Patent Docs

Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd. (Fed. Cir. 2025)

By Kevin E. Noonan --

The Federal Circuit affirmed a District Court decision that the label for a generic drug obtained from an ANDA would not induce infringement by reciting optional drug storage conditions the read on the NDA holder's Orange Book-listed patents, in Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd. (non-precedential).

The matter arose in ANDA litigation over Rubicon's generic version of Metacel's Ozobax® product (an oral solution of baclofen at a dosage strength of 5 mg/5 mL; in a footnote the opinion states that this version of the drug is no longer available in the U.S.).  The drug is used to treat spasticity consequent to multiple sclerosis including "relief of flexor spasms and concomitant pain, clonus, and muscular rigidity."  The Orange Book-listed patent asserted by Metacel, U.S. Patent No. 10,610,502, contains two claims, claim 1 reciting:

1.  A method of relaxing muscles or treating spasticity in a subject in need thereof comprising administering to the subject an effective amount of an aqueous oral solution comprising (i) baclofen, (ii) a buffer comprising citric acid, a salt of citric acid, or any combination thereof, and (iii) optionally one or more preservatives, wherein . . . the oral solution is stored . . . at from about 2 to about 8° C.

(where the italicized language was at issue and being the purported patentable distinction over the prior art).  For its part, Rubicon's label for its ANDA-approved generic version of Metacel's drug contained these storage temperature specifications:

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].  It can also be stored at 2°C to 8°C (36°F to 46°F).

(where again the italicized language was at issue).  The distinctions in storage temperature formed inter alia the basis for Rubicon's assertions in its Paragraph IV letter that its generic drug would not infringe the '502 patent under 21 U.S.C. § 355(j)(2)(A)(vii)(IV), (B)(i).

The language in Rubicon's label was the basis for Metacel's infringement allegations that Rubicon's generic product would induce physicians and other healthcare providers to infringe the '502 patent.  Rubicon countered by filing a summary judgment motion asserting that there was no genuine issue of material fact that its product would not infringe.  Rubicon distinguished its label by arguing that inducement of infringement under 35 U.S.C. § 271(b) required the label to "to instruct or encourage, and not merely permit, infringement."  According to Rubicon, storage at temperatures encompassed in Metacel's claim language was optional and the label recommended room temperature storage conditions.  Metacel countered that Rubicon in its ANDA filing had made statements to the effect that "[t]here is no difference in [Rubicon's] storage temperature statement compare[d]" to Ozobax's label, and that Rubicon's "[s]torage [s]tatement contained in its ANDA filing also instructs" storage "at from about 2 to about 8° C."

The District Court granted Rubicon's motion for summary judgment, based on users being guided by the label and not by statements in Rubicon's ANDA, citing  HZNP Meds. LLC v. Actavis Lab'ys UT, Inc., 940 F.3d 680, 701–02 (Fed. Cir. 2019).  After denying Metacel's request for reconsideration based on there being genuine issues of material fact and alleged procedural defects, the District Court entered judgment and this appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges Chen and Hughes.  Because the question before the Court was summary judgment, the panel applied the law of the Third Circuit, under Frolow v. Wilson Sporting Goods Co., 710 F.3d 1303, 1308 (Fed. Cir. 2013), while reserving questions limited to patent law to Federal Circuit law under Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 104 F.4th 1370, 1376 (Fed. Cir. 2024).  Metacel argued that the District Court had neglected to consider evidence that raised genuine issues of material fact and reasserted its procedural objections that had failed before the District Court.  Neither argument prevailed before the Federal Circuit.

On the merits, the panel held that there was no genuine issue of material fact regarding the label instructing users that storage at temperatures reading on the '502 patent claims was optional.  The standard for inducement applied by the Court was that the ANDA applicant's label must "'encourage, recommend, or promote infringement" under HZNP Meds. LLC v. Actavis Lab'ys UT, Inc., and not "merely describe the infringing use."  By its plain language, claim 1 of the '502 patent requires refrigeration while the panel appreciated Rubicon's label not to so encourage refrigeration.  According to the opinion:

[T]he label indicates that if a downstream user decides to refrigerate the product, despite instructions to store the product at room temperature (which is noninfringing), then it should store the product at temperatures from 2°C to 8°C.  That is not inducement [emphases in opinion].

This interpretation was similar to the issues before the Court in HZNP Meds. LLC, according to the opinion in its "if/then" factual posture.  Permissive statements such as these "do[] not encourage infringement, particularly where the label does not require subsequent application," under HZNP Meds. LLC according to the Court.

Like the District Court, the panel also disregarded any statements limited to Rubicon's ANDA.  While acknowledging that "given the proper facts, circumstantial evidence may lend support to a finding of specific intent in drug label cases," under AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed. Cir. 2010), the "pertinent question is whether the proposed label instructs users to perform the patented method," under AstraZeneca LP and  Grunenthal GmbH v. Alkem Lab'ys Ltd., 919 F.3d 1333, 1339–40 (Fed. Cir. 2019).  Circumstantial evidence cannot override plain language where the label is unambiguous according to the Court, citing Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 1324 (Fed. Cir. 2012), and that is the situation here.  The Court also considered, as did the District Court, that the statements purported by Metacel to raise material fact issues were not available to the individuals who would be induced (i.e., healthcare workers).  And the panel agreed with the District Court that Metacel had not presented this evidence in full (omitting disclosure that did not support their argument, for example).  Finally, regarding these arguments, the panel discounted Metacel's expert testimony because it relied on Metacel's label as evidence of Rubicon's intent to induce infringement.

On the procedural questions under Third Circuit law, the panel was unpersuaded by Metacel's arguments that the District Court abused its discretion in denying Metacel's reconsideration request.  This decision was based on Metacel raising the issue for the first time in its reconsideration motion.

Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd. (Fed. Cir. 2025)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Chen, and Hughes
Opinion by Circuit Judge Lourie

Recentive Analytics, Inc. v. Fox Corp. (Fed. Cir. 2025)

By Michael Borella --

For the last several years, patentees and patent practitioners have been waiting for the Federal Circuit to weigh in on the patent eligibility of machine learning models.  There was an expectation that, like any other technology, the patentability under 35 U.S.C. § 101 of inventions that incorporate machine learning would need to be evaluated on a case by case basis.  But there was also some hope that the Court would provide the public with at least some hint of what aspects of machine learning might signal eligibility.  In Recentive Analytics, Inc. v. Fox Corp., these signals are weak at best.

