’s expert was not properly qualified as an expert for failing to satisfy the standard of having “ordinary skill in the art,” based on lack of experience incorporated into the definition adopted by the District Court (having a relevant doctorate degree and ‘at least two years of experience in the synthesis, research, and development of medicinal compounds’”).  The opinion notes that Otsuka had made these same arguments during post-trial briefing but the District Court refused to “entertain the merits” for failure to object and thus preserve challenge to admissibility of Lupin’s expert’s testimony on this basis.  The panel found that the District Court properly determined that Otsuka had forfeited this objection under the law of the Third Circuit under Harbor Bus. Compliance Corp. v. Firstbase.io, Inc., 152 F.4th 516, 527 (3d Cir. 2025); United States v. Rivas, 493 F.3d 131, 136 (3d Cir. 2007).  In addition, the panel cited Otsuka’s failure to file a Daubert motion under these circumstances, Daubert v. Merrell Dow Pharmaceuticals (1993).  On these bases, the Federal Circuit affirmed the District Court’s conclusion that Otsuka had failed to establish infringement.

Regarding the District Court’s invalidity holding, the opinion sets forth the bases on the District Court record for that determination.  These include a reference to Kondo et al.^* that teaches small-scale synthesis of tolvaptan, which the District Court found would provide motivation for the skilled artisan “to specifically select the reduction step for modification” based on testimony from Lupin’s expert.  Having so chosen, that artisan would have been motivated to “reduce the amount of sodium borohydride used in Kondo’s reduction step” and to achieve the claimed invention either “in light of his or her background knowledge or in light of two other [unidentified herein] pieces of prior art.”  The District Court also found that these motivated alterations in prior art synthetic methods would have been pursued by the skilled artisan with a reasonable expectation of success.

The Federal Circuit, in affirming these conclusions by the District Court, rejected Otsuka’s arguments based on Lupin’s expert witness’s deficiencies in his focus on the Kondo reference and its reduction step as an indication of hindsight bias, as well as dismissing secondary considerations including “unexpectedly high tolvaptan purity and yield” over the Kondo prior art.  The panel found that Lupin’s expert in his testimony considered other prior art but found Kondo to be “a particularly promising reference.”  Also significant for the panel was that a non-prior art reference referred to the Kondo reference to be “a standard method for synthesizing tolvaptan.”  The Federal Circuit concurred, despite acknowledging that there were “major obstacles” in developing the method.  The Federal Circuit further found no clear error in the District Court’s assessment of the motivation to combine the prior art.  This conclusion appears to be due in part to both parties’ experts having identified “many of the steps of Kondo” to have been “considered for modification,” including the reduction step.  This conclusion was bolstered by Lupin’s “significant” expert testimony as to why the skilled worker would have done so, including “cost savings, improvement of the reaction’s safety profile, post-processing simplification, and knowledge that the hydrogenating agent was already being used in molar excess.”

As for the secondary considerations aspect of the District Court’s obviousness determination, the panel noted that Otsuka’s expert testimony was not based on Kondo’s methods but on modifications that used double the amount of reducing agent (emphasis in opinion).  The opinion also asserts that the purported evidence of “unexpectedly high [product] yield” was inaccurate (comparing 30% to the 82-93% yield using the claimed process).  In any event, the Federal Circuit dismissed secondary considerations errors by the District Court (should they exist) as being harmless, on the basis (“[a]fter all”) that “weak secondary considerations generally do not overcome a strong prima facie case of obviousness,” citing Genentech, Inc. v. Sandoz Inc., 55 F.4th 1368, 1378 (Fed. Cir. 2022).

* Kazumi Kondo et al., 7-Chloro-5-hydroxy-1-[2-methyl-4-(2 methylbenzoyl amino)benzoyl]-2,3,4,5-tetrahydro-1H-1-benzazepine (OPC-41061): A Potent, Orally Active Nonpeptide Arginine Vasopressin V2 Receptor Antagonist, 7 Bioorganic & Med. Chemistry 1743, 1743–54 (1999).

Otsuka Pharmaceutical Co. v. Lupin Ltd. (Fed. Cir. 2026)
Nonprecedential disposition
Panel: Circuit Judges Hughes and Cunningham and District Judge Burroughs
Opinion by Circuit Judge Hughes

The Supreme Court issued an Order this morning denying certiorari in Newman v. Moore.  The Court’s Order states that:

The motion for leave to file a brief in opposition under seal with redacted copies for the public record is granted.  The motion for leave to file a reply under seal with redacted copies for the public record is granted.  The petition for a writ of certiorari is denied.

By Kevin E. Noonan –

At the beginning of June, the New Civil Liberties Alliance (representing Judge Paulene Newman) filed the Judge’s Reply Brief to the Federal Circuit Judicial Council’s Opposition to her Petition for Certiorari*.  The brief specifically identifies Judge Newman’s argument that prospective relief is not foreclosed by the Judicial Councils Reform and Judicial Conduct and Disability Act of 1980, 28 U.S.C. § 357(c), and her ultra vires argument regarding the Judicial Council’s application of the statute.  And Judge Newman is not remiss in her inclusion of reference to the amicus brief by former judges of the court that sat with her (and with Chief Judge Moore, if any of the Justices have missed that undercurrent in the proceedings) supporting the petition.

