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 (non-precedential).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

DNA Genotek Inc. v. Spectrum Solutions LLC (Fed. Cir. 2025)

By Kevin E. Noonan --

Sometimes important contributions to innovation can come from the mundane rather than the extraordinary.  One (perhaps apocryphal) example comes from the story of the early development of television by Philo Farnsworth (the story, but not the apocrypha, is set forth in Evan Schwartz's book The Last Lone Inventor).  In this aspect of the tale, Farnsworth's brother-in-law, wanting to help but knowing nothing about electronics, learned to blow glass television tubes which he realized were necessary components of Farnsworth's invention.  This story comes to mind in a recent nonprecedential Federal Circuit decision regarding methods for isolating DNA from biological samples (such as sputum), found not to be infringed in DNA Genotek Inc. v. Spectrum Solutions LLC.

The case arose over U.S. Patent No. 10,619,187 that claimed a device for "preserving nucleic acids at room temperature for extended periods of time and for simplifying the isolation of nucleic acids" according to the opinion.  Claim 1 is set forth in the opinion as being representative:

A device for receiving and preserving nucleic acid in a biological sample, said device comprising:
    one or more walls defining a containment vessel having a top having an opening, and a closed bottom having a sample receiving area for holding said biological sample, said opening for receiving a liquid sample and for sealably receiving a sealing cap, said top having an opening for receiving a biological sample from the mouth of a user and further comprising at least one marking on said one or more walls which corresponds to a fluid volume in the sample receiving area;
    a reagent compartment having a barrier, said barrier sealing and containing reagents in said reagent compartment and capable of disestablishment to release said reagents into the sample receiving area;
    reagents in the reagent compartment for preserving nucleic acids potentially present in the sample wherein said reagents comprise a denaturing agent, a chelator and a buffer agent; and,
    the sealing cap, whereby the device is configured such that, when sealably closing said opening with said sealing cap, the barrier mechanically disestablishes to release said reagents to form a mixture of reagents and said biological sample wherein said buffering agent maintains a pH of said mixture equal to or above 5.0 to preserve nucleic acids potentially present in the sample.

As explained in the opinion, the device contains a first region for collecting a biological sample and a second region containing reagents for preserving the nucleic acid in the sample, with a barrier between the two regions; the device further comprises means for "disturbing the integrity" of the barrier so that the reagents in the second region and the biological sample is mixed.  Said second region also contains reagents for disrupting cells in the sample, "liberating" nucleic acids, solubilizing the lipid components, stripping [proteins] from DNA and digesting proteins therein," wherein the liberated nucleic acid is stably preserved at room temperature for later analysis.  Benefits of the claimed devices and methods for using them include eliminating the need for refrigeration between biological source and clinical or analytical laboratories.

Genotek sued Spectrum for infringement by the latter company's SDNA home saliva-collection kit for providing COVID-19 PCR testing.  The District Court granted Spectrum summary judgment of non-infringement based, according to the opinion, on construction of the term "reagent compartment."  This appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Rodney Gillstrap,* sitting by designation, joined by Judges Lourie and Hughes.  The opinion focused on the District Court's construction of the term "reagent compartment" to mean "a region or section of the containment vessel" and that the '187 patent specification provided "clear guidance" regarding the location of that compartment in the device.  Specifically, the District Court construed the location of the reagent compartment to be within the containment vessel of the device.  This construction was supported by the prosecution history and the record of an inter partes review (IPR) proceeding in which the '187 patent was involved, according to the opinion.  In particular, the District Court held and the Federal Circuit affirmed that Genotek had intentionally deleted "any explicit disclosure of the reagent compartment being in the cap/lid," which evinced "a clear intent to limit the final scope of the invention to a device with the reagent compartment in the containment vessel."

Genotek argued on appeal that the District Court erred in its construction by importing limitations from the specification into the claims and that the plain language of the claims contained no limits on the location of the reagent compartment.  The Federal Circuit disagreed, citing several portions of the specification that consistently supported the District Court's construction and that these portions described the invention "as a whole" and not merely preferred embodiments, citing Regents of Univ. of Minnesota v. AGA Med. Corp., 717 F.3d 929, 936 (Fed. Cir. 2013), for the principle that "[w]hen a patent thus describes the features of the 'present invention' as a whole, this description limits the scope of the invention."

Equally unavailing was Genotek's argument that a provisional application from which the '187 patent claimed priority (and which was incorporated by reference) disclosed an embodiment where the reagent compartment was in the cap.  The panel found support in the prosecution history for the District Court's construction excluding the cap location for the reagent compartment.  According to the opinion, "[w]hen Genotek filed its non-provisional application, it intentionally deleted all references to that embodiment and included only embodiments with the reagent compartment in the container."  Such deletions have been held to "contribute[ to] understanding . . . the intended scope of the final application," citing MPHJ Tech. Invs., LLC v. Ricoh Ams. Corp., 847 F.3d 1363, 1369 (Fed. Cir. 2017), and thus the Federal Circuit agreed with the District Court that the properly construed claims of the '187 patent did not include embodiments where the reagent compartment was in the cap or lid.

Finally, Genotek objected to the District Court relying on distinctions between the device claimed in the '187 patent and prior art patents having a reagent compartment in the lid on the grounds that those statements were made with regard to preferred embodiments of the invention claimed in the '187 patent and not the invention as described a whole.  The panel noted that these statements were not dispositive but also understood the District Court's consideration of them as permissively "informing the district court's construction" of the claims to the device.

On these bases, the Federal Circuit affirmed the District Court's grant of summary judgment for Spectrum that their SDNA devices did not infringe the asserted claims of the '187 patent.

*Chief Judge of the U.S. District Court for the Eastern District of Texas.

DNA Genotek Inc. v. Spectrum Solutions LLC (Fed. Cir. 2025)
Nonprecedential disposition
Panel: Circuit Judges Lourie and Hughes, and Chief District Judge Gilstrap
Opinion by Chief District Judge Gilstrap

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

By Kevin E. Noonan --

Completing a recent jurisprudential "hat trick,"* the Federal Circuit affirmed a District Court grant of a preliminary injunction against a biosimilar applicant for Regeneron's EYLEA biologic drug in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.

As in the earlier appeals, the injunction was based on infringement by Celltrion's EYLEA biosimilar (designated CT-P42) of U.S. Patent No. 11,084,865 and the appeal limited to the propriety of the District Court granting a preliminary injunction (PI) to Regeneron (as well as some jurisdictional issues).  The opinion dealt summarily with those issues resolved in the earlier appeals, including whether the District of West Virginia could exercise jurisdiction against Celltrion, a Korean company.  Based on the Court's earlier decisions, in this opinion the panel held that Defendant-Appellant Celltrion had sufficient minimum contacts with the West Virginia forum to satisfy the jurisdictional standard in the Fourth Circuit.  The opinion also set forth the Court's determination that Regeneron satisfied its burden for being granted a PI, specifically that "(1) it is likely to succeed on the merits, (2) it is likely to suffer irreparable harm in the absence of preliminary relief, (3) the balance of equities tips in [its] favor, and (4) an injunction is in the public interest," citing BlephEx, LLC v. Myco Indus., Inc., 24 F.4th 1391, 1398 (Fed. Cir. 2022).  Once again, the panel held that questions of the nexus between Celltrion's sales of its EYLEA biosimilar and irreparable harm to Regeneron had been established in the earlier appeals and applied here.

The only issue recognized by the Federal Circuit to be before it in this appeal was whether Celltrion had raised a "substantial question of invalidity" against Regeneron's '865 patent, specifically on obviousness-type double patenting (ODP) grounds.  This challenge was based on Claim 5 of an earlier-issued Regeneron patent, U.S. Patent No. 9,340,594:

5.  [A pre-filled syringe suitable for intravitreal administration comprising a 1 mL luer glass syringe fitted with a plunger and a stable ophthalmic formulation of a vascular endothelial growth factor (VEGF) trap, which consists of (i) a receptor component consisting essentially of an immunoglobulin-like domain 2 of a first VEGF receptor and an immunoglobulin-like domain 3 of a second VEGF receptor, and (ii) a multimerizing component, wherein the stable ophthalmic formulation comprises:
    (a) 1-100 mg/ml a VEGF antagonist;
    (b) 0.01-5% of one or more organic co-solvent;
    (c) 5-40 mM of buffer; and
    (d) optionally comprising 1.0-7.5% of a stabilizing agent[,
    wherein the first VEGF receptor is Flt1, and the second VEGF receptor is Flk1 or Flt4, wherein the VEGF trap is stable for at least 4 months, and] wherein the VEGF trap consists of amino acids 27-457 of SEQ ID NO:4, wherein the stable ophthalmic formulation comprises 40 mg/mL of the VEGF trap, 10 mM phosphate, 40 mM NaCI, 0.03% polysorbate 20, 5% sucrose, at pH 6.2-6.4,

Wherein the italicized limitations were recited in independent claim 1 and intermediate dependent claims 2 through 4.

