By Michael Borella –

Eligibility wins at the Federal Circuit are scarce enough that any decision finding a claim to survive § 101 is worth a read.  Constellation Designs, LLC v. LG Electronics Inc. is worth two reads, because the panel managed to do something more useful than affirm or reverse across the Board.  Confronted with four patents drawn to the same basic invention, the Federal Circuit held one group of claims ineligible and a second group eligible, in a single opinion, and explained why.  The result is about as clean a side-by-side of result-oriented claiming and specific-implementation claiming as one is likely to find (even though the difference between these approaches is blurrier in practice than the Court suggests).

By way of reminder, Alice v. CLS Bank Int’l sets up the familiar two-step eligibility inquiry.  At step one, a court asks whether the claim is directed to a patent-ineligible concept such as an abstract idea. If it is, then at step two the court searches the claim, element by element and as an ordered combination, for an inventive concept that amounts to significantly more than the abstract idea itself.

The Technology

The patents concern digital communication systems, such as those that carry over-the-air television signals.  A transmitter maps groups of bits to symbols and sends them across a noisy channel.  Then, a receiver demodulates, demaps, and decodes them back into bits.  The set of possible symbols is called a constellation, typically drawn as points on a plane, where each point corresponds to a unique bit pattern.

For years, the conventional wisdom held that capacity was maximized by spacing constellation points as far apart as possible, that is, by maximizing the minimum distance between points.  The inventors took a different approach.  Rather than optimizing for the minimum distance, they optimized non-uniform (unequally spaced) constellations for a measure called parallel decode (PD) capacity, which compares the information going into the mapper at one end of the channel with the information coming out of the demapper at the other.  The payoff was a constellation that delivered a given capacity at a lower signal-to-noise ratio than a conventional minimum distance based design.  Counterintuitively, the inventors found that the best results sometimes came from letting constellation points be on top of one another.

One feature of the record looms over the eligibility analysis.  An inventor conceded that they did not invent the communication hardware, did not invent the use of non-uniform constellations, and did not even invent the idea of optimizing non-uniform constellations for a particular characteristic.  The patents themselves cite an earlier reference optimizing a non-uniform constellation for PD capacity to achieve a shaping gain.  That framing mattered to the panel when considering the scope of the claims.

The Claims

Constellation asserted nine claims across four patents, and the panel sorted them into two groups.  The first, which it called the optimization claims, comprises claims in U.S. Patent Nos. 8,842,761 and 10,693,700.  Claim 17 of the ‘761 patent is representative:

17. A digital communication system, comprising:
a receiver configured to receive signals transmitted via a communication channel using a QAM symbol constellation;
wherein the receiver, comprises:

a demodulator configured to demodulate the signal received via the communication channel;

a demapper configured to estimate likelihoods of symbols in a QAM symbol constellation from the demodulated signal;

a decoder that is configured to estimate decoded bits from the likelihoods generated by the demapper using an LDPC code; and

wherein the QAM symbol constellation is a geometrically spaced symbol constellation optimized for capacity using parallel decode capacity that provides a given capacity at a reduced signal-to-noise ratio compared to a QAM signal constellation that maximizes d_min.[1]

The second group, the constellation claims, comprises claims in U.S. Patent Nos. 11,019,509 and 11,018,922.  Claim 21 of the ‘509 patent is representative:

21. A communication system, comprising a receiver that receives signals via a communication channel having a channel signal-to-noise ratio (SNR), wherein the receiver uses a symbol constellation to transform the received signals into received bits, and the symbol constellation includes constellation points at a plurality of unique point locations, where:

the plurality of unique point locations are unequally spaced;
the constellation points each have a location and a different label;
and the locations of at least two of the constellation points are the same.

Claim 17 recites a constellation “optimized for capacity using parallel decode capacity” to achieve a stated objective.  Claim 21 recites a constellation with particular structural properties – unequally spaced points, distinct labels, and at least two points sharing a location.  This distinction was determinative to the court.

The Eligibility Decision

The District Court had granted summary judgment that all of the asserted claims were eligible, on the theory that they recited a technical solution to a technical problem.  The Federal Circuit agreed in part and disagreed in part.

The Court held that claim 17 is directed to the abstract idea of optimizing a constellation for PD capacity.  The problem was breadth.  The claim recites that the constellation is optimized for PD capacity to reach a particular result, namely a given capacity at a reduced SNR relative to a minimum distance based approach, but it does not recite how that optimization is accomplished.  The panel invoked the venerable O’Reilly v. Morse and its more recent descendant ChargePoint v. SemaConnect, both of which look dimly on claims drafted so that they capture every means of achieving a result rather than a particular way of achieving it.  Claim 17, the Court reasoned, covers all manners of optimizing a constellation based on one known characteristic, capacity, and one known capacity measure, PD capacity, and thus is drawn to an abstract idea.

Notably, the specification was not short on technical detail.  It describes an iterative process, illustrated in Figure 5, for selecting the points and labeling of a geometrically shaped constellation.  But the optimization claims do not recite that process, and the court reaffirmed the unforgiving rule that the § 101 inquiry focuses on the claim language and that details left in the specification cannot be imported to rescue a claim that does not recite them.  At step two, the court found no inventive concept, observing that Constellation’s asserted inventive concept was the abstract idea itself, and that the company’s reliance on novelty and on LG’s failed obviousness challenges conflated the §§ 102 and 103 inquiries with the search for something significantly more.  Claim 17, and the optimization claims with it, were held ineligible.

The constellation claims fared differently, and the Court resolved them at step one without ever reaching step two.  Rather than claiming the objective of optimization, claim 21 recites specific structural constraints on the constellation.  The points are unequally spaced, bearing different labels, and with at least two occupying the same location.  The panel treated this as a concrete implementation of a technological solution to a technological problem, the problem being the capacity constraints of conventional constellations and the solution being a particular class of non-uniform constellations with overlapping point locations.  Because the claim recited enough specificity and structure, it was not directed to an abstract idea, and the inquiry ended there.  The constellation claims are eligible.

Analysis

The reason this case is interesting is that it isolates the eligibility inquiry better than most.  Both groups of claims are based on the core innovation, that optimizing non-uniform constellations for PD capacity yields better performance at lower SNR.  What differs is not the invention but the drafting.  The optimization claims tried to capture the invention at the level of its goal, reciting a constellation “optimized for capacity using parallel decode capacity”, and in doing so claimed just the result.  Under Morse and ChargePoint, claiming the result without how to achieve it is claiming in the abstract.  The constellation claims captured the same invention at the level of its output, reciting the structural aspects of the constellation, and in doing so claimed a particular solution.

Still, there is an irony worth dwelling on.  The “how” that the optimization claims lacked was not missing from the patents at all.  It was present in the specification and the drawings.  But a disclosure is not a claim, and the Federal Circuit is generally unwilling to read the specification’s language into claims that do not recite it.  That is a harsh rule and is not new, but few cases illustrate its bite as plainly as this one, where the eligible and ineligible claims were litigated in the same case before the same panel.

Nonetheless, Thales Visionix Inc. v. United States, which we covered when it issued in 2017, makes for an uneasy comparison.  Thales upheld a single-step method claim reciting only “determining an orientation of an object relative to a moving reference frame” based on signals from two inertial sensors mounted on the object and the frame.  That is at least as result-oriented as a constellation “optimized for capacity using parallel decode capacity,” yet the Court found it eligible at step one by leaning on the specification’s account of why the underlying sensor configuration was unconventional.  Here, the Court held that a disclosed-but-unclaimed technique counts for little.  The two cases are not easily reconciled, and the friction is the sharper because this panel cited Thales for its step-one analysis and because Judge Stoll, who wrote this opinion, was on the Thales panel.

Also, when viewed against the record, the ineligibility of the optimization claims starts to look like the Court’s answer to claims that it regarded as scarcely distinguishable from the prior art but insulated from an easy dismissal under §§ 102 and 103 by fact-finding of lower tribunals.  The breadth that doomed the optimization claims is breadth relative to the prior art, the very concern that animates novelty and obviousness, and the panel’s refrain that Constellation’s asserted inventive concept “was the abstract idea itself” reads at points less like a holding about eligible subject matter than like a finding that the gap between the claims and the prior art was too small.

Patent eligibility has long been the tool of choice for disposing of a patent a court does not believe in, precisely because it can reach that result on the pleadings or on summary judgment without the evidentiary discipline §§ 102 and 103 demand.  Thales may simply be a case where the court believed in the invention while here it did not.  That is not a principle one can put in a treatise, but it may explain this outcome.

Further, the Court’s reliance on preemption is a curious yardstick, because every valid patent claim preempts something.[2]  That is what a claim is – a boundary that excludes others from practicing what falls inside it.  Every single granted claim preempts all uses and objects that meet its limitations.  The question can never be whether a claim preempts, only whether it preempts too much, which is exactly the judgment that § 101 was never designed to make and supplies no metric for making.  The eligible constellation claims preempt every non-uniform constellation with unequally spaced points, distinct labels, and at least two coincident locations, which is hardly a narrow swath.  What separated them from the optimization claims was not the quantity of preemption but the Court’s gut feeling that they claimed a thing rather than a goal.  If that is the real distinction, and the analysis above suggests it is, then preemption is doing rhetorical rather than analytical work.

Indeed, after 12 years of post-Alice head scratching, it seems that one could replace the entire patent eligibility test with squinting at a claim and pronouncing whether it is “just too broad” in the subjective view of the beholder.[3]  We would at least be spared the pretense that Morse and ChargePoint are supplying anything more than a framework to support an educated guess.  It is a strange body of law that operates on intuition while insisting that it operates on doctrine, but here we are.

For practitioners, the lesson at hand is about drafting claims.  When the inventive contribution is a way of producing a particular structure, claim the structure with the constraints and parameters that distinguish it, rather than the aspirational outcome that motivated it.  A claim that recites just the goal of achieving a result invites a Morse problem.  A claim that recites how the goal is achieved gives a court something concrete to hold.  If the drafter decides to draft a result-driven independent claim anyway, at least one of its dependents should recite the “how” and not just the “what.”

None of this resolves the deeper incoherence in § 101, of course.  But within the rules as they are, Constellation Designs is a rare decision that shows where the line between eligibility and ineligibility (a lightly drawn and dotted line, at best) is roughly located.

Constellation Designs, LLC v. LG Electronics Inc. (Fed. Cir. 2026)
Panel: Circuit Judges Lourie and Stoll and District Judge Oetken
Opinion by Circuit Judge Stoll

---

[1] Here, d_min refers to the minimum distance.

[2] Again, we get to blame the Supreme Court for this mess, as they introduced the notion of preemption into the § 101 analysis without providing substantive guidance as to how it should be used.

[3] This is not an academic or hyperbolic criticism.  Many, many times I have interviewed USPTO examiners and the only rationale that they could give me for their § 101 rejection of a claim is that it was “too broad.”

By Kevin E. Noonan –

The measurement of the hydrogen ion concentration in an aqueous solution is represented (on a logarithmic scale) as the pH, wherein water under ambient conditions (a temperature of 25°C) has a neutral pH of 7 and the solution becomes more acidic as the pH value trends towards 1 and more basic as it trends towards 14.  Characterizing such solutions as elements of patent claims has a long judicial history (being critical in the seminal case on the doctrine of equivalents, Warner-Jenkinson Co., Inc. v. Hilton David Chemical Co.) and the property was recently a part of the Federal Circuit’s decision in Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc.

The matter arose in ANDA litigation over Mylan’s attempt to obtain approval for its generic version of Actelion’s hypertension drug Veletri^Ò, having as its active ingredient epoprostenol.  As set forth in the opinion, “[e]poprostenol is a vasodilator and antiplatelet agent that can be used to treat cardiovascular disease” but “is unstable in water and will react with water molecules to form a different compound that lacks epoprostenol’s desirable pharmacological properties.”  This reaction is catalyzed by the presence of acid in solutions of epoprostenol and, due to their catalytic function can even in trace amounts facilitate epoprostenol’s breakdown.  According to the opinion, pH can be influenced by including a base that neutralizes the acid or by decreasing the temperature that reduces acid production in aqueous solutions.

Actelion overcame the existence of prior art formulations of epoprostenol (Flolan^Ò) by distinguishing over three features for increasing the pH: storing epoprostenol as a lyophilized powder that was reconstituted for use; performing such reconstitution in a diluent having a more basic pH than conventional intravenous fluids; and storing the reconstituted epoprostenol formulation by refrigeration.  As disclosed in the ‘802 patent, Actelion’s formulation was reconstituted in commercially available intravenous fluids and kept at room temperature (which had a pH greater than 11 which was greater than the pH of Flolan^Ò).

Actelion’s resulting pharmaceutical composition was patented in U.S. Patent Nos. 8,318,802 and 8,598,227, with claim 1 of the ‘802 patent being representative:

1.  A lyophilized pharmaceutical composition comprising:
    (a) a unit dose of 0.5 mg or 1.5 mg of epoprostenol or a salt thereof;
    (b) arginine; and
    (c) sodium hydroxide,
    wherein said lyophilized pharmaceutical composition is (i) formed from a bulk solution having a pH of 13 or higher and (ii) capable of being reconstituted for intravenous administration with an intravenous fluid.

The beneficial properties of the claimed pharmaceutical compositions (such as greatly reduced degradation rates) were supported by experimental evidence comparing the stability thereof at various basic pH values (pH 10.5, 11, 12 and ultimately pH 13 as claimed).

The District Court’s claim construction regarding the pH limitation was challenged by Mylan in an earlier embodiment of this case and the Federal Circuit vacated that construction; see Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., 85 F.4th 1167, 1173 (Fed. Cir. 2023).  On remand, the District Court construed the claim term “a pH of 13 or higher” to mean “a pH of 12.98 or higher,” which was unchallenged on appeal.

Mylan argued that its epoprostenol formulation did not infringe the asserted claims of these patents, on the grounds that its bulk solution had a pH “well below” the pH 12.98 recited in the claim as construed by the District Court.  Actelion asserted infringement on the basis that Mylan’s bulk solution would have a pH greater than 13 when refrigerated (the conditions under which Mylan’s bulk solution was manufactured).  Actelion also argued that Mylan infringed under the doctrine of equivalents, because “Mylan’s manufacturing process performs the same function (improved manufacturing stability) to achieve the same result (composition stability) in the same way (reducing hydrogen ion concentration) as the claimed invention.”