Patent eligibility was historically not a major concern until the Supreme Court's judicially-imposed patent eligibility test[1] of Alice Corp. Pty. Ltd. v. CLS Bank Int'l that came down in 2014.  A valid criticism of Alice is that it behaves like the proverbial nose of wax -- the test exhibits a large degree of inherent subjectivity.  Depending on who is applying the test, what case law they are considering, and perhaps the phase of the moon, virtually any claim under review can be viewed as both eligible and ineligible.

To that point, the Alice opinion made it crystal clear that the computer-controlled rubber mold of Diamond v. Diehr was still patent-eligible.  Even though Diehr was not overturned and remains good law, the Alice test as currently applied by the Federal Circuit and USPTO can easily be used to establish a strong position that the claims of Diehr were in fact ineligible.[2]

As a consequence, the last decade has seen patent assets take on the nature of Schrodinger's Cat.  Any issued patent is in a quantum superposition -- both valid and invalid -- until its eligibility is "observed" by a judicial body.  This uncertainty has real-world anti-competitive consequences, making patent acquisition more expensive yet less effective for small businesses while allowing incumbent technology companies to develop into monopolies or cartels of two-three major players who never assert their patents against one another.  Why does the United States -- ostensibly a proud capitalist society that welcomes competition -- have such a weak patent law?  As a stated in the film version of All the President's Men, "Follow the money."

In any event, Recentive sued Fox for infringement of U.S. Patent Nos. 10,911,811, 10,958,957, 11,386,367, and 11,537,960 in the United States District Court for the Eastern District of Pennsylvania.  According to the Federal Circuit:  "The patents purport to solve problems confronting the entertainment industry and television broadcasters: how to optimize the scheduling of live events and how to optimize network maps, which determine the programs or content displayed by a broadcaster's channels within certain geographic markets at particular times."

The Court divided the four Recentive patents into two categories:  machine learning training and network maps.  The former are directed to (in the words of the Court):

(i) a collecting step (receiving event parameters and target features); (ii) an iterative training step for the machine learning model (identifying relationships within the data); (iii) an output step (generating an optimized schedule); and (iv) an updating step (detecting changes to the data inputs and iteratively generating new, further optimized schedules).

The latter are directed to (again in the words of the Court):

(i) a collecting step (receiving current broadcasting schedules); (ii) an analyzing step (creating a network map); (iii) an updating step (incorporating real-time changes to the data inputs); and (iv) a using step (determining program broadcasts using the optimized network map).

Despite the Court's summarization of the claim language at a high level, the actual claims are quite lengthy and narrow.  They are reproduced in the appendices below.

Fox moved to dismiss for failure to state a claim, alleging that the patents were invalid under § 101.  The District Court agreed, finding that the claims were "directed to the abstract ideas of producing network maps and event schedules, respectively, using known generic mathematical techniques" and further lacked an inventive concept "because the machine learning limitations were no more than broad, functionally described, well-known techniques and claimed only generic and conventional computing devices."

On appeal, the Federal Circuit affirmed.  In doing so, the Court relied heavily on admissions from Recentive that its iterative training was a known technique, fundamental to development of a machine learning model.  But the Court when further, dismissing Recentive's argument that the invention comprised a technical improvement by noting that "neither the claims nor the specifications describe how such an improvement was accomplished."  The Court also quickly disposed of Recentive's argument that the claims were eligible because they apply machine learning to specific acts of event planning.  Indeed, the Court illustrated its reductionist, myopic view of patent eligibility by stating "patents may be directed to abstract ideas where they disclose the use of an already available technology, with its already available basic functions, to use as a tool in executing the claimed process."

The Court also found no inventive concept in the claims.  Recentive argued for "using machine learning to dynamically generate optimized maps and schedules based on real-time data and update them based on changing conditions."  Here, the Court provided a rather substance-free and conclusory analysis, stating that:

[T]his is no more than claiming the abstract idea itself.  Such a position plainly fails to identify anything in the claims that would 'transform' the claimed abstract idea into a patent-eligible application . . . .  [W]e perceive nothing in the claims, whether considered individually or in their ordered combination, that would transform the Machine Learning Training and Network Map patents into something significantly more than the abstract idea of generating event schedules and network maps through the application of machine learning.

Accordingly, all four Recentive patents were found to be ineligible under § 101.

This decision, like § 101 jurisprudence as a whole, leaves itself open to criticism on numerous fronts.  Let's discuss just a few.

First, the claim language of the machine learning patents involved updating the models based on a "real-time change to the one or more user-specific event parameters."  Once trained, models are typically used for quite a while before being retrained.  Thus, it could have been argued that this feature is unconventional.  The opinion never specifically addressed the feature, and did not appear to appreciate this nuance.

Second, continuing a disturbing trend, the Court appears to ignore its older holdings (notably, BASCOM Global Internet Services v. AT&T Mobility) finding that computer-implemented inventions can be eligible even when involving only a combination of generic components and claimed at a high level.

Finally, the Court fails to articulate exactly what is required for us to consider claims as an "ordered combination."  Here, as in many § 101 decisions over the years, the Court's reasoning amounts to no more than "Because we said so."

It is a cliché that bad facts make bad law.  In an effort to stave off the worst types of overreach that might follow because of this decision, let's make it clear what the Court did not hold.

• That all machine learning inventions are ineligible (the Court hinted that more detail in the claim and the specification regarding the technical improvement provided may be sufficient to establish eligibility);

• That any claim reciting a machine learning process at a high level is ineligible (such a claim could be eligible based on its other elements);

• That any claim applying a machine learning model to a new field of data is ineligible (the Court leaves open the possibility that the model or its training process can be the technical improvement if explained in enough detail).

Nonetheless, § 101 is still a mess.  This case does nothing to change today's irrational, arbitrary, and mine-ridden patent eligibility landscape.