The District Court had held that the patentable distinctions between this claim and the claims of the '865 patent included "(1) the stability requirement that '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'; (2) the requirement that aflibercept [the EYLEA active ingredient] is glycosylated; and (3) the use of a vial versus a pre-filled syringe."  The panel set forth in the opinion the specific distinctions between claim 5 and claim 4 of the '865 patent to be that claim 5 requires stability of the VEGF trap to be maintained for "at least 4 months," whereas claim 4 of the '865 patent recites that "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."  The District Court concluded (and the Federal Circuit agreed) that the 98% limitation was "neither inherent nor obvious" in what was claimed in claim 5 of the '594 patent.  Celltrion's specific challenges to this determination were the District Court's claim construction of the term "stable," wherein the District Court did not construe the term to mean the specific requirement recited in claim 4 of the '865 patent, instead holding that the term "stable" had "a broader meaning than the particular SEC measurements of aggregation and threshold levels (98%) to which Celltrion attempts to limit the term."  The District Court rejected Celltrion's assertions that such stability was sparsely reported in the '594 specification, finding "numerous descriptions of stability beyond simply 98% native conformation as measured by SEC."  The Federal Circuit agreed with the District Court's construction of the term "stable" and accordingly rejected Celltrion's argument that claim 5 of the '594 patent "expressly anticipates the stability limitations in the asserted claims [of the '865 patent]."

Celltrion's second challenge was that the "98% native conformation claim limitation" in claim 4 of the '865 patent was inherent in the stability limitation recited in claim 5 of the '594 patent.  According to the District Court:

Celltrion's reliance on the native conformation data in Examples 3 and 4 [of the '594 patent] is legally inadequate to prove inherency.  That the practice of '594 claim 5 sometimes results in 98% native conformation is insufficient; inherency requires that the 98% native conformation limitation be present necessarily, not just possibly or probably [emphasis in original].

The Federal Circuit rejected as a contradiction of the plain meaning of the claims Celltrion's arguments that the skilled artisan would have interpreted the stability limitations of "at least 98% [to] define[] a rate of aggregation over a particular time, under particular conditions" because the claim recites that the 98% of the VEGF antagonist be "present in native conformation following storage . . . for two months" which in no way implicates calculation of a rate of aggregation as argued by Celltrion.

Third, the panel rejected Celltrion's argument of error by the District Court in deciding that the 98% native conformation limitation was not obvious, which was based on expert testimony.

Finally, the Court briefly turned to Celltrion's arguments regarding the glycosylation limitations, which the District Court had rejected based on the extent of glycosylation of aflibercept.  Celltrion argued that claim 5 of the '594 patent anticipated the asserted claims of the '865 patent because it covers "a genus with only two species – glycosylated and non-glycosylated."  The District Court held that, in view of the "five distinct glycosylation sites," "there are at least thirty possible glycosylated forms of aflibercept . . . in addition to the nonglycosylated form."  In view of the Court's determination that "one patentably distinct limitation [i.e., the stability limitation] is enough" to support the District Court's rejection of Celltrion's assertion of invalidity for ODP, and Celltrion's opportunity to pursue this invalidity argument at trial, the Court held that there was no need to address the issue here and affirmed the District Court's determination that Celltrion had not rebutted Regeneron's evidence of there being a likelihood of success on the merits to support its motion for a preliminary injunction.

Trial against this defendant, and the remaining defendants** is ongoing.

* See "Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)" and "Regeneron Pharmaceuticals, Inc  v. Formycon AG"
** In addition to Mylan Pharmaceuticals Inc. and Formycon AG these include Amgen USA, Biocon Biologic Inc., Samsung Bioepsis Co. Ltd, and Amgen Inc.

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)
Nonprecedential disposition
Panel: Circuit Judges Prost, Wallach, and Chen
Opinion by Circuit Judge Prost

 

Immunogen, Inc. v. Stewart (Fed. Cir. 2025)

By Kevin E. Noonan --

After creating something of a frisson due to the apprehension that the Federal Circuit might be convinced to re-evaluate whether it was a necessary element for establishing obviousness for the skilled artisan to have had a reasonable expectation of success (see "U.S. Patent Office Challenges the Reasonable Expectation of Success Prong of Obviousness Law Precedent in Immunogen v. Vidal")*, cooler (or perhaps more conventionally doctrinal) heads prevailed in the Court's recent decision in Immunogen, Inc. v. Stewart (albeit by ignoring the argument while nevertheless affirming the District Court's obviousness determination).

The technology at issue (in U.S. Patent Application Publication No. US 2015/0132323 A1) was directed to methods for treating ovarian and peritoneal cancer patients using an antibody-drug conjugate ("ADC") called IMGN853 (mirvetuximab soravtansine).  The molecule is a conjugate of "an antibody known as 'huMov19,' . . . a toxic maytansinoid payload known as 'DM4,' and . . . a charged chemical linker known as 'charged sulfo-SPDB linker.'"  However, as set forth in the opinion, the drug had the deleterious side-effect that it was capable of causing ocular toxicity, including keratitis and blurred vision; this side effect was not recognized in the prior art.  The methods recited in the rejected claims specify that the administered dose be calculated from the adjusted ideal body weight (or "AIBW"), which will vary from patient to patient and will also likely vary for the same patient during the course of the treatment; claim 1 is set forth as being representative (wherein the limitation in italics was at issue here):

1.  A method for treating a human patient having an FOLR1-expressing ovarian cancer or cancer of the peritoneum comprising administering to the patient an immunoconjugate which binds to FOLR1 polypeptide,
    wherein the immunoconjugate comprises an antibody or antigen-binding fragment thereof that comprises the variable light chain (VL) complementarity determining region (CDR)-1, VL CDR-2, VL CDR-3, variable heavy chain (VH) CDR-1, VH CDR-2, and VH CDR-3 of SEQ ID NOs: 6-9, 11, and 12, respectively, and a  maytansinoid, and
    wherein the immunoconjugate is administered at a dose of 6 milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient.

The standard for determining the amount of ADC to be administered is different from the total body weight (or "TBW") standard used in the prior art.  Using the TBW standard led to an unacceptable level of ocular toxicity which was not recognized in the art, and such ocular toxicity was significantly alleviated if this drug was dosed using the AIBW approach.

This is the second time Immunogen has come before the Federal Circuit to appeal rejections for indefiniteness and obviousness from the Patent Office for the '809 application.  In the first case, Immunogen challenged the rejections by filing suit under 35 U.S.C. § 145 and the District Court held for the Office on summary judgment.  The Federal Circuit (before a panel of Judges Newman, Stoll, and Clevenger) vacated and remanded; see "ImmunoGen, Inc. v. Hirshfeld").  With respect to obviousness, the Court's prior judgment was based on factual errors appreciated by the panel, finding that there were genuine issues of material fact in dispute mandating reconsideration by the District Court on remand.

Here, the Office once again prevailed at the District Court on Immunogen's § 145 action and once again Immunogen appealed to the Federal Circuit.  Once again, the District Court found the claims to be invalid for indefiniteness under § 112(b) and obviousness under § 103 (as well as obviousness-type double patenting, which was not at issue in the appeal).  The indefiniteness judgment was based on the specification "fail[ing] to define AIBW . . . anywhere in its claims" which was significant because the District Court also found that "there are various formulas for AIBW from which a person of ordinary skill in the art could have chosen."  The District Court also held that method of treatment claims using this drug were obvious in view of Immunogen's earlier disclosure of IMGN853 administration using total body weight (TBW) dosing and AIBW dosing for other drugs.  The specific bases for the District Court's obviousness determination set forth in the opinion was that "(i) the problem of ocular toxicity was known, (ii) skilled artisans understood that changing the dose was a possible solution for adverse side effects such as ocular toxicity, and (iii) the prior art disclosed AIBW dosing as a potential means to eliminate or ameliorate ocular toxicity."

The Federal Circuit affirmed, in an opinion by Judge Lourie, joined by Judges Dyk and Prost.  Regarding obviousness, the panel addressed Immunogen's argument that the District Court erred in its motivation to combine analysis.  According to Immunogen, the ocular toxicity motivating use of AIBW was not recognized in the art.  The Federal Circuit made the distinction that, while the solution to an unappreciated problem may be non-obvious "it does not follow that a claimed solution to an unknown problem is necessarily non-obvious" (emphasis in opinion).  According to the Court, what matters (under KSR Int'l Co. v. Teleflex Inc) is "the objective reach of the claim," i.e., "any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed," citing KSR, Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., 97 F.4th 915, 929 (Fed. Cir. 2024), and Alcon Rsch., Ltd. v. Apotex Inc., 687 F.3d 1362, 1368 (Fed. Cir. 2012).  Accordingly, the opinion rejected Immunogen's argument because specific problems not recognized in the prior art do not mandate a finding of non-obviousness under KSR in the Court's view.  The opinion credits the District Court's determination that ocular toxicity was a "well-known adverse event in administration of immunoconjugates" comprising the maytansinoid component of IMGN853 (despite such effects not being seen in experimental animals).  Lack of knowledge does not prevent the skilled worker from being motivated to monitor for the unknown side effects according to the panel (which seems to smack at least a little of hindsight and special pleading).

