• 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

    Federal Circuit SealThe 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

  • By Kevin E. Noonan

    Federal Circuit SealThe 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.

  • By Kevin E. Noonan

    USPTO SealThe U.S. Patent and Trademark Office has a history of attempting to challenge judicial decisions that the Office, usually for its own policy reasons, takes issue with.[1]  Recently, the Office decided to challenge the rationale behind the Supreme Court's decision in KSR v. Teleflex for certain technologies, specifically by advocating that claims to dosage regimens for pharmaceuticals should be almost per se obvious, particularly for such claims for which the pharmaceutical was itself patent protected; in the Office's defense, the motivation appears to be eliminating so-called "evergreening" patents.[2]  The relevant portion of the KSR decision involved in this effort provides a standard that requires there to be a reasonable expectation of success when prior art is combined:

    When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.  If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.  In that instance the fact that a combination was obvious to try might show that it was obvious under §103.

    The technology at issue (in U.S. Patent Application Publication No. US 2015/0132323 A1) is directed to methods for treating ovarian cancer patients using an antibody-drug conjugate ("ADC") called mirvetuximab soravtansine.  The methods specified 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.  This is a different standard from  the total body weight (or "TBW") used in the prior art.  The claimed methods solved a previously unknown problem, that mirvetuximab soravtansine dosed using TBW led to an unacceptable level of ocular toxicity, and the inventors' unexpected solution to this problem, that such ocular toxicity was significantly alleviated if the same drug was dosed using AIBW.

    This is the second time Immunogen has come before the Federal Circuit to appeal rejections for indefiniteness and obviousness from the Patent Office.[3]  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.  With respect to obviousness, the Court's judgment was based on factual errors appreciated by the panel, finding that there were genuine issues of material fact in dispute.

    Here, the Office once again prevailed at the district court on Immunogen's § 145 action and once again Immunogen has appealed to the Federal Circuit.  What is new in this appeal is one of the positions taken by the Office.  In its briefing, the Office has taken 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.  Importantly, this position includes 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 decries 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."

    Despite the Office's protestations, unpredictability has been a hallmark of biotechnological inventions and has been recognized almost from the dawn of biotechnology patenting.  The doctrinal approach to determining the distinction between what is obvious to try and what is obvious under the statute was set forth by Judge Rich in In re O'Farrell and reiterated (with broadening to all technologies) in KSR v. Teleflex (which was concerned with obviousness of an electromechanical device).  Immunogen raised several fact-based distinctions with the Office's position, including that just because AIBW was known in the art (in contexts other than administering ADCs) does not render its use obvious in these claims because, inter alia, ADC administration is known to be unpredictable.  The Office argues that AIBW has been used to identify dosages in pharmaceutical compositions ranging in size from small molecule drugs and to CD34+ cells, but these arguments disregard the qualitative differences between these reagents and ADCs due to the unique characteristics of the latter pharmaceuticals.  The Office's arguments generalize dose optimization methods without regard to the particular properties and characteristics of ADCs which make their used unpredictable as known in the art (exemplified by the undisputedly high level of skill of the person having ordinary skill in this art).  This is not to mention that AIBW had never been used for determining ADC dosages until successfully used by Immunogen for mirvetuximab soravtansine.

    As sanctioned by the Supreme Court, the standard for determining obviousness is whether the combination leads to success anticipated by a person of ordinary skill in the art and thus the predictability of the prior art combination is a necessary consideration, whether the art is inherently predictable or not.  The Office's position also ignores evidence that doses determined using the AIBW method resulted in reduced or eliminated ocular toxicity, a deleterious side-effect not appreciated in the prior art (as determined by the district court).  These facts implicate another part of the Supreme Court's KSR rubric, which requires that obviousness can properly be found where "there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions," neither of which was the case here.  This distinction further supports the non-obviousness of Immunogen's claims.

    Late in the appellate proceedings, the Office asserted the recent Federal Circuit decision in Janssen Pharmaceuticals v. Teva Pharmaceuticals.  In that case, the Federal Circuit (in a panel comprised of Judges Dyk, Prost, and Hughes) vacated and remanded the district court's determination in ANDA litigation regarding an antipsychotic medication that the asserted claims were non-obvious.  In its opinion, the panel found fault with the district court's determination of non-obviousness based on its consideration of claims teaching generally what doses should be used (based on confidential clinical trial evidence of patient populations not available to the skilled worker) despite reciting that the dose was determined for "a" psychiatric patient.  The error appreciated by the Court was that in considering whether there was a reasonable expectation of success in the district court's obviousness determination the court evaluated a "generalized multi-dose regimen" of the population contrary to the limitation to "a" psychiatric patient recited in the claims.  The Office has represented to the Federal Circuit that this decision means that if there is no difference in dosing for some patients between the AIBW- and TBW-based dosages then the claims would have been obvious (as the Office has argued).  However, the Office does not provide any evidence showing that such hypothetical ovarian cancer patient even exists.  More importantly, this argument ignores the basis of the Federal Circuit's decision in Janssen that the claims by their terms were limited to dosage considerations to "a" psychiatric patient and thus the district court erred in applying the KSR framework to predictability in a population.  Here, immunogen's claims require calculation of AIBW for each patient before dosing.  Therefore, even if a method using TBW resulted in the same dose for a particular patient as calculated using AIBW, that method is different from and not covered by the "claimed" method because it involves a different calculation.

    It should also be appreciated that the basis for the Office's position appears to be related to its efforts to assess the extent to which secondary patents contribute to (or are responsible for) excessive drug prices (the relationship having been debunked by several knowledgeable commentators).  The Office has asserted that it is "problem[atic]" that "this Court routinely cites the unpredictability of the pharmaceutical arts as a basis for upholding follow-on pharmaceutical patents" and illustrates the problematic nature of this approach by citing CAFC's prior decision in this case and a string of precedential decisions.