The District Court rejected both Actelion arguments and found neither literal infringement, based on its construction that the term “a pH of 13 or higher” specified a pH measured at a temperature standard in the field, nor infringement under the doctrine of equivalents.  The Court held that the skilled worker would consider that the pH 13 claim limitation was determined under standard conditions of 25±2°C, which was supported by implicit disclosure in the specification (“many of the specification’s reported experimental results would ‘not make sense’ if the measurements were not taken at 25±2°C”).  The District Court also considered its application of the construed claims to be supported by extrinsic evidence, including how pH was determined under the United States Pharmacopeia (USP).  Regarding infringement under the doctrine of equivalents, the Court found application of the doctrine to be precluded by the “disclosure-dedication” rule, whereby “Actelion’s specification discloses, but does not claim, pH ranges for bulk solutions including values under 13, e.g., pH 12–13 and 12.5–13.”  The doctrine was also barred by prosecution history estoppel, because during prosecution Actelion amended the claims to recite a pH of 13 or above to overcome an obviousness rejection and thus had surrendered lower pH conditions for the bulk epoprostenol solutions.  Finally, the District Court considered Actelion’s evaluation of the “function” prong of the “function-way-result” test for equivalents was performed “at an impermissibly high level of generality.”

Accordingly, the District Court entered final judgment of non-infringement and this appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Taranto joined by Judges Reyna and Stoll.  Importantly for the Federal Circuit, the term pH was not expressly defined nor were the conditions for measurement directly stated.  (The former perceived deficiency might have been addressed with regard to the statement in Lindemann that “a patent need not teach, and preferably omits, what is well known in the art” (which pH certainly is); Lindemann Maschinenfabrik v. American Hoist and Derrick, 730 F.2d 1452, 1457 (Fed. Cir. 1984)).  The panel rejected Actelion’s arguments that the District Court committed reversible error in construing the meaning of the claim term “a pH of 13 or higher” but held that that meaning was not resolved under its plain meaning because no conditions were specified in the claims.  Turning to other intrinsic evidence, the opinion asserts that this disclosure favors the District Court’s construction over the construction asserted by Actelion on appeal, albeit only implicitly (e.g., to be consistent with the District Court’s construction rather than expressly defining it).  This is particularly true of comparative pH determinations which the opinion characterizes as “straightforward” and “without [having] any suggestion of accommodating the complications of measuring pH at different temperatures.”  The panel also rejected Actelion’s arguments regarding the Examiner’s “reasons for allowance” (which the Court considers to be consistent with pH being determined at standard temperature), and also considered the “purpose of the invention” disclosed in the specification to be similarly consistent with the District Court’s construction.

The opinion states that although such intrinsic evidence is usually enough to support the District Court’s construction, here extrinsic evidence was also considered to the same effect.  Specifically, the opinion states that “extrinsic evidence . . . may sometimes be informative,” citing Seabed Geosolutions (US) Inc. v. Magseis FF LLC, 8 F.4th 1285, 1287 (Fed. Cir. 2021), and Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1584–85 (Fed. Cir. 1996), and that “evidence that relevant artisans use a claim term in an established and consistent way, including evidence of a “[w]ell known industry standard[] can be persuasive of the term’s meaning,” citing Wellman, Inc. v. Eastman Chemical Co., 642 F.3d 1355, 1367 (Fed. Cir. 2011), and Canatex Completion Solutions, Inc. v. Wellmatics, LLC, 159 F.4th 39, 45 (Fed. Cir. 2025).  The opinion states that the District Court “properly relied” on such extrinsic evidence (particularly with regard to the USP) and committed no clear error, rejecting Actelion’s arguments to the contrary as failing to “leave [the panel] with a definite and firm conviction that the district court made a mistake.”

Similarly, the panel found no error in the District Court’s rejection of Actelion’s assertion of Mylan’s purported infringement under the doctrine of equivalents with regard to either prosecution history estoppel (Actelion made a narrowing amendment of its claims to overcome rejection by an examiner, citing Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 727 (2002)) or the disclosure-dedication doctrine (Johnson & Johnston Associates Inc. v. R.E. Service Co., 285 F.3d 1046, 1054 (Fed. Cir. 2002) (en banc)).  The Federal Circuit expressly rejected Actelion’s attempt to rely on the “tangential relationship” exception to application of prosecution history estoppel under the circumstances of how that estoppel arose in this case (including there having been several instances of amending the claims to overcome rejection surrounding the pH limitation).  This amounted to a “discernible objective reason for the narrowing amendment” that raised the estoppel under Ajinomoto Co., Inc. v. International Trade Commission, 932 F.3d 1342, 1354 (Fed. Cir. 2019), sufficient for the Court to affirm the District Court’s rejection of Actelion’s doctrine of equivalents assertions.  And with regard to the District Court’s application of the disclosure-dedication rule, the Court held that the disclosures in the common specification of the asserted patents were “sufficiently specific to identify the ranges of pH 12.5 to 13, 12 to 13, and greater than 12,” which were nevertheless not included in the asserted claims.  On this basis, the Federal Circuit affirmed the District Court’s denial of Actelion’s assertions that Mylan infringed under the doctrine of equivalents.

Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2026)
Panel: Circuit Judges Reyna, Taranto, and Stoll
Opinion by Circuit Judge Taranto

By Michael Borella –

Applicants who appeal a § 101 rejection to the Patent Trial and Appeal Board (PTAB) face long odds.  Our annual surveys have put the affirmance rate for examiner eligibility rejections at roughly seven out of eight, year after year, and Technology Center 3600 has historically been one of the least hospitable places on earth for a software-adjacent claim.[1]  So when the PTAB reverses a § 101 rejection out of Art Unit 3662, it is worth a look to see what went right for the Applicant.  The short answer, in Ex parte Martineau, is that nothing in particular went right on the merits.  Instead, the Examiner went wrong on the procedure, and the PTAB declined to paper over it.

In Alice v. CLS Bank Int’l, the Supreme Court set forth its now-familiar two-part test for patent eligibility under 35 U.S.C. § 101.  One first asks whether the claim is directed to a judicial exception, such as an abstract idea.  If so, one then asks whether any additional element or combination of elements supplies an “inventive concept” sufficient to transform the claim into something significantly more than the exception itself.  The USPTO has overlaid its own structure on top of this test by way of its 2019 Revised Patent Subject Matter Eligibility Guidance, now baked into the MPEP.  Under that framework, Alice step one is split into Step 2A Prong One (does the claim recite a judicial exception?) and Step 2A Prong Two (is the exception integrated into a practical application?), while Alice step two becomes Step 2B (do the additional elements amount to significantly more?).  The distinctions among these steps are not academic, as this case demonstrates.

The Claimed Invention

The application is directed to methods and devices for predictive maintenance of components of a road vehicle.  Claim 1 reads as follows:

A method for predictive maintenance of a plurality of components of a road vehicle, each of the components being connected to a computer, the road vehicle comprising a predictive maintenance display unit connected to the computer, the method comprising:

identifying, by operation of the computer, a plurality of predetermined wear parameters, each of which represents wear of a given one of the components, each of the wear parameters taking a value in a predetermined range of wear values corresponding to the component with which a given said wear parameter is associated,

dividing each said predetermined range of wear values, by operation of the computer, into a plurality of predetermined wear value intervals,

combining, by operation of the computer, at least some of the wear value intervals associated with a first of the components with at least some of the wear value intervals associated with a second of the components, according to a first predetermined combination pattern, so as to obtain a plurality of intervals of combination of wear parameters,

determining, by operation of the computer, a duration of use of each said interval of combination of wear parameters as a function of at least one distance traveled by the road vehicle, so as to obtain a determined wear profile,

comparing the determined wear profile, by operation of the computer, with a predetermined wear profile, and

giving a warning, by operation of the computer, via the predictive maintenance display unit upon detecting that the determined wear profile diverges from the predetermined wear profile.

In other words, the claim builds a wear profile for a vehicle’s components from per-component wear intervals and usage duration, compares that profile to a baseline, and triggers a warning on a dashboard-style display unit when the two diverge.  Based on the aggressive way that Alice has been applied to claims with similar language, one can see why an examiner in 3600 might reach for § 101.

The Examiner’s Rejection

And reach the Examiner did.  Claim 1 was rejected under § 101 as directed to patent-ineligible subject matter.  Under Step 2A Prong One, the Examiner concluded that “taken as a whole, the recited process [of the claims] is considered an abstract idea.”  Under Step 2A Prong Two, the Examiner determined that additional elements such as a computer, a predictive maintenance display, and sensors were recited at a high level of generality and did nothing more than what a generic computer, display, or sensor components “that are routine, well understood features of the art would enable.”  The Examiner went on to characterize the recited warning as encompassing, under its broadest reasonable interpretation, ordinary dashboard indicator lights, which the Examiner deemed routine in the art.  Under Step 2B, the Examiner concluded for the same reasons that the additional elements did not amount to significantly more than the judicial exception.

The PTAB’s Decision

The PTAB reversed the Examiner.  Notably, it did not hold that the claims are eligible.  It held that the Examiner failed to adequately show that they are not, and it found reversible error at all three steps.

Starting with Step 2A Prong One, the PTAB faulted the Examiner for reaching a conclusion about what the claims are directed to before completing the Prong Two analysis.  As the PTAB explained, Step 2A is a two-prong inquiry, and it is the two prongs together that determine whether a claim is directed to a judicial exception.  Even assuming some claim elements recite an abstract idea, that does not end the matter.

The more substantial problem arose at Step 2A Prong Two.  Here the Examiner asked whether the additional elements were well-understood, routine, and conventional.  That is the wrong question for this step.  As the MPEP makes clear, Step 2A specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity.  Indeed, the Guidance instructs examiners that additional elements may integrate a judicial exception into a practical application even if those elements are themselves conventional, because the relevant inquiry is whether the claim improves the relevant existing technology, not whether it improves over routine activity.  The Examiner, in short, imported a Step 2B question into a Step 2A analysis.  The PTAB also observed that the rejection went so far as to quote from Alice step two while purporting to apply step one, when the proper Prong Two inquiry asks whether the claims focus on a specific means or method that improves the relevant technology or are instead directed to a result that is itself the abstract idea.

Compounding matters, the PTAB noted that the Examiner never performed the analysis that Prong Two actually requires.  The Applicant pointed to specific asserted improvements to vehicle maintenance technology, including enabling predictive rather than reactive maintenance through real-time monitoring and reducing unexpected component failures through early warning.  Under the Guidance, the Examiner was obligated to look to the specification to determine whether it provides sufficient detail that one of ordinary skill would recognize the claimed invention as an improvement, and then to evaluate whether the claims reflect that disclosed improvement.  The PTAB could not find that analysis in the record.

Step 2B fared no better, and here the defect is the familiar one from Berkheimer v. HP.  A conclusion that an additional element is well-understood, routine, and conventional is a factual determination, and it must be expressly supported in writing by one of the four forms of evidence the MPEP enumerates: a citation to the specification or to an applicant statement, a citation to one of the court decisions recognizing the conventional nature of the element, a citation to a publication, or a statement of official notice.  The Examiner asserted that the additional elements were well-understood, routine, and conventional but supported the assertion with none of the four.  As the PTAB put it, the Examiner failed to provide the requisite factual determinations to support the Step 2B conclusion.

Because the rejection failed to follow Office guidance at both Step 2A and Step 2B, the PTAB held that the Examiner had not adequately articulated why the claims are patent ineligible, and it reversed the rejection of all claims on appeal.[2]

Analysis

It would be easy to read Ex parte Martineau as a substantive win for predictive-maintenance claims, but that reading would be too generous.  The PTAB did not decide that the claims were eligible.  What it decided is narrower and, in its way, more useful – that an examiner cannot sustain a § 101 rejection by blurring the steps of the Office’s own framework together and asserting conventionality without evidence.

Three lessons stand out for practitioners.  First, the boundary between Step 2A and Step 2B is important, and examiners cross it more often than one might expect.  When a Prong Two rejection turns on whether the additional elements are routine and well understood, the rejection has wandered into Step 2B territory and is vulnerable on that basis alone.  Second, Berkheimer still has teeth at the PTAB, at least where the examiner makes no attempt to satisfy it.  A bare assertion that a computer, a display, or a dashboard light is conventional, untethered to any of the four enumerated forms of support, is not a factual finding.  Third, and most practically, the Applicant here gave the PTAB something to work with by articulating concrete technological improvements in the specification and the briefing.  Prong Two rewards that kind of record, and its absence is what the PTAB found missing in the examiner’s rationale.

None of this fixes the larger problem, of course.  The reason an examiner can run all three steps together and still issue a rejection that survives until appeal is that the underlying jurisprudence supplies so little discipline that the Office’s framework is doing most of the work.  When applicants prevail at the PTAB on § 101, it is frequently not because anyone has clarified what an abstract idea is, but because the examiner failed to follow the procedural guardrails the Office erected precisely because the case law would not. Ex parte Martineau is a clean example of the genre.  This decision can be helpful when you are dealing with an examiner who takes shortcuts in their § 101 rejections.[3]

Decision on Appeal
Panel: Administrative Patent Judges Horner, Jung, and Jeschke
Decision by Administrative Patent Judge Horner

---

[1] See Michael Borella & Ashley Hatzenbihler, Think Twice About Appealing a § 101 Rejection to the PTAB, Patent Docs (Sept. 13, 2022), https://patentdocs.org/2022/09/13/think-twice-about-appealing-a-101-rejection-to-the-ptab/ (reporting an 87.1% affirmance rate for 2021); Michael Borella, PTAB Remains Hostile to Section 101 Appeals, Patent Docs (Feb. 1, 2023), https://www.patentdocs.org/2023/01/ptab-remains-hostile-to-section-101-appeals.html (88.4% for 2022); Michael Borella, Mackenna Dunn, & Garrett “Jake” Lee, 91%: That is the Rate at Which the PTAB Affirms Examiner Section 101 Rejections, Patent Docs (Aug. 12, 2024), https://patentdocs.org/2024/08/12/91-that-is-the-rate-at-which-the-ptab-affirms-examiner-section-101-rejections/ (91% for 2023); Michael Borella & Walter DeGroft, PTAB § 101 Appeal Stats for 2024: The More Things Stay the Same, the Worse They Remain, Patent Docs (Aug. 25, 2025), https://patentdocs.org/2025/08/25/ptab-101-appeal-stats-for-2024-the-more-things-stay-the-same-the-worse-they-remain/ (88.6% for 2024).