The panel similarly rejected Immunogen's contentions that the specific use of AIBW in place of TBW would not have been obvious.  The District Court held that the skilled worker would have been motivated to try to solve the unrecognized ocular toxicity problem by using alternative methods for determining an effective dose known in the art (as was AIBW, known for avoiding ocular toxicity in drugs such as antibiotics, radioimmunoconjugates, and other anticancer drugs).  These facts formed the bases for the District Court in finding motivation for using AIBW as a dosing metric and the Federal Circuit found no clear error in this determination.  This decision was based on the panel's apprehension that, while not having been used to determining dosing for an ADC in the prior art, it "would have been within the range of knowledge of a person of ordinary skill in the art when confronted with dosing-induced toxicities, and particularly when confronted with dosing-induced ocular toxicity" (despite ocular toxicity for IMGN853 not being appreciated in the prior art).  The District Court (and the Federal Circuit) supplemented the art with Immunogen's own U.S. Patent Application Publication No. 2012/0282282 (ImmunoGen's own publication) that disclosed both IMGN853 and ocular toxicity.

Turning to the question of the specific dose (6 mg/kg) set forth in the claims, a seemingly important factor (for both the District Court and the Federal Circuit) was that "patients who weigh exactly their ideal body weight receive an identical dose of IMGN853 when dosed based on either AIBW or TBW."  There was specific disclosure in the art for administering "about" 6 mgkg (5 mg/kg or 6 mg/kg) of IMGN853.  In addition to these facts, the panel was concerned that in finding the claimed method non-obvious the Court could be "prevent[ing] doctors from practicing what is already disclosed in the prior art for patients at their ideal body weight" (which would occur even if the doctor did not know the amount to be administered using AIBW dosing).  This outcome should be sufficient to support the District Court's obviousness conclusion according to the opinion, citing PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014), quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981).

Finally, turning to the question of reasonable expectation of success that the Patent and Trademark Office had argued should not be a consideration in this and similar cases, Immunogen's argument was focused on the lack of such reasonable expectation for the 6 mg/kg dose.  The absence of any limitation in the claims relating to avoiding ocular toxicity formed the basis for the panel to reject this argument; specifically what the District Court was required to do (and did under these circumstances according to the Court) was to determine whether "a person of ordinary skill in the art would have had a reasonable expectation that dosing a human at 6 mg/kg AIBW would have been effective in treating ovarian and peritoneal cancers," citing Teva Pharms. USA, Inc. v. Corcept Therapeutics, Inc., 18 F.4th 1377, 1381 (Fed. Cir. 2021).  The Court again relied on this dosage being the same using AIBW as was found using TBW to provide the requisite reasonable expectation of success to support the District Court's obviousness holding.

For Immunogen, the outcome was the same as in the earlier appeal, but for the rest of us some comfort can be taken that the Court did not take the USPTO's suggestion that it fundamentally rewrite how obviousness is properly determined.

* In its briefing, the Office took the position that claims to methods for administering drugs (particularly ones subject to independent patent protection) that rely, as do Immunogen's, on dosing regimens are (almost per se) obvious.  This position included an attack on Immunogen's argument that the claims were non-obvious because the unpredictability of these claims would preclude the skilled worker from having the requisite reasonable expectation of success.  The Office decried this argument, asserting that "ImmunoGen should not be able to use 'unpredictability' as talisman for getting a patent.  Otherwise, drug companies may be able to get patent protection on any follow-on pharmaceutical development no matter how obvious to try - because the result of pharmaceutical experiments are nearly always somewhat unpredictable."

Immunogen, Inc. v. Stewart (Fed. Cir. 2025)
Panel: Circuit Judges Lourie, Dyk, and Prost
Opinion by Circuit Judge Lourie

Judge Newman Files Reply Brief in Newman v. Moore

By Kevin E. Noonan --

The Honorable Pauline Newman, Circuit Judge for the U.S. Court of Appeals for the Federal Circuit, has been battling her suspension from the Court imposed by the Judicial Council for two years (including proceedings leading up to the suspension; see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit"; "Judge Newman Matter Continues"; "Federal Circuit Special Committee Responds to Judge Newman's Counsel's Request for Clarification Regarding Misconduct Hearing"; "Federal Circuit Special Committee Recommends One-Year Suspension of Judge Newman"; "Judge Newman Suspended for One Year by Federal Circuit"; "Judge Newman's Suit Continues";  "Special Committee of the Judicial Council of the Federal Circuit Replies").  Recently, her efforts came to naught, as the D.C. District Court dismissed her suit against her colleagues (see "Judge Newman's Suit Comes to an End") and the Judicial Counsel renewed her suspension for another year (see "Special Committee's Suspension Recommendation Adopted by Federal Circuit; "Judge Newman Suspension Renewed").  Judge Newman has filed an appeal in the D.C. Circuit (see "Judge Newman Files Appeal with D.C. Circuit") and the Judicial Council of the Federal Circuit has responded.  Last month, Judge Newman filed her Reply.

The brief addresses the arguments set forth in the Judicial Council's brief responding to Judge Newman's principal arguments on appeal:  that Congress cannot legitimately enact legislation that permits removal (actual or constructive) of an Article III Judge outside the impeachment provisions of the Constitution, and that the District Court erred in failing to construe the statute to permit the Judicial Council's de facto removal of Judge Newman from the bench; that the Judicial Council's assertions that their suspension was temporary is inconsistent with the record; that prior precedent (McBryde v. Comm. to Rev. Cir. Council Conduct & Disability Ords. of Jud. Conf. of U.S.) was not controlling; and that permitting the Judicial Council to participate in this process violates Judge Newman's due process rights.

The brief begins by highlighting the Achilles heel of the Judicial Council's justifications for how it had conducted the inquiry directed towards Judge Newman, saying that "Defendants-Appellees fail to dispute that as a result of her unlawful suspension Judge Newman does not exercise any functions of her office."  The tack the Council has taken in its Responsive brief, and throughout is that the Judicial Conduct and Disability Act, 28 U.S.C. §§ 351-364, gives the Council the authority to act as it has, and that Judge Newman has the "keys" to her return to the bench by complying with the Council's demand that she submit to neuropsychological testing by physicians of the Council's choice.  The brief also disputes, and argues that the Council does not "address, much less rebut, Judge Newman's argument that this Court has authority to ensure that the Judicial Council, as an administrative body, does not act beyond its statutory remit."  While seeming not to dispute that the Act permits suspension from a judge's duties only "on a temporary basis for a time certain," it is clear that, absent the Judge's compliance, the suspension will never be lifted.  The situation is unprecedented, Judge Newman argues, stating that "a complete involuntary suspension from judicial duties has never been attempted irrespective of the seriousness of misconduct by a federal judge" (emphasis in brief), nor has there a "single instance of a case where a misconduct investigation of a circuit judge was conducted within that judge's own circuit."  And, the brief argues, no Judicial Council has ever before asserted the power to debar a "duly nominated, confirmed, and appointed United States Circuit Judge" from the "powers and duties" of her judicial office other than by impeachment by the House of Representatives (this lack of historical precedent being "highly probative" according to the brief, citing several authorities).

Judge Newman summarizes her argument in three major points.  The first is that the D.C. Circuit Court has the duty to construe the statute and this includes ruling on the constitutionality of a Judicial Council removing an Article III judge from the court other than by recommending impeachment to the House.  Either the Council has exceeded its authority under the Act, or the Act permits the Council's actions, in which case it is unconstitutional to the extent that it permits such removals.  And the fact that the removal is at the hands of federal judges acting as a judicial council does not justify abrogation of the Constitution's guarantee of life tenure, which guarantee "protects the independence of individual judges from their colleagues as much as from other branches."

The second prong of Judge Newman's argument is that the District Court erred by relying on McBryde v. Comm. to Rev. Cir. Council Conduct & Disability Ords. Of Jud. Conf. of U.S., 264 F.3d 52, 64-67 (D.C. Cir. 2001), as precedent that it could not considered "as applied" constitutional challenges.  According to the brief, the Court had "explicitly reserved the issue now presented here: whether a long-term disqualification can constitute an unconstitutional removal from office."  The crux of this argument was that the Court made this reservation in the context of having jurisdiction over whether an agency decision exceeded the statutory authority under which the agency acted, and that when acting under the Act a judicial council was acting as an agency not as a court.