As to the Judicial Council’s response to Judge Newman’s first argument, that the statute properly forecloses claims relating to prospective relief (i.e., any such foreclosure not extending past retrospective challenges), the Reply brief asserts that there is nothing in the statutory language relating to the current situation; in fact the brief sets forth this portion of the statute in toto, illustrating not only the failure of specific language but how in context the language is clearly directed to orders and determinations that have been already entered in the matter.  After all, “[a] future order or determination that might someday be issued by a judicial council does not exist” and thus “cannot be accorded finality or conclusiveness by the language of section 357(c).”  Similarly, the brief states that a court cannot “‘review’ an order or determination that has not yet issued.”  As for the “practical problems” the Solicitor General apprehends should arise if judicial review were permitted under current circumstances, the brief posits that

[I]f a court acknowledges that it is statutorily prohibited from vacating a previously issued “order” or “determination,” then it is not conducting judicial review of that past agency action even if it enjoins the issuance of similar “orders” or “decisions” in the future.  The previously issued order will remain in place, even if the reasoning of the court’s opinion implies that it never should have issued in the first place.

Thus, judicial review of the prospective orders and determinations arising in this case (the continued reiteration of annual suspension of Judge Newman that prevents her from performing her duties as an Article III judge) “does not violate section 357(c) because the past ‘orders’ and ‘determinations’ of the judicial council remain undisturbed.”  The status quo will not be disturbed “if courts remain powerless to vacate those previously issued orders and determinations no matter how wrong they think they are.”

As to the Solicitor General’s argument that Judge Newman forfeited these arguments for not making them in earlier briefing to the D.C. District and Circuit courts, the brief asserts that she did, and to the extent they were not entered with sufficient fulsomeness, the Judge was precluded from doing so by those court’s application of McBryde v. Committee to Review Circuit Council Conduct and Disability Orders of Judicial Conference of the United States, 264 F.3d 52 (D.C. Cir. 2001), citing specific incidents thereof in the record.  “The pressed-or-passed-upon doctrine does not require Judge Newman to present or develop arguments in the lower courts that are incompatible with binding precedent, and that cannot be considered or accepted by those courts until this Court repudiates McBryde,” the brief asserts (thereafter citing the Court’s decision in Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215 (2022), as well as Janus v. American Federation of State, County, and Municipal Employees, Council 31, 585 U.S. 878 (2018), and Citizens United v. FEC, 558 U.S. 310 (2010), as illustrations of the principle).  Indeed, on the contrary, the brief states that “[i]t merely provides additional arguments in favor of a claim that Judge Newman has asserted and preserved throughout these proceedings: that the federal judiciary has jurisdiction to consider her constitutional challenges to the judicial council’s actions,” citing Yee v. Escondido, 503 U.S. 519, 534 (1992) (emphasis in brief).

Turning to Judge Newman’s ultra vires argument, the brief characterizes the Solicitor General’s position as being that the statute “precludes any type of collateral attack on anything that a judicial council does and gives courts no latitude to characterize a purported ‘order’ or ‘determination’ as outside the scope of the council’s delegated authority,” somewhat turning the rhetorical tables on the Solicitor General’s pithy “all means “all” assertion (emphasis in brief).  The brief contrasts this position with the Solicitor General’s acquiescence regarding the availability of facial constitutional challenges to the statute as not being a request for judicial review (“[t]hat is not true” according to Judge Newman).  The relief a facial challenge seeks “can occur only in the context of a ruling that sets aside the “order” or “determination” that was purportedly authorized by the unconstitutional statutory provision” because, inter alia, “[i]t is impossible for litigants to ‘challenge’ a federal statutory provision in the abstract.”  And ultimately the source of any such (successful) challenge would be that actions taken under the statute were constitutionally ultra vires.  The brief dissects the Solicitor General distinctions regarding earlier Supreme Court precedent regarding challenges to purportedly unreviewable agency action in Johnson v. Robison, 415 U.S. 361 (1974), and Webster v. Doe, 486 U.S. 592 (1988) (relevant in view of the administrative character of decisions by Judicial Councils under the Act).

The brief also challenges and distinguishes the Solicitor General’s assertions that Judge Newman forfeited this claim, citing the record where the Judge had argued that the Judicial Council’s actions were ultra vires.  And to the extent that the Court may be tempted to rely on the “pressed-or-passed-upon doctrine” in denying certiorari, Judge Newman reminds that it is “far from an absolute rule and this Court often indulges and considers claims or arguments that were never considered or ruled upon by lower courts,” citing (in a footnote) Hormel v. Helvering, 312 U.S. 552, 557 (1941); Illinois v. Gates, 462 U.S. 213, 219 (1983); and more contemporaneously Kennedy v. Braidwood Management, Inc., 606 U.S. 748, 779–93 (2025).

The Court considered Judge Newman’s petition in the Justices’ June 11th Conference, and Orders were to be handed down on the next two Mondays before the Court begins its summer recess.

* Large portions of the Reply brief are redacted (including the entire section responding to the Solicitor General’s argument that the petition should be considered moot).