Appendix A: Claim 1 of the '367 Patent

1.  A computer-implemented method of dynamically generating an event schedule, the method comprising:
    receiving one or more event parameters for series of live events, wherein the one or more event parameters comprise at least one of venue availability, venue locations, proposed ticket prices, performer fees, venue fees, scheduled performances by one or more performers, or any combination thereof;
    receiving one or more event target features associated with the series of live events, wherein the one or more event target features comprise at least one of event attendance, event profit, event revenue, event expenses, or any combination thereof;
    providing the one or more event parameters and the one or more event target features to a machine learning (ML) model, wherein the ML model is at least one of a neural network ML model and a support vector ML model;
    iteratively training the ML model to identify relationships between different event parameters and the one or more event target features using historical data corresponding to one or more previous series of live events, wherein such iterative training improves the accuracy of the ML model;
    receiving, from a user, one or more user-specific event parameters for a future series of live events to be held in a plurality of geographic regions;
    receiving, from the user, one or more user-specific event weights representing one or more prioritized event target features associated with the future series of live events;
    providing the one or more user-specific event parameters and the one or more user-specific event weights to the trained ML model;
    generating, via the trained ML model, a schedule for the future series of live events that is optimized relative to the one or more prioritized event target features;
    detecting a real-time change to the one or more user-specific event parameters;
    providing the real-time change to the trained ML model to improve the accuracy of the trained ML model; and
    updating, via the trained ML model, the schedule for the future series of live events such that the schedule remains optimized relative to the one or more prioritized event target features in view of the real-time change to the one or more user-specific event parameters.

Appendix B: Claim 1 of the '811 Patent

1.  A computer-implemented method for dynamically generating a network map, the method comprising:
    receiving a schedule for a first plurality of live events scheduled to start at a first time and a second plurality of live events scheduled to start at a second time;
    generating, based on the schedule, a network map mapping the first plurality of live events and the second plurality of live events to a plurality of television stations for a plurality of cities,
    wherein each station from the plurality of stations corresponds to a respective city from the plurality of cities,
    wherein the network map identifies for each station (i) a first live event from the first plurality of live events that will be displayed at the first time and (ii) a second live event from the second plurality of live events that will be displayed at the second time, and
    wherein generating the network map comprises using a machine learning technique to optimize an overall television rating across the first plurality of live events and the second plurality of live events;
    automatically updating the network map on demand and in real time based on a change to at least one of (i) the schedule and (ii) underlying criteria,
    wherein updating the network map comprises updating the mapping of the first plurality of live events and the second plurality of live events to the plurality of television stations; and
    using the network map to determine for each station (i) the first live event from the first plurality of live events that will be displayed at the first time and (ii) the second live event from the second plurality of live events that will be displayed at the second time.

[1] For sake of completeness, the test was explained by the justices as "First, we determine whether the claims at issue are directed to one of those patent-ineligible concepts [(i.e., laws of nature, natural phenomena, and abstract ideas)]. If so, we then ask, '[w]hat else is there in the claims before us?' To answer that question, we consider the elements of each claim both individually and 'as an ordered combination' to determine whether the additional elements 'transform the nature of the claim' into a patent-eligible application. We have described step two of this analysis as a search for an 'inventive concept'—i.e., an element or combination of elements that is 'sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.'"

[2] Michael Borella, Could Alice Be Used to Invalidate Diehr? Of Course It Could, Patent Docs, Apr. 20, 2021.

Recentive Analytics, Inc. v. Fox Corp. (Fed. Cir. 2025)
Panel:  Circuit Judges Dyk and Prost and Chief District Judge Goldberg
Opinion by Circuit Judge Dyk

Sage Products, LLC v. Stewart (Fed. Cir. 2025)

By Kevin E. Noonan --

When a prevailing challenger withdraws from an appeal in post-grant proceedings, the Director can intervene under 35 U.S.C. § 143, which is what happened in an appeal in Sage Products, LLC v. Stewart after Challenger Becton Dickinson & Co. ("BD") withdrew after prevailing in having all challenged claims invalidated for anticipation or obviousness.

The case arose as an inter partes review (IPR) of Sage Products' U.S. Patent Nos. 10,398,642 and 10,688,067 directed to antiseptic compositions comprising chlorhexidine for disinfecting skin.  Claims 1-3, 5-8, 10-18, and 20 of the '642 patent and claims 1-3, 5-8, and 10-19 of the '067 patent were challenged, and representative challenged claims of the '642 patent are set forth in the opinion:

1.  A sterilized chlorhexidine product for topical dis- infection, said sterilized chlorhexidine product comprising:
    a sterilized chlorhexidine gluconate composition;
    an applicator for facilitating application of the sterilized chlorhexidine composition; and
    a receptacle containing the sterilized chlorhexidine gluconate composition to provide the sterilized chlorhexidine gluconate composition to impregnate the applicator when the receptacle is compromised;
    wherein the sterilized chlorhexidine gluconate composition comprise s chlorhexidine gluconate and alcohol.

7.  The sterilized chlorhexidine product of claim 1, wherein the sterilized chlorhexidine gluconate composition further comprises one or more additives selected from the group consisting of a sterilized surfactant, a sterilized pH adjuster, sterilized odorant, a sterilized colorant, a sterilized stabilizer, a sterilized skin protectant, a sterilized preservative, or combinations thereof.

10.  The sterilized chlorhexidine product of claim 1, wherein said sterilized chlorhexidine article has a sterility assurance level [SAL] of from 10-3 to 10-9.

(where italicized terms were at issue in the IPR).  The opinion notes that the specification defines the term "sterilized" to mean "where such sterility can be validated" and that sterilization can be achieved using heat and radiation treatment.

Four prior art references were successfully asserted against Sage's claim:  first, a printed publication (termed "PAR") from the United Kingdom's Medicine and Healthcare Products Regulatory Agency ("MHRA"), which related to a specific product, ChloraPrep, comprising a marketing license grant and packaging materials related to the product approved by MHRA.  This document was relied upon in the Patent Trial and Appeals Board's (PTAB) Final Written Decision (FWD) for disclosing the ChloraPrep composition of 20 mg/mL chlorhexidine gluconate for disinfecting skin prior to medical procedures, including an applicator wherein a user breaks an interior ampule of this solution by squeezing.  Significant for the Federal Circuit's opinion is that ChloraPrep is a "sterile alcoholic antiseptic solution containing chlorhexidine gluconate and isopropyl alcohol in an applicator" (emphasis in opinion).  The second reference was a British governmental standard ("BS EN-556-1"), which sets forth specifications for labeling a medical device as being sterile (the relevant provision thereof specifies that "probability of there being a viable micro-organism on/in the device shall be equal to or less than 1 × 10^-6").  The third reference was U.S. Patent Application Publication No. 2015/0190535 ("Degala"), which discloses sterilization using a "sterilizing antiseptic solution[]" and a sterilizing temperature of "about 85° C . . . to about 135° C" for "from about 1 minute to about 19 hours."  Finally, the opinion relates that the fourth reference was U.S. Patent Application Publication No. 2014/0371695 ("Chiang"), which discloses antiseptic composition applicators that include "one or more antimicrobial . . . materials in a single use applicator."  Importantly, regarding this reference, Sage's expert testified that the chlorhexidine gluconate composition in ChloraPrep was not sterilized.