The third argument involved Judge Newman's due process complaint, to which she was constitutionally entitled the brief asserts.  The brief argues that there is no disputing in the Responsive brief that the Judicial Council was acting as "investigators" and "witnesses" and thus not as neutral judges required to ensure due process is received in an adjudicatory proceeding.

Regarding the first argument, Judge Newman asserts that what is properly before the D.C. Circuit Court is her facial challenge on the constitutionality of the Act, based on what she asserts is the Judicial Council's "complete debarment from judicial functions" which "necessarily prevents a judge from exercising judicial power and therefore effects a functional 'removal' from office" (emphasis in brief).  In this argument, Judge Newman presents the Court with two alternatives:  either the Judicial Council's indeterminate suspension was improper under a narrow construction of the Act, or the Act is unconstitutional if within its proper scope it permits divesting an Article III judge from her office.  In addressing the Judicial Council's argument that Judge Newman had waived this argument (which she denies), her brief reminds the Court of their duty "to construe the statute and give meaning to the statutory language," citing Crowell v. Benson, 285 U.S. 22, 62 (1932) (emphasis in brief).  The brief disputes the Responsive brief's characterization of Judge Newman's argument to the extent that it is anything but that the Act does not permit judicial councils to remove a judge from the performance of her judicial functions indefinitely and, if the Act permits this outcome, it is unconstitutional.

And in that case, that the Act does permit suspensions for indefinite terms, then "the Act can never be validly applied" and is unconstitutional on its face.  The brief recognizes that there are some limits that can be placed on a judge's purview under the Act but that the power to suspend a judge from all judicial functions is not (constitutionally) one of them.  "[H]aving a framed commission on the wall while being unable to exercise any powers granted by that very commission, is meaningless," the brief asserts in making its distinction between the question of the length of the suspensions a judicial council is entitled to impose to be constitutional (and the mere fact that Judge Newman technically still has her seat is not enough; "the Constitution 'deals with substance, not shadows'" the brief asserts, citing  Cummings v. Missouri, 71 U.S. (4 Wall.) 277, 325 (1867).  And distinguishing McBryde, the brief concedes that "an act of Congress that authorizes some forms of judicial intra-branch discipline (e.g., censure, reprimand, or diminution of caseload) does not raise the same constitutional concerns."

Further on this point, the brief rebuts what it terms the "parade of horribles" in the Responsive brief with regard to the purported negative consequences that would ensue should the Court agree with Judge Newman on the merits (which is somewhat illuminating reading but not particularly germane to the issues here).  But in this portion of the brief Judge Newman takes the opportunity to address the argument that disabled judges would not be able to be divested of their office by, first, stating that "this simply reflects the Constitution's limits on the power of the Judicial Council," and second that while "not ideal circumstances "the Constitution, for better or worse, placed the determination of when to step down from the bench in the hands of the judge herself and of Congress as a backstop—not in a judge's colleagues' hands" (while noting in an aside that Judge Newman is not a disabled judge).

Finally, the brief addresses and rebuts the Judicial Council's argument that the interpretation of the Act they advance does not threaten judicial independence.  In this regard, the brief cites Northern Pipeline Construction Co. v. Marathon Pipe Line Co. that "[t]he guarantee of life tenure insulates the individual judge from improper influences not only by other branches but by colleagues as well and thus promotes judicial individualism," 458 U.S. 50, 59 n.10 (1982) (emphasis in brief).

On Judge Newman's second line of argument, the brief makes short work of the argument in the Responsive brief that Judge Newman's suspension is only temporary.  The brief argues that suspensions by judicial councils are not empowered to "induce compliance" as the Responsive brief contends.  Instead, the Act empowers a judicial council to impose suspensions as remedies for past conduct, and Judge Newman notes that the Judicial Council in this case has itself "abjured the claim that Judge Newman's suspension is meant to be 'coercive.'"  The brief uses the case of Judge John Adams to illustrate the distinctions, wherein while Judge Adams was required to be subject to a psychiatric exam the suspension imposed was "without any possibility of renewal," In re Complaint of Judicial Misconduct, No. 06-13-90009 (6th Cir. Judicial Council, June 27, 2018).  The brief also reminds the Court (or brings to its attention) the fact that "even before the formal disciplinary process against Judge Newman began, Chief Judge Moore demanded Judge Newman's resignation."  "The entire history of this process shows that Defendants-Appellees have already concluded that Judge Newman has no place on the bench and they are willing to remove her irrespective of what medical evidence shows," the brief asserts.

The brief then sets forth an expanded version of the argument that the McBryde precedent does not stand for what the Responsive brief would have the Court believe that it does.  The legal principle upon which Judge Newman continues to rely is that the existence of "intervening authority" (here, the reservation enunciated in footnote 5 of McBryde) relieves this panel from being bound by McBryde under Carpenters Loc. Union No. 26 v. U.S. Fid. & Guar. Co., 215 F.3d 136, 141 (1st Cir. 2000).

Finally, the brief turns to Judge Newman's due process arguments, colorfully addressing the Responsive brief's reliance on Judge Newman's opportunity to proffer her arguments by stating "Even Soviet justice permitted attorney arguments" in response.  What due process requires, Judge Newman argues, is "a neutral and detached judge in the first instance," citing Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers Pension Tr. for S. Cal., 508 U.S. 602, 617 (1993) (quoting Ward v. Village of Monroeville, 409 U.S. 57, 61-62 (1972)), which has not been available to Judge Newman according to her brief.  The brief rebuts the assertion that the misconduct allegations are predicated on Judge Newman's failure to comply by reminding the Court that "the reason Judge Newman has declined to cooperate is precisely because the evaluation of any medical report would be done by people who are, by their own admission, witnesses to the underlying allegations" (emphasis in brief).  The basis for this situation has been the unprecedented insistence by this Judicial Council to retain jurisdiction over this matter instead of transferring it to a judicial council in another Circuit, she argues.  The reasonableness of Judge Newman's request for transfer and the importance of the due process implications are illustrated in the brief by the history of such proceedings in other circuits and the behavior (recusal) of judges in similar circumstances as the judges on the Federal Circuit's judicial council here.  "The unprecedented nature of these proceedings, overseen by judges who are also witnesses, weighs heavily in favor of their unlawfulness," this brief strongly argues.

The saga continues.

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

Note: This post addresses two Federal Circuit decisions issued on January 29, 2025.  Both appeals involved Plaintiff-Appellee Regeneron Pharmaceuticals, Inc., with the first appeal involving Defendant-Appellant Formycon AG (Case 24-2009) and the second appeal involving Defendant-Appellant Samsung Bioepsis Co. (Case 24-1965).  At trial, each case also included Defendants Mylan Pharmaceuticals Inc., Amgen USA, Inc., Biocon Biologics Inc., Celltrion, Inc., and Amgen Inc., as well as the two Defendants-Appellants.

By Kevin E. Noonan --

The Federal Circuit recently affirmed the District Court's grant of preliminary injunctions against each of the Defendant biosimilar applicants recited in the caption, as well as the District Court's finding of the court having personal jurisdiction over each, in two decisions captioned Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir 2025) having the Defendants-Appellants listed above.

The case arose in multidistrict litigation (28 U.S.C. § 1407) under the Biologics Price Competition and Innovation Act (BPCIA; 42 U.S.C. § 262(k)–(l)) over Regeneron's Eylea® (aflibercept) product.  Aflibercept is a VEGF (vascular endothelial growth factor) antagonist (also termed a "VEGF trap") which is used to treat a number of angiogenic eye diseases including age-related macular degeneration (AMD) and diabetic retinopathy.  Each of the Defendants had filed an Abbreviated Biologics License Application or were involved in the production of the biosimilar product for Eylea®, and at issue was Regeneron's U.S. Patent 11,084,865, specifically claim 4 as asserted against Samsung Bioepsis ("SB"):

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.

2.  The vial of claim 1, wherein the concentration of said VEGF antagonist fusion protein is 40 mg/ml, and wherein said organic co-solvent comprises polysorbate.

4.  The vial of claim 2, wherein said organic co-solvent comprises about 0.03% to about 0.1% poly-sorbate 20.

Also relevant to the proceedings was claim 5 of a related Regeneron patent, U.S. Patent No. 9,340,594, which was asserted by SB in arguing that the '865 patent was invalid under the judicially created doctrine of obviousness-type double patenting:

1.  A pre-filled syringe suitable for intravitreal administration comprising a 1 mL luer glass syringe fitted with a plunger and a stable ophthalmic formulation of a vascular endothelial growth factor (VEGF) trap, which consists of (i) a receptor component consisting essentially of an immunoglobulin-like domain 2 of a first VEGF receptor and an immunoglobulin-like domain 3 of a second VEGF receptor, and (ii) a multimerizing component, wherein the stable ophthalmic formulation comprises:
    (a) 1-100 mg/ml [of] a VEGF antagonist;
    (b) 0.01-5% of one or more organic co-solvent;
    (c) 5-40 mM of buffer; and
    (d) optionally comprising 1.0-7.5% of a stabilizing agent.