    But these policy concerns cannot justify the Office urging the Federal Circuit to ignore established precedent regarding how obviousness is to be determined (in a technology-agnostic way), directly contrary to Supreme Court precedent.  And in view of the Supreme Court's decision in Loper Bright v. Raimondo, it is improper for the Office, as an administrative agency, to do so no matter its motivations.

    [1]  For example, the Federal Circuit ruled not once (In re Bell) but twice (In re Deuel) that the Office misapplied the law on obviousness by using the purported obviousness of a method of isolating a gene as evidence that the isolate gene itself was obvious.  Another example involved the Office's rejection of biotechnology inventions based on the enablement requirement; when a new Commissioner precluded such rejections the Examining Corps imposed the same rejections on the utility prong of Section 112, first paragraph.  This attempt at extrajudicial policymaking only ceased with the Federal Circuit decision in In re Brana.

    [2] This latest tactic was also in response to the Biden Administration's efforts to identify and correct any influence patent law has had on excess drug prices (that connection having only tenuous support; see, e.g., Mossoff, 2022, Policy Memo: Unreliable Data Have Infected the Policy Debates Over Drug Patents, Hudson Institute.

    [3] Only the obviousness rejection is discussed here.

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

    By Joshua Rich

    Federal Circuit SealLynk 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).

  • By Kevin E. Noonan

    U.S. Trade RepresentativeThe Office of the U.S. Trade Representative (USTR) issued its "2024 Review of Notorious Markets for Counterfeiting and Piracy" on January 8th, directed to "prominent and illustrative examples of online and physical markets that reportedly engage in, facilitate, turn a blind eye to, or benefit from substantial piracy or counterfeiting," having the goal of "motivate[ing] appropriate action by the private sector and governments to reduce piracy and counterfeiting" globally.

    The Overview of the Results is focused on pharmaceuticals highlighted in detail in its Issue Focus section.  The Overview asserts that "[c]ounterfeit medicines pose a significant health and safety risk to consumers, and the growing market of illicit online pharmacies has increased the spread of these dangerous counterfeits."  The remaining sections of the Report involve Positive Developments, Online Markets and Physical Markets; Positive Developments "identifies actions that governments and private entities have taken this past year to reduce piracy and counterfeiting" and the other two Sections highlight two types of markets that "may require further actions."

    The USTR justifies this rather critical view of U.S. trading partners and other, less friendly countries by stating that "the scale of infringing activity in these markets can cause significant harm to U.S. intellectual property (IP) owners, workers, consumers, and the economy" and recognizes that some countries have a mixture of legitimate and authorized activities others "openly or reportedly exist solely to engage in or facilitate unauthorized activity."  Not all countries identified in the last Report (2023) are included in this one, but some remain because officials have not acted ("failed to address") regarding the flow of counterfeit goods to the U.S.  Not being included should not be interpreted as meaning the issues have been completely resolved, the Report warns, noting that "the United States may continue to raise concerns related to these markets on a bilateral basis with the relevant countries."  Nor is the Report exhaustive, and the reader's attention is drawn to the Special 301 Report for a more comprehensive analysis.

    In the Issue Focus section, the USPR addresses "the risks and growing availability of counterfeit medicines, which has been driven by the proliferation of illicit online pharmacies."  These risks and availabilities stem, inter alia, from the popularity of e-commerce generally, providing as it has for many other goods "a convenient solution for individuals who seek easy access to medications from the comfort of their homes."  The COVID-19 pandemic resulted in "explosive growth" due to the increased demand for both medical supplies (masks, for example) and prescription medicines.  The benefits of legitimate online pharmacies do not escape the USTR's notice, including "fast access to medical information and medications online."  But legitimate online pharmacies are licensed throughout the U.S. through state pharmacy boards (which the Report notes also regulate "pharmacists, technicians, suppliers, distributors, and other parties involved in providing medicines to consumers"; the Virginia Board is provided as an example).  In addition to these licensing regulations, legitimate online pharmacies require prescriptions and provide licensed pharmacists to counsel patients.

    Not so for "bad actors who engage in illegal activities," and with regard to online pharmacies these include those that "are not licensed and operate outside of governing laws, regulations, and inspection systems."  These are not so different from other purveyors of counterfeit goods, but the difference of course is the possibility (indeed, likelihood) that the safety and quality of the dispensed drugs are uncertain (this is in addition to patients without a prescription obtaining medicine for which no physician has ascertained the need or benefits of the drug).  And there is evidence that drugs sold from illicit online pharmacies are more likely to be counterfeit and made from "substandard, unregulated, and potentially dangerous materials"; see Mackey et al., 2016, "Digital danger: a review of the global public health, patient safety and cybersecurity threats posed by illicit online pharmacies".  These dangers arise, the Report notes, because counterfeit medicines are manufactured and sold "outside regulatory oversight, deliberately evading compliance with safety standards and quality control" imposed by FDA in the U.S.  As a consequence, such drugs (often bearing trademarks and other false indicia of their purported source) are sold "often" "made with substandard, dangerous, and potentially deadly materials."  Such counterfeit drugs bearing U.S. brand identifiers comprise 38% of seizures globally according to recent reports from the U.S. Drug Enforcement Agency and Center for Disease Control.

    The Issue Focus is set forth in four sections.  The first, entitled "The Prevalence of Illicit Online Pharmacies," provides information developed by the USTR and other agencies to address the extent of the issue (and risks).  Much of the information set forth in this section was derived from the Alliance for Safe Online Pharmacies (ASOP), which reports that each day twenty new illicit online pharmacy sites are created.  The obvious issue is that these sites "look legitimate [and] purportedly offer[] brand-name drugs at discounted prices, but they bypass regulations designed to protect consumers by operating without a license, selling medications without prescriptions, without safety warnings, and without proper oversight of the drugs being distributed."  More remarkably, the statistics reveal that 96% of the 35,000 online pharmacies operating globally are in violation of the law.  How these websites appear are effective; further ASOP statistics show that 54% of survey respondents (putatively having experience with such sites) believe them to be compliant with relevant laws and regulations, and 63% of prescription medicine purchasers hold this belief (not surprising due to confirmation bias; after all, how likely is it that someone purchasing medicines online would believe the drugs were unsafe?).