This art was asserted by BD on three grounds of invalidity.  First, that the PAR reference anticipated the challenged claims under Section 102; second, that the claims were rendered obvious under Section 103 by the PAR reference; and third, that the claims were made obvious by the PAR reference in view of Degala.  The Board construed the term "sterilized" to mean "subjected to a suitable sterilization process such that sterility can be validated."  The Board's FWD determined that the skilled worker would have understood the term "sterile" as used in the UK was the equivalent to "sterilized" as used in the U.S., and that under the totality of the evidence all of the challenged claims were invalid under all of the grounds asserted by BD.  This appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Stark, joined by Judges Reyna and Cunningham.  The Court applied a substantial evidence standard of review under IOENGINE, LLC v. Ingenico Inc., 100 F.4th 1395, 1402 (Fed. Cir. 2024); Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1378 (Fed. Cir. 2023), and PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1196-97 (Fed. Cir. 2014); it also applied this standard to the Board's determination of the level of skill of the person of ordinary skill in the art, under Best Med. Int'l, Inc. v. Elekta Inc., 46 F.4th 1346, 1353 (Fed. Cir. 2022); and Innovention Toys, LLC v. MGA Entertainment, Inc., 637 F.3d 1314, 1324 (Fed. Cir. 2013).  The panel identified three principles under review: whether there was substantial evidence that the skilled artisan would have equated the disclosure of the PAR reference to teach a "sterilized" composition and a "sterilized" product; whether there was substantial evidence supporting the Board's determination that all elements recited in the challenged claims were also disclosed in the PAR reference; and finally whether there were procedural errors by the Board requiring appellate correction.  As put simply in the opinion after reciting the tasks the Court considered at issue the panel succinctly concluded that "Sage has not persuaded us there is any reversible error on any of these points."

Regarding the question of whether the PAR reference taught a sterilized product, the Court rejected Sage's challenges to the Board's determinations concerning the level of skill of the ordinarily skilled worker, and specifically asserted that the artisan would have been "familiar with the challenges involved in the sterilization of chlorhexidine gluconate" and further would have had "a familiarity with UK regulations that Sage asserts the skilled artisan would lack."  These issues were part of the Board's factual findings on these questions and the competency of the skilled worker under the Board's construction regarding them (it being "implausible" for a worker having the level of skill determined by the Board not to have such an understanding).  These determinations by the Board were supported, according to the opinion, by expert testimony from BD that the Board accepted over testimony from Sage's expert, while crediting (albeit in a footnote) that apprehensions regarding the sterilization issue might have raised persuasive concerns that were quelled by the teaching of the secondary Degala reference.  The Court also found no support for Sage's contentions that the Board had "ignore[d]" or "disregard[ed]" evidence in reaching these conclusions.  Based on the equivalence the Board and the Federal Circuit understood between "sterile" in the PAR reference and "sterilized" as recited in the claims the panel also held that "the Board's conclusion that the PAR teaches a sterilized chlorhexidine product or article -- that is, a sterilized chlorhexidine composition and an applicator -- is also supported by substantial evidence," including in this regard the further teachings of the Chiang reference.  And the Court also affirmed the Board's conclusions regarding the qualifications of BD's expert and the Board's crediting of his conclusions over those proffered by Sage's expert.  In every regard the Court concluded that Sage had shown no reversible error by the Board.

The opinion further addresses the Board's conclusions concerning limitations recited in challenged dependent claims and found no error there either.  These included the term "sterilized colorant" and that "sterilized chlorhexidine article has a [SAL] of from 10^-3 to 10^-9."  For the former the Board relied upon the parties' experts that these "inactive" ingredients would also need to be sterilized for the composition as a whole to be characterized as being "sterile," which determination the panel affirmed as being supported by substantial evidence.  Similarly, the Court held that BD's expert's testimony regarding the SAL range recited in certain of the challenged claims would be satisfied by the PAR prior art disclosure.

Turning to Sage's arguments reciting procedural errors by the Board the opinion found none on several issues.  These included, for example, alleged abuse of discretion by the Board in understanding the petition to contend that "sterile," as used in the PAR, would be understood by the skilled artisan to mean "sterilized" as recited in the claims.  These contentions by Sage "simply repeat[], in procedural garb, the same factual challenge we have already discussed relating [to] the knowledge of the person of ordinary skill in the art" and were rejected by the panel for the same reasons.  Nor was the panel persuaded that the Board had erred in considering the expert testimony proffered by the parties, particularly BD's expert under Monsanto Tech. LLC v. E.I. DuPont de Nemours & Co., 878 F.3d 1336, 1345 (Fed. Cir. 2018), and Telemac Cellular Corp. v. Topp Telecom, Inc., 247 F.3d 1316, 1328 (Fed. Cir. 2001), or confirmatory testimony from BD employees knowledgeable regarding that the product sold in the UK contained sterilized chlorhexidine gluconate (while somewhat confusingly also holding that even if this testimony had been introduced in error Sage was not prejudiced by it).

The opinion concludes with one further Sage objection, that the PAR reference was not enabling, which it must be under Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1379 (Fed. Cir. 2001).  The panel's "brief" comment in rejecting this argument was that the Board had properly considered BD's expert testimony of what the skilled worker would understand regarding PAR's teachings; the disclosure in the Chiang reference that the product was sterilized with ethylene oxide; Sage's expert testimony regarding sterilization using ethylene oxide; and the Degala reference's testimony regarding more generally methods for sterilizing a solution of chlorhexidine gluconate.  None of these considerations raised any procedural issues according to the Federal Circuit that would justify disturbing the Board's decision that the claims of the '642 and '067 patents were invalid.

Sage Products, LLC v. Stewart (Fed. Cir. 2025)
Panel:  Circuit Judges Reyna, Cunningham, and Strark
Opinion by Circuit Judge Stark

Recor Medical, Inc. v. Medtronic Ireland Mfg. (Fed. Cir. 2025)

By Kevin E. Noonan --

The inter partes review provisions of the Leahy-Smith America Invents Act have been criticized for the propensity of the Patent Trial and Appeal Board (PTAB) to find invalid all or at least some of the challenged claims, frequently on obviousness grounds.  Failure to so find, in addition to being less common has also often upheld on appeal, in view of the substantial evidence standard of review on factual questions involved in both novelty and obviousness questions before the Board.  The Federal Circuit's recent decision in Recor Medical, Inc. v. Medtronic Ireland Mfg. illustrates circumstances under which the Board's obviousness determination did not pass muster.