2. The pre-filled syringe of claim 1, wherein the first VEGF receptor is Flt1, and the second VEGF receptor is Flk1 or Flt4.

3.  The pre-filled syringe according to claim 2, wherein the VEGF trap is stable for at least 4 months.

4.  The pre-filled syringe according to claim 3, wherein the VEGF trap consists of amino acids 27-457 of SEQ ID NO:4.

5.  The pre-filled syringe according to claim 4, wherein the stable ophthalmic formulation comprises 40 mg/mL of the VEGF trap, 10 mM phosphate, 40 mM NaCl, 0.03% polysorbate 20, 5% sucrose, at pH 6.2-6.4.

(in each instance the opinion sets forth relevant claim limitations in italics).

The District Court granted a preliminary injunction to Regeneron against SB preventing it from selling or offering to sell its FDA-approved aflibercept biosimilar product without a license from Regeneron.  The District Court rejected SB's arguments to the contrary, based on Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc.  SB appealed, based on its assertions that the District Court improperly found personal jurisdiction in the multidistrict forum (the District of West Virginia) and improperly granted the injunction over its assertion that the '865 patent was invalid for ODP, failure to satisfy the written description of 35 U.S.C. § 112(a), and for failing to establish a "causal nexus" between its infringement and irreparable harm to Regeneron.

The Federal Circuit affirmed, in an opinion by Judge Taranto joined by Chief Judge Moore and Judge Reyna.  The opinion relied on Merial Ltd. v. Cipla Ltd. for making its jurisdiction determination, setting forth the "two inquiries" under Federal Rule of Civil Procedure 4(k)(1)(A), upon which such determinations are made:  first, "whether a forum state's long-arm statute permits service of process, and whether the assertion of jurisdiction would be inconsistent with due process," citing Electronics for Imaging, Inc. v. Coyle (finding that the West Virginia "long arm" statute is co-extensive with due process under In re Celotex Corp.).  SB had argued that it lacked the "minimum contacts" required for a district court in a forum state to exercise jurisdiction, International Shoe Co. v. Washington, and that "there is no evidence that it plan[ned] to commercialize [aflibercept biosimilar] in West Virginia.  Regeneron countered that "filing of its aBLA, serving of its Notice of Commercial Marketing, failure to deny the allegation that it would commercialize . . . in West Virginia through Biogen, and establishment of a robust distribution channel that includes West Virginia" was sufficient, and the Federal Circuit agreed.

Turning to Acorda, the panel set forth a comparison between the circumstances here and in that case, which involved ANDA litigation under § 271(e)(2) (the opinion noting that none of the parties argued that the jurisdictional standards were different between ANDA and BPCIA litigation).  In Acorda, the ANDA filing, as "formal acts that reliably indicate plans to engage in marketing of the proposed generic drugs," was enough to establish personal jurisdiction in view of the Court's understanding that the Hatch-Waxman regime enacted by Congress illustrated an understanding of the "close connection between an ANDA filing and the real-world acts that approval of the ANDA will allow and that will harm patent-owning brand-name manufacturers."  As in Acorda, the panel recognized SB's behavior -- filing an aBLA, serving the Notice of Commercial Marketing under 42 U.S.C. § 262(l)(8)(A), engaging with "several manufacturing, testing, labeling, and/or packaging partners," and entering into an "elaborate distribution agreement with Biogen" -- were consistent with the intent to sell its FDA-approved aflibercept biosimilar product in the forum state (the extent of SB's involvement with Biogen regarding distribution being particularly significant to the Court).  Also significant was the lack of any evidence that the nationwide distribution network had any provisions for states where SB's product would not be sold, the panel holding that the District Court had not "clearly erred in finding that SB will retain a significant role in Biogen's activities through contractually established mechanisms."

The panel expressly rejected SB's assertion that there is a "bright-line constitutional difference" between SB distributing its product itself and contracting with a third party (Biogen) to do so, based on Acorda.  Also rejected was SB's argument that Regeneron bore the burden of producing affirmative evidence that SB would market its product in West Virginia, saying "there is simply no good reason, under the constitutional standard, for demanding such singling-out evidence as a substitute for persuasive evidence of nationwide targeting without a carve-out."

Turning to the grant of the preliminary injunction, the issue before the Court was whether SB raised a "substantial question as to the invalidity of the '865 patent for obviousness-type double patenting" over the '594 patent.  The question concerned three limitations arising in claim 1 of the '865 patent and claim 5 of the '594 patent.  These were: "(1) a very specific stability requirement—that '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'; (2) a requirement that the VEGF antagonist is 'glycosylated'; and (3) a "vial."  The first distinction that the District Court relied upon in finding no ODP was that the '865 patent claim required that at least 98% of the claimed VEGF antagonist retained the native conformation after storage at 5°C for two months, wherein claim 5 of the '594 patent merely required that the protein was "stable for at least four months."  The District Court construed these limitations to be that the "stability requirement' in the '594 patent was "broader than, and not limited to," the stability requirement recited in the '865 patent, based in part on the disclosure of their shared specification.  Further, the District Court held that the limitation in the '865 patent claim was "not inherent (and thus not anticipated by)" the '594 claim.  Accordingly the District Court found that the '865 patent claim "was non-obvious because a relevant artisan would not have been motivated to arrive at this requirement with a reasonable expectation of success."

On appeal, SB argued that the stability recited in the '865 patent claim was an obvious variant because it is "simply an additional property of the composition."  The specifically recited stability in the '865 patent claim was "encompassed by" the generic stability limitation recited in the '594 patent claim according to SB.  The Federal Circuit held that these arguments "bypass the focused factual analysis of motivation and reasonable expectation of success" and were thus unpersuasive, for at least the reasons that SB did not support its assertion that the existence of an additional property was enough to defeat patentable distinctness and that the cases relied upon by SB (Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co.; Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.; AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust; Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC) did not support their argument.  Also, "domination" (of a genus claim over a species, for example) "by itself[] does not give rise to 'double patenting'" according to the opinion, citing In re Kaplan.  The panel asserts that "[w]e are not persuaded that SB has put forth a substantial basis for questioning that the 98% native conformation limitation of claim 1 of the '865 patent makes the claim patentably distinct from claim 5 of the reference patent" including, inter alia, that SB did not challenge the District Court's claim construction (regarding the term "stable") nor several of the District Court's factual findings on motivation and reasonable expectation of success.

The opinion notes that this would be enough to affirm the District Court's decision, but further states that the panel agreed with the patentable distinction that the '865 patent specifies that the protein is glycosylated while the '594 claims are silent on this feature (encompassing both glycosylated and non-glycosylated forms) and that SB had presented no persuasive argument to overturn the District Court on this issue.

The panel then addressed SB's contentions that the '865 patent failed to satisfy the written description requirement of 35 U.S.C. § 112(a) (itself a question of fact for which the District Court's determinations were entitled to deference under the clear error standard).  The limitations SB challenged in this regard were the glycosylation limitation, the upper bound of 98% stability, and the lower boundary of the stability requirement.  Regarding the glycosylation limitation, the panel assessed the challenge using the rubric that "a disclosure must be considered as a whole" as the skilled artisan would consider it, and determine whether the specification "reasonably conveys possession" of the claimed invention, citing Allergan USA, Inc. v. MSN Laboratories Private Ltd. (emphasis in opinion).  The District Court relied on specific portions of the specification that disclosed the glycosylated forms and the stability data, supported by expert testimony that the skilled worker would understand that what was taught was glycosylation of specific residues.  The Federal Circuit opined that on this record they could find no clear error.  Moreover, the panel also found no contradictions between the District Court's finding on ODP (which were limited to the claims) and the District Court's findings on the written description requirement (which was based on the disclosure in the specification).  Regarding the upper stability boundary, the panel found no clear error by the District Court in relying on expert testimony (including SB's own expert), and for the lower boundary held that the District Court properly distinguished the precedent SB relied upon in making its arguments (including Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A.).