By Kevin E. Noonan –

The Judicial Council of the Federal Circuit, represented by the U.S. Solicitor General, recently filed its Respondents’ Brief in Opposition to Judge Pauline Newman’s Petition for Certiorari.  While the brief followed its expected path of rebutting Judge Newman’s arguments, like much of these proceedings there was an undercurrent of at least a little disparagement (despite the general litany of encomiums the Judge deserves after her 40+ years of service on the bench).

The Respondents’ arguments were simple: there was ample basis for the Chief Judge to have initiated proceedings under the Judicial Councils Reform and Judicial Conduct and Disability Act of 1980; Judge Newman had committed judicial misconduct for refusing to submit to the medical and psychological testing required by the Special Committee; and there was nothing ultra vires, against the Constitution, or that violated Judge Newman’s due process rights by the Judicial Council submitting the Judge to serial punishments of having her judicial powers and prerogatives suspended year after year after year.  Nor were there deficiencies in the legal reasoning in the D.C. Circuit Court’s decision in McBryde v. Committee to Review Circuit Council Conduct & Disability Orders, 264 F.3d 52 (D.C. Cir. 2001) (despite the questions raised by members of the panel that affirmed the D.C. District Court’s dismissal of Judge Newman’ complaint against the Judicial Council on these grounds).

The brief contains a Statement section setting forth the proceedings below, the history of enactment of the Act, and the purported policies behind it.  These include imputing to Congress the intention of seeking to “balance” multiple “competing risks” taken from a report to the Chief Justice from Justice Breyer’s Committee reviewing the Act.  The Committee recognized, according to the brief that permitting other judges to investigate sitting federal judges for “misconduct or disability” could risk “undue interference with the Constitution’s insistence upon judicial independence,” while at the same time other judges could risk “inappropriate sympathy with the judge’s point of view or de-emphasis of the misconduct problem.”  Accordingly, the brief contends, the system was designed to rely on chief circuit judges and members of the judicial councils to apply “strict statutory standards.”  The relevant assertion to these proceedings is that the purpose of the Act was “not to punish but to protect the judicial system and the public from further acts by a judicial officer that are detrimental to the fair administration of justice.”  Also relevant is the assertion that only “[i]n exceptional circumstances [would] a chief judge or a judicial council . . . ask the Chief Justice to transfer a proceeding.”

This portion of the brief lays out the procedures governing proceedings according to the statute, in an effort to portray the history of the actions taken in Judge Newman’s case as arising in the ordinary course.  The brief then sets out the history of how the events behind the eventual suspension of Judge Newman unfolded, including tardiness (a “backlog” in fulfilling the Judge’s duties in producing assigned opinions) as justification for precluding assignment of any further opinions to Judge Newman as a way of ensuring “the effective and expeditious administration of justice.”  What followed was a “limited inquiry” to assess Judge Newman’s capacity for performing an active judge’s duties and Chief Judge Moore’s determination that health problems precluded Judge Newman from adequately performing those duties, supported by concerns from half the active judges on the Federal Circuit (concerns that the brief contends Judge Newman rejected regarding efforts to arrive at “any informal resolution”).  Next came an “extensive investigation” by the Special Committee (consisting of Chief Judge Moore, former Chief Judge Prost, and Judge Taranto) and evidence (“more than 20 statements” and the Judge’s e-mails) supporting a picture of “paranoia, increased confusion, and worsening memory problems”; these were accompanied, according to the brief, by instances where the Judge had purportedly “accused staff of trickery, deceit, acting as her adversary, stealing her computer, stealing her files, and depriving her of secretarial support” (the brief mentions that Judge Newman had not challenged the accuracy of this evidence).  Then came the predicate for the circumstances that led to the current situation, wherein the Special Committee “directed petitioner (1) to produce certain medical records to an independent neurologist and (2) to undergo a full battery of non-invasive neurological and neuropsychological examinations to enable resolution of the disability issue,” the brief mentioning that Judge Newman’s own expert neurologist recommended such examinations.  The result of Judge Newman’s refusal to comply (really, to be forced to be examined by medical experts of the Special Committee’s choosing rather than her own) was the Judicial Council’s determination that her refusal constituted judicial misconduct and its decision to suspend the Judge from her judicial duties for one year, not once but (so far) a total of three times.  This decision was supported by the refusal by the Judicial Conference’s JC&D Committee (comprising seven Article III judges from outside the Federal Circuit) to transfer the matter away from the Federal Circuit’s Judicial Council (including its decision that Judge Newman’s due process of law rights had not been violated, based on procedures in “an administrative proceeding” before the Judicial Council under Withrow v. Larkin, 421 U.S. 35,47 (1975)) nor had there been a constitutional violation due to the “temporary” (albeit ongoing) nature of the suspensions imposed on the Judge by the Judicial Council).

The brief then turns to the history of Judge Newman’s complaint before the D.C. District Court and the D.C. Circuit Court of Appeals on due process and constitutional grounds, in which these courts ruled against her.  These outcomes relied (almost entirely) on the McBryde decision and while the unanimity of the Circuit Court’s decision is emphasized, there is no mention of the misgivings of the panel over the legal reasoning of the McBryde decision.