[2] As of this writing, the application has been returned to the examiner who has yet to take any further action on it.

[3] A glance at the examiner’s analytics supplies some useful context for how this rejection came to be. The examiner who issued it carries an allowance rate of roughly 43%, against an art unit average of about 82%. That is not a rounding error. It means an application drawn to this examiner is allowed at a little more than half the rate of the art unit as a whole. This serves as a tidy illustration of a point we have made before, that prosecution under § 101 can be far more a function of which examiner one draws than of the claim language actually at issue.

By Joshua Rich –

When we last encountered the Collison Communications v. Samsung case in the Eastern District of Texas, the U.S. Department of Justice’s Antitrust Division and U.S. Patent and Trademark Office had submitted a “Statement of Interest” on whether a non-practicing entity could obtain a permanent injunction after prevailing in patent infringement litigation.[1]  Since that time, the parties submitted supplemental briefs and the Court held oral argument.  Then, on May 17, 2026, Judge Gilstrap entered an Opinion and Order denying the motion for permanent injunction.

The Government’s Statement of Interest purported to support neither party, but sought to reinforce the position that a non-practicing patentee could demonstrate irreparable harm and the inadequacy of monetary damages.  It noted that a court must consider two other factors under the controlling precedent of eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006), namely the balance of the hardships between the parties and whether the public interest would be disserved.  The Statement of Interest identified the two remaining factors as part of the eBay test, but addressed only in a single footnote in which the Government identified factors regarding the balance of the hardships that had been considered (whether there were non-infringing alternatives and the parties’ respective sizes, products, and revenue sources) and disregarded (the infringer’s commercial success or sunk development costs).

The Statement of Interest came at an awkward time in the case:  principal briefing on the motion for entry of preliminary injunction had been completed, and all that remained was oral argument.  But both sides submitted short supplemental responses to the Statement of Interest, and both suggested that the Government did not get the law quite right.

Samsung’s response started from its points of agreement with the Statement of Interest:  that the Government had not weighed in on the balance of the equities or public interest (which Samsung asserted heavily favored it) and that all parties accepted the eBay four-factor test.  But it argued that the legal issues raised by the Government on the first two factors did not fit the facts of the case and that the Statement of Interest was incorrect to the extent that the uncertainty of future events would be sufficient to establish irreparable harm.  Specifically, Samsung highlighted that damages were not hard to quantify here because Collision’s business was licensing and therefore quantification of damages – both retrospective and prospective – was straightforward.  Then, most pointedly, Samsung disputed that “courts should be included to issue injunctions to encourage ‘license negotiations’ and thereby ‘leave[] it to the parties . . . to determine the value of the technology.’”  As Samsung pointed out, the Government had submitted a Statement of Interest less than a year earlier in which it acknowledged that the Federal Circuit had not yet found irreparable harm for a patentee who relies solely on licensing.

Collision then responded, arguing that the Government had gotten much of its analysis of the first two factors right, but had erred by not recognizing that “courts must apply equity as it was applied by the English Court of Chancery in and around 1789” and that eBay had not superseded the equitable principle that ongoing violations of rights constituted irreparable harm.  Essentially, although Collision included a heading that “Collision’s Patents are Unique and Difficult to Value,” it believed that the law was categorical:  if there was ongoing infringement, the harm was irreparable.  It argued that Justice Kennedy’s concurrence in eBay was not only not binding law, but it – and the Government’s reliance on it – was simply wrong in suggesting that the case displaced the traditional, categorical presumption of irreparable harm in favor of a burden on the patentee to prove the element of the injunction test.

Judge Gilstrap’s decision recognized the difficulty of rendering a decision when the two sides argue wholly inconsistent legal presumptions, rather than focusing on the facts of the individual case.  Collision presumed all four elements of the eBay test by dint of being a prevailing patentee subject to continuing infringement.  Samsung, on the other hand, presumed that there could be no irreparable harm or inadequacy of damages because Collision was a non-practicing entity that sought only to license its patents.  Instead of choosing one of the two poles, Judge Gilstrap split the difference:  he noted that the Federal Circuit prior to eBay had presumed the entry of an injunction “absent a sound reason to deny such relief,” whereas the eBay district court had presumed a lack of irreparable harm for a non-practicing entity but the Supreme Court had rejected both.  And although he noted that “since eBay monetary damages have become the presumptive remedy in practice,” he pointedly held “that there is no presumptive remedy in patent cases.”  That is, “[e]ither a plaintiff seeks an injunction and shows that it meets the eBay test, or if not, money damages apply.”

On irreparable harm, Judge Gilstrap set forth both parties’ categorical positions then, citing the Government’s Statement of Interest, rejected them both.  Instead, he focused on the facts of the case before him, specifically a “design-win” competition between Collision and Samsung’s internal design team.  Although the parties contested what the loss (which involved Nokia losing interest in Collision’s technology) meant, Judge Gilstrap found that it, alongside Samsung’s continuing infringement, was sufficient to constitute irreparable harm.

On adequacy of monetary damages, Judge Gilstrap again rejected Collision’s call to apply 18th century equity principles or Samsung’s call to apply only money damages to relieve the harm of future infringement.  Although not setting forth any specific facts, he agreed that “the historical underpinnings of the injunction as an equitable remedy in patent cases must not be ignored or swept away.”  Therefore, on the totality of the record before him, Judge Gilstrap found money damages inadequate.

The momentum of the decision shifted when it moved to the balance of the hardships, however.  Collision relied upon the historical presumption in its favor and asserted that a one-month grace period would “give[] Samsung ample time to bring its infringement to an end.”  Samsung argued that the injunction would “impose burdens” on its hundreds of thousands of employees, but made no argument regarding the burden an injunction would place on the company itself.  In short, both sides failed to present sufficient factual arguments.  Based primarily on the burden of proof – that a plaintiff has to establish all of the elements of the injunction test – Judge Gilstrap found that Collision’s failure of proof prevented the imposition of an injunction.

The most important consideration on the balance of hardships may have been relegated to a footnote, however.  Judge Gilstrap noted that Collision had made arguments at trial inconsistent with its injunction papers on the centrality of the technology to Samsung and the absence of non-infringing alternatives.  That is, to prove its case on the merits (and increase damages), Collision had taken positions inconsistent with its argument that Samsung would bear no hardship in switching away from its existing technology.  Given the difficulty for a non-practicing entity to show any hardship itself, the circumstances disclosed in the footnote show the difficult bargain that it must make:  a lack of non-infringing alternatives may bolster a non-obviousness case and drive up damages, but doom any potential permanent injunction.  It creates a far more tenuous tightrope walk than that faced by a practicing, competing entity that can point to ongoing harm to its business in a way that a non-practicing entity cannot.

Finally, on the public interest, Collision again argued for a categorical rule (based on a pre-eBay decision).  Samsung, in contrast, asserted that an injunction “would drive up the price of smart phones, limit consumer choice, prevent necessary repairs, and prevent wireless carriers from meeting consumer demand.”  As with the balance of hardships, Judge Gilstrap rejected Collision categorical rule as inconsistent with eBay‘s requirement of a showing on each of the elements.  He found that “Collision has made no showing that in this case, on these particular facts,” that enforcement of patent rights would be in the public interest.

Again, a footnote showed Judge Gilstrap’s thought process:  he suggested that Collision’s combined arguments – that irreparable harm and insufficiency of monetary damages were established as a matter of law and that harm to Samsung would be immaterial to hardships – signaled that Collision was “seeking a return to the Federal Circuit’s pre-eBay practice of near-automatic injunctions once infringement is found.”  His analysis suggested that Collision was being disingenuous in arguing that public interest was the only barrier to an injunction and would also always favor injunctive relief.  As he put it, “Collision’s briefing seems to say, ‘Heads I win, tales you lose.’”

Judge Gilstrap’s decision in Collision Communications v. Samsung shows just how difficult it is for a non-practicing patentee to obtain injunctive relief, even with the weight of the Department of Justice’s thumb on the scale on two of the eBay factors.  All patentees must carefully now weight how their arguments on liability and damages will affect their chance for injunctive relief; for a non-practicing entity, the scales are far more delicately balanced.  The opinion is carefully worded, relying on factual showings rather than the legal absolutes proposed by the parties, which makes it less susceptible to reversal on appeal.  All in all, the decision will likely push other non-practicing entities back toward putting their eggs in the liability and damages basket:  if Collision cannot get a permanent injunction in this case, it will be nearly impossible for a non-practicing entity to obtain that relief without the Government standing behind it.

---

[1] https://patentdocs.org/2026/03/05/uspto-and-doj-statement-of-interest-in-collision-communications-another-thumb-on-the-scale-in-favor-of-npe-patent-plaintiffs/

By Kevin E. Noonan –

The United States recently filed a Statement by the Antitrust Division of the Department of Justice under the provisions of 28 U.S.C. § 517 regarding the “Interests of United States in pending suits” in Corteva Agriscience LLC, Pioneer Hi-Bred International, and Agrigenetics, Inc. v. Inari Agriculture, Inc. and Inari Agriculture NV pending in the District of Delaware.

The Statement references the Government’s concerns with the agricultural sector of the economy, citing Department of Justice, Competition and Agriculture at 6, 13-14, 23 (May 2012), and Department of Justice, Antitrust Enforcement and Agriculture(Aug. 20, 2002).  The subject matter of this litigation is the seed industry, which “is highly concentrated with formidable market entry barriers, as ongoing consolidation has resulted in a global seed industry dominated by just a few companies,” the Government asserts, citing U.S. Department of Agriculture, More and Better Choices for Farmers: Promoting Fair Competition and Innovation in Seeds and Other Agricultural Inputs at 11 (March 2023) (“USDA Report”).  Examples of this concentration cited in the Statement are that (according to USDA estimates) “the top four firms [Bayer, Corteva, ChemChina, and BASF] hold 84% of the corn market and 79% of the soybean market” (elsewhere estimated at 95% and 84%, respectively), citing USDA Economic Research Service, Concentration and Competition in U.S. Agribusiness, Economic Information Bulletin No. 256, at 11 (June 2023), Concentration and Competition Report.

The issues provoking the Government’s interest involve Corteva’s IP rights, and the extent of disclosure by patentee under Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc)(written description), through deposits of its patented seeds with the American Type Culture Collection (ATCC).  The Statement asserts that “[t]he boundaries of permissible conduct for the public to access and ‘read’ claimed patented material must be carefully policed to prevent the IP laws from being misused to blunt rather than foster innovation.”

For “nascent” companies there is a legitimate need for them to “accurately identify the extant products and the parameters of [the] IP protection” held by their larger competitors, the Statement asserts.  The nature of seeds and plant varieties prevents patents and patent applications to readily provide this information (i.e., by simply reading a patent specification), according to the Statement, leading to the filing of the Statement.

The Statement goes on to set forth the need for deposits to satisfy the written description and enablement provisions of 35 U.S.C. § 112(a) under certain circumstances and for some inventions under the provisions of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.  These include biological materials such as seeds, insofar as “[the material] cannot reasonably be enabled by a description in written form,” and thus must instead “be described in surrogate form by a deposit that is incorporated by reference into the specification,” citing Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 965 (Fed. Cir. 2002) (quoting 37 C.F.R. § 1.802(b)).  This has become “common practice” for such inventions, according to the Statement, citing Ajinomoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338, 1345-46 (Fed. Cir. 2000).  This system has the added benefit, in the Government’s view, that “U.S. companies can access biological material deposited in foreign depositories” and vice versa to satisfy the requirements, citing Feldman v. Aunstrup, 517 F.2d 1351, 1355-56 (C.C.P.A. 1975).

Under these circumstances the question arose:  can you infringe a patent merely by obtaining access to information in a biological deposit?  Corteva sought on summary judgment to prevent disclosure of such biological deposit information by ATCC.  The Government’s position is that “the Court should not deem any activity to constitute ‘infringement’ if it is a means of accessing and ‘reading’ biological material that the law requires be made publicly available in exchange for a valid patent or other IP protection.”  In the context of ATCC deposits, Corteva’s objections run contrary to the provisions of 37 C.F.R. § 1.808(a)(2), whereby “all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.”

These provisions of the law and regulations rebut any allegations by Corteva that access thereof by Inari is “without authorization” and thus infringing under § 271, the Statement argues.  This is despite the reality that “‘reading’ deposited biological materials requires something more,” specifically “following the appropriate techniques to excise the [patented material] from the deposit[s]” under 37 C.F.R. § 1.802(b) as provided in Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 965 (Fed. Cir. 2002).  This is so because to do otherwise would prevent the public from receiving “meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time” (emphasis in Statement).  The Statement faults Corteva for recognizing the beneficial effects of depositing for protecting its patent rights but ignoring the concomitant public benefit from its disclosure to permit the scope of those rights to be appreciated.  And the Statement notes that regulations require that “all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.”  The access Inari demands are part of all those restrictions according to the Government.

The Statement also recognizes that there can be a requirement for “a certain process be followed for public provision of the material” (emphasis in Statement) but these should not constitute “contractual, extra-statutory encumbrances” imposed by patent holders or the depository.

In a footnote, the Statement somewhat ironically says “[m]ost of the filings in this case are under seal, and the United States has no access to them.”

By Kevin E. Noonan –

On April 27, the Supreme Court heard oral argument in Hikma  v. Amarin, with Charles Klein, representing Hikma, Michael Huston representing Amarin, and Malcolm Stewart addressing the Court on behalf of the Government.

First, some statistics.  Charles Klein was questioned by the fewest Justices (Justices Thomas, Sotomayor, and Jackson), while Malcolm Stewart and Michael Huston were each questioned by seven of the Justices (Justices Thomas, Alito, Sotomayor, Kagan, Kavanaugh, Jackson, and Chief Justice Roberts questioning Stewart, and Justices Thomas, Alito, Kagan, Gorsuch, Kavanaugh, Barrett, and Jackson questioning Huston).