Finally, the Federal Circuit addressed and rejected SB's arguments that Regeneron had not established a causal nexus between its infringement and irreparable harm.  First, SB argued that its biosimilar was approved by FDA to require only 96% stability, which would not infringe the '865 patent claims.  The panel asserted in response that "[t]here is no evidence that SB possesses or plans to sell or offer to sell a non-infringing biosimilar under its approved aBLA [and i]ndeed, the evidence in the record indicates otherwise," citing expert testimony including that SB could not alter its FDA-approved formulation to be non-infringing with any guarantee that such a product would work as intended.  Second, SB argued that the nexus required is that the stability feature of retaining 98% native conformation "must drive demand" for its product to establish such nexus.  The panel stated that the precedent properly interpreted limits the causal nexus inquiry as argued by SB to "'complex, multi-featured' products," in instances where "a court must analyze whether the patented feature is a driver of consumer demand for the accused infringer's product," citing Apple Inc. v. Samsung Electronics Co.  In contrast, for cases like this one, for "a product that essentially is the claimed invention" the causal nexus assessment is not required to establish irreparable harm according to the opinion (emphasis in opinion).  In closing, the panel noted that "if SB produces a noninfringing product within the scope of its aBLA, it may seek modification of the injunction from the District Court.

The companion, nonprecedential decision (also written by Judge Taranto) relied on the Samsung decision for much of the background facts and arguments.  The District Court in this case held that personal jurisdiction arose for Defendant Formycon and issued a preliminary injunction against this defendant; Formycon appealed both decisions.

Like Samsung Bioepsis, on the personal jurisdiction issue, Formycon argued that it has no "direct" ties to the forum (West Virginia), including being "not registered to do business there; ha[d] not appointed an agent for service of process there; ha[d] no assets or employees there; ha[d] not previously been sued there; and ha[d] not developed, manufactured, or packaged its drugs there" and also "has no plans or rights to itself commercialize (market and distribute)" its FDA-approved aflibercept biosimilar product there.  Instead, a yet unnamed third party would be engaged to commercialize the drug for U.S. sales (including in West Virginia).  But as described in the opinion, Formycon will not step away from commercialization efforts, and through "various contracts" will have "continuing rights and responsibilities regarding" its biosimilar product.  The opinion states that the evidence as a whole showed Formycon planned to market its product in the U.S., including West Virginia, constituting  affirmative acts such as filing its aBLA, serving Regeneron with a Notice of Commercial Marketing and engaging companies to "manufacture, package, and label" its biosimilar product in the U.S.  In its efforts to establish a "distribution channel" for its product, the opinion states, Formycon has taken no steps to exclude West Virginia.  While a separate corporate entity will "market, sell, and distribute" the product, Formycon through a supply agreement will make the FDA-approved aflibercept biosimilar product.  The Federal Circuit "on the record as a whole" sees no difference between the SB and Formycin situations with regard to the personal jurisdiction question.

Regarding whether the District Court had improperly granted the preliminary injunction against Formycon, the panel asserts that the same bases for denying SB's invalidity contentions applied to Formycon (in the Samsung case the opinion asserts "we agreed with the district court on the [insufficiency of SB's ODP assertions based on the] first two [claim] limitations, and that agreement sufficed to affirm the district court's ruling on the ODP defense without our reaching the other issues.  We do the same here").  And Formycon's "only argument arguably falling outside the category ("with respect to the 98% native conformation limitation")" also fails, according to the opinion, inter alia, because Formycon did not challenge the claim construction on which the District Court based its opinion ("The point is forfeited").  The Federal Circuit found no reversible error in the District Court's rejection of Formycon's ODP-based challenge to the District Court's grant of a preliminary injunction on the stability limitation, and as in its Samsung opinion assessed the glycosylation argument (albeit addressing a more detailed argument and additional bases for Formycon's contentions) and yet arrived at the same conclusion in rejecting it.

Similarly, the Federal Circuit did not see any "material difference between Formycon's arguments and those presented by SB" with regard to invalidity for failure to satisfy the written description requirement, and "Formycon has presented no argument we have not already considered and rejected in the SB decision" on the question of a lack of causal nexus between Formycon's infringement and irreparable harm to Regeneron in the absence of the injunction granted by the District Court.

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)
Nonprecedential dispostion
Case 24-2009 involving Defendant-Appellant Formycon AG
Panel: Chief Judge Moore and Circuit Judges Reyna and Taranto
Opinion by Circuit Judge Taranto

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)
Case 24-1965 involving Defendant-Appellant Samsung Bioepsis Co.
Panel: Chief Judge Moore and Circuit Judges Reyna and Taranto
Opinion by Circuit Judge Taranto

Aurobindo v. Merck Sharp and Dohme -- Oral Argument

By Kevin E. Noonan --

The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme).  The issue before the Court is whether Patent Term Extension under 35 U.S.C. § 156 in a reissue patent should be calculated from the original grant date of a patent or from the grant date of a subsequent reissue (wherein the length of PTE can be significantly shorter if the latter date is chosen).  The panel consisted of Judges Dyk, Mayer, and Reyna.  Auribindo was represented by Eric Werlinger, Merck was represented by Danny Krinski, and Maureen Queler argued for the U.S. Patent and Trademark Office.

Auribundo's argument (methodically structured to go through the different sections of the statute at issue) was focused on the statutory text and in particular the meaning of the word "term" in 35 U.S.C. § 156 (the part of the Hatch-Waxman Act providing for patent term extension, PTE).  According to counsel, Congress enacted the PTE statute in the context of the reissue statute, arguing that patent law has contained statutory provisions for reissuing patents for 150 years.  Judge Dyk asked the first question (from what was a fairly hot bench) about the effects of the same claim being in the original patent and the reissue.  Specifically, Judge Dyk wanted to know why such a reissue patent should be treated any differently if there had been no change in the claim to the approved product.  Judge Dyk called it counter-intuitive that Congress would draft § 156(c) in such a way that it would make a difference, and Counsel argued that Congress was aiming for the statute to have a "bright line" definition without getting into "claim-by-claim" analysis.  Judge Dyk, sounding somewhat incredulous asked if Aurobindo's position was that "you could lose your PTE in a reissue even if the same claim [for the approved product] survived reissue"?  Counsel hied back to the statutory language, seeming to hint that "policy reasons" for Congress intending the answer to Judge Dyk's question to be "no" could not trump the plain meaning of the statute.  On the question of losing patent term, Counsel argued that Merck delayed ("a number of years") in filing for reissue even though they knew "full and well" that their patent did not contain the species claim for which the reissue was filed.  Judge Dyk found those answers not to be responsive to his question of why Congress would want two different outcomes for PTE between the original patent and its reissue.  Counsel's response was that this wasn't want Congress wanted, but rather to establish a "single regime" that would accommodate all patents applying for PTE.

Counsel returned to his theme that policy should not be a determinant, and instead that the Court should look to the plain meaning of the statute.  Judge Dyk noted that the plain meaning of § 156(a) for the term to be extended could refer to the term of the original patent.  Judge Dyk pressed counsel to get an answer to his question, and counsel argued that the word "original" refers to the situation before PTE is applied not before the patent was reissued.  Judge Dyk interrupted this argument with a direct assertion that "you would lose" if the § 156(a) definition of "term" was directed to the original patent.  "Not necessarily true" was counsel's response, based on the idea that what is meant is "when do we start counting" (presumably the time lost for which PTE is earned).

Counsel then referred to Merck's argument that the term of the reissue incorporated the term of the original patent and made three responsive arguments.  First, that Section 251 recites that the reissue patent takes the unexpired part of the term of the original patent ("a piece of it, not the whole thing"), and if Congress intended the reissue to take the entire term they could have said so (but they didn't).  Second, Section 251(c) incorporated Sections 151 through 154, and Section 154 defines when the term begins, i.e., the issue date.  Third, that the issue date of a reissue patent is a "legally distinct and meaningful moment" based on Section 252 (that provides that date to be when the reissue patent "takes effect").

Moving on to Section 252, counsel explicated how the Federal Circuit had earlier addressed the section.  He said, "PTE is not granted in litigation," and Judge Dyk reminded counsel that Sections 251 and 252 were enacted "long before" Section 156, so why not interpret Section 156 on its own terms?  Counsel argued context:  that Congress was aware of Sections 251 and 252 and the "mechanics" of reissuing patents when it enacted Section 156.  Counsel characterized how Congress has behaved regarding the interactions of the reissue statute and Section 156 as being "purposeful silence."  This silence is meaningful, counsel argued, and reading the statute as Merck asserts would violate canons of construction regarding the meaning of the word "issue" in the various sections.

Judge Reyna asked about the possibility of "absurd" results?  Counsel did so with relish, speaking about the circumstances under which PTE could be lost by minor differences (a matter of days) resulting in 5 years of PTE or none at all.  Counsel embraced these possibilities, asserting that such outcomes are not uncommon in patent law, here as a consequence of a purported "bright line" drawn by the statute regarding PTE.  These possibilities are not sufficient to deviate from the "otherwise" plain text of the statute according to Aurobindo's counsel.  Judge Reyna stated that the statute is not plain and counsel disagreed, asserting that neither Merck nor the PTO has identified a "facial ambiguity" in the text of the statute.  Judge Dyk disagreed, returning to Section 156(a) as referring to the "term of the patent" phrase clearly referring to the original patent.  Counsel attempted to rely on Section 156(f) for a definition of the term "patent" but Judge Dyk did not agree that the definition helped.