In the brief’s Argument, the Solicitor General makes the Government’s case that Judge Newman’s petition should be denied for two reasons: first, that many of the claims have been forfeited for not being “adequately pressed or passed upon below,” thus making them “manifestly unsuited for [the] Court’s review.”  The brief cites Cutter v. Wilkinson, 544 U.S. 709, 718 n.7 (2005), for the principle that the Supreme Court is “a court of review, not of first view.”  In the Government’s view, Judge Newman failed to preserve many of the theories presented in her petition (which would itself be enough to merit denial of the petition).  These defective contentions include that the Judicial Council’s application of the provisions of the statute that preclude judicial review were ultra vires; the brief asserts that the D.C. Circuit had recognized that Judge Newman had not properly pressed this argument before the District Court.  A similar argument is asserted for Judge Newman’s claims that 28 U.S.C. § 357(c) does not apply to claims for “prospective relief.”  And even those arguments not so forfeited, such as her request for judicial review of “as-applied” constitutional claims should fail on the merits.

Second, in a similar vein the brief argues that Judge Newman’s contentions “lack merit and implicate no circuit split,” because the statute reflects a “sensible policy decision [that] ensures a mechanism for reviewing allegations of judicial misconduct or incapacity that comports with separation-of-powers considerations, offers multiple layers of review, and prevents overburdening federal courts with complaints about judicial-council decision.”  According to the Government, the Judge’s ultra vires contentions concern express provisions in the statute that “‘all orders and determinations by a judicial council or the Judicial Conference ‘shall not be judicially reviewable on appeal or otherwise‘” (emphasis in brief).  Pithily, the brief states that “all means all” and Congress explicitly directed complaints such as Judge Newman’s to the Judicial Conference under 28 U.S.C. §§ 357(a) and 357(b).  The brief acknowledges exceptions (“in narrow contexts”) in instances where the Court has permitted judicial review for ultra vires actions under the Administrative Procedures Act, such as Leedom v. Kyne, 358 U.S. 184, 185-89 (1958), but counters with other decisions where the Justices have not done so, such as Nuclear Regulatory Comm’n v. Texas, 605 U.S. 665, 681 (2025), and Board of Governors v. MCorp Fin., Inc., 502 U.S. 32, 44 (1991).  The brief counters Judge Newman’s citations of Johnson v. Robison, 415 U.S. 361 (1974), and Webster v. Doe, 486 U.S. 592 (1988), on the merits, distinguishing Webster on the basis that the statute invoked in that case “did not clearly indicate that ‘Congress meant to preclude consideration of colorable constitutional claims’” and in Johnson on the grounds that the decisions deemed not precluded under the statute were constitutional claims.  And the Government contends that the availability of Judicial Conference review provided further distinctions between the situations in Webster and Johnson.

Regarding the Judge’s argument that only previously issued orders and determinations were precluded from judicial review, in contradistinction to prospective, future orders, is ” completely atextual” and that “is hard to imagine any prospective relief that would not entail judicial review of an extant order or determination.”  The brief asserts that to recognize the distinction Judge Newman draws would “drive a gaping hole in the scheme Congress prescribed,” i.e., intending that “virtually all claims to end up before the Judicial Conference rather than being diverted to district court” (categorizing Judge Newman’s approach as being an “end-run” around that scheme).  The Government also counters Judge Newman’s reliance Bowe v. United States, 146 S. Ct. 447 (2026), regarding the Court’s reach of reviewing the statute as being more properly limited to “the reach of a statutory exception to this Court’s certiorari jurisdiction, and turned on the specific language of that provision.”

The brief also reminds the Court that there is no disagreement amongst the inferior courts regarding the patent statutory limitation on judicial review of as-applied constitutional claims, citing In re McBryde, 117 F.3d 208, 220 n.7 (5th Cir. 1997), cert. denied, 524 U.S. 937 (1998), and Miller v. Judicial Council, No. 25-2616, 2026 WL 1091647, at *1 (3d Cir. Apr. 22, 2026), further reminding the Court that while it will have the opportunity for review should such conflict arise “none has happened in the 40-plus years since the Act was passed.”

Additional arguments suffer the same fate; the brief counters Judge Newman’s argument that the Court’s review is necessary to ensure judicial independence by reference to the statutory provisions for Judicial Conference review and asking why that review is “insufficient to protect judges.”  In view of the statistics that “[m]ost of those aggrieved by judicial conduct and disability decisions made by Chief Judges or Judicial Councils are not judges, but rather litigants,” the brief warns that “Congress did not intend to open the federal courts to a flood of as-applied challenges to sensitive decisions made under the Act,” which would “not only burden the court system, but expose the judges targeted in such challenges to the possible need to attempt to participate to defend their conduct or abilities in such suits.”

Interestingly, the brief relies in part on a blog post by Dennis Crouch regarding a subtext of the contretemps against Judge Newman relating to her role as “The Great Dissenter” and how collegial displeasure with her dissenting opinions may have played a role in any animus her colleagues have been accused of directing towards the Judge (see Dennis Crouch, “Federal Circuit Dissent Rates Collapse After Newman’s Removal,” Patently-O (Mar. 3, 2026)).  Unfortunately, Mr. Crouch also asserted in the post that “it is ‘unlikely’ that ‘misconduct proceedings themselves exerted a chilling effect.’”