Recor Medical and Otsuka Medical Devices Co. challenged claims 1-4 and 8-12 of Medtronic's U.S. Patent No. 8,845,629 on obviousness grounds under 35 U.S.C. § 103; the challenged claims concerned an apparatus used to disrupt or destroy renal nerves to treat diseases exemplified in the opinion as "heart failure, renal failure, and hypertension."  Claim 1 was set forth in the opinion as representative:

1.  An ultrasound apparatus for thermally-induced renal neuromodulation, the apparatus comprising:
    a catheter sized and shaped for delivery within a blood vessel to a vicinity of neural fibers that contribute to renal function;
    an ultrasound transducer carried by the catheter, wherein the ultrasound transducer is configured to transmit ultrasound energy waves to target renal neural fibers outside of the blood vessel to thermally induce modulation of target neural fibers while protecting non-target tissue in the blood vessel wall from thermal injury; and
    an expandable member carried by a distal region of the catheter,
    wherein the expandable member is configured to vary between a reduced configuration for delivery and retrieval and an expanded deployed configuration, and
    wherein the ultrasound transducer is positioned on a shaft of the catheter and within the expandable member.

Challengers asserted U.S. Patent App. Pub. No. 2003/0216792 ("Levin") and U.S. Patent No. 6,669,655 ("Acker") in combination, and on other grounds based on the Acker disclosure and the knowledge of those of ordinary skill in the art.  Levin was relied upon for teaching renal nerve ablation using a "catheter-based approach" combined with Acker for using an ultrasound catheter, which obviousness contention the PTAB rejected based on there being no motivation to combine these references' teachings nor it not being obvious to try using ultrasound for renal neuromodulation as claimed.  The Board applied similar reasoning to Challenger's obviousness contentions based on Acker as the sole prior art reference coupled with the knowledge of the ordinarily skilled artisan.  The Board issued its Final Written Decision and this appeal followed.

The Federal Circuit vacated and remanded for further consideration by the PTAB, in an opinion by Judge Prost, joined by Judges Mayer and Lourie.  Challengers made two contentions before the Federal Circuit:  first, that the Board erred in not considering the Acker reference for "everything it teaches," citing Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015); and second that it would not have been "obvious to try" using ultrasound for this purpose.

Regarding the first argument, the panel agreed that the Board erred for limiting its consideration of the Acker reference to pulmonary veins.  The Court considered this reference to teach using ultrasound catheters to deliver the energy used in the '629 patent to "a blood vessel" or "circulatory vessel" (emphasis in opinion).  This understanding of greater breadth of the Acker reference's teaching was supported by disclosure in Acker that ultrasound energy "can be used to ablate ring-like regions around other tubular anatomical structures" (which presumably could include blood vessels other than the pulmonary veins expressly disclosed in the Acker reference).  Failure to consider this broader scope was error according to the panel, citing Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989).  The panel further found error in a suggestion from the Board's reasoning that the art either "actually operate[d] to perform the claimed invention or that the prior art be enabled," citing Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989), and In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc).  Under KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007), an obviousness determination must employ an "expansive and flexible approach" in which the person of ordinary skill is "a person of ordinary creativity, not an automaton," according to the opinion, and failure to apply these principles was error requiring the Board to reconsider the challenge on remand.

With regard to Challengers' "obvious to try" contentions, the panel treated this as a question of fact for which the Board is entitled to "substantial evidence" review.  The argument was taken directly from the KSR decision, wherein the Court recognized the requirements that there be "(1) a design or market need to solve a particular problem, and (2) that 'there are a finite number of identified, predictable solutions'" for which there was a reasonable expectation of success.  In this case, the panel recognized that the methods in the prior art and the ultrasound energy source recited in the challenged claims of the '629 patent used thermal energy to ablate renal nerves, and that ultrasound was one of the finite number of alternatives that included "electrical, ultrasound, radiofrequency, cryogenics, microwave, laser, chemical, induction, radiation, and mechanical methods."  The panel rejected Medtronic's arguments that the failure of the prior art to suggest ultrasound put the claimed method outside the scope of the "finite number of alternatives" supporting an obviousness determination, on the grounds that KSR requires a consideration of whether the skilled person "ha[d] good reason to pursue the known options within his or her technical grasp."  Challengers provided "ample evidence" in that regard, according to the opinion, from the cited prior art as well as other references using catheters for renal neuromodulation that relied on other energy sources (Levin) and perhaps more persuasively, using ultrasound for neuroablation in blood vessels in other organs (Acker), as well as "DC current, AC current, radiofrequency, microwave, heating elements, light emitting elements, and ultrasound" disclosed in other prior art.  This universe of alternatives was sufficiently limited to satisfy the KSR rubrics for what is "obvious to try" for this panel, citing Valeant Pharms. Int'l, Inc. v. Mylan Pharms. Inc., 955 F.3d 25, 34 (Fed. Cir. 2020) (ten variables).  The Court also considered successful use of ultrasound to have been reasonably predictable, and thus that "a person of ordinary skill [would have] good reason to pursue [these] known options" under KSR.

Recor Medical, Inc. v. Medtronic Ireland Mfg. (Fed. Cir. 2025)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Mayer, and Prost
Opinion by Circuit Judge Prost

Newman v. Moore -- Down to a "Battle of the Experts"?

By Kevin E. Noonan --

The dispute between the Judicial Council of the Federal Circuit and The Honorable Pauline Newman, Circuit Judge for the U.S. Court of Appeals for the Federal Circuit has been waging for more than a year (see links below).  The case has prompted amici to weigh in (see "Enough is (Apparently) Enough," Parts I, II, III, and IV) and last month a panel of physicians (neurologist James Noble, clinical neuropsychologist Jonathan DeRight, and diagnostic radiologist Jason Johnson) disputed the conclusions that Judge Newman's counsel asserted to refute allegations that the Judge was mentally incapable of performing her duties.  Today, one of Judge Newman's doctors, Dr. Aaron G. Filler of the Institute for Nerve Medicine in Santa Monica, California, addressed those criticisms.  The positions of the two groups of physicians are technical enough to be impossible for someone without a medical degree to effectively evaluate and yet are filled with deprecations and quasi-personal attacks (the results are "highly subjective, unscientific, and unreliable" as one example, and that criticisms of the methods used to evaluate Judge Newman's competency "work to effectively, objectively, and conclusively, rule out the known forms of dementia" which, being newer methods, "may be threatening" to doctors relying on more conventional diagnostic methods).