Finally, counsel turned to Section 156(c) because in applying it the phrase "the term of the patent eligible for extension" cannot refer to the original patent because it no longer existed when PTE was obtained for the reissue patent.  Counsel also brought up the situation where a broadening reissue is obtained where the claim or claims relevant to the approved product was first obtained in such a reissue; this would create a problem, which Judge Dyk dismissed as not being eligible for extension.

Counsel for Merck (who underwent much less questioning by the panel) addressed the argument that Merck is attempting to avoid the statutory text, specifically with regard to Sections 251 and 252.  Judge Reyna asked why the Court should reference the original patent where the claims are "dead" under Section 252.  Counsel argued that the original patent's claims are dead but the reissued patent is essentially the same regarding the claims that recite the approved drug product.  Judge Reyna noted that the statute does not recite the "claims" but rather the "patent."  Counsel argued that Section 251 ("reissuing a/the patent") indicates that the statute is referring to "one and the same patent with one and the same term."  Considering a patent that claimed a drug under FDA review and was subject to effective loss of patent term thereby and then reissued, this "one and the same" interpretation is the only interpretation that gives a sensible result under the Hatch-Waxman Act, counsel argued.

Counsel obliquely answered the allegation by Aurobindo's counsel of Merck's delay being strategically intentional by noting that the decision in In re Tanaka clarified the opportunity for reissue under these circumstances and prompted its filing.  He also emphasized that the original patent and the reissue had a claim (claim 4) unaffected by the reissue that encompassed the approved drug.  Nor should the fact that the patent was reissued prior to FDA approval and PTE length determination make any difference according to counsel, confirmed by Sections 251 and 252 (which referred to a single term that remains the same term).  When beginning to address the effect on litigation under Section 252, Judge Dyk interrupted, saying "well, it isn't litigation"; when counsel disagreed, the Judge went on to say "not the kind of litigation [Congress] was talking about" when the statute was enacted.  Counsel mentioned in response that filing the ANDA and filing the complaint in response thereto occurred after the reissue, and thus the intervening rights provisions of Section 252 "compels that the claims be treated as if they had been present all along" (further supported by the "continuous effect clause" in the statute).

Another issue counsel addressed was the effect of a broadening reissue, which he was careful to emphasize (again) was not the case here (nor does Merck advocate for PTE under such circumstances).  Counsel also mentioned that this situation had not arisen in any of the ~40 cases where reissue applications were the basis for PTE request, and that (perhaps) Section 156(a) was the more appropriate section of the statute to consider when deciding this question.  In response to counsel's assertion that under these circumstances the court need not address this issue here, Judge Dyk disagreed, saying that the Court's decision must take this into account ("we [can't] view this with blinders on") and counsel was quick to say "if the court wishes to decide [that question] it should result in affirmance either way" under both Sections 156(a) and 156(c).  And this interpretation was also supported by the "continuous effect" clause under Section 252, he reiterated, under circumstances as here "where there is a substantially identical claim" that survived the reissue.  And here, the change effected by the reissue was not a change to the claim the encompassed the drug.

Turning to policy, counsel argued there was no "gamesmanship" involved due to the timing of the reissue request being recognition after Tanaka that Merck could so seek it.  Also to be considered according to counsel was that at the date of the reissue request filing the drug had not been approved, no one knew how long FDA review would take or if it would be approved at all.  Further, without drawing the court's attention to this being an absurd result, counsel suggested that it would be unlikely that Congress intended that the "relative ordering" of reissue and FDA approval should make a difference of whether PTE was curtailed by that ordering ("it doesn't make any sense" otherwise), if only because neither when FDA review is completed nor the date the PTO grants the reissue patent was within the patentee's control.  Counsel also asserted that Section 156 is an remedial statute to enable patentees to recover lost term for patents reciting claims to the approved drug.

Finally, counsel addressed the argument that a reissue patent needed to be treated as a different patent than the original patent because the latter is "dead."  Counsel contends that the "dead" case law stems from Seattle Box Co. v. Indus. Crating Packing, which also says "the statute permits the claims in the reissue to reach back to the claims in the original" provided that those claims are identical (i.e., unchanged by the reissue proceedings).

Ms. Queler, arguing for the U.S. Patent and Trademark Office, began a strong presentation by saying that, taken in the context of the Patent Act as a whole, the "issue date" used in determining patent term adjustment under Section 156 is best interpreted under Sections 251 and 252 as the date the original patent was issued.  As Merck's counsel had argued, the PTO interprets Section 252 to require that a reissue patent has "the same effect" as the original patent.  Judge Dyk once again stated his uncertainty regarding his view that Section 252 does not relate to PTE because that section was enacted well before Section 156.  PTO counsel addressed this argument by saying it is counterintuitive (it "doesn't make sense") to assess the patent term in an administrative procedure differently than in litigation involving such a patent.  She cited Section 251 to require that a reissue expires on the same date (pre-AIA, 17 years from issue) as the original patent.  Everything, she stated, is tied to the original patent and it "would simply not make sense" to under these statutory provisions to have the expiration date be derived from a different date.

For the PTO, she argues, the paradox raised by Aurobindo's calculus is that a patentee would be entitled to less PTE as the amount of FDA delay increases.  This is nonsensical; if Merck had waited to file its reissue patent until after FDA approval, they would have been entitled to the full PTE to which they were entitled.  The best reading is to use the original patent issue date according to the PTO.

Judge Reyna asked whether it is the case that these instances are rare, and counsel agreed that they are, saying that there had been only about 40-50 instances responsive to questions from Judge Reyna and that that in almost all such cases the PTO had used the original patent issue date for determining PTE.

A line of questioning arose that was to some extent amusing and illustrates how delving deeply into these questions can obscure a simple solution.  Judge Dyk asked about the situation where a claim for the approved drug product is cancelled in reissue.  This question was because Section 156 is concerned with patents and not claims, could the reissue patent still be entitled to PTE even though it no longer (due to reissue) recited a claim encompassing the approved drug product?  Counsel responded by reminding the Court that Section 156(a) requires a patent requesting PTE to be only one "which claims a product," so such a reissue patent would not be entitled to PTE.  The Judge was concerned about an original patent having a claim that encompassed the approved drug product being granted PTE but then cancelling that claim upon reissue.  Counsel addressed the situation where PTE was obtained before the reissue occurs, but Judge Dyk asked about the situation where the reissue happens before PTE is granted.  The Judge believes the construction of Section 156 needs to accommodate such a circumstance to ensure that a reissued patent that had a claim or claims that encompassed the drug product, but cancelled any/all claims that encompassed the approved drug, is not entitled to and does not get PTE.  Counsel responded that PTE could not be obtained for a patent that does not encompass the approved drug product.  Judge Dyk then asked counsel to confirm that if PTE was applied for after the reissue that cancelled all drug-related claims such PTE would be denied and asked her how to get to that outcome under the language of the statute.  Counsel again resorted to Section 156(a), but the Judge said that would be the case for a new claim (i.e., in a broadening reissue).  PTO counsel also stated that the Office does not have a policy on this scenario because it has never arisen (it is theoretical and highly unlikely in practice).  She suggested that such an unlikely eventuality should not motivate changes in statutory interpretation of Sections 251 and 252 that would have the consequences discussed in this case.

Stepping back, it seems evident that this scenario is a tempest in a teapot (however entertaining).  Any patent (reissue or not) no longer reciting any claim that encompasses the approved drug product could not be asserted in litigation (ANDA or otherwise) and would likely lead to an immediate and successful motion to dismiss, risking sanctions for asserting a patent where the patentee took affirmative steps to cancel the claims on the FDA-approved product and then tried to assert such a patent in litigation.  Moreover, such a patent could not be properly Orange Book listed for failure to satisfy the requirement that any Orange Book listed patent must recite claims to the drug product or methods for using the product to treat a disease, ailment, or disorder.  (The FTC had recently started a delisting campaign for improper listing, threatening sanctions, for listing patents for which the propriety of listing was much less uncertain than in the case argued here.)

Judge Reyna raised the possibility for gamesmanship -- "shenanigans" -- and asked whether the likelihood would increase if PTE was to be determined using the reissue date rather than the earlier date.  Counsel responded by speculating that the patentee could delay seeking a reissue (which would be contrary to the public interest in not disclosing the errors motivating the reissue) but wait until the original patent was granted PTE (which extension of term would remain with the reissue under the express terms of the statute).