    The second section, entitled "The Dangers of Counterfeit Medicines from Illicit Online Pharmacies," cites steps FDA has taken in view of the "risks of purchasing medications from illicit online pharmacies [that] are numerous and potentially life-threatening."  These steps include issuing warning letters to identified illicit online pharmacies (without any statistics regarding their effectiveness).  The need for FDA and other agencies to take steps is evident from a 2023 ASOP survey showing that "24 percent of Americans with prior experience using online pharmacies reported first-hand exposure to substandard, counterfeit, or harmful medication from an illicit online pharmacy, [which is] an increase of 7 percent from the same survey conducted in 2021."  Some of these counterfeits include "inert or substandard ingredients"; the complexities of these products (which would require "[e]xpert chemical analysis" to detect that they are counterfeit) "mak[e] it difficult for consumers to identify the potential for danger."  The types of such ingredients can be harmful per se, or be supplied in incorrect dosages, or contain no active ingredient at all.  The Report provides a reminder of counterfeit Adderall identified more than 10 years ago was being sold that contained the wrong "active" ingredient and as a consequence was ineffective for treating attention deficit hyperactivity disorder (ADHD).  Countering the likely perception that many of these "bad actors" come from abroad the Report imparts the story of a New Jersey man and wife who were (admittedly) selling "misbranded and unapproved drugs" online, which had no therapeutic value.

    The third section, entitled "Enforcement Against Counterfeiting," reassures to the extent that there are "[s]trong enforcement measures that exist in the United States to combat the growing threat of counterfeit medicines."  Examples include Department of Justice (DOJ) successes in indicting 18 persons "for allegedly selling, manufacturing, and shipping millions of pills disguised as legitimate pharmaceuticals," with conviction providing for "a mandatory minimum of 20 years in prison and a maximum penalty of life in prison."  Additional DOJ successes include "seiz[ing] nine website domains used by the defendants and their co-conspirators to sell counterfeit pills and seizing hundreds of pounds of such counterfeits."  In another case, the CEO of "a nationwide dark net drug trafficking organization was sentenced to life in prison for the manufacture and sale of more than a half million counterfeit pills throughout the United States," some of which included fentanyl sourced from China.  Perhaps less comforting is the outcome of an investigation of several Canadian companies shown to have "circumvented" FDA approval and having shipped "unapproved, misbranded, and counterfeit prescription drugs into the United States"; the penalty was forfeiture of the websites used to order the drugs, five years of probation, and disgorgement of $29 million of proceeds from the sites, with the "leader" fined $250,000 and given five years' probation (with the first six months including home confinement).

    One agency responsible for such investigations is the FDA's Office of Criminal Investigations (OCI) Cybercrime Investigations Unit.  This agency was responsible in 2017 for seizing 4,229 internet domain names for "selling misbranded, adulterated, and counterfeit devices and drugs, including illicit opioids.

    The Report acknowledges that an important challenge to enforcement efforts is that many (but not all) of these illicit online pharmacy websites (and source of the counterfeit drugs) are located abroad.  Agencies involved in interdicting importation of counterfeit drugs include U.S. Customs and Border Protection (CBP), which has seized "millions of counterfeit goods (only some of which are drugs); in 2023 such drug counterfeits amounted to more than 1.5 million items.  Such seized items are then inspected by FDA.  The U.S. Postal Service is also involved in identifying counterfeit drugs sent by mail, and in 2021 FDA received almost 70,000 drug products received at international mail facilities and sent for analysis, some of which were opioids.

    Despite these successes, the Report acknowledges that the overseas aspect of the problem limits the regulatory and enforcement capacity for U.S. agencies to be even more effective.  Some of these efforts involve "urging its trading partners to provide law enforcement with the tools needed to combat counterfeiting" and to "urge trading partners to undertake more effective criminal and border enforcement against the manufacture, import, export, transit, and distribution of counterfeit goods."  These urgings include "bilateral consultations, trade agreements, and international organizations to help ensure that penalties" (which can include monetary fines and imprisonment) as well as seizure and destruction of counterfeit pharmaceuticals identified by such foreign agencies.

    This Issue Focus section of the report concludes by reemphasizing the "significant health and safety risk to consumers" posed by the "proliferation of illicit online pharmacies."  Moreover:

    Like the falsified branding of the medicines they sell, illicit online pharmacies seek to appear as legitimate platforms to exploit the misplaced trust of unaware consumers.  Counterfeit medicines are manufactured outside the strict regulatory and inspection systems of genuine pharmaceuticals, and they are then sold through platforms also operating outside the law and evading oversight.  Consumers must continue to be made aware of the risks associated with purchasing medications through illicit unlicensed online pharmacies and strong enforcement measures must continue to be implemented to combat the growing threat of counterfeit drugs.  Adequate and effective enforcement against counterfeiting plays a key role in reducing the potential dangers of counterfeit products, including counterfeit medicines.

    The Notorious Markets Report echoes (with regard to pharmaceutical products) comments made in the 2024 Special 301 Report issued in the spring.  These include:

    Counterfeit pharmaceuticals remain a particular concern as a growing problem with "important consequences for consumer health and safety [that are] exacerbated by the rapid growth of illegitimate online sales . . . [and] contributes to the proliferation of substandard, unsafe medicines that do not conform to established quality standards."  Most of these goods confiscated by the U.S. were sourced from India, Singapore, and China, the Report alleges, and transshipped through China, India, Pakistan, Indonesia, the Philippines, and Vietnam.  The Report also states that counterfeit U.S. brand-name medicines amount to 38% of global counterfeit medicine seizures and that "substandard or falsified medical products comprise 10% of total medical products in low- and middle-income countries" (although the Report qualifies this statement with the caveat that "it may not be possible to determine an exact figure" for the latter statistic).  These trends are increasingly exacerbated by use of on-line pharmacies, with illicit providers comprising "between 67% to 75% of web-based drug merchants" according to a 2020 study.  And these counterfeit items are being distributed by "legitimate express mail, international courier, and postal services to ship counterfeit goods in small consignments" rather than large cargo ships, making detection and enforcement more difficult.