By Kevin E. Noonan –

In a decision that, in retrospect, is not surprising (in view of the haste with which the Court took up the case after granting certiorari; see “Solicitor General Proves Persuasive; Supreme Court Grants Hikma’s Certiorari Petition“), the Supreme Court in a unanimous opinion by Justice Jackson reversed the Federal Circuit’s decision that branded drugmaker Amarin had provided sufficient evidence of inducement to infringe under 35 U.S.C. § 271(b) by generic drugmaker Hikma to withstand the latter party’s motion to dismiss under Fed. R. Civ. Proc. 12(b)(6) in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.

To recap, the case arose over Amarin’s Vascepa® (icosapent ethyl) drug product, an omega-3 fatty acid from fish oil, for treatment of severe hypertriglyceridemia (blood triglyceride levels at least 500 mg/dL; normal range is less than 150 mg/dL) (the “SH indication”).  Amarin also later received approval for a second indication, reducing cardiovascular disease risk (wherein the second approval removed a Limitation of Use in this regard on the original label) (the “CV indication”).  Hikma filed its ANDA against the first approved indication for the Vascepa® product; upon Amarin receiving its second FDA approval, Hikma filed a section viii statement to carve-out the newer CV indication under 21 U.S.C. § 355(j)(2)(A)(viii) (the so-called “skinny label” approach).  The FDA approved Hikma’s skinny label ANDA in 2020 not containing the CV Limitation of Use on the label.

Thereafter, in a series of press releases, Hikma asserted its product as a “generic version of Amarin’s Vascepa®.”  In a particular press release, Hikma claimed its two-month U.S. sales to be $1.1 billion, a figure for all uses of its product, with up to 75% of these sales being for the putatively carved-out CV (off-label) indication (albeit there being other press releases emphasizing the limitation of FDA approval to the SH indication).  And on Hikma’s website, while asserting an AB rating for its product (generic approval for all indications on the label), the website also said “Hikma’s generic version is indicated for fewer than all approved indications of the Reference Listed Drug.”

In its complaint, Amarin asserted Hikma’s press releases, website content, and product label as evidence of “specific intent to actively encourage physicians to directly infringe the asserted patents by prescribing its generic icosapent ethyl product for the off-label CV indication, an indication for which Hikma did not get FDA approval.”  The District Court granted Hikma’s motion to dismiss under Fed. R. Civ. Pro. 12(b)(6) for failure to state a claim in Amarin’s complaint alleging inducement of infringement, based on its determination that the complaint failed to allege facts that Hikma had taken “affirmative steps” to induce infringement (a decision contrary to the recommendation of the Magistrate Judge to whom the District Court Judge referred the motion).  The District Court Judge cited the cautionary language in Hikma’s label regarding side effects as “hardly instruction or encouragement” for the alleged off-label use and that removal of the CV Limitation of Use from Hikma’s label would not have been persuasive that its product had been “shown to reduce cardiovascular risk” and thus to have “encourage[d] its use for that purpose.”  The distinction relied upon by the District Court was that “merely describing an infringing [treatment] mode is not the same as recommending, encouraging, or promoting an infringing use,” quoting, with alterations, Takeda Pharms. U.S.A., Inc. v. W.-Ward Pharm. Corp., 785 F.3d 625, 631 (Fed Cir. 2015).  With regard to Hikma’s press releases and other public statements, the District Court considered that while they “may be relevant to Hikma’s intent to induce infringement” (emphasis in opinion), they were not evidence of “an inducing act” constituting a separate element for inducement under § 271(b).  The website evidence was deemed insufficient because it did not “rise to the level of encouraging, recommending, or promoting taking Hikma’s generic for the reduction of CV risk,” comparing GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 7 F.4th 1320, 1336 (Fed. Cir. 2021) (per curiam) (“GSK”), with Grunenthal GmbH v. Alkem Lab’ys Ltd., 919 F.3d 1333, 1339 (Fed. Cir. 2019).

The Federal Circuit reversed, applying the standard of “whether the totality of the allegations, taken as true, plausibly plead that Hikma induced infringement” (emphasis in opinion) that would provide “substantial evidence to support a jury verdict of induced infringement.”  The Court stated that it is responsible here for “reviewing allegations, not findings, for plausibility, not probability” under Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556 (2007) (emphasis in opinion).  The opinion states as being “undisputed” that there has been direct infringement by doctors and other healthcare providers in prescribing Hikma’s alleged infringing product for off-label use (the CV indication) and that Hikma had “the requisite intent and knowledge to induce that infringement” as found by the District Court.  (These conclusions by the District Court and the Federal Circuit were adopted by the Supreme Court in its opinion.)  On the merits, the Federal Circuit found that Hikma’s removal of the CV Limitation of Use regarding CV indications as well as including warnings of potential cardiovascular side effects from its drug communicated to physicians that its generic drug could be used off-label for the CV indication.  Hikma countered that the FDA required that the label for generic copies of branded approved drugs be “the same as the labeling approved for the listed drug” under 21 U.S.C. § 355(j)(2)(A)(v), and that its silence regarding its product’s effects on risk of cardiovascular complications “cannot plausibly instruct infringement.”  However, while conceding to some of Hikma’s contentions regarding evidentiary elements asserted by Amarin were by themselves insufficient to establish the requisite intent to induce infringement, the Federal Circuit asserted that it is the combination (emphasis in opinion) of the label and Hikma’s “public statements and marketing materials” that rendered the District Court’s grant of Hikma’s motion to dismiss to be in error.