This post was informed by Ryan Davis reporting on IPLaw360.

For additional information regarding this topic, please see:

• "Judge Newman Files Reply Brief in Newman v. Moore," March 4, 2025
• "Judge Newman Suspension Renewed"; "Judge Newman Files Appeal with D.C. Circuit," December 22, 2024
• "Special Committee's Suspension Recommendation Adopted by Federal Circuit," September 8, 2024
• "Judge Newman's Suit Comes to an End," July 9, 2024
• "Special Committee of the Judicial Council of the Federal Circuit Replies," May 27, 2024
• "Judge Newman's Suit Continues," April 28, 2024
• "Judge Newman Suspended for One Year by Federal Circuit," September 20, 2023
• "Federal Circuit Special Committee Recommends One-Year Suspension of Judge Newman," August 6, 2023
• "Federal Circuit Special Committee Responds to Judge Newman's Counsel's Request for Clarification Regarding Misconduct Hearing," June 21, 2023
• "Judge Newman Matter Continues," June 20, 2023
• "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit," May 21, 2023

Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (Fed. Cir. 2025)

By Kevin E. Noonan --

Early last year, Aurobindo, one of the Defendants* in ANDA litigation against Merck, advanced the proposition that in cases where a patent had been reissued patent term extension ("PTE") under 35 U.S.C. § 156 should be calculated based on the grant date of the reissue patent and not of the "original" patent from which the reissue was obtained.  The Federal Circuit weighed in on this argument and found it unavailing (at least under the circumstances of these patents) in its Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. decision handed down earlier this month.

The case arose in ANDA litigation between Plaintiffs Merck Sharp & Dohme B.V and Merck Sharp & Dohme LLC and a variety of Defendants over sugammadex (6-per-deoxy-6-per-(2-carboxyethyl)thio-γ-cyclodextrin), the active ingredient in Merck's Bridion drug, which is used to "assist[] patients' recovery of muscle function after a form of paralysis induced during surgery":

The patent at issue was U.S. Reissue Patent No. RE44,733** having claims expressly reciting the active ingredient and methods of use thereof without cancelling any of the claims of U.S. Patent No. 6,670,340 from which it originated.  Importantly, the '340 patent issued on December 30, 2003 and had an original expiration date of January 27, 2021.  The reissue patent was granted on January 28, 2014, 686 days before FDA approval on December 15, 2015, and Merck applied for patent term extension (PTE) on the reissue patent.  The USPTO granted to RE '733 the maximum PTE of five years (until January 27, 2026) due to nearly 12 years of FDA delay as calculated from the December 30, 2002 grant date of the '340 patent.

Defendants did not challenge Merck's assertion that their generic sugammadex would infringe but instead argued that the portion of the term extending after December 14, 2022 was improperly granted.  According to Defendants, the plain meaning interpretation of the statutory language of § 156(c) regarding proper calculation of PTE was from "the date the patent issued," and because the patent whose term was extended was RE '733, not the '340 patent, the proper length of PTE should be 686 days, not five years (or 1,825 days).  Their argument was that the PTO improperly interpreted the statute and they moved that the District Court determine the correct, shorter PTE term based on their statutory interpretation.

Merck argued against Aurobindo's position by relying on § 251 and § 252 (regarding the effects of reissue), and § 156 of the Patent Act, as well as provisions in the MPEP (amended close upon this litigation) at § 2766:

With respect to calculating the amount of extension to which the reissued patent is entitled to receive, so long as the original patent claimed the approved product and the reissued patent claims the approved product, the original patent grant date would be used to calculate the extension to which the reissued patent would be entitled.

(which constitutes current Office policy).  While the PTO's position was not dispositive, the District Court stated that "the Court may 'take notice of public reports and filings, such as those prepared by an administrative agency or pursuant to government regulation, to extent they have indicia of authenticity," citing In re Plum Baby Food Litig., No. 21-2417, 2022 WL 16552786, at *3 (D.N.J. Oct. 31, 2022) (citing Sturgeon v. Pharmerica Corp., 438 F. Supp. 3d 246, 259 (E.D. Pa. 2020)).

The District Court held that, "when read in its proper context alongside the provisions of the Patent Act addressing reissues," the use by the USPTO of the grant date of the '340 patent instead of the reissue RE '733 patent was proper "unambiguously," inter alia, because it did not create a conflict with either § 251 or § 252 regarding the effect and characteristics of reissue applications, was consistent with established USPTO practice, and did not contravene the policy choices evinced by Congress in passage of the Hatch-Waxman Act.  These policy provisions and considerations included that PTE established in the Act "provides the holders of patents on approved patented products with an extended term of protection under the patent to compensate for the delay in obtaining FDA approval," citing Merck & Co., Inc. v. Kessler, 80 F.3d 1543, 1547 (Fed. Cir. 1996).  The District Court opinion characterized Defendants' position as being "an untenable reading of the statutory scheme on the whole, creating conflict with various provisions of the Patent Act as well as unintended results."  And on policy grounds, the opinion asserted that Defendants' "plain meaning" of the statute "would undermine the purpose of the Hatch-Waxman Act, in contrast to Merck's interpretation, which aligns with it."  Finally, the opinion held that in the face of an ambiguity the District Court did not recognize but Defendants' contend has arisen in the statute, the District Court held that consistent PTO practice of using the grant date of the original patent deserves deference under Skidmore v. Swift & Co., 323 U.S. 134 (1944).  This appeal followed.

The Federal Circuit affirmed the District Court's determination that PTE was properly calculated from the grant date of the '340 patent, in an opinion by Judge Dyk joined by Judges Mayer and Reyna (a substantial percentage of which opinion was set forth in extensive footnotes).  The panel differed with the parties on the relevant statutory term, stating that it was not the word "issue" but rather the term "the patent" with regard to which patent's issue date should be used under § 156(c):

The term of a patent eligible for extension under subsection (a) shall be extended by the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued[.]  35 U.S.C. § 156(c) [emphasis added].