    With regard to pharmaceuticals and medical devices and market access for U.S. products, the Report contends that "[t]he COVID-19 pandemic has highlighted the importance of pharmaceutical, medical device, and other health-related innovation, as well as a lack of widespread, equitable distribution of these innovations," including the need for fighting current as well as future pandemics.  The Report thus seems to seek to strike a balance between "adequate and effective protection for pharmaceutical and other health-related IP around the world to ensure robust American innovation in these critical industries to fight" in this and future pandemics and "access to medicines in developing economies [that] is important to development itself."

    The Report notes that, paradoxically while the USITC Report evinces the reality that "the price of medicines can be untenably high for some countries" another report shows that "low and middle-income countries maintain the highest tariffs on medicines and pharmaceutical inputs among the World Trade Organization (WTO) Members" and that "large developing countries" (Brazil, India, and Indonesia) have the highest tariffs for these products.  Exacerbating these problems are "unreasonable regulatory approval delays and non-transparent reimbursement policies" that "discourage the development and marketing of new drugs and other medical products" according to the Report.  The U.S. in the past year has monitored, enforced, or engaged with trading partners (China, Canada, Mexico, Japan and India) in efforts to remedy these impediments to efficient global access to medicines while protecting IP rights.  The Report notes that stakeholders have "expressed concerns" about practices in Australia, Brazil, Canada, China, Colombia, Japan, Korea, Mexico, New Zealand, Russia, Saudi Arabia, and Turkey "on issues related to pharmaceutical innovation and market access," providing specific examples for each country.

    The relevant governmental agencies have identified the problem.  Solutions have been more difficult to come by.

    These problems are not of course new and are not limited to the U.S.; over 15 years ago the Wall Street Journal reported that such problems were endemic in Venezuela; see "Ironically, It Seems Big Pharma Is Preferred by Venezuelan People".

  • Distinguished Judges File Amicus Brief in Newman v. Moore et al.

    By Kevin E. Noonan

    It has been a remarkable feature of the Federal Circuit's suspension of the Honorable Judge Pauline Newman that few have taken a stand publicly on the propriety of the suspension (something the Judge herself recently mentioned; see "An American (and Entirely Unnecessary) Tragedy").  That has now changed, with the D.C. Circuit Court of Appeals receiving amicus briefs from four separate groups submitted in support of Judge Newman's challenge.  These amici ask the Court to reverse the District Court's dismissal of her lawsuit challenging the Judicial Council's actions on, inter alia, Article III and due process grounds.  Another one of these amicus briefs is discussed herein, submitted by a cadre of distinguished former judges:  Hon. Paul R. Michel, Hon. Randall R. Rader, Hon. Thomas I. Vanaskie, Hon. Paul G. Cassell, and Hon. Susan G. Braden.

    As have other amicus briefs recently filed with the Court, this one begins with reciting what has perhaps become Judge Newman's preeminent judicial distinction, the frequency of her dissenting from her colleagues' opinions and how frequently her views have been vindicated, including by citations to those dissents in Supreme Court opinions reversing the Federal Circuit.  Of course the judicial pedigree of this group of former judges impose a gravitas on these sentiments that would be difficult to exceed.  The brief continues by noting that Judge Newman's physicians have reached the same conclusions that anyone who have witnesses her in public appearance, that she is "cognitively sharp" (which may be an understatement) and that she is not "disabled or otherwise incapable of performing her judicial duties."

    But then the brief reaches the crux:  regardless of the Judge's eminent capacity to continue her contributions to the Federal Circuit her fellow members of that court have "effectively . . . removed [her] from judicial office."  In addition to reminding the Court of the history of the contretemps between Judge Newman and her Federal Circuit colleagues, these introductory remarks tweak the D.C. District Court judge with the reality that "[i]nstead of addressing the merits of those constitutional issues, the district court dismissed Judge Newman's claims largely on the ground that judicial review was precluded."  That decision "cuts against the strong presumption that all U.S. citizens are entitled to have their federal constitutional claims heard in a federal court" according to this collection of federal court judges, succinctly stating that "Judge Newman is entitled to her day in court."  On the merits, the brief endorses as being "a valid claim" the facts underlying her complaint.  "The Constitution assigns to the U.S. Senate alone the power to remove Article III judges from office," amici state, and the indefinite suspension effectively (and thus improperly) does so outside the proper ambit of the Constitution.

    The brief then provides a "Statement of the Case" informed (according to a footnote) by the factual statements "drawn from Judge Newman's Amended Complaint."  Although overall an evenhanded account, there are instances where the source of this narrative peeks through (for example, attributing Judge Newman's refusal to submit to examination by doctors "selected by the committee" to her being "[d]ismayed by the inaccuracy of many of the Special Committee's statements regarding her medical history and its unreasonable time demands"; mentioning that Judge Newman was suspended despite the Special Committee having "made no finding regarding whether Judge Newman's health was such that she lacked the capacity to perform the work of an active judge").  The brief notes that the Judicial Conduct and Disability Committee of the Judicial Conference (JC&D) did not deign to consider any of Judge Newman's constitutional challenges to her suspension.  Rather, expressly relying on the Kafka-esque aspects of these proceedings, the JC&D did not uphold Judge Newman's suspension because she is in any way cognitively or otherwise impaired but because her refusal to submit to being examined by the Committee's doctors amounted to "a serious form of continuing misconduct."  (Perceptive followers of this case will recognize that the September 2023 suspension was appealed to the Committee, which allowed it to stand in a February 2024 decision.  The September 2024 suspension has not yet been appealed to the Committee, although such an appeal is likely.)