In his argument to the Court, Mr. Klein emphasized that “[Hikma’s] public statements entirely consistent with selling skinny-label generic drug products under Section viii cannot actively induce infringement,” which “requires a clear message that necessarily promotes infringement.”  Moreover, “[a]ctive inducement cannot depend on whether doctors might read infringing instructions into product descriptions that, on their face, are entirely consistent with non-infringing use.”  He concluded these remarks by warning that “under the decision below, patent lawsuits filed after skinny-label product launches will routinely survive a pleading challenge.”

Justice Thomas began by asking whether it would have been “safe” for Hikma to have said that its generic version of Vascepa was approved solely for the severe hypertriglyceridemia (SH) indication.  While responding to the question, Mr. Klein stated that the earliest press releases did make such statements but that they were not required under the law.  The Justice then asked whether Hikma would have been “baiting people into inducement” had they merely quoted Amarin’s comments regarding its indications for the drug, which Mr. Klein conceded could support a claim “if it’s a clear message that necessarily promotes infringement.”  The Justice concluded his questioning by asking whether “the only way to actively induce infringement is overstating or your own statements sound as though the patented use is covered by your product,” to which Mr. Klein responded by saying that “­if the generic basically adopts by reference statements by the brand that would encourage the infringing use, then that could plausibly state a claim.”

Justice Sotomayor asked whether Hikma was advocating any “special rules” for Section viii cases.  Mr. Klein responded that “the complaint does not pass the standard for plausibility under Twombly and Iqbal” and thus special rules are not necessary.  The Justice noted that such rules are “­almost impossible in this area because determining whether or not there’s active inducement is always contextual.”  The Justice further noted that it seems Hikma wants the Court to “change the words” the Court has used in earlier cases, but asks whether Hikma wants the Court to change the standards for finding inducement.  Mr. Klein responded that “there are obvious alternative explanations in view of the anodyne statements” made by Hikma and thus there is no need for a change in standards.

Justice Jackson, the last Justice to question Hikma’s counsel, asked for clarification that “generics have to have a label that essentially in all relevant circumstances mirrors the brand label, except for just admitting the patented indication.  Is that correct?” and that “even if Amarin is right that it thinks Hikma could have or should have excluded a certain study or included some other information, if those aren’t on the original label, Hikma can’t do that?”  Mr. Klein assured the Justice that a “generic can’t add new disclaimers or new labeling.”  In her follow-up, the Justice asked “it can’t be accused of inducing infringement by refusing to put things on the label that the brand didn’t have, right?” to which Mr. Klein answered the “statute doesn’t require active discouragement of infringement.”  Expounding on his answer, Mr. Klein stated that “under the decision below, you can get FDA approval of your skinny product label, but as soon as you put that product into commerce and you say anything about that product, anything, you call it a generic version, even if you have disclaimers, you can be sued.”  As a consequence, “[o]nce a generic launches its product, its profits will be much, much lower than the brand’s profits.  And so, if the generic gets hit for a lost profits damages award, it’s devastating,” something that has already happened in the GSK litigation against Teva, wherein “Teva got hit for hundreds of millions of dollars that dwarfed its actual profits.”

Mr. Stewart for the Government first stated that while “the label itself was not sufficient to get Amarin past 12(b)(6) in this case, we think the court of appeals erred in giving any weight at all to the label.”  He mentioned that “[t]he contents of a Hatch-Waxman skinny label are largely dictated by federal law and to treat the generic manufacturers’ compliance with those requirements as any evidence of intentional inducement to infringe would be wrong.”  With regard to Amarin’s explanation regarding the other generic manufacturers included in press releases that Amarin has not sued because they had expressed disclaimers that their product is not authorized for use to treat the cardiovascular (CV) indication, Mr. Stewart stated that “it’s a bedrock principle of inducement law that active inducement to infringe is required” and “[t]he question is not whether the defendant has adequately warned people away from infringement.”

Justice Thomas again posed the first questions to counsel, whether “in our world . . . not the Federal Circuit’s world . . . [w]hat would Respondent have to have alleged to survive a motion to dismiss?”  Mr. Stewart responded that “to identify statements or actions that had the clear purpose of causing others to infringe as something that the brand wanted to bring about” and “[under Grokster] by clear expression or other affirmative steps taken to foster infringement is liable for the resulting acts of infringement by third parties.”  The Justice next asked about the effect of state mandatory substitution laws, and Mr. Stewart said that the “difficulty of going after the direct infringer or getting the direct infringement to stop is not a justification for watering down inducement principles.”  He suggested that “Amarin and similarly situated companies could urge state legislatures to take measures to prevent this from happening” and that while branded drugmakers would not want to sue the doctors, “they could attempt informational campaigns to doctors and tell the doctors our product is the only one that is authorized to be used for the CV indication.”

Justice Alito asked about the effects on Hikma if they “had not just said its drug is generic Vascepa but went on to say that Vascepa is approved to treat cardiovascular risks?” and the Government’s counsel responded that if “it had said those two things in the same breath, that you would have a pretty strong case of active inducement,” whereas (responding to Justice Alito’s follow-up regarding statements that “studies have shown that icosapent ethyl, the active ingredient in our drug, reduces cardiovascular risks?”) Mr. Steward said “although probably closer to the line . . . when Hikma prepared its skinny label in conformity with the rules, kind of the most obvious thing it took off of Amarin’s label was the indication at the beginning [regarding the CV indication].”

Justice Sotomayor “asked the same question of you that I asked of Petitioners’ counsel” regarding whether the Court “need[ed] your new definition that you gave the Chief or saying again that following the label alone, exactly what the Federal Circuit said, is not enough?  Do we need any special rules?”  Mr. Stewart, consistent with Hikma’s position said no, that what was before the Court was “interpreting Section 271(b), which is not specific to Hatch-Waxman.”  Justice Sotomayor noted that she “always ha[s] problems when we use policy reasons to set a standard.  That’s not our job.  If they’re infringing a patent, they’re infringing a patent.  If they’re not infringing a patent, they’re not.  But why should we change our rules, narrow them or expand them – to avoid either result?”  Providing the Government’s position, Mr. Stewart answered that “if you sell something that can be used either in an infringing or a non-infringing way, then you still won’t be held liable for others’ infringement unless you’ve actively encouraged them to infringe.”

Justice Kagen asked her first questions about the FDA’s role and whether the reasonableness of Hikma’s actions depended on “how much patent review the FDA is doing when it approves the skinny label.”  Mr. Stewart gently disabused the Justice of any help available to the Court from the FDA by reminding her that “[t]he FDA has disclaimed patent expertise, and so it doesn’t purport to read patents.”  The extent of FDA’s involvement is that “the brand-name manufacturer will provide for the Orange Book what’s called a use code, which will describe what it believes its patents cover” and if the brand name is saying this wide range of uses would be patented, the FDA won’t look behind that.”

Justice Kavanaugh next asked questions, regarding “the United States’ concerns about the broader market implications of the decision?”  Mr. Stewart responded that of the evidence before the Federal Circuit the government was “most concerned with . . . the skinny label because all of the things that Amarin is complaining about are things that were on the brand name’s label, and the rule is the generic is supposed to use the same label as the brand unless there’s a good patent-specific reason to take things off.”  Moreover, “the flavor of [the Federal Circuit’s] opinion was that  [the skinny label] is almost enough, and if you have some pretty ethereal stuff at the — in addition, that will be enough to get you over the hump.”  The Government also thought the Federal Circuit “shouldn’t have attached any weight to the label” [because] Hikma” just did what it was supposed to do.”

Justice Jackson brought up the “the risk of liability and what it could do to a generic, I would think, would be pretty significant.”  Mr. Stewart responded that the risk “[is] very substantial in part because the generic is charging a lot -­ typically, a lot less for the drug than the brand name manufacturer is.”  Thus, “if the generic has to pay lost profits to the brand name, the profits that the brand name would have earned on a particular volume of sales would be much more than the generic has actually earned.”  He also noted that there was “more than an intimation in the Respondents’ brief that Hikma was doing something wrong by describing its drug in press releases as a generic version or a generic equivalent of Vascepa” although “that’s a normal thing to say.”  He also stated that it was not necessary for the Court to take state mandatory substitution laws into consideration.

The Chief Justice stated that the Government’s position regarding “that the generic person clearly reveal a purpose of infringement” is “a pretty broad safe harbor.”  Mr. Stewart responded that “it is supposed to be a difficult standard for the pleader to satisfy” and that “the Court has said in various contexts that when a product is capable of both infringing and non-infringing uses, it’s important that a patent on one method of use not become a de facto monopoly on the product as a whole.”  Further, Government’s counsel asserted that “it’s supposed to be feasible for people in Hikma’s position to market their product for the unpatented use without running afoul of liability for third parties who choose to use the product in infringing ways, unless they have affirmatively encouraged that to be done, the mere knowledge that it will be done or the expectation that some people will infringe is not.”

Amarin’s counsel, Mr. Huston, began his remarks by stating that “[t]he implications of this Court’s ruling in this case will go far beyond the pharmaceutical industry.”  Regarding Hikma, he said that in return for receiving the “full benefit of the Hatch-Waxman compromise” they were “required to promise not to promote its product for any still patented use of Amarin’s branded drug.”  This limitation is “absolutely vital” and is “the only thing that makes it economically rational for a branded company like Amarin to spend the $300 million that Amarin spent in the REDUCE-IT trial to discover that an existing drug, Vascepa, actually had life-changing implications to treat cardiovascular risk.”  While recognizing that most questions of inducing infringement involve evidence of intent, here Hikma has not contested intent at the pleadings stage.

Justice Thomas, responding to Amarin’s counsel’s reference to Hikma’s statements that “Hikma alone was the one who described its product as AB rated for ‘hypertriglyceridemia,’” asked whether there was anything inaccurate about that statement?  Mr. Huston said that “[y]es, there absolutely was” but he “also do[es]n’t think, frankly, it matters whether it was inaccurate” because “[a] statement can be absolutely true” but “truth is not a defense to liability in an induced infringement situation.”  Should Hikma simply quote Amarin, Mr. Huston responded that “­they cannot do that, Your Honor, because the whole point of the compromise is that Hikma is allowed to market its product but only for the unpatented use.”  Whereas “If Hikma comes on and quotes Amarin’s marketing of its product to treat for the patented purpose, that’s the most classic case of induced infringement.”  Mr. Huston also stated that “the key statement on which we rely here, the statement on Hikma’s website where it described what its drug is for, was not accurate.  Hikma said its product was for treating hypertriglyceridemia.  That’s misleading, if not false, because Hikma’s product was approved by FDA only to treat severe hypertriglyceridemia, and that’s a distinct medical condition that presents distinct medical risks.”

Justice Alito asked his only question, whether “just saying generic Vascepa would be enough?” Mr. Huston said it was not where it was “merely saying, one time, generic Vascepa is enough to state a claim for liability.”  Amarin’s allegation was that “Hikma said it over and over and over again [at a] key moment where there was a key market association between Vascepa and treating cardiovascular risk” [which] was the context.  Grokster says, of course, that induced infringement is a context-dependent analysis.”

Justice Kagan raised the issue that the press releases “were really issued for investors” and that “this was not the way the company marketed itself to doctors” but Mr. Huston challenged that conclusion, stating that “they’re not consciously directed at investors, not expressly directed at investors” and that at “the pleading stage . . . all inferences that are fair have to be taken in our favor.”  Justice Kagan persisted, asking for “any evidence at all [that] Hikma directed these to the medical community, that Hikma gave these press releases to doctors?” and Mr. Huston maintained that “this is advertising, Your Honor, which is, as Grokster said, a classic form of induced infringement since common law.”  He again asserted that at the pleading stage such evidence was not required, while noting that “evidence has come in in other cases where doctors have testified that they do pay attention to press releases and that they do pay attention to the announcements of when generics are coming online.”  The Justice also asked whether her apprehension was correct, that Amarin had “really dialed down your reliance on the skinny label” in its response to Hikma’s arguments to the Court, and asked whether Amarin agreed with the Government’s contention that the label “has no relevance?”  Counsel demurred, stating that “this Court is not accustomed in pleading cases and in Section 271(b) cases to saying there’s a category of evidence that’s sort of fundamentally off the table.  That to me sounds like the creation of a safe harbor, and I think that’s a legislative task fundamentally.”  Mr. Huston also argued that “the skinny label is not the heart of our case by any means,” being “one piece of evidence.”  Indeed, he also argued that the label was “an opportunity for Hikma to try to sort of mitigate the damage from its unlawful statements,” which Hikma did not take.

Procedurally Mr. Huston argued that “the Court’s far and away most common practice [in the event that the Justices rule against Amarin] would be to vacate the Federal Circuit’s opinion and remand” and “not . . . enter the form of judgment in this Court that Hikma requests, which would be to sort of declare the case over.”  One reason in support of this decision by the Court would be that “since Hikma did not stay the mandate, extensive discovery has occurred . . . that has revealed substantial new evidence of Hikma’s intent to infringe and the effect.”

Justice Gorsuch in his only line of questioning asked about the effect of “a further disclaimer on the website, saying that “Hikma’s generic version is indicated for fewer than all approved indications of the reference listed drug.”  Mr. Huston pointed out that the disclaimer appears “in quite tiny print” and that “It doesn’t disclaim that Hikma’s product can and should be used to treat the most famous use of Vascepa, the billion-dollar use, which is saving patients’ lives by treating cardiovascular risk.”  He also ascribed the disclaimer to being produced “by a clever lawyer to try to minimize Hikma’s liability while still sending the fundamental message that is coming across by all the collection of Hikma’s statements that says doctors can and should prescribe Hikma’s product anytime they would prescribe Vascepa.”  The Justice brought up the intent issue in the context of Twombly and Iqbal, which were antitrust cases, which is “a whole different world.”  Mr. Huston conceded that “it’s very hard for me sitting here in the Supreme Court of the United States to put myself in what arguments we would have made if Hikma in a motion to dismiss had said we want to contest our unlawful intent the same way the defendant in Twombly contested its intent” in this case, where “Hikma did not contest its unlawful intent at this stage.”  Counsel also took the opportunity to refute Hikma’s argument that deciding in Amarin’s favor would “devastate the generics market,” which he contended “is just factually untrue” saying “the surest reason you can know it’s not true is because there’s seven other generics in this market selling this product who know how to market their product lawfully.”