The Court agreed with the Patent Office that § 156(c) is ambiguous with regard to whether it is the original or the reissue patent that is "the patent."  Relying on the Supreme Court's opinion in Caraco Pharm. Lab'ys, Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 412 (2012), the Court assessed the meaning of the term by the statutory text in the context in which it is used (wherein in Caraco the Court interpreted the meaning of 21 U.S.C. § 355(j)(5)(C)(ii)(I))) regarding the distinctions, if there were any, between "not an" and "not any" for counterclaims a generic drugmaker could raise in ANDA litigation).  In Caraco, the Court held that "[w]ithin [the Hatch-Waxman Act's] framework, the counterclaim naturally functions to challenge the brand's assertion of rights over whichever discrete use (or uses) the generic company wishes to pursue."  Here, the panel assessed the statutory meaning with regard to the "specific" context in which it was used and the "broader" context of the statute "as a whole," citing Robinson v. Shell Oil Co., 519 U.S. 337, 341 (1997); Dep't of Homeland Sec. v. MacLean, 574 U.S. 383, 393 (2015); and Centripetal Networks, Inc. v. Cisco Sys., Inc., 38 F.4th 1025, 1031 (Fed. Cir. 2022).  That "broader" context involved Congressional intent to "compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications" according to the opinion, citing Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1568 (Fed. Cir. 1997); Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 1323 (Fed. Cir. 2007); PhotoCure ASA v. Kappos, 603 F.3d 1372, 1374 (Fed. Cir. 2010); and Merck & Co. v. Kessler.

Accordingly, the opinion states that Congressional purpose was for PTE to be granted to patents ("and only those patents") that claimed drugs for which regulatory approval delayed the benefit of patent exclusivity.  Finding for Merck, the opinion states, satisfies this Congressional intent, whereas agreeing with Aurobindo would "den[y] Merck compensation for all but a small period of the delay."  "There is no reason why the Hatch-Waxman Act's purpose would be served by disabling extensions of the unexpired term solely based on a patent holder's decision to seek reissue, and Aurobindo offers none," according to the panel.

The opinion addresses Aurobindo's argument that it would be improper statutory construction to use the original patent grant date for calculating PTE term because that original '340 patent was "dead" upon reissue, citing case law interpreting the effects of reissue including Seattle Box Co. v. Indus. Crating & Packing, 731 F.2d 818, 827 (Fed. Cir. 1984), and others extending back into the 19th Century.  The distinction the Court drew in rejecting this argument was that the status of the original patent was "irrelevant" because "the reissued patent inherits 'the unexpired part of the term of the original patent'" under 35 U.S.C. § 251(a) and mentioning that this date is unambiguous (albeit stating in a footnote that the panel did not find the parties' reliance on this portion of the status to be helpful because "it does not shed any light on the meaning of the term "the patent'" ).  "[A] 'reissue patent does not simply replace an original patent nunc pro tunc'" according to the opinion, citing Intel Corp. v. Negotiated Data Sols., Inc., 703 F.3d 1360, 1364 (Fed. Cir. 2012).

The opinion holds further that the panel's conclusion is consistent with § 156(a) regarding the provision that "the term of a patent . . . shall be extended . . . from the original expiration date of the patent" (emphasis added) (stating this is "the most natural reading" of this statutory language to refer to the original patent) as well as § 154(a)(2) regarding calculation of patent term.

The opinion concludes by acknowledging that the panel's interpretation is also consistent with how the PTO has construed the statute (in the overwhelming number of cases in which the issue has arisen) and, in the face of Aurobindo's argument, expressly revised the MPEP in this regard (consistent with the Court's assessment of the Hatch-Waxman statutory scheme).

* The complete roster of ANDA defendants before the District Court in consolidated actions were Aurobindo Pharma USA, Inc.; Aurobindo Pharma, Ltd.; Eugia Pharma Specialties Ltd.; Gland Pharma Ltd.; Mankind Pharma Ltd.; Lifestar Pharma LLC; Mylan API US LLC; Mylan Pharmaceuticals Inc.; Mylan Inc.; Sandoz Inc.; LekcPharmaceuticals d.d.; Sun Pharmaceutical Industries, Inc.; Sun Pharmaceutical Industries Ltd.; Fresenius Kabi USA, LLC; Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.; and USV Private Ltd.

** In a footnote, the panel noted that Merck filed its reissue application only after the Federal Circuit held that the addition of narrower claims could provide a proper basis for a reissue filing, in In re Tanaka, 640 F.3d 1246, 1251 (Fed. Cir. 2011).

Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (Fed. Cir. 2025)
Panel: Circuit Judges Dyk, Mayer, and Reyna
Opinion by Circuit Judge Dyk

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)

Note: This post addresses a Federal Circuit decision that issued on March 14, 2025.  This appeal involved Plaintiff-Appellant Regeneron Pharmaceuticals, Inc., Defendant-Appellee Amgen Inc. (Case 24-2351).  At trial, this case also included Defendants Mylan Pharmaceuticals Inc.; Amgen USA, Inc.; Biocon Biologics Inc.; Celltrion, Inc.; Formycon AG; and Samsung Bioepsis Co.; as well as the Defendants-Appellee.

By Kevin E. Noonan --

The Defendants in biosimilar litigation involving Regeneron's EYLEA biologic drug got off the schneid last week (see "Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)," involving Defendant-Appellant Celltrion), when one of the Defendants (Amgen) obtained a decision affirming the District Court's denial of a preliminary injunction under the litigation provisions of the BPCIA.

As in the earlier appeals, Regeneron's injunction motion was based on infringement of U.S. Patent No. 11,084,865 by Amgen's EYLEA biosimilar (designated ABP 938) and the appeal was limited to the propriety of the District Court's denial thereof to Regeneron.  The basis for the District Court's denial was that Regeneron had not satisfied the burden for being granted a PI, that they were likely to succeed on the merits, and this determination was based on differences between Regeneron's approved formulation and Amgen's biosimilar version of it.

Regeneron's '865 patent recited in representative claim 1 the components of its formulation of its EYLEA biologic drug (aflibercept):

1.  A vial comprising an ophthalmic formulation suitable for intravitreal administration that comprises:
    a vascular endothelial growth factor (VEGF) antagonist,
    an organic co-solvent,
    a buffer,
    and a stabilizing agent,
    wherein said VEGF antagonist fusion protein is glycosylated and comprises amino acids 27-457 of SEQ ID NO:4; and
    wherein at least 98% of the VEGF antagonist is present in native conformation following storage at 5° C. for two months as measured by size exclusion chromatography.

(wherein the italicized limitations were important to the district court's denial of the PI).

The specific ingredients that differed in Amgen's formulation and Regeneron's patented formulation was the absence of the buffer recited in the '865 patent claims.  As produced by Amgen, the opinion explains that "Amgen had discovered a way to prepare and formulate the active ingredient, aflibercept, in a manner that eliminates the need for a separate buffer component—i.e., the aflibercept itself provides sufficient buffering capacity to stabilize the formulation."