    With regard to the District Court's decision below, the brief notes that the District Court dismissed Judge Newman's challenge without deciding whether Judge Newman was correct that 28 U.S.C. § 354 was being applied to her "in an unconstitutional manner" and because the District Court "believed its rulings were mandated by [the D.C. Circuit Court's] decision in McBryde v. Committee to Review Circuit Council Conduct and Disability Orders, 264 F.3d 52 (D. C. Cir. 2001).

    The brief makes two arguments:  first, that Judge Newman "is entitled to bring her constitutional claims before an Article III court," and second that "the Judicial Council of the Federal Circuit violated separation-of-powers principles by removing Judge Newman from her judicial powers for an indefinite period of time."

    Regarding amici's first argument, the brief asserts that the remainder of the Federal Circuit judges "cannot" overcome the "strong presumption" that Judge Newman is entitled to judicial review of the Judicial Council's actions in suspending her from her position on the Court.  The exercise of jurisdiction by the federal courts "has always served as a critical safeguard of individual liberties" and provided "a vital check against the modern administrative state," their brief asserts.  The Founders envisioned the "importance of an independent judiciary to protect constitutional rights and prevent government abuse" according to the brief.  This importance was recognized (and procedurally facilitated) by Congress in enacting a broad jurisdictional statute (28 U.S.C. § 1331).  Acknowledging that Congress has the power to limit such jurisdiction the brief asserts that "courts have been very reluctant to interpret federal statutes as barring jurisdiction over constitutional claims because of the threat to liberty posed by any such interpretation," citing Johnson v. Robison, 415 U.S. 361, 366 (1974).  The District Court held that § 357(c) "clearly and convincingly" evinced Congress's intent to preclude Judge Newman's "as-applied constitutional claims" but amici argue that this section of the statue "says nothing about whether its limitations on judicial review of Judicial Council actions apply to constitutional claims—whether facial or as-applied."  This is not the "explicit reference" to such jurisdictional limitations concerning constitutional questions that Robison requires to preclude judicial review (citing the Supreme Court's decision in Demore v. Kim, 538 U.S. 510 (2003), for the same principle).  The brief emphasizes the "serious constitutional dilemma" that the District Court's decision raises, i.e., that Judge Newman has no recourse in any forum to seek redress for her constitutional injury should the Court her uphold the District Court's decision in light of the JC&D's taking the position that it will not decide constitutional questions.  Making a reductio ad absurdum argument to illustrate the resulting predicament, the brief posits that Judge Newman would have no recourse to challenge their constitutionality should the Judicial Council or JC&D render decisions by a "flip of a coin" or by "subject[ing] Judge Newman to 'trial by ordeal.'"  The statute's very silence is evidence that Congress did not intend this result in enacting § 357(c), according to amici.

    In their second argument, amici assert that the District Court erred in relying on McBryde v. Committee to Review Circuit Council Conduct and Disability Order to support its decision to dismiss.  First, the brief argues that the McBryde decision arose in a different factual context.  Specifically, the sanctions imposed by the Judicial Council had in large part expired and so were moot.  While McBryde held that "§357(c) preclude[d] judicial consideration of as-applied constitutional challenges to Judicial Council public reprimand," it was "not a bar to all consideration of constitutional challenges to Judicial Council orders."  But "[n]either of those holdings has direct application to the issue presented here" according to the brief, which is "whether Judge Newman may bring an as-applied challenge to Appellees' efforts to remove her from the federal bench."  Accordingly, the District Court's reliance on McBryde to support its decision to dismiss was improper.  The brief also notes specific "passages" from the McBryde decision that support Judge Newman's complaint, wherein some of these satisfy judicial review for more serious grounds for dismissal (albeit admitting that "a long-term disqualification from cases" could amount to unconstitutional removal).  The brief also asserts that the District Court did not draw a "bright line" or provide any indication of the distinctions to be drawn between constitutional claims that are subject to § 357(c) and ones that are not; the absence of such an effort makes implausible the District Court's conclusions regarding Judge Newman's challenge.  In addition, the brief cites to a statute (the 21st Century Department of Justice Appropriations Authorization Act, Pub. L. No. 107-273, Div. C, Title I, Subtitle C, § 11044, 116 Stat. 1758, 1856 (Nov. 2, 2002)) enacted one year after the McBryde decision "expressly acknowledged [that] the Disability Act is subject to as-applied constitutional challenges."  Amici find the District Court's response to the existence and interpretation of this statute to be "nonsensical."  Even the distinction purportedly rendered in McBryde between facial and as-applied constitutional claims "has not stood the test of time" according to amici, evidence thereof including the Supreme Court's refusal (or non-recognition) that even suggested that the strength of any "strong presumption" of whether constitutional claims are reviewable depends on whether they are facial or as-applied, citing Demore.

    Turning to the brief's argument that the Judicial Council violated separation of powers principles in removing Judge Newman constructively, the brief asserts that the conclusion that this was exactly what has happened is borne out by the facts.  Long-term deprivation of Judge Newman's judicial authority is "impossible to distinguish from an outright removal from office given her advanced age" (the first mention of this "elephant in the judicial corner" in the brief).  The brief reminds the Court that the Constitution provides that federal judges shall "hold their offices during good behavior" and they can be removed from office only through a vote of impeachment by the U.S. House of Representatives and a trial and conviction by the Senate under Art. I, § 3, cl. 6.  The brief asserts that the Judicial Council of the Federal Circuit violated the Constitution by "impinging on [impeachment] powers delegated solely to the Senate" (emphasis in brief).  At a minimum, amici argue, Judge Newman is entitled to have the Court reverse the District Court's dismissal of Counts II and III relating to these constitutional questions (see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit") (the brief also asserting a challenge to the Judicial Council and Judge Newman's colleagues on the Court to provide "substantial evidence that Judge Newman is not actually subject to an indefinite suspension").  The brief rejects the Judicial Council's justification for the suspension as being "a serious form of continuing misconduct."  If that is indeed the case, amici assert that the proper course of conduct is "to refer the matter to Congress for possible impeachment and trial, [but w]hat they may not do is take it upon themselves to effectively remove Judge Newman from office by suspending her indefinitely."