Mr. Huston also responded to Justice Gorsuch’s procedural question that Amarin should be able to ask the District Court for leave to amend if the Court rules against them.

Justice Kavanaugh asked Mr. Huston to address Hikma’s argument (echoed somewhat by Congressman Waxman’s amicus brief) regarding the potential, if affirmed, for this decision to “have some serious implications market wide.”  Mr. Huston relied on “the other side of that compromise [that] was about protecting the need to encourage branded drugs to take existing products and invest massive resources to discover how those drugs can be used for new cures” in response.  When the Justice responded to this argument by stating that he “take it seriously when someone says this is upsetting the compromise,” Mr. Huston in rejoinder stated that the Court can have “confidence” that this will not come to pass are the other generics who have taken advantage of the “ready road map to avoid induced infringement liability.”

In her only questioning of the day, Justice Barrett asserted that “this is a pretty fact-bound case about the plausibility standard” and that she didn’t know whether the Court had anything more to do than applying Twiqbal (Twombly and Iqbal) to the complaint?  Mr. Huston took this opportunity to reiterate Amarin’s position that “the Court [need] not adopt a new induced infringement standard with words like express promotion is required.”  In responding, Mr. Huston said (in addition to agreeing with the Justice) “the key question in the case is as in most cases of induced infringement, what was the message that the doctors who read these Hikma statements took away?” to which Justice Barrett agreed.

Mr. Huston took the opportunity to assert that, should the Court rule against Amarin and that their complaint does not state a claim for relief, then “that’s going to have serious implications” and “[i]t’s going to make it much, much harder to plead induced patent infringement.”  And the consequence of that decision would be that “would just be economically irrational to make that kind of investment that discovers a lifesaving cure” spending “five years, we spent $300 million, and we discovered something that is literally saving people’s lives.”

Mr. Huston also responded to the Justice’s procedural question by reiterating that Amarin intends to amend its complaint.

Justice Jackson, the last Justice to pose questions to Mr. Huston, contrasted the Government’s position, that would require evidence “for . . . an intent on the part of this manufacturer to be inducing people for the patented purpose” with Amarin’s standard (“as far as I can tell”) is “more just what message would the doctors have taken away from the marketing materials?”  The Justice asked “if the intention of the generic is to mention Vascepa and the size of the market, et cetera, et cetera, for the purpose of getting investment, not for the purpose of inducing doctor infringement, what do we do with that in terms of understanding whether active inducement liability lies?”  Mr. Huston replied that the Court should not accept Hikma’s assertion but the Justice replies that “it’s your burden,” Mr. Huston responding  that “the inducer has to both have the intent that that happen and take active steps.”

Mr. Klein in rebuttal (which drew no questioning from the Court) contested Amarin’s argument that additional evidence of intent to induce infringement arose during discovery (“Just to be clear, there is no such evidence”).  Procedurally, Hikma argues that should the Court reverse and remand, Amarin’s lone remedy was a Rule 60 Motion.  Hikma also argues that under Twombly and Iqbal “if there’s an obvious alternative explanation, a complaint doesn’t survive the pleadings stage just because maybe some physician out there might possibly read an instruction” (which there are in this case).

It is never wise to opine, or worse speculate on, how the Court will rule or even why the Justices granted certiorari (indeed, Justice Barrett herself states that “[before the Court in this case] is a fact question [as] Justice Alito observed the other day [and] I’m not sure why this case is here except four of my colleagues wanted it to be”), particularly under a very expedited briefing schedule as there was here).  Certain themes are evident:  for example, Justice Sotomayor is leery of the Court establishing new rules or standards for inducement of infringement outside the standards under current case law.  Certain of the Justices were asking for clarification of the statute or patent procedures while others were concerned about disruptions of the Hatch-Waxman regime that has promoted generic drug entry for over forty years.  There is even the barest of hints that the Court may decide that the opportunity certain of the Justices might have thought the case represented was in fact not the case.  The answer should be forthcoming in the next four to six weeks.

By Kevin E. Noonan –

While the Supreme Court established a rather definitive standard (“reasonable certainty by a person having ordinary skill in the art”) for determining indefiniteness under 35 U.S.C. § 112(b) in Nautilus, Inc. v. Biosig Instruments, Inc., and indefiniteness is a question of law mandating less deference by the Federal Circuit, the issue has arisen again in Enviro Tech Chemical Services, Inc. v. Safe Foods Corp.

The litigation relates to U.S. Patent No. 10,912,321 (“the ‘321 patent”) that is directed to “[m]ethods for treating poultry during processing for increasing the weight of the poultry,” using “peracetic acid,” according to the opinion; claim 1 of the ‘321 patent is reproduced in the opinion as being representative:

1.  A method of treating at least a portion of a poultry carcass with peracetic acid, said method comprising the steps of:

providing, in a reservoir, a peracetic acid-containing water, wherein the peracetic acid-containing water comprises water and an antimicrobial amount of a solution of peracetic acid;

after the step of providing the peracetic acid-containing water, determining the pH of the peracetic acid-containing water, and altering the pH of the peracetic acid-containing water to a pH of about 7.6 to about 10 by adding an alkaline source;

after the step of determining the pH and altering the pH of the peracetic acid-containing water, placing into the peracetic acid-containing water at least a portion of a poultry carcass;

after the step of placing at least the portion of the poultry carcass into the peracetic acid-containing water, determining the pH of the peracetic acid containing water in the reservoir with at least the portion of the poultry carcass therein, and altering the pH of the peracetic acid containing water to a pH of about 7.6 to about 10 by adding an alkaline source; and

after the step of determining the pH and altering the pH of the peracetic acid-containing water having at least the portion of the poultry carcass therein, removing at least the portion of the poultry carcass from the peracetic acid-containing water.

Defendant Safe Foods convinced the District Court that the terms “an antimicrobial amount” and “about” were indefinite, and this appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judge Prost and District Judge Burroughs,* addressing the “about” limitation alone.  The panel specifically affirmed the District Court’s conclusion that neither the “the claims, specification, [nor] prosecution history,” i.e., the totality of the intrinsic evidence “inform[ed] a skilled artisan as to the scope of the term ‘about’ with reasonable certainty” and thus was indefinite.  While that determination could have been dispositive, relying as it does on the standard set forth by the Supreme Court in Nautilus, Inc. v. Biosig Instruments, Inc., the opinion fleshes out its jurisprudence (that has so far withstood negative Supreme Court review) by citing a number of its own cases.  These cases stand for the propositions that “words like ‘about’ and ‘approximately’ may be appropriately used to ‘avoid[] a strict numerical boundary to the specified parameter,’” OrthoMcNeil Pharm., Inc. v. Caraco Pharm. Lab’ys, Ltd., 476 F.3d 1321, 1326 (Fed. Cir. 2007) (quoting Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1217 (Fed. Cir. 1995)); and “[t]erms of degree, like ‘about’ and ‘approximately,’ are not inherently definite or indefinite,” citing Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1218 (Fed. Cir. 1991).  However, these considerations are bounded by the requirement that “[w]hen a word of approximation is used, . . . the parameter’s range must be reasonably certain based on the ‘technological facts of the particular case,” under Ortho-McNeil, 476 F.3d at 1326 (quoting Pall, 66 F.3d at 1217); and Amgen, 927 F.2d at 1218.

The opinion then dissects the claims, specification, and prosecution history in search of disclosure regarding the definiteness or lack thereof of the term “about.”**  The claims do not recite any guidance relating to how much below the limits of pH 7.6 to pH 10 the word “about” modifies, the opinion asserts; substituting “approximately” for “about” provides no additional clarity.  Nor is there any disclosure in the specification that provides any “reasonable certainty” for the definition of the term; the best that could be gleaned would depend on the restriction of the variability for large number of experiments disclosed but even there “[in the] majority of the experiments, Enviro Tech proceeded only when the difference of the actual pH was less than or equal to 0.3 of the target pH.” In what the Court perceives as being a “particularly informative” example (due to the large number of chickens involved and recitation of the “goal” of the claims as being to “increase . . . a processing plant’s percent yield”) the disclosed experimental variation (of up to 0.35 to 0.5 of the target pH) provides “conflicting guidance” when compared with the consistent 0.3 variance in the majority examples.  Finally, in the prosecution history, Enviro Tech inconsistently argued inter alia non-obviousness with regard to specific limitations (“pH 7.6”) or the more flexible version thereof (“about [pH] 8 to about [pH] 9”).  The totality of the inconsistent use of the word “about” with regard to pH informed the Court that the term was “material to some claims and immaterial to others,” supporting indefiniteness according to Infinity Comput. Prods., Inc. v. Oki Data Ams., Inc., 987 F.3d 1053, 1059 (Fed. Cir. 2021).  And Enviro Tech’s arguments that its behavior during prosecution surrendered claim scope fell on deaf judicial ears based on those consistent inconsistencies and lack of simple declarative sentences providing the Office with the construction Enviro Tech now asserts.

Finally, the panel notes that claim 1 was amended to avoid certain prior art (having a pH of 7.0), which requires “much more clarity [to achieve?] than the vague term ‘about.’”

* Honorable Allison D. Burroughs, District Judge, U.S. District Court for the District of Massachusetts, sitting by designation.

** A short perusal of the use of the word “about” in the ‘321 patent (specification, claims, and abstract) discloses 241 uses of the word, none of which is associated with an express definition.

*** A broader review of indefiniteness relating to the term “about” can be found in Claim Construction and the Federal Circuit (The Intellectual Property Law Association of Chicago Litigation Committee, Noonan, KE, and Kelly, AG, eds.), West Publishing Co., 2024, Chapter 7.2 including:

• General Hospital v. Sienna Biopharmaceuticals, 888 F.3d 1368 (Fed. Cir. 2018), construed based on express disclosure of range of nanoparticle sized

• Allergan v. Sandoz, 796 F.3d 1293 (Fed. Cir. 2015), construed “about pH 7.3” to encompass variations of no more than one decimal place based on disclosure of a range of pH 6.8-7.2

• In re Cyclobenzoprine Hydrochloride Extended-Release Capsule Patent Litigation, 676 F.3d 1063 (Fed. Cir. 2012), reversed a construction wherein the claim limitation “about 125%” of a reference Cmax value was found to be infringed by an accused article having 129.5% of the reference in the absence of specification support

• Fering B.V. v. Watson Laboratories, 764 F.3d 1382 (Fed. Cir. 2014), held that, without additional disclosure in the specification the term “about” had an “ordinary and accepted” meaning of “approximately” as that term and the scope thereof would be understood by the skilled worker in the art.

Enviro Tech Chemical Services, Inc. v. Safe Foods Corp. (Fed. Cir. 2026)
Panel: Circuit Judges Lourie and Prost and District Judge Burroughs
Opinion by Circuit Judge Lourie

By Kevin E. Noonan –

In addition to the briefs from the parties, seventeen amicus briefs were filed with the Supreme Court in Hikma v. Amarin: six in favor of Petitioner Hikma, seven in favor of Respondent Amarin, and the remaining five on behalf of neither party (although the latter category is in some instances shaded by underlying biases).  Synopses of the briefs in favor of neither party are provided in this post.  Synopses of the briefs in favor of Hikma were provided here, and synopses of the briefs in favor of Amarin were provided here.

New York Intellectual Property Law Association

This brief argues that the Court should “preserve ordinary inducement and pleadings standards,” and reminds the Court of its history of having “consistently rejected bespoke pleadings standards.”  And while not being submitted in support of either party, amicus argues that the Federal Circuit “correctly articulated the ordinary inducement pleading standard” below.  Amicus assert that both parties have argued for modified (Hikma) or heightened (Amarin) pleadings standards to be applied; amicus argue that:

This Court should reinforce that there is no special or specific standard for inducement, no heightened or permissive pleading standard, and no prescriptive rules about what can or cannot be considered under either standard.  There are just the broadly applicable general standards—the same inducement standard and the same pleading standard this Court has long embraced.

Amicus argues that “for decades, courts have stuck with a commonsense, common law standard, without the need to ratchet the standard up or down to account for differences in factual circumstances, technological subject matter, or even the area of law (e.g., patent versus copyright).”  And the “[c]ourt has declined . . . invitations repeatedly” for bespoke pleadings standards, citing as an example Berk v. Choy, 607 U.S. ___, 2026 WL 135974, at *4 (Jan. 20, 2026) (citing cases).  Further:

Neither party appears to question that the complaint adequately alleges both direct infringement by physicians and Hikma’s scienter for purposes of an inducement claim.  The only issue is whether, in this mix of facts and circumstances, the complaint has also plausibly alleged active steps to induce infringement—which, as explained above, is a question bound up with the nature of the industry, relationships between Hikma and physicians, and degree of Hikma’s scienter.

“Swinging too far in either direction—too rigid or too lax a standard—would instead unsettle the ‘balance’ Congress struck in the Hatch-Waxman Act . . . between . . . (1) inducing pioneering research and development of new drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to market’” according to amicus, citing Caraco Pharm. Lab’ys, Ltd. v. Forest Lab’ys, Inc., 527 F.3d 1278, 1282 (Fed. Cir. 2008) (citation omitted).

The brief maintains that “[a]micus NYIPLA takes no position on the circumstances under which the user of a skinny label may be found to have induced infringement, nor whether Amarin successfully states a claim here.”  Perhaps somewhat surprisingly, the brief concludes with an analysis of the grounds for the Federal Circuit’s opinion and the conclusion that the appellate court had not erred because it had “announced the correct, ‘run-of-the-mill’ standard for pleading inducement.”

Public Interest Patent Law Association

This amicus takes the position that “the Hatch-Waxman regime combined with limits on statutory inducement strikes the proper balance between innovation and affordable health care.”  Nevertheless, the brief contains warnings regarding whether “uncertainty over equivalence and marketing statements raises compliance costs and creates confusion, resulting in a chilling of the marketplace” and that “increased costs for generic manufacturers will ultimately trickle down to consumers.”  These include placing limits on Section viii, which amicus argues “would allow U.S. drug companies to raise prices for American consumers.”  The brief also raises First Amendment concerns based on potential limits on commercial speech such as advertising that have arisen below.