In reversing these determinations by the Federal Circuit, Justice Jackson’s opinion began by noting that “a generic drug is, by definition, ‘biologically equivalent to . . . the brand-name drug’” according to Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405 (2012), and the reality is that “many medical providers use brand-name and ge­neric drugs interchangeably, regardless of whether the in­tended use is covered by a patent.” While “[s]uch substitution is al­lowed (and sometimes required) by state laws across the Nation,” generic manufacturers may be subject to liability under federal law if they “actively induc[e] infringement of [the brand manufacturer’s] patent.”  35 U.S.C. § 271(b).  The Court considered the basis for the Federal Circuit’s decision to reverse the District Court’s grant of Hikma’s motion to dismiss to be that it was “at least plausible that a physi­cian could read” the relevant statements “as an instruction or encouragement to” infringe.”  104 F. 4th 1370, 1380 (2024).  That, the Court said, was error.  “The central question,” according to the opinion, “is whether Amarin plausibly alleged that Hikma actively encouraged infring­ing uses, not merely whether doctors could plausibly read the alleged statements as instructions to infringe.”

“[T]he skinny label may not give instructions for uses that would infringe the patented methods of use” but “[t]hese provisions do not foreclose the possibility that an approved ANDA may still interfere with a patented method of use” because “medical professionals routinely prescribe (and phar­macists routinely dispense) the former interchangeably with the latter, including for patented methods of use, under Inwood Laboratories, Inc. v. Ives Laboratories, Inc., 456  U.S. 844, 847, n. 4 (1982), according to the opinion.  This substitution practice results from and “with the blessing of their States’ generic substitution laws, which, depending on the State, permit or require providing the cheaper generic version to patients,” which laws have been enacted in all 50 stated and the District of Columbia.  The Court recognizes that under these circumstances “generic manufacturers surely know (and perhaps even expect) that their products will be put to infringing use.”  But “mere knowledge of infringing potential or of actual infringing uses [is] not . . . enough . . . to subject a distributor to liability” under Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 937 (2005), and Cox Communications, Inc. v. Sony Music Entertainment, 607 U.S. ___, ___ (2026) (slip op., at 8), according to the opinion.  (The Court as has been its wont is happy to rely on its decisions rendered in copyright cases to decide patent law matters, even where, as here, there is no statutory basis in copyright law for inducement of infringement; the justification (insofar as the Court has felt the need to provide one) is that both the power to grant patents and to grant copyrights reside in Article I of the Constitution.)  Still, the opinion acknowledges that a generic manufacturer can cross the line into liability if it “actively induces infringement of [the brand manufacturer’s] patent.”  35 U.S.C. § 271(b).

The Court then enunciates the three elements for showing inducement.  First, “there must be direct infringement by a third party,” citing Limelight Networks, Inc. v. Akamai Technologies, Inc., 572 U.S. 915, 920–921 (2014).  Second, “the inducer must know that “the induced acts constitute patent infringement,” citing Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 766 (2011).  Third, and most relevant here, the inducer must take “ac­tive steps . . . to encourage direct infringement,” citing Grokster, 545 U.S., at 936.  The parties and each Court below having recognized that the first two elements are satisfied here, the Supreme Court then assesses the propriety (or rather, lack of it) of the Federal Circuit’s determination that the steps taken by Hikma were sufficiently “active” to satisfy the third.

The Court recognized four allegations for this third element of inducement:

• “First, the label omitted the CV Limitation of Use and retained information about a clinical study in which some of the patients were taking statins.”

• “Second, the patient information leaflet that accompanied the label warned against possible side effects for “people who have heart (cardiovascular) disease”—the target population for Vascepa’s patented CV-indication method of use—and noted that “[m]edicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.”

• “Third, Hikma’s website described its generic drug as “AB” rated, and listed the drug’s therapeu­tic category as “[h]ypertriglyceridemia,” a category that in­cludes but is broader than SH.”

• “Finally, prior to the launch of its generic drug, Hikma issued a series of press releases describing the product as “‘generic Vascepa’ without mentioning that th[e] approved use was limited to the far-lesser-known SH indication,” and touting Vascepa’s U.S. sales figures attributable to both the SH and CV indications.

The Federal Circuit had found that on this evidence it was “at least plausible that a physician could read” the label, website, and press releases “as an instruction or encouragement to prescribe [Hikma’s generic] for any of the approved uses of icosapent ethyl.”

Importantly, the opinion notes that “[o]ur well-established federal pleading standards (Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007), and Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)) are not up for debate in this case,” thus addressing the concern of some of the Justices at oral argument that the parties were asking for a change or new application of those standards in skinny label situations.  Under those established standards, “If the complaint ‘pleads facts that are merely consistent with a defendant’s liability, it stops short of the line between possibility and plausibility of entitlement to relief.’”  The required standard, according to the Court, is that a claim cross the line from “‘conceivable to plausible’ if the facts pleaded ‘allo[w] the court to draw the reasonable inference that the defendant is liable for the misconduct alleged’ . . . and rule out ‘obvious alternative explanation[s]’ for the defendant’s conduct” under Twombly.