    This is not just an issue limited to one Circuit Court judge (no matter how unjust it may appear to be).  The brief recites "particular[] concern[]" regarding "the threat to judicial independence posed by Appellees' alleged actions" and returns to the theme of Judge Newman providing dissents without regard to whether they might provoke resentment, exasperation, or animosity from her colleagues, and the benefits that have accrued by her willingness to be faithful to her view of the law.  The risk is that "[i]f the Federal Circuit Judicial Council succeeds in shutting down Judge Newman without going through the constitutionally prescribed process for removing Article III judges from office, other judges may conclude that they should hesitate to act boldly in defense of justice for fear of the adverse consequences of doing so."  The brief cites the Supreme Court for evidence of the importance of avoiding such a consequence:

    [I]t is a general principle of the highest importance to the proper administration of justice that a judicial officer, in exercising the authority vested in him, shall be free to act upon his own convictions, without apprehension of personal consequence to himself.  Liability to answer to every one who might feel himself aggrieved by the action of the judge, would be inconsistent with the possession of this freedom, and would destroy that independence without which no judiciary can be either respectable or useful.

    citing Bradley v. Fisher, 80 U.S. 335, 347 (1871) and Pierson v. Ray, 386 U.S. 547, 554 (1967).

    The brief concludes with the exhortation that confidence in their ability to follow their views on the law requires "[a]dherence to the constitutionally prescribed impeachment process" because it "ensures that Article III judges can feel confident that their rulings will not endanger their job security and that they cannot be removed from office except through a rigorous process that entitles them to raise all plausible defenses before an impartial Senate jury."

  • D.C. Bar Association File Amicus Brief in Newman v. Moore et al.

    By Kevin E. Noonan

    DC Bar AssociationIt has been a remarkable feature of the Federal Circuit's suspension of the Honorable Judge Pauline Newman that few have taken a stand publicly on the propriety of the suspension (something the Judge herself recently mentioned; see "An American (and Entirely Unnecessary) Tragedy").  That has now changed, with the D.C. Circuit Court of Appeals receiving amicus briefs from four separate groups submitted in support of Judge Newman's challenge.  These amici ask the Court to reverse the District Court's dismissal of her lawsuit challenging the Judicial Council's actions on, inter alia, Article III and due process grounds.  Another one of these amicus briefs is discussed herein, submitted to the Court by the District of Columbia Bar Association.

    The brief begins with reciting what has perhaps become Judge Newman's preeminent judicial distinction, the frequency of her dissenting from her colleagues' opinions and how frequently her views have been vindicated, including by citations to those dissents in Supreme Court opinions reversing the Federal Circuit.  This combination of judicial independence and a propensity for her views to be legally correct, in light of her "indefinite suspension" deprives our legal community of an experienced and fiercely independent voice in the ongoing weaving of the tapestry of caselaw at the Federal Circuit" and amounts to an impeachment, which being effected by the Judicial Council circumvents the Constitution, the brief asserts.  The brief also asserts that there is "widespread, but silent, support" for the Judge, and a concomitant fear ("justified or not") that such support if voiced publicly might "adversely impact [their] own appeals before [the Federal Circuit]" (itself a somewhat damning indictment).  But to the extent this is current reality of the relationship between the Court and the patent bar, this dishonest silence "underscores why this Court should approach with skepticism the suspension and Appellees' refusal to transfer the complaint against Judge Newman to another circuit's judicial council."

    Amounting to a mere 548 words, the brief, unfettered by discussion of the underlying legal basis for assessing competency amongst the federal judges making up the judicial branch of the government, it in some ways provides the most powerful advocacy for the D.C. Circuit Court to rectify the current situation.

  • Academics and Other Experts File Amicus Brief in Newman v. Moore et al.

        By Kevin E. Noonan

    It has been a remarkable feature of the Federal Circuit's suspension of the Honorable Judge Pauline Newman that few have taken a stand publicly on the propriety of the suspension (something the Judge herself recently mentioned; see "An American (and Entirely Unnecessary) Tragedy").  That has now changed, with the D.C. Circuit Court of Appeals receiving amicus briefs from four separate groups submitted in support of Judge Newman's challenge.  These amici ask the Court to reverse the District Court's dismissal of her lawsuit challenging the Judicial Council's actions on, inter alia, Article III and due process grounds.  Another one of these amicus briefs is discussed herein. 

    The amici here include:

    • The Manhattan Institute, a "nonprofit policy research foundation whose mission is to develop and disseminate ideas that foster individual responsibility and agency across multiple dimensions."

    • Dean Pinkert, an "international trade and human rights consultant, whose projects range from labor practices in U.S.-facing supply chains to trade remedies and intellectual property."

    • Steve C. Charnovitz, who is on the faculty of George Washington University Law School and who "writes on international trade, foreign relations law, and environmental sustainability."

    • Rochelle Dreyfuss, emerita law professor at the NYU School of Law whose scholarship focused on patent law and the Federal Circuit.

    • Brian Dean Abramson, "a leading expert on vaccine law."

    • Andrew C. Michaels, associate professor of law at the University of Houston Law Center who specializes in intellectual property law.

    • Hugh Hansen, emeritus professor of law at Fordham Law School.

    • Howard Knopf, a retired Canadian lawyer.

    These amici assert that the legitimacy of the judiciary "relies on its ability to resolve disputes impartially and maintain public confidence in its integrity."  In instances such as the one before the Court, the law contains "structural safeguards," like transferring a case to a different circuit to "ensure that disciplinary proceedings are both impartial and perceived as fair," the latter effect being "essential."  These amici characterize the allegations raised against Judge Newman to be "precisely the type of circumstances that demand such precautions."  The manner in which these proceedings have been conducted in this case "create a risk of impropriety or the appearance of bias if the case were to remain within the circuit," amici assert.