“Inducement liability has long required purposeful encouragement of infringement, not mere awareness that infringement might occur through lawful commerce” the brief asserts, citing Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364 (Fed. Cir. 2003), and Congress legislated in reliance on this “settled understanding,” citing Takeda Pharms. U.S.A. v. West-Ward Pharm. Corp., 785 F.3d 625, 631 (Fed. Cir. 2015).  Section 271(b) was intended to “safeguard conduct Congress expressly authorized to facilitate timely generic entry” provided that it is properly applied, but “[t]reating lawful Section viii marketing, truthful competitive statements, or FDA-required disclosures as evidence of inducement collapses the specific intent requirement into mere foreseeability.”  As a consequence, “[g]eneric manufacturers may face liability for engaging in lawful competition,” and “[f]aced with unpredictable exposure, manufacturers may delay or abandon carved-out approvals altogether—undermining Congress’s chosen mechanism for introducing lower-cost medicines while patients on discrete uses remain in force.”

And the brief obliquely set out the specter of the “patent thicket” meme (the liberal use of “monopoly” in the brief being a hint to this amicus’ biases), stating that “[s]econdary method of use patents tend to require less innovation and provide limited benefits to patients” (apparently willing to ignore examples such as Rogaine as inconveniences to their argument).  This is perhaps the argument that may have the most resonance with the Court with the least justification; it is ironic that significant efforts have been undertaken in the past decade to find secondary uses for known drugs, which have the benefit for being known to be safe and effective and for which side or adverse effects have been identified through population use (having a number of patients that have been administered the drug being much greater than any clinical trial could possibly have).

But accepting the premise, the brief argues that such patents “should not be further strengthened” inter alia because “such patents are frequently deployed strategically to delay competition.”  The solution for this amicus is that “[r]obust Section viii entry under the Hatch-Waxman Act, by good faith actors, should be preserved” to avoid “entrenching monopoly practices and rendering the statutory provision effectively meaningless.”

Intellectual Property Owners Association

This brief contends that the Federal Circuit used the correct legal standard in the pleadings, specifically as set forth in Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009), and Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556-557 (2007), and that there is neither statutory basis nor need for special pleadings standards for Section viii carve-out litigation.  “Plausibility” pleading should be sufficient, this amicus argues, to “preserve[] the statutory balance between generic competition and innovation.”

The brief succinctly sets forth what should be done for Section viii pleadings:

[L]ower courts should review all well-pled facts in determining whether a claim for active induced infringement of a granted U.S. patent has been sufficiently pled under 35 U.S.C. § 271(b). In the context of a pharmaceutical patent, this would include all statements and information included in the FDA-approved drug label, as well as all statements made by the accused infringer in connection with the marketing of the alleged infringing drug product. Such an evaluation of the totality of the circumstances will turn on the particular facts plausibly pled in the complaint, as IPO contends it should.

“The crucial point here is that context matters.  Analyzing statements in isolation rather than in the total context of well-pled facts can lead to incorrect conclusions,” this amicus counsels.  But the brief cautions against instituting “bright line rules” which are not supported by either the Federal Food, Drug, and Cosmetic Act (“FFDCA”) or the Patent Act of 1952.  Such rules would enable “generic drugmakers to game the carefully balanced system set up by Congress, allowing generic drugmakers to receive FDA approval based on a Section viii carveout while, at the same time, promoting potentially infringing, off-label uses” (which is, of course, what Amarin and other branded drug makers are afraid is happening without application of inducement of infringement liability to prevent it).

Licensing Executives Society

This amicus argues the platitude that “reliable patent rights are essential for robust innovation and investment” as well as assessing the role of induced infringement in protecting patent rights.  Amicus argues that stable patent rights are promoted by “clear, flexible pleading requirements” and remind the Court that “FDA approval concerns equivalence—not patent law.”  And regardless of the conventionality of these sentiments, the brief argues that “[t]he outcome of this case will have significant practical implications for the American innovation ecosystem—in the pharmaceutical industry as well as all other industries that rely on patent protection to enable investment in innovative research and development” because “[w]hen the rights granted under a U.S. patent become unpredictable, investment in innovation declines, which in turn reduces research and development.”  The importance of having certainty is reflected in the costs of bringing pharmaceuticals to market, the brief citing Michael Schlander et al., “How Much Does It Cost to Research and Develop a New Drug? A Systematic Review and Assessment”, 39 PharmacoEconomics 1243 (August 2021), regarding pre-launch capitalized costs ranging from $161 million to $4.5 billion in USD as of 2019, particularly in an industry where “[m]any of these products never reach the market,” citing Chi Heem Wong et al., “Estimation of clinical trial success rates and related parameters,” 20 Biostatistics 273 (April 2019) (probabilities of success in clinical trials ranging from 3.4% for oncology drugs to 33.4% for infectious disease vaccines).

The brief sets out the consequences of affirmance or reversal by the Court:

If the Court affirms, permitting enforcement of claims of induced infringement as presented here, patent rights will be seen as more reliable and predictable and, thus, stronger.  This will lead to increased investment in innovation, including the discovery of new drugs and new treatments.

Conversely, if the Court reverses and curtails enforcement of induced infringement claims such as are made here, entry of follow-on (generic) products during the patent term—in pharmaceutical markets and others—will be more likely to occur.  And it bears repeating that the outcome of this case will have implications for patent law generally and thus will reach far beyond the pharmaceutical sector.  As noted above, the pleading requirements for induced infringement will apply equally to all patents and all industries, from microchips to baseball mitts.

Gugliuzza and Sherkow

These academic amici make the argument that the Federal Circuit’s decision “improperly expands induced infringement liability beyond the proper bounds of § 271(b), “continu[ing] the trend of imposing inducement liability for regulated statements by generic drug companies” (citing GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.; United Therapeutics Corp. v. Liquidia Technologies, Inc.; and Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., in support of this assertion).  The Court’s error (or at least one of them) is that the Federal Circuit “improperly relied on Food and Drug Administration (FDA)-regulated drug labeling to expand inducement liability beyond its proper boundaries,” in these amici‘s opinion (i.e., the “bare textual reading of a drug label”) in combination with “anodyne public statements about generic equivalence.”  What is missing in the evidence relied upon by the Federal Circuit, according to the brief, is that labeling “reflects regulatory compliance rather than affirmative encouragement” and “cannot be inducement without evidence of causation” (which they have termed elsewhere “infringement by label,” see Sherkow & Gugliuzza, 2026, “Infringement by Drug Label,” 78 Stan. L. Rev. 131).  Skinny labels, on their own, should not raise inducing infringement liability amici contend; after all, “[g]enerics do not write their drugs’ labels” and thus labels alone should not raise inducing infringement liability.  The brief also emphasizes the restrictive nature of FDA label requirements, and (citing Judge Prost’s dissent in GSK v. Teva“) “the statutory design of the Hatch-Waxman Act makes it untenable to infer culpable intent from what the law mandates.”

The remedy is for the Court to reaffirm existing inducement law, these amici argue, particularly the requirement for volitional conduct by the generic drug maker that “encourages, recommends, or promotes infringement” and “actually [(presumably) imposing an evidentiary burden on plaintiffs)] influences physicians’ prescribing behavior” (emphasis in brief).  Under these circumstances, “in cases where there are plausible allegations and genuine, disputed evidence of inducement beyond the mere wording of a label, both brands and generics would retain their right to have those factual disputes resolved at trial.”

By Kevin E. Noonan –

In addition to the briefs from the parties, seventeen amicus briefs were filed with the Supreme Court in Hikma v. Amarin: six in favor of Petitioner Hikma, seven in favor of Respondent Amarin, and the remaining five on behalf of neither party (although the latter category is in some instances shaded by underlying biases).  Synopses of the briefs in favor of Amarin are provided in this post.  A prior post provided synopses of the briefs in favor of Hikma, and a subsequent post will provide synopses of those in favor of neither party.

AbbVie and BMS

These amici argue that generic drugmakers know and should not “support and profit” from “pervasive end-user (i.e., physician) infringement.”  This case, in the view of amici, is a “classic case” of induced infringement, and that selling goods (of any kind, presumably) with knowledge of end-user infringement and “taking no steps to mitigate or prevent it” suffices to state a plausible claim for induced infringement.  The comparison the brief makes is “aiding and abetting” unlawful actions of another.  The brief bases the predicate harm to Amarin on Hikma’s knowledge that 75% of the prescriptions filled for their generic drug for the treatment of the CV indication.  It is Hikma’s inaction with regard to informing its customers – drug wholesalers and physicians – not to prescribe CV patients with Hikma’s generic version of the drug that provides the plausibility to support Amarin’s complaint.  For these amici, the evidence adduced by Amarin and relied upon by the Federal Circuit (“Hikma’s website, investor statements, or press releases”) while consistent with Hikma’s liability was unnecessary in view of their inaction in the face of infringement that they profited from.

In the view of these amici, the allegations against Hikma made here by Amarin were “even stronger” than in prior cases (such as Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011); Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913 (2005); and even more recently, Cox Communications, Inc. v. Sony Music Entertainment, No. 24-171, 607 U.S. __, slip op. (Mar. 25, 2026)) where the Court found infringement inducement liability.  The brief makes a distinction between the authorized Section viii carved-out indication and “the infringing uses of the patented indication.”  These amici accuse Hikma of seeking “a categorical rule that would effectively expand the section viii carveout to foreclose inducement claims whenever a skinny label is present, regardless of the defendant’s knowledge of pervasive and systemic infringement and its decision not to try to mitigate or prevent it.”  And as for policy implications, “[i]mposing liability here would create a narrow and administrable rule that is consistent not just with well-established patent law, whereas reversing would “trigger deleterious reverberations throughout all of these areas of law and frustrate the clear congressional purpose of Section 271(b) of the Patent Act.”

Imposing such liability is not unfair to Hikma, according to these amici, because using “readily available measures” it could have informed its customers of the limitations of what its drug should be used to treat, and its own prescription data would have identified infringing entities to whom these restrictions should have been told (making reference to practices in other countries applicable to this situation).  Amici characterize this as “a classic case of induced infringement,” based on Hikma’s inaction while in possession of knowledge of infringing activities of its end users (citing Grokster and A&M Records, Inc. v. Napster, Inc., 239 F.3d 1004, 1022 (9th Cir. 2001), for the sufficiency of this evidence).

The brief concludes with a historical overview of aiding and abetting law and the frank comparisons and similarities to inducement of infringement in this case, the brief citing Grokster and Global-Tech as well as Aro Mfg. Co. v. Convertible Top Replacement Co., 377 U.S. 476, 485-86 n.6 (1964); Dawson Chem. Co. v. Rohm & Haas Co., 448 U.S. 176, 188 (1980); Thomson-Houston Elec. Co. v. Ohio Brass Co., 80 F. 712, 721 (6th Cir. 1897); and Chas. H. Lilly Co. v. I.F. Laucks, Inc., 68 F.2d 175, 181 (9th Cir. 1933); and that “[k]nowledge of downstream infringement has long been central in patent and other intellectual property cases, citing Bowker v. Dows, 3 F. Cas. 1070 (C.C.D. Mass. 1878); Henry v. A. B. Dick Co., 224 U.S. 1 (1912), overruled as superseded by statute; Motion Picture Patents Co. v. Universal Film Mfg. Co., 243 U.S. 502, 517–18 (1917); and Harper v. Shoppell, 28 F. 613, 615 (C.C.S.D.N.Y. 1886).  Finally, the brief argues that a more recent case, Twitter v. Taamneh, 598 U.S. 471 (2023), supports the position advocated here.

Judge Michel and Scholars

Former Federal Circuit Chief Judge Paul Michel, joined by 9 scholars,* filed an amicus brief that argued that new indications while yielding “great public benefits” still required “the incentives of patent protection.”  In addition, these amici argue that Section viii “was never intended to be a safe harbor for infringing method of use patents.”  Finally, they argue that “allowing this case to proceed past the Rule 12 stage will not deter Section viii carve-outs.”

The brief agrees with the Federal Circuit as this case being “nothing more than a run-of-the-mill induced infringement case arising under 35 U.S.C. § 271(b)” at a “nascent stage” of litigation and “this staging is critical” because it negates Hikma’s argument that the case is about Section viii carve-outs.  Amici believe that the issue before the Court is “about substantially more than skinny labels.  It is about the totality of the allegations necessary to state a plausible claim for induced patent infringement—including, but not limited to, allegations about the content of the skinny label itself—necessary to state a plausible claim for induced patent infringement.”  The brief reminds that the standard for induced infringement is an “intent-based liability” standard, citing Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 930 (2005); Global-Tech Appliances, Inc. v. SEB SA, 563 U.S. 754, 760 (2011); Commil USA, LLC v. Cisco Sys., Inc., 575 U.S. 632, 642 (2015); Cox Commc’ns, Inc. v. Sony Music Entertainment, 607 U.S. ___, 2026 WL 815283, at *6 (U.S. Mar. 25, 2026); and  Grokster, 545 U.S. at 936.  An important distinction drawn in the brief is that “matters of intent must be proven inferentially, based on the totality of the circumstances.”

As other amici have discussed, “direct infringement inevitably is enabled by generic drug entry into the marketplace” and the “economic incentives for doing so are ample and obvious.”  And, the brief goes on, “a generic manufacturer need not do much to actively encourage further, and more entrenched, infringement of method-of-treatment patents.”  Under those circumstances, “a complaint such as Amarin’s need not plead much in terms of a generic manufacturer’s actions—including, but scarcely limited to, its skinny label—to establish a plausible claim that the accused infringer has expressed an affirmative intent that the generic drug be used to induce infringement of a method-of-treatment patent.”