The Court then applied these standards to the third element of the requirements for showing induced infringement claim: “that the inducer took ‘active steps . . . to encourage direct infringement’” under Grokster.  With regard to what comprises an active step, the opinion asserts that “inducement must involve the taking of affirmative,” as opposed to passive, “steps to bring about the desired result” of patent infringement, citing Global-Tech., 563 U.S., at 760; Grokster, 545 U.S., at 935 (requiring “statements or actions directed to promoting infringement”), and Cox Communications, 607 U.S., at ___ (slip op., at 9) (citing lack of “evidence of express promotion [or] marketing” as a reason for no liability (internal quotation marks omitted)).  To avoid “trenching on regular commerce,” the opinion states that “ordinary acts incident to product distribution” are insufficient to support liability under Grokster, 545 U.S., at 937.  In view of these standards, the opinion states that Amarin “misses the mark” by arguing that they “need not do more than “allege . . . a plausible chain of events through which statements made by [Hikma] could lead a healthcare provider . . . to prescribe or dispense Hikma’s drug to reduce a patient’s cardiovascular risk,” relying (unsuccessfully as it turns out) on National Rifle Association of America v. Vullo, 602 U.S. 175 (2024), and, ironically, on Grokster.

The Court rejected Amarin’s argument on NRA because it would import (unnecessarily) First Amendment considerations into the inducing infringement standard.  Regarding Grokster, the Court distinguished statements in Grokster “designed to stimulate others” to infringe from other statements that “could stimulate others” as here, citing affirmative and much more direct statements and actions by Grokster than those Hikma assertions and statements relied upon by Amarin here.

The fundamental teachings from this opinion can be found in the statement that “[a]ll in all, inducement cannot be based only on ‘vague’ language’ combined with speculation about how [others] may act,” citing Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp., 785 F.3d 625, 632 (Fed. Cir. 2015); and Grokster, 545 U.S., at 937 (requiring “purposeful, culpable expression and conduct”).

However, it should be kept in mind that the Court also states that “Hikma overshoots by urging that active inducement must be ‘express,’” because “[a] defendant can achieve active inducement through implicit encouragement, as StreamCast did through the ‘suggestiv[e]’ name of its ‘OpenNap program’” in Grokster, 545 U.S., at 937, 938.  But implicit or explicit, the necessary inducement must be “clear” to the relevant audience and “affirmative” in its expression.

In the Court’s opinion, Amarin failed this test, for not alleging “more than a sheer possibility” that Hikma had actively induced infringement of the patents in the CV indication.  The opinion then goes through each of Amarin’s allegations and describes these failures.

First, there are “obvious alternative explanations” for many of Hikma’s statements that Amarin asserted to be evidence of infringements under Twombly.  Moreover, some of these statements were “just complying with the law or with standard industry practice,” citing FDA regulations as the obvious alternative explanation for acts including omitting the CV Limitation of Use and retaining information about a clinical study involv­ing patients taking statins, because these were features of Amarin’s label that FDA approval required Hikma to do by statute 21 U.S.C. § 355(j)(2)(A)(v).

In addition, Hikma’s description of its approved product as “generic Vascepa” or the “‘generic equivalent’ of Vascepa” were “normal industry practice,” citing Inwood Laboratories, 456 U.S., at 847–48.  In this regard, the opinion asserts that the Court “decline[s] to put generic manufacturers between a rock and a hard place by turning adherence to the law and industry standards into building blocks for illegal conduct.”

Second, active inducement cannot be supported by “mere omissions, inactions, or nonfeasance” under Twitter, Inc. v. Taamneh, 598 U.S. 471, 489 (2023).  It would take “a healthy stretch of the imagination” for “one [to] believe that some medical providers could read between the lines and draw improper conclusions from the skinny label’s omission of the CV Limitation of Use” and the press releases’ failure to “mentio[n] that [Hikma’s] approved use was limited to the far-lesser-known SH indication,” according to the Court.  This is not enough to support inducement to infringe; the opinion stating that the Court “look[s] for affirmative ‘statements or actions’ precisely to avoid ‘trenching on regular commerce’ based on such a contingent chain of events” under Grokster (emphasis in opinion).  Echoing the Court’s concerns in a copyright case regarding overextension of infringement liability, Kirstaeng v. J. Wiley & Sons, the opinion states that if permitting less that the stringent requirements clearly enunciated here, “ordinary merchants could become liable for any misuse of their goods and services, no matter how attenuated their relationship with the wrongdoer” might be.

The opinion finds the remainder of Amarin’s evidence for inducement to be the kind of “‘vague’ statements ‘combined with speculation about how [medical providers] may act” in response to those statements under Takeda.  These include Amarin’s argument that “medical providers ‘would plausibly understand’ the label’s patient infor­mation leaflet to encourage infringing uses because it iden­tifies potential side effects for people with cardiovascular diseases and notes that medication is sometimes prescribed for uses other than those specifically indicated.”  The question, the opinion recites, is not “whether the statements could be ‘plausibly underst[oo]d’ to induce infringement, but whether they plausibly constitute ‘affirmative steps to bring about the desired result’ of infringement” under Global Tech.  Amarin’s assertions regarding statements in Hikma’s leaflet “are implausibly roundabout ways to induce medical providers to infringe.”  The consequence of not rejecting the sufficiency of this evidence is characterized in the opinion thusly:

Treating them otherwise would turn any statement extraneous to the unpatented method of use—even one warning people against the patented method of use—into active inducement of infringement.  Our case law leaves generic manufacturers more breathing room than that.