    The brief's first argument is that "history and case law suggest" that an accused judge not be tried by her colleagues on the court, which is particularly the case where, as here, some of these colleagues are the judge's accusers.  The brief reminds the Court that until recent times the only mechanism for disciplining a federal judge was impeachment, citing United States v. Claiborne, 727 F.2d 842, 845 (9th Cir. 1984), and McBryde v. Comm. to Rev. Cir. Council Conduct & Disability Ords. of Jud. Conf. of U.S., 264 F.3d 52, 66 (D.C. Cir. 2001).  Amici consider there to have been "good reason" for this, inter alia, to avoid "overreach" by different branches of government against other branches (protections particularly important to the judiciary; to paraphrase Stalin, "how many divisions [of troops] do judges have"?).  Being entitled to such protection depends, according to the brief, on judges deserving the benefits thereof, and entitlement depends on the judiciary's integrity remaining "beyond reproach."  Because there are instances where a judge's past conduct, while not amounting to impeachable conduct needs correction, and in other instances where methods for alternative relief are necessary, as evidenced by decisions that "highlight[] how the role of the judicial council is to provide administrative remedies in the absence of judicial relief," citing Chandler v. Jud. Council of Tenth Cir. of U. S., 398 U.S. 74, 85 (1970).  Enactment of the Judicial Conduct and Disability Act showed that the court had the authority to effectively discipline federal judges for "conduct unbecoming or that reflected poorly on the integrity on the institution."  The Act contained provisions aimed at these protections, giving initial responsibility to the Circuit's Chief Judge.  But importantly. the Act provided, as these amici see things, proceedings that are "forward-looking and not punitive," citing  In re Complaints of Jud. Misconduct, 9 F.3d 1562, 1566 (U.S. Jud. Conf. 1993), and "inquisitorial and administrative" rather than "adversarial," the brief citing In re Memorandum of Decision of Jud. Conf. Comm. on Jud. Conduct & Disability, 517 F.3d 563, 567 (U.S. Jud. Conf. 2008).  And one provision ensuring "good behavior" in such circumstances is moving the proceedings to another circuit.

    Here the Federal Circuit has ignored these built-in safeguards, amici assert.  Part of the implementation of the Act included establishment of a set of Judicial Conference Rules "designed to provide a mandatory and nationally uniform governing structure to the procedural aspects of judicial conduct and disability proceedings."  These may differ from circuit to circuit according to the brief, but it is the uniformity of the rules that stand out amici argue (the brief further stating that complaints such as this one are "the rarest type"; this conclusion stems from the information contained in a report, entitled Implementation of the Judicial Conduct and Disability Act of 1980: A Report to the Chief Justice, 22 (2006) by former Justice Breyer).  The brief walks through the typical procedural steps involved in evaluating a complaint against a judge, including early determinations of whether a complaint has merit and, if determined to be so the Chief Judge of the Circuit convening a special committee to further investigate (all these steps having been features of this investigation of Judge Newman).  Even these early procedural steps are rare, the brief stating that "only 25 out of 1,363 complaints in 2023 being referred to a special committee" according to Complaints Against Judges, U.S. Cts. (2024).  It is up to the judicial council from that circuit to decide whether to recommend public reprimand or other penalties (which can include recommending impeachment to the House of Representatives).

    This is a recitation of the "ordinary course of events," according to the brief, and while it "may appear straightforward, there are structural concerns that give pause."  One such concern is a recognition that "the process for judicial discipline is built on the presumption of good-faith action by the investigating judges," which is usually ("the vast majority of cases") but not always true.  The need for such good faith "is a critical element because the chief judge acts as detective, prosecutor, and arbiter for the accused through the entire procedure" (statuses that Judge Newman has asserted in her complaint relating to due process deficiencies), citing McBryde.  Because there is this "potential for misconceived actions against a particular judge serving on the same circuit," the Rules contain provisions for transferring the matter to another circuit, or for the Chief Judge to recuse herself as safeguards.  But, the brief emphasizes, these steps are discretionary to the Chief Judge.  The brief provides illustrative examples (taken from the Breyer Report) and enumerates the benefits of such safeguards.  These include that "transferring cases eases internal tensions," citing In re Jud. Misconduct J.C. Nos. 03-20-90043 and 03-20-90044, 2 (Jud. Coun. Third Cir. 2021), and In re Charges of Jud. Misconduct, 769 F.3d 762, 763 (D.C. Cir. 2014).  Amici also assert that such transfers "preserve[] the public trust," using to illustrate "perhaps the highest-profile such instance in modern times, [wherein] 83 judicial-misconduct complaints against D.C. Circuit Judge Brett Kavanagh were transferred from the D.C. Circuit's judicial council to the Tenth Circuit's judicial council" in In re Complaints Under the Judicial Conduct and Disability Act, Nos. 10-18-90038 through 10-18-90112 (10th Cir. Jud. Council 2022).  Amici draw a comparison between these "unfounded complaints" (that were ultimately dismissed) with those against Judge Newman (the brief asserting "as those against Judge Newman should be [dismissed]").  The brief also notes the strong motivation of avoiding a perception of impropriety, citing transfer from the Ninth Circuit to the Second Circuit in a case of alleged sexual impropriety against "then-Judge Alex Kozinski in In re Complaint No. 17-90118, at 1 (2d Cir. Jud. Council Feb. 5, 2018)."  The brief also notes that "transfers for independent review are common in instances where public confidence and the perception of impartiality are in jeopardy," setting forth several other instances for illustration.