On rebuttal, Aurobindo's counsel went through with increased vigor a number of issues raised by Merck and the PTO.  Counsel argued that the Court should recognize that the arguments raised by Plaintiff and amicus were not identical.  He also argued that the term "term" was not defined in the statute (at least expressly) and thus should be construed for the ordinary meaning (such as by using a dictionary definition).  He disputed Merck's position that the reissue and original patent are the same patent, citing Seattle Box for contrary precedent from the Federal Circuit (and unnamed Supreme Court precedent to the same effect).  He mentioned that Merck amended its complaint to recite the reissue patent and updated the Orange Book as evidence that Merck itself recognized they were not the same patent ("a different bundle of rights"); Judge Dyk interjected to mention that what Merck thought doesn't determine proper claim construction.  Counsel responded that Merck's opinion matters because it illustrates an attempt to obliquely provide an alternative definition for the term "issue" that Merck cannot give through a plain text analysis.  He also made the distinction that reissue is itself distinct from the original patent (which is what Congress wanted).  Judge Dyk interjected that it appeared Auribindo thinks that someone was thinking of these issues when the statutes were enacted and counsel responded that Congress is presumed to have done so.  Counsel also criticized the PTO's amended MPEP § 2766 for proposing that broadening reissue patents are entitled to the original patent issue date only if the original and reissue both recite claims to the drug product, which while sensible policy is, according to counsel, even further from the text of the statute.  Finally, counsel asserted that Skidmore deference is not appropriate, because using conventional canons of construction, the interpretive issues can be resolved and because the Office has not provided a coherent articulation for Section 156.

It would be imprudent for an observer to assert any definitive predictions regarding how the Federal Circuit will rule, but the tenor of the argument seems to have favored Merck's (and the PTO's) position.

Lynk Labs, Inc. v. Samsung Electronics Co. (Fed. Cir. 2025)

Published Patent Applications Are Prior Art as of the Filing Date, Not the Publication Date

By Joshua Rich --

Lynk Labs raises a simple question of statutory interpretation with surprisingly important ramifications:  in inter partes review, is a published patent application considered prior art as of the date of filing or the date of publication?  The former answer has been how the law has long been applied and would comport with Federal court practice, but Lynk argued that Congress had chosen the latter approach by keeping the language that had been in the statute for decades before IPRs existed and not expressly including patent applications as a separate category of available art.  The Federal Circuit found that the statutory language governed only whether a reference could constitute prior art, not when it would.  As a result, the Court rejected Lynk's approach and decided that patent applications, like patents, are treated as prior art as of the filing date.

The issue arose out of Samsung's IPR challenge to Lynk's U.S. Patent No. 10,687,400.  The '400 Patent relates to alternating current ("AC")-driven light emitting diodes ("LEDs"), LED circuits, and AC drive circuits and methods.  Basically, it covers the type of lighting now used in many Christmas tree lights:  "an LED circuit array comprising an LED circuit comprising a plurality of LEDs connected in series" and a number of other elements, "wherein a forward voltage of the LEDs of the LED circuit array matches the rectified input AC voltage output" of a connected driver.[i]

Samsung brought its IPR based on an argument that the claims were obvious in light of numerous combinations of prior art.  Importantly, many of the combinations relied on U.S. Patent Application Publication No. 2004/0206970 (the "Martin Application").  The Martin Application was filed more than one year before the application that ripened into the '400 Patent, but published several months after the filing; it never issued as a patent.  Given those circumstances, Lynk argued that the Martin Application was potential prior art as a "printed publication," not a published patent application (to the extent that is a separate category under the Patent Act) and would not qualify as prior art in this case because it was not printed until after the '400 Patent's critical date.  The PTAB disagreed and found all of the relevant claims unpatentable.[ii]

Lynk appealed, arguing that IPRs are limited to "patents and printed publications,"[iii] and published patent applications could only be considered the latter.  That is, unlike the pre-AIA § 102 that applied here, the scope of IPRs does not explicitly contemplate published patent applications in any context separate from the printed publications referenced in §§ 102(a) and (b).  It follows, according to Lynk's  reasoning, that published patent applications should be treated like all other printed publications for purposes of determining the prior art date, regardless of the provisions of § 102(e)(1) that relate specifically to published patent applications.  Lynk argued that the use of the long-used term "printed publications" carried with it the "old soil" of prior uses and court opinions.

It is true that the terms "patents and printed publications" have long been used in patent law and post-grant review proceedings.  Since 1980, there have been opportunities for post-grant review of patents:  first ex parte reexamination (created by the 1980 Patent Act), then inter partes reexamination (created by the 1999 American Inventors Protection Act), and most recently post-grant review and inter partes review (created by the 2011 America Invents Act).  Throughout that time, the identification of available prior art has remained the same:  "patents and printed publications."[iv]  But in truth, the parameters for what is available to challenge the validity of patents -- both in USPTO proceedings and in district court litigation -- have changed.  Prior to the AIPA, the USPTO had maintained strict secrecy over patent applications so there were no published patent applications.  Then, the AIPA ushered in the era of published patent applications and added the "secret prior art" provisions of § 102(e), establishing that a patent would be invalid if:

the invention was described in

(1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or

(2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language

Those two changes under the AIPA set the stage for the Federal Circuit's decision in Lynk Labs.

Lynk had admitted that published patent applications constitute "printed publications," but argued that whether they are prior art should be considered under the paradigms of § 102(a) and (b) regardless of the language added by the AIPA.  It argued that it would be anomalous to treat documents within the ambit of printed publications differently based on what type of printed publication they are.  And it had on its side older court decisions that suggested that all printed publications should be treated as prior art only when they are published.

The Federal Circuit recognized that Lynk's position found some support in older case law, but reasoned otherwise based on the language of the entirety of § 102.  It found the addition of § 102(e) dispositive because it specifically addressed the timing of prior art status of published patent applications.  And responding to the anomaly Lynk pointed out, it noted another one if it applied the test urged by Lynk -- that published patent applications would not be treated the way set forth in § 102(e), but patents would be.  In a bit of statutory interpretation legerdemain, the court suggested this was all just a plain language reading of §§ 311 and 102.  A better approach would have been to use the canons of construction that suggest that the proper reading of a statute gives effect to all of the clauses and reads each of them in the context of the statute as a whole.

The Federal Circuit then took a confused, and confusing, trip through the cases that Lynk cited to suggest that published patent applications are only an unremarkable subset of printed publications.  When Congress amends a statute but retains the same language as used before, it is presumed to be importing the prior usage of that language, which would suggest that "printed publications" would be defined consistently throughout the history of post-grant proceedings.  But the court rejected that approach because published patent applications did not exist throughout that history.  And it argued that printed publications could have different prior art dates based on the differential scenarios of § 102(a) and § 102(b).  But that seems wrong -- the date of the printed publication does not change, only whether it is before or after the time point identified in the statute.  That is, a journal article has a fixed date of publication -- just like a published patent application -- which may be before or after the date of invention or bar date for a claimed invention.  In the end, the Federal Circuit concluded that "whether, and how, something that qualifies as a 'printed publication' is considered prior art depends on other statutory language" -- again defaulting to the language of § 102(e).

Remarkably, the Federal Circuit relegated to a footnote perhaps the best policy argument for interpreting the statute as it did.  That is, in district court litigation, published patent applications and patents are both treated as prior art as of the date of filing.[v]  Had the case come out the other way, accused infringers would have yet another reason to avoid IPRs because some of the patent applications considered prior art in district court proceedings would not be considered prior art in IPRs.  Nothing about the references would be different, just the legal treatment of the reference between the two venues.  Not only would such an approach increase the likelihood of gamesmanship in the choice of venue to resolve validity, it would also have created numerous other difficulties – Would estoppel apply to a published patent application like the Martin Application? Would the same approach apply in post-AIA cases, where the language of § 102 was altered slightly?  And would a different approach apply in IPRs and ex parte reexamination?

In the end, regardless of the reasoning, the Federal Circuit reached the correct conclusion in Lynk Labs.  A contrary decision would have made a mess of the interplay of IPRs and district court litigation, and would also have been inconsistent with the totality of § 102.  And it would have called into question IPRs already decided and currently pending that have been decided or filed based on the presumption that the approach to published patent applications would not change suddenly after 25 years of clear precedent.

Lynk Labs, Inc. v. Samsung Electronics Co. (Fed. Cir. 2025)
Panel: Circuit Judges Lourie, Prost, and Stark
Opinion by Circuit Judge Prost

[i] For Taylor Swift fans, the timing of the Federal Circuit decision may draw a smirk because, as she sings in Lover, "We could leave the Christmas lights up 'til January."

[ii] Lynk Labs cancelled certain claims in response to the IPR filing, rather than having those claims invalidated.

[iii] 35 U.S.C. § 311(b).

[iv] The exception to this rule is post-grant review, for which any basis under 35 U.S.C. § 101 is available, including other forms of prior art.

[v] See pre-AIA 35 U.S.C. § 102(e) and current 35 U.S.C. § 102(d).