The District Court construed the '865 patent claims to require that the aflibercept and buffer were separate components ("[w]here a claim lists elements separately, the clear implication of the claim language is that those elements are distinct components of the patented invention" (emphasis in the opinion)), relying on Becton, Dickinson & Co. v. Tyco Healthcare Grp., LP, 616 F.3d 1249, 1255 (Fed. Cir. 2010), for the principle that "[t]here can be no literal infringement where a claim requires two separate structures and one such structure is missing from an accused [product]."  But this is just a presumption, and the District Court then considered whether there was a basis to overcome the "clear implication" it applied in its initial claim construction (it did not).  In coming to this conclusion, the District Court assessed both intrinsic and extrinsic evidence, which the opinion asserts "only reinforced the implication that the 'VEGF antagonist' and 'buffer' must be separate components of the claimed formulation."  The Court was careful to note that while the term "buffer" had been construed in earlier litigation with co-defendant Formycon (see "Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)"), the issue on claim construction before the District Court here was different to the extent that the issues raised by Amgen in this litigation were different (if only because the Court was tasked to determine whether the buffer was a distinct component of the claimed formulation under the Court's Becton precedent).  The District Court decided that Becton controlled and Amgen had raised "a substantial question of noninfringement" that precluded Regeneron from demonstrating there was a likelihood of success on the merits for its infringement action.  On this basis, the District Court denied Regeneron's motion for a preliminary injunction and this appeal followed.

The Federal Circuit affirmed, in a decision by Judge Lourie joined by Chief Judge Moore and Judge Stark.  The panel relied not only on Becton but on follow-on cases coming to the same conclusions, including Kyocera Senco Indus. Tools Inc. v. Int'l Trade Comm'n, 22 F.4th 1369, 1382 (Fed. Cir. 2022), and Schindler Elevator Corp. v. Otis Elevator Co., 593 F.3d 1275, 1282 (Fed. Cir. 2010), on the principle that where a claim recites limitations separately the clear implication is that each recited limitation is a "distinct component" of the claimed invention.  Reviewing how the District Court applied this principle, the panel asserted that "claim 1 plainly recites a pharmaceutical formulation, comprising four separately listed components."  (The opinion in a footnote is careful to say that this is not a per se rule but raises a presumption that "may always be rebutted in the context of a particular patent," citing Google LLC v. Ecofactor, Inc., 92 F.4th 1049, 1058 (Fed. Cir. 2024).)

Here, the panel found that the plain meaning of the claims raises the "separate elements" presumption, and the opinion states that Regeneron's arguments to the contrary are "misplaced."  In particular, the Court rejected Regeneron's argument that the District Court's previous construction of the term "buffer" with regard to the PI granted against Defendant Formycon precluded Becton from applying here.  One basis for this decision was that the District Court in fact did apply established principles of claim construction, specifically Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en banc), to determine whether the elements are separate and that the buffer cannot be substituted with aflibercept.

In addition, the opinion states that the proper way to construe the claim is to determine "whether a formulation is claimed in a way that clearly implies it requires distinct components."  Regeneron's proposed construction analysis was directed to whether the term "VEGF antagonist" overlaps with the term "buffer," the opinion saying that these inquiries are independent of each other.  This assessment provided the Court another basis for rejecting Regeneron's argument that the prior construction from the Formycon decision should be binding.

Having concluded that the District Court properly applied Becton, the panel then turned to the evidence for whether Regeneron had rebutted the Becton presumption.  The panel's basis for deciding that they had not done so began with the determination that the '865 patent's claims and the specification supported the District Court's decision that the terms at issue were separate.  The opinion turned first to the claims, and the requirement for rebuttal that there was "evidence that shows that the impliedly distinct components, instead, can be satisfied by a single component" (the Court reminding that extrinsic evidence cannot alter the meaning found in the intrinsic evidence under Intel Corp. v. VIA Techs., 319 F.3d 1357, 1367 (Fed. Cir. 2003)).  The panel found the intrinsic evidence supported the District Court's determination that the two claim elements were separate under Becton.  This intrinsic evidence included the plain meaning of the claims, wherein all the '865 patent claims made the separateness distinction found by the District Court here, including the use of "different concentrations and different units of measurement" (emphasis in opinion).  Turning to the specification, the panel agreed with the District Court that "the specification of the '865 patent uniformly describes the 'VEGF antagonist' and the 'buffer' as separate and distinct components of the formulation" (providing examples and in particular the lack of any instances where the buffering capacity of aflibercept was taught as a substitute for buffers disclosed therein).  "'Nothing in the specification indicates' that the VEGF antagonist 'might' also satisfy the distinct 'buffer' component" according to the opinion.

Concluding their review of the intrinsic evidence considered by the District Court, the panel held that the lower court "correctly concluded that the only reasonable construction of the claim language, in light of the specification (which does nothing to rebut the presumption of separateness), is that the 'VEGF antagonist' and 'buffer' are distinct components."

The Federal Circuit then considered whether extrinsic evidence asserted by Regeneron rebutted the District Court's conclusions regarding Becton separateness of the recited elements, concluding that such evidence did not do so.  The panel noted that the District Court could have refused to consider extrinsic evidence under the circumstances arising here where the intrinsic evidence is "clear and unambiguous."  Having considered the extrinsic evidence presented by Regeneron "for completeness," the Federal Circuit found no clear error in the District Court's analysis that such evidence (consisting of expert testimony and citation of a prior art reference explaining the buffering capacity of polypeptides) did not rebut the Court's conclusions based on intrinsic evidence.

In sum, the Federal Circuit held that on this record there was "at least a substantial question of noninfringement" raised by Amgen's formulation differences and accordingly Regeneron had not established the requisite likelihood of success for the District Court to grant a preliminary injunction, citing as an example Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997).

It remains to be seen, of course, whether Amgen will launch "at risk" (that risk being a finding of willful infringement under 35 U.S.C. § 284 and enhanced damages including attorneys' fees for doing so).  Under the circumstances behind the Federal Circuit's decision (including non-infringement) Amgen may decide it is worth the risk, which then raises the possibility that Regeneron will settle with Amgen or other defendants.  Those decisions will likely be based on considerations to which others outside the parties are unlikely to be privy and thus remain to be seen.

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)
Panel: Chief Judge Moore and Circuit Judges Lourie and Stark
Opinion by Circuit Judge Lourie