Under these circumstances, the Federal Circuit was correct with regard to Amarin’s pleadings, amici argue.  The alternative would be “that the Section viii skinny-label carve-out insulates a defendant from liability for induced infringement,” if the Court were to reverse that decision, and “the consequences for our Nation’s innovation economy would be profoundly negative,” because “a system of incentives reflected in the patent bargain would be seriously undercut if a defendant were immunized from liability simply by claiming a narrow indication in its label, while at the same time engaging in other conduct demonstrating an intent to encourage healthcare practitioners to administer the drug for infringing, off-label uses.”

Also included in the brief is a review of drugs having later-discovered indications and the costs incurred to bring that indication to market (and the need for patenting incentives to incur such costs).

These amici take a moment to disagree with assertions in the 76 Scholars brief that determining inducing infringement is “simple, clear, easily determined matter, . . . particularly at this nascent pleading stage.”

*Kristina M.L. Acri, The Colorado Collee; Michael Doane, University of Akron; Bowman Heiden, UC-Berkeley; Joshua Kresh, University of Akron; Emily Michiko Morris, University of Akron; Kristen Jakobsen Osenga, University of Richmond School of Law; Douglas Park, University of Akron; Mark F. Schultz, Senior Scholar IPPI; Ted M. Sichelman, University of San Diego School of Law.

Regeneron

Regeneron argues that the Court’s Twombley and Iqbal precedent (combined with the Federal Rules of Civil Procedure) provide “a neutral, workable pleading standard,” as well as a “flexible standard that keeps the Federal Court system open without constant Congressional intervention.”  In this case, the Federal Circuit applied the pleading standards “exactly as Twombly and Iqbal require.”

Whether a plaintiff satisfies the pleading standard for induced infringement requires “an evaluation of all the alleged facts” (emphasis in brief), wherein “no facts are excluded from the analysis, and no specific facts or words need be recited.”  This situation would be changed should the Court adopt Hikma’s position, amici argue, wherein “some facts (e.g., “general” marketing statements) would not be considered in determining whether a defendant either intended to cause or actually did cause infringement” (emphasis in brief).  And “at the same time . . . petitioners’ position would require a plaintiff to plead certain ‘magic words’—namely it would require a plaintiff to allege that the defendant expressly called for a specific, patented use of its product.”  Regeneron “urges” the Court not to “either (i) exclude[e] certain kinds of factual allegations from the analysis or (ii) require[e] a plaintiff to plead that a defendant has expressly mentioned the patented use.”

In this amicus‘s view, the Court being persuaded to reverse the Federal Circuit’s decision would undermine this precedent and involve creating heightened pleading rules.  Adapting such “special pleading” rules would be inconsistent with patent protection in their view.

AIPLA

The brief filed by the American Intellectual Property Association argues that inducing infringement liability is enshrined in the statute and requires a “totality of the circumstances” analysis (a comprehensive recitation of the development of inducement of infringement through its codification in 35 U.S.C. § 271(b) is provided that provides historical context), while more recent cases (Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 760 (2011); Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc., 843 F.3d 1315, 1332 (Fed. Cir. 2016) (quoting Astornet Techs. Inc. v. BAE Sys., Inc., 802 F.3d 1271, 1279 (Fed. Cir. 2015)) are provided in support of its argument.  The brief also cites cases where defendant’s advertising that encouraged consumers to practice patented methods were used to support an inducement of infringement liability determination; Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d 1201, 1220, 1222 (Fed. Cir. 2014).  Application of an “affirmative acts” standard is set forth in Power Integrations as assessed by the Federal Circuit to consistently require “all facts and circumstances” to be considered in making such a determination.

Amicus posits that the Hatch-Waxman Act does not exempt or absolve “skinny label” entrants from liability.  The Court should not change the pleadings standard or create “special pleading” standards this amicus contends; like other amici, the AIPLA believes that the Court’s Twombley and Iqbal precedent is appropriately flexible enough to properly evaluate an inducement of infringement allegation.  The Twombley/Iqbal standard “permits plaintiffs who allege specific affirmative acts, knowledge, and intent to proceed to discovery, where the factual record may be developed to support the allegations, while screening out complaints resting on bare awareness and speculation” (citing Cleveland Clinic Foundation v. True Health Diagnostics LLC, 859 F.3d 1352, 1364 (Fed. Cir. 2017), as an example of the latter situation).  The Federal Circuit correctly applied that standard in this case, taking into account the totality of the circumstances including but not limited to the terms of the skinny label, this amicus argues.

The brief also provides a response to Hikma’s argument that the Federal Circuit’s decision would “effectively nullify” Section viii as being unfounded because that pathway “has never been entirely free from the risk of inducement liability.”

This amicus further reminds the Court that should correction be needed, that task should be left to Congress not the courts.

Academic Medical Centers*

The brief takes the position that the law is in a “delicate balance” between the branded drug makers (citing F.T.C. v. Actavis, Inc., 570 U.S. 136 (2013); Caraco Pharma. Labs., Ltd. V. Novo Nordisk A/S, 566 U.S. 399 (2012); Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990)) and generic entrants.  Amici assert that generic drugmakers have used the Section viii portion of the Hatch-Waxman Act to carve out a non-patented indication for an unpatented drug (using amantadine as a relevant example of the benefits and incentives of finding new indication for “old” drugs).

This balance has been lost, they contend, due to “judicial interpretation, measures by federal regulators and states, and the influence of pharmacy benefit managers,” which constitutes “a travesty to patients waiting for tomorrow’s cures.”  Using Section viii can be taken too far, amici argue, and should a generic company get such a “free pass” without consequence for otherwise infringing uses it would “destroy all incentives to research new uses of an old drug,” inter alia because “[t]here would be no way for a party to recoup their investment and drug companies would simply stop researching new uses of old drugs as the end of patent exclusivity approaches.”

The Court reversing the Federal Circuit judgment below “would undermine any remaining semblance of balance in the statutory scheme” and provide generic drugmakers with “a free pass from even an allegation of infringement,” amici argue.

The brief then sets forth for the Court a detailed survey of the drug market as “a complex payer” and provides a description of this complexity (which involves prescribing decisions being made by PBMs and others than the patient or provider).  This information in any particular case can be obtained only by discovery, which could be foreclosed should the Court reverse the Federal Circuit’s decision here.  Analogously, the brief provides that what constitutes “active inducement” requires context, citing Barry v. Medtronic, Inc., 914 F.3d 1310, 1317-18 (Fed. Cir. 2019), and GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320, 1327-28 (2021), as examples, which can include the relevant market, as illustrated in Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 936-37 (2005).

Finally, the brief asserts that “law and policy counsel in the case that affirming and remanding” would permit the factual record to be better developed in order for the courts to determine whether active inducement had occurred.

*The Dana-Farber Cancer Institute, Memorial Sloan-Kettering Cancer Center, Memorial Hospital for Cancer and Allied Diseases, Sloan-Kettering Institute for Cancer Research, and The Johns Hopkins University on behalf of the Johns Hopkins University School of Medicine.

PhARMA and BIO

The Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) filed an amicus brief arguing that Hikma is seeking (improperly) a “special immunity” for generic drugs that would upset Congress’s balance in the Hatch-Waxman Act between “permitting generics to enter the market and encouraging the research and development of additional indications” that would amount to “bright-line immunity for generic drug manufacturers to encourage infringing use through their promotional materials and statements to investors.”  This would result in disrupted investment and discourage discovery of new uses for existing drugs (making the point ignored by other amici that “novel indications may prove even more consequential than the first,” providing examples (including that “half of all approved uses and three-quarters of industry-funded clinical trials occurred post-approval” for cardiovascular drugs like Vascepa; this is also true for “small-molecule drugs used to treat conditions related to oncology, cardiology, and immunology,” where the numbers are 35% for initial approval and 65% for subsequent approved indications).  There are similar outcomes for rare diseases reported by amici.  The amici also note the “massive investments in post-approval needed for the development of such drugs,” which will (at best) “be inhibited if generic manufacturers are permitted to infringe patented uses.”  And:

Pharmaceutical companies cannot rationally invest in developing new uses if, on the other side, they will be denied the opportunity to obtain meaningful judicial review of whether a generic manufacturer induced infringement.  Petitioners’ position thus undermines the legal protections that are necessary for pharmaceutical companies to justify continued investment in developing lifesaving new treatments.

Hikma’s request to the Court is for “more than this fair balance” between generic drug entry for unpatented indications and branded drugmaker protection for patented indications according to the brief.  “The practical effect of Petitioners’ standard would be that a skinny label could be deemed non-inducing as a matter of law regardless of any other allegations showing inducement in a particular case, and generic manufacturers would be granted license to make public statements about the patented use without risk of inducement liability” according to these amici.

The brief also reminds the Court that:

Nor is there any crisis in generic manufacturing requiring this Court’s intervention.  The Hatch-Waxman Act skyrocketed generic uptake in the United States—from 19% of prescriptions to 90%, [according to the 40th Anniversary of the Generic Drug Approval Pathway].  Other metrics reinforce the prevalence of generics.  For example, more than 80% of approved medications have generic versions available on the market, up from only 35% in the time before Hatch-Waxman [according to] PhRMA, What is Hatch-Waxman? (June 2018).  And generics often enter the market immediately upon patent expiration and are adopted rapidly—some capture as much as 90% of the market within three months.  Id.

Accordingly, amici argue that “[t]here is thus no cause to contort either patent law or pleading standards to provide generic manufactures like Petitioners with additional market advantages beyond those fairly afforded by Congress.”

Sanofi

Sanofi argues that it is critical for maintaining the balance Congress struck between generic drug entry and incentives for additional indications by branded drugmakers to “police” the line between them.  This amicus also promotes a “plausibility” analysis for induced infringement that is sensitive to context which should include “market realities.”  In contrast to other amici who have analogized induced infringement with the Court’s aiding-and-abetting cases, this amicus argues they are fundamentally different because in those cases “the actor being held secondarily liable is typically less culpable than the primary wrongdoer,” whereas in inducing infringement (in the Section viii context) “the secondary offender—here, the generic manufacturer—who is most culpable and the primary infringer’s intent is irrelevant.”

Inducing infringement is part of the Congressional bargain, according to the brief, playing a “critical role” in incentivizing continued discoveries through preserving patent protection for “pioneer” drug innovators.  This is true because “[c]osts for research, development, and approval of innovative new uses for existing drugs are immense,” citing statistics that “investments associated with developing supplemental indications ranged from $149.3 million to $905.3 million” compared with estimates of $2 million for generic copies.  This is so in the context of “factual market realities” the create a preference for generic substitution “even for off-label uses.”  This is particularly the case where there are “powerful incentives to fill market demand for infringing uses, particularly where, as here, infringing uses are far more popular than non-patented uses.”

Finally, amicus argues that while “[a] generic manufacturer can actively induce infringement through express statements promoting the infringing use” they can also induce infringement “through more subtle communication or without communication at all [by] nuanced conduct that promotes an infringing use” and the brief provides examples of such subtleties.

By Kevin E. Noonan –

In addition to the briefs from the parties, seventeen amicus briefs were filed with the Supreme Court in Hikma v. Amarin: six in favor of Petitioner Hikma, seven in favor of Respondent Amarin, and the remaining five on behalf of neither party (although the latter category is in some instances shaded by underlying biases).  Synopses of the briefs in favor of Hikma are provided in this post.  Subsequent posts will provide synopses of the briefs in favor of Amarin and those favoring neither party.

76 Scholars* in Law, Business, Economics, and Medicine

The Scholars’ principal argument is that inducement requires “an act that is specific, unambiguous, and affirmative,” citing Glob.-Tech Appliances, Inc. v. SEB SA, 563 U.S. 754, 766 (2011), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d1464, 1469 (Fed. Cir. 1990).  “Conduct that (1) does not specifically encourage infringement, (2) is ambiguous as to infringing or noninfringing behavior, or (3) is an omission has long been insufficient for patent inducement liability” the brief asserts, accusing the Federal Circuit of “disregard[ing] these principles,” wherein “inducement liability could arise based on speculative inferences from general marketing statements and mandatory drug labeling text—statements that bore no specificity to the patented methods of use at issue,” consistent with the Court’s decision (erroneous in the Scholars’ view) with GlaxoSmithKline LLC v. Teva Pharmaceuticals USA.

These instances are both errors of law and “threaten[] the statutory scheme for generic drug competition, the innovation economy, the patent system’s foundational principles, and patient health and welfare” in the Scholars’ view.

Much of the Scholars’ arguments are consistent with Hikma and other amici, that the Federal Circuit’s decision is contrary to the Congressional scheme under the Hatch Waxman Act to promote generic competition in pharmaceutical products (although there is much less discussion of Congress’s attempt to promote balance between innovator and generic drugmakers).  They also raise a concern (shared in Hikma’s brief and by other amici) that the decision will raise the specter of inducement liability that could chill if not stifle drug competition, made worse by the Federal Circuit’s use of statements required by law (on the label) in support of inducement.

The Scholars posit that the failure of Congress to set forth guidelines and “mechanisms” for determining the standards for inducement in the skinny label context was evidence of “congressional understanding that avoidance of patent inducement is a simple, clear, easily determined matter.”

Doctrinally, the Scholars set forth three requirements for establishing inducement: specific actions, lacking ambiguity, and affirmative acts of commission.  The need for the specific prong of the active inducement standard in the brief is supported in caselaw by A. Stucki Co. v. Worthington Indus., Inc., 849 F.2d 593, 597 (Fed. Cir. 1988); Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364 (Fed. Cir. 2003); Vita-Mix Corp. v. Basic Holding, Inc., 581 F.3d 1317, 1329 n.2 (Fed. Cir. 2009); DSU Med. Corp. v. JMS Co., Ltd., 471 F.3d 1293, 1306 (Fed. Cir. 2006) (en banc); Tegal Corp. v. Tokyo Electron Co., Ltd., 248 F.3d 1376, 1379 (Fed. Cir. 2001).

The Scholars’ support for the “lack of ambiguity” requirement is supported by Takeda Pharms. U.S.A., Inc. v. W.-Ward Pharm. Corp., 785 F.3d 625, 632 (Fed. Cir. 2015); C.R. Bard, Inc. v. Advanced Cardiovascular Sys., 911 F.2d 670, 675 (Fed. Cir. 1990); HZNP Meds. LLC v. Actavis Lab’ys UT, Inc., 940 F.3d 680, 702 (Fed. Cir. 2019); Eli Lilly & Co. v. Bd. of Regents, 334 F.3d 1264, 1369 (Fed. Cir. 2003).