The opinion finds equally inadequate the statements on Hikma’s website regarding the AB rating and the therapeutic category of its generic drug to be “hypertriglyceridemia” (as opposed to “severe hypertriglyceridemia”) saying “[i]t is not plausible that Hikma ‘designed’ these statements ‘to stimulate others to commit’ infringement” under Grokster.  The opinion analogizes the “hypertriglyceridemia” description to be akin to describing a drug for leukemia as being a “cancer drug.”  And the “AB rating” description is limited to the limitations set forth in the label, which “excludes unapproved, patented methods of use” under GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320, 1335 (Fed. Cir. 2021), and “in any event” the opinion notes that Hikma’s website itself provides some correction by stating that its generic version of the drug “is indicated for fewer than all approved indications of the Reference Listed Drug,” Vascepa.

The last (and even more vague in the Court’s opinion) of the vague statements cited by Amarin are press releases on Amarin’s sales figures.  Amarin had maintained that those quoted figures included sales for the drug for treatment the patented CV indication as well as sales for the unpatented SH indication, and in doing so “encouraged using its generic for the patented CV indication.”  As an indication of Hikma’s acts supporting inducement, this evidence fails because “there are myriad steps between those statements and induced infringement that Amarin fails to mention.”  In the Court’s understanding of the link between inducement and these statements:

[M]edical provider[s] would have to look up and read the press releases, which were di­rected to investors rather than doctors and pharmacists; have enough background knowledge of pharmaceutical sales to understand the quoted sales figures to be attribut­able to both the SH-indication and the CV-indication meth­ods of use; and draw from this fact a subtle encouragement to start prescribing Hikma’s generic to hypertriglycer­idemia patients who already take statins.

While acknowledging that Amarin’s “chain of events” was possible (with the somewhat disparaging caveat that “anything is possible”), the opinion finds that this evidence, “without more,” is not a plausible scenario sufficient to satisfy the third element of inducement.

With this opinion of the Court addresses the (in its opinion, overbroad) scope of evidence supporting liability for inducement under 35 U.S.C. § 271(b) that the Federal Circuit has applied and has been castigated for in earlier cases (even by members of the Federal Circuit itself) as frustrating Congressional intent for permitting if not promoting the skinny label route to generic competition for unpatented indications.  The Court (albeit in a footnote) frankly connects these jurisprudential dots in the opinion:

To Amarin’s credit, this argument reflects the recent approach of the Federal Circuit, which has increasingly trained its focus on whether the relevant statements could be read by medical providers as instructions to infringe.  See, e.g., GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F. 4th 1320, 1336–1337 (2021).  The decision below appears to follow this trend line.  See 104 F. 4th, at 1378–1380 (resting reversal on the conclusion that it is “at least plausible that a physician could read “the relevant statements “as an instruction or encouragement” to in­fringe).  We reject that trend today, and hereby emphasize that the key question is whether a defendant actively encouraged infringement through its statements, not merely how others may understand those statements.

The decision while completely clear in establishing the standard for inducement of infringement, does raise some concerns, however, particularly with regard to potential unintended consequences.  While generic drugmakers have been liberated from the stringency of the test for inducement set forth by the Federal Circuit (which under certain circumstance has the potential for devolving into a “nod, nod, wink, wink, nudge, nudge” standard), the decision also provides a roadmap regarding the extent to which generic drug manufacturers can take advantage of off-label use without incurring infringement liability.  While one consequence may be greater patient access to drugs for certain indications (depending on how payers treat such uses) another consequence may be reducing incentives for innovator research on finding additional indications.  Some may dismiss any such concerns on the basis that branded drugmakers may reap the lionshare of the profits from later-patented, follow-on indications, the economic realities that may ensue certainly present the possibility that any such prognostications are not as incentive-promoting as expected.

As for Amarin, the interesting question is whether the District Court will permit the company to file an amended complaint.  The factual basis for this might be the additional evidence Amarin contended they had acquired due to the District Court not staying fact discovery while the appeals progressed.  Amarin has asserted at oral argument and in some of its briefing that it had amassed significant new evidence supporting its inducement claim which will go for naught should the District Court dismiss with prejudice.  The Supreme Court provided additional support for Amarin’s entitlement to an opportunity to file an amended complaint in its statements that “[t]o Amarin’s credit, this argument reflects the recent approach of the Federal Circuit, which has increasingly trained its focus on whether the relevant statements could be read by medical providers as instructions to infringe.  See, e.g., GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F. 4th 1320, 1336–1337 (2021).”  A fair interpretation of this statement would be that Amarin should not be penalized for following the law as it existed when they filed their first complaint and should not be penalized now that the Court has clarified the legal requirements for establishing inducement of infringement against generic drug makers in skinny label cases provided that the new evidence satisfies the new standards.  It would be ironic indeed if Hikma prevailed in changing the standard for generic drug companies in skinny label cases to a more friendly one while at the same time ultimately being found liable for inducing infringement in view of new evidence submitted by Amarin under that new standard.

Hikma Pharmaceuticals USA Inc.  v. Amarin Pharma, Inc. (2026)
Opinion or a unanimous Court by Justice Jackson