Finally, the Scholars support for the affirmative “act of commission” requirement finds support in Beverly Hills Fan Co. v. Royal Sovereign Corp., 21 F.3d 1558, 1568 (Fed. Cir. 1994); Global-Tech, 563 U.S. at 760; and Tegal, 248 F.3d at 1378.

More generally, the Scholars cite a century and a half of precedent on the standards for inducement of infringement, namely Wallace v. Holmes, 29 F. Cas. 74, 80 (C.C.D. Conn. 1871); Motion Picture Pats. Co. v. Universal Film Mfg. Co., 243 U.S. 502, 516 (1917) (overruling Henry v. A.B. Dick Co., 224 U.S. 1 (1912); Carbice Corp. of Am. v. Am. Pats. Dev. Corp., 283 U.S. 27, 32 (1931); and G.S. Rich in Infringement Under Section 271 of the Patent Act of 1952, 21 Geo. Wash. L. Rev. 521, 542 (1953).

The remainder of the brief sets forth arguments regarding drug policy and the deleterious effects on drug pricing and innovation that will accrue should the Federal Circuit’s decision be permitted to stand.

* Gerard Anderson, Johns Hopkins Bloomberg School of Public Health; Reed Beall, University of Calgary Cumming School of Medicine; Jeremy Bock, Tulane University Law School; Timothy F. Bresnahan (Emeritus), Stanford Department of Economics; Jeremy I. Bulow, Stanford Business School; Darren Bush, University of Houston Law Center; Michael A. Carrier, Rutgers Law School; Michael W. Carroll, American University Washington College of Law; Peter Carstensen, (Emeritus),  University of Wisconsin Law School; Bernard Chao, University of Denver Sturm College of Law; Thomas Cheng, University of Hong Kong, Faculty of Law; Ralph D. Clifford (Emeritus), University of Massachusetts School of Law; Jorge L. Contreras, University of Utah S.J. Quinney College of Law; Rochelle Dreyfuss (Emerita), New York University School of Law;  Charles Duan, American University Washington College of Law; Michael Dube, University of New Hampshire Franklin Pierce School of Law; Stacie B. Dusetzina, Vanderbilt University Medical Center; William Feldman, UCLA David Geffen School of Medicine; H.E. Frech, III, University of California, Santa Barbara, Department of Economics; Erin C. Fuse Brown, Brown University School of Public Health; Michal S. Gal, University of Haifa, Faculty of Law; Jon M. Garon, Nova Southeastern University Shepard Broad College of Law; Shubha Ghosh, Syracuse University College of Law;  Hiba Hafiz, Boston College Law School; Bronwyn H. Hall (Emerita), University of California, Berkeley, Department of Economics; Jeffrey Harrison (Former), University of Florida Levin College of Law; Yaniv Heled, Georgia State University College of Law; Christina S. Ho, Rutgers Law School; Cynthia M. Ho, Loyola University Chicago School of Law; Tim Holbrook, University of Denver Sturm College of Law;  Erik Hovenkamp, Cornell Law School;  Michael J. Hutter, Albany Law School; Aaron S. Kesselheim, Harvard Medical School; Shweta Kumar, University of Kentucky J. David Rosenberg College of Law; Amy Landers, Drexel University Thomas R. Kline School of Law; Stacey M. Lantagne, Suffolk University Law School; Mark A. Lemley, Stanford Law School; Jack I. Lerner, University of California, Irvine School of Law; Christopher R. Leslie, University of California, Irvine School of Law; Yvette Joy Liebesman, Saint Louis University School of Law; Daryl Lim, Penn State Dickinson Law; Orly Lobel, University of San Diego School of Law; Lee Ann Wheelis Lockridge (Emeritus), Louisiana State University Law Center; Brian Love, Santa Clara University School of Law; Duncan Matthews, Queen Mary University of London, School of Law; Mark P. Mckenna, UCLA School of Law; Frances Miller (Emerita), Boston University Law School; Christopher J. Morten, New York University School of Law; Roger Noll (Emeritus), Stanford University, Department of Economics; Tyler T. Ochoa, Santa Clara University School of Law; Luigi Palombi (Former), University of Sydney;  Jordan Paradise, Loyola University Chicago School of Law; Stephanie Plamondon, Brigham Young University J. Reuben Clark Law School; Srividhya Ragavan, Texas A&M University School of Law; Zia Rahman, Sidney Kimmel Medical College at Thomas Jefferson University; Arti K. Rai, Duke Law School; Jason Reinecke, University of Wisconsin Law School; Christopher Robertson, Boston University Law School; Benjamin N. Rome, Harvard Medical School; Joseph Ross, Yale School of Medicine; Ana Santos Rutschman, Villanova University Charles Widger School of Law;  William Sage, Texas A&M University School of Law and College of Medicine; Joshua D. Sarnoff, DePaul College of Law; Ameet Sarpatwari, Harvard Medical School; Kurt Saunders, California State University, Northridge, David Nazarian College of Business and Economics; Fiona M. Scott Morton, Yale School of Management and Yale Law School; Steven Semeraro, Thomas Jefferson School of Law; Michael S. Sinha, Saint Louis University School of Law; Aram Sinnreich, American University School of Communication; Katherine J. Strandburg, New York University School of Law; Hannibal Travis, Florida International University College of Law; S. Sean Tu, University of Alabama School of Law; H.H.B. Vedder, University of Gronigen, Faculty of Law; Liza Vertinsky, University of Maryland Francis King Carey School of Law; Rebecca E. Wolitz, The Ohio State University, Mortiz College of Law; Olivier Wouters, Brown University School of Public Health

Michael A. Carrier, Charles Duan, S. Sean Tu, and Aaron S. Kesselheim are named on the cover of the brief

Shashank Upadhye

The argument set forth by this amicus is that the conduct was lawful and liability depends solely on Hikma’s intent, which amicus does not believe was sufficiently established.  The brief focuses on the proper application of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009), and that these decisions “permit heightened specificity” in this instance.  Inducement as defined by this amicus is “not negligence,” “not strict liability,” “not mere foreseeability” but rather “[i]It is a doctrine of purposeful encouragement” for direct infringement based on the same caselaw (Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 766 (2011); Commil USA, LLC v. Cisco Sys., Inc., 575 U.S. 632, 642 (2015); Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 937 (2005)) cited by others.  Inducement cannot be promised solely on lawful conduct this amicus contends, citing Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364 (Fed. Cir. 2003).

The question identified here is “a distinct procedural question: what level of factual specificity is required at the pleading stage when inducement is alleged based on conduct that Congress has affirmatively authorized”?  It cannot be the skinny label itself (nor designation as a generic or a therapeutic equivalent rating) but must be “something more.”  As an indication of what such something more can be, the brief asserts that “when intent is the sole element transforming statutorily authorized conduct into alleged wrongdoing, the pleading burden carries unusual institutional significance.”  Amicus uses Grokster* as illustrative: “inducement liability arose not from neutral instructions or product descriptions, but from an integrated course of conduct designed to foster infringement.”

If the “underlying conduct” is lawful, and liability depends entirely on proving purposeful encouragement beyond that conduct, then plausibility demands concrete factual content, not inference built upon inference, amicus argues, and “when an inducement claim rests primarily on legal conduct Congress has authorized, the complaint must plead with particularity the objective facts that render specific intent plausible by identifying the acts of encouragement, the audience targeted, the connection to the claimed method, and a plausible causal pathway to infringement.”  These arguments are consistent with arguments from other amici that inducement requires “purposeful, culpable encouragement.”

*One difference, of course, is that inducement of infringement is not codified in any statute under Title 17, which might bring some pause to the Court when asked to use copyright principles/jurisprudence in coming to a conclusion here.

Association for Accessible Medicines

This amicus argues that offering a drug for sale does not induce infringement of carved-out method patent because Section viii only applies to methods for using an unpatented drug.  Further, the brief asserts that unlike ANDA filings, Section viii does not trigger pre-launch infringement litigation because skinny labels per se do not themselves induce infringement.  The existence of state automatic substitution laws inhibits generic drug companies from prescribing a specific manufacturer’s generic drug according to this amicus.

Amicus sets out the principal differences between ANDA litigation and the Section viii carve-out strategy to be:

[W]ith a skinny label, a generic can get on the market immediately—no litigation, no delays, and under a correct view of the law, no fear that the skinny label will induce infringement.  The results have been spectacular—hundreds of generic drugs on the market sooner, with billions of dollars in savings.

The brief sets forth four errors or “fundamental” misunderstandings of the law by the Federal Circuit that provide a basis for the Court to reverse the judgement:

(1) Section viii applies only to method patents. The sale (or offer for sale) of an unpatented product cannot induce infringement of a patent that claims only one way of using that product.

(2) Skinny labels do not induce infringement of the carved-out patent. That is why the statute requires no notice to the brand and no pre-launch adjudication when the generic carves out the patent, whereas it does require notice and provides for pre-launch adjudication (and delayed FDA approval of the generic) when a generic challenges a patent as invalid.

(3) True statements that a generic product is the “generic version” or “generic equivalent” of a brand product merely echo what the government itself says; they are characterizations of the (unpatented) product, not the labeled uses.

(4) Generics generally do not market their products, because of state automatic-substitution laws, and because doctors do not specify which company’s generic product will be used to fill a prescription. Press releases directed to investors, not doctors, have no bearing on doctors’ prescribing decisions.

Active inducement requires affirmative encouragement and calling a drug “generic” or having a skinny label itself or press releases itself not enough.  This amicus blames high drug costs on lack of competition, using arguments based mostly on a dire consequences scenario:

But if the Federal Circuit’s decision is not reversed, Section viii will plummet in significance.  The Federal Circuit has opened the floodgates for litigation against generic manufacturers, allowing cases to get past the pleading stage merely by alleging conduct that is utterly commonplace in skinny-label launches.

Amicus further argues that that Congress enacted the skinny label regime knowing off-label infringement of the unpatented drug for a patented use would occur (at least under State automatic substitution laws):

Section viii reflects Congress’s judgment that patents on a specific use of an unpatented drug must not delay approval of a generic version of the drug itself, and its insight that removing the patented use from the label suffices to prevent inducement.

This amicus‘ argument came down to (in its view) that Hikma did what it was supposed to do under Section viii, and shared many of the same policy arguments asserted by other amici.

Henry A. Waxman

Not surprisingly, Congressman Waxman’s amicus brief describes in some detail the historical antecedents to Section viii as part of the Hatch-Waxman scheme for facilitating generic drug entry into the marketplace and the success the Act has had in the past forty years in achieving Congress’s aims in that regard.  The brief asserts that the Congressman “believes both that the Federal Circuit’s decision in this case is flatly inconsistent with the language of the Act and congressional intent, and that unless overturned it will devastate the Hatch-Waxman Act’s generic drug program, which has saved patients, the federal government, and other payers trillions of dollars” (“nearly $3.4 trillion” over the past ten years” and later in the brief stating that “In 2024 generic drugs comprised 90% of prescriptions filled nationally, saving $447 billion, including $142 billion in Medicare savings and $62.1 billion in Medicaid savings”).

The principal benefit has been that branded drug makers can be incentivized to find new indications for drugs and at the same time generic drug makers can enter the marketplace for earlier-claimed indications as exclusivities and patents for the drug itself, stating that “section viii provides the mechanism for a generic company to identify those uses, so that a product with a label matching them can quickly come to market,” citing Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 415 (2012) (emphasis added); Takeda Pharm. U.S.A., Inc. v. West- Ward Pharm. Corp., 785 F.3d 625, 630 (Fed. Cir. 2015); Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1360 (Fed. Cir. 2003) (emphasis in brief).

The brief cautions that “[c]ourts ‘must respect the role of the Legislature, and take care not to undo what it has done.  A fair reading of legislation demands a fair understanding of the legislative plan,’” citing King v. Burwell, 576 U.S. 473, 498 (2015), and that the Federal Circuit rationale against Hikma in this case “ignores the legislative text and undermines Congress’s careful and considered ‘legislative plan.’”  The brief further asserts that “Congress . . . anticipated this exact situation” in this case, that the Federal Circuit’s decision was “inconsistent [(i.e., cannot be reconciled)] with the statute” and “will have major adverse implications” should the decision be permitted to stand by the Court.  These statements are particularly directed to the evidence considered by the lower court in determining that the question of infringement inducement should have survived Hikma’s motion to dismiss.

Public Citizen

This brief argues that Hikma “played by the [statutory] rules” and the Act does not “permit patent liability to be imposed on generic manufacturers who play by the rules when marketing drugs approved with skinny labels.”  The arguments are particularly focused on “making medicines more affordable [by] the adoption of policies that facilitate regulatory approval and marketing of generic drugs that compete with expensive brand-name drugs.”  The brief further states that “Public Citizen submits this brief to explain that the [Federal Circuit’s] opinion in the case disregards the language and structure of the Hatch-Waxman Amendments, is likely to cause significant harm to consumers, and runs counter to the strong federal policy of promoting the availability of generic medications as a means of lowering costs for patients” (which is exactly that it does in detail, reciting many of the arguments made by Hikma and other amici down to referring to certain of the evidence as comprising “anodyne” statements not supporting a conclusion of inducement to infringe).  The brief concludes with policy arguments that the Federal Circuit’s decision “threaten[s] serious harm to the consumer-protection and public-health goals of the Hatch-Waxman Amendments,” supported by statistics from governmental and non-governmental sources.

Solicitor General

The government’s brief follows the arguments made by the Solicitor General’s brief to the Court giving the Justices its views on whether to grant certiorari.  These include 1) that “Amarin’s allegations do not make out a plausible claim of active inducement to infringe”; 2) The “statements on which the Federal Circuit relied provide no basis for liability”; and 3) “[t]he Federal Circuit’s decision undermines the broader Hatch-Waxman scheme.”  After providing the Court with a thorough but focused synopsis of the Act itself, the course of proceedings below, and the policy goals and questions involved, the brief provides arguments (reciting the characterization of certain of Amarin’s evidence as being “generic manufacturer’s anodyne descriptions of its product”) for the Court to reverse the Federal Circuit’s decision.