    The brief concludes with confirmation by retired Federal Circuit Chief Judge Paul Michel of amici's "reading of the situation" with regard to the wisdom of a circuit transfer in this case.  The Chief Judge's views were set forth in an IP Watchdog article entitled Judge Newman's Suspension by the CAFC Has Marred Public Faith in the Federal Judiciary.  The brief states that in this article the former Chief Judge "raises timely concerns that should be taken seriously" and takes the opportunity (and word count) to set forth these comments in detail:

    Normally, one would assume the chief judge's motivations are proper: simply to protect the court and litigants before it.  But the mere appearance of bias is regarded as being just as harmful to justice as actual bias.  Given Judge Newman's accounts of their interactions, at least the appearance of bias against her by the chief judge is hard to dismiss. . . .

    Given the chief judge's apparent animus against Judge Newman, how can she herself be regarded as an impartial adjudicator?  Even the impartiality of the other judges may be questioned if, like the staff, they were perhaps fearful of adverse consequences if they failed to support the wishes of the chief judge.

    No one, I suggest, can confidently untangle these diametrically opposing versions of the truth without a trial-like proceeding.  And, so far, that has been repeatedly denied by all the external authorities who have looked at this case.

    Finally, all should be able to agree that the disputed facts should be decided by a neutral body.  Such neutrality must be beyond question for the sake of faith in the courts by litigants and the public alike.  That, after all, is the basis of judicial recusals.  Yet requests by Judge Newman to transfer the case to another circuit have all been rejected.  That alone is troubling. . . .

    Getting the facts straight always lies at the heart of doing justice.  In this case, however, the relevant facts have yet to be established and verified.  In its brief filed in the district court, the Federal Circuit wrote that all the disability charges were "moot", removing these charges from the district court.  Yet, Judge Newman was not returned to judicial service, and she has now been "suspended" for a second year, on the same charge of "failure to cooperate."

    Judges from around the country anxiously ask me regarding the actions taken against Judge Newman: "What's going on with the Federal Circuit?"  Is it not time for some outside authority to intervene and to end this impasse before it further undermines the credibility of the Federal Circuit, and potentially the entire judiciary?

    It should go without saying that amici here wholeheartedly agree with former Chief Judge Michel and request that the Circuit Court reverse the judgment of the district court and "render a judgment indicating a need to transfer the underlying proceedings to another circuit."  This judgment "would obviate any concerns about impartiality arising from internal tensions within the Federal Circuit and begin to remedy the damage being done to the rule of law by Judge Newman's arbitrary suspension," amici assert.




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  • The Buckeye Institute Files Amicus Brief in Newman v. Moore et al.

        By Kevin E. Noonan

    Buckeye InstituteIt has been a remarkable feature of the Federal Circuit's suspension of the Honorable Judge Pauline Newman that few have taken a stand publicly on the propriety of the suspension (something the Judge herself recently mentioned; see "An American (and Entirely Unnecessary) Tragedy").  That has now changed, with the D.C. Circuit Court of Appeals receiving amicus briefs from four separate groups submitted in support of Judge Newman's challenge and asking the Court to reverse the District Court's dismissal of her lawsuit challenging the Judicial Council's actions on, inter alia, Article III and due process grounds, one of which is discussed herein.

    The Buckeye Institute is a self-described non-partisan "think tank" dedicated to "formula[ing] and promot[ing] free-market policies" in Ohio and elsewhere.  Their amicus brief is based on the importance of public confidence in the judiciary, which the brief argues has been harmed by the manner in which the Judicial Conduct and Disability Act has been employed in this case.  The importance of the judiciary is one reason why the Founders "insulated" judges with impeachment as the "sole means" for removing them, the brief asserts.  The public nature of impeachment is the antithesis of proceedings which, as here, are conducted "behind closed doors," ascribing the need and right to such open proceedings as being protected under common law and the First Amendment.

    The brief asserts that "conducting judicial disciplinary proceedings in the dark undermines public confidence in our judiciary."  The standard for judicial proceedings has been their "openness," with "contemporaneous review in the forum of public opinion [being] an effective restraint on possible abuse of judicial power," amici citing Justice Brennan's concurring opinion in Richmond Newspapers, Inc. v. Virginia, 448 U.S. 555, 592 (1980), and quoting in re Oliver, 333 U.S. 257,279 (1948).  This case, amici argue, "illustrates the improper secrecy used throughout judicial disciplinary proceedings."  Amici's apprehension of the lack of public confidence finds support in commentators including former Chief Judge Michel, quoted in IP Watchdog.  As a consequence, the brief asserts that unless there are such open proceedings "the appearance of bias cannot be refuted."  The brief notes that Judge Newman has asked that the proceedings and materials involved be disclosed to the public and that her request has been denied (despite seemingly contrary understanding in the Commentary of Rule 23 of the Rules for Judicial-Conduct and Judicial Disability Proceedings) (while at the same time imposing a "gag order" on Judge Newman and her counsel precluding their release of the materials).  The brief further sets forth a history of preventing Judge Newman from disclosing the purported evidence against her (Defendants-Appellees have "threatened [Judge Newman] and her attorneys with unspecified sanctions if any portion of the documents contained in that volume were made publicly available") and a certain amount of reneging on representations that some of these materials would be permitted to be disclosed, for example after Judge Newman dropped Court IV of her complaint regarding her First Amendment claim.

    The brief goes on to assert that such actions are contrary to the intent of the Judicial Conduct and Disability Act of 1980, which amici assert "was intended to boost public confidence in the judicial complaint process" (based on the circumstances prior to its enactment, where "informal internal discussions were the only means of enforcing judicial misconduct short of impeachment"), saying that in this case that intention "falls short of that goal."  The Federal Circuit Judicial Council's actions in this case to suppress disclosure, which contrary to the need for openness is not in fact against the law, and which is ratified under 28 U.S.C. § 360(a) (granting the Council's discretion in this regard but amounting to "near total ban on disclosure" according to amici), as well as prohibiting any person from intervening or appearing as amicus in the proceedings.

    The situation is contrary to amici's assertions that free and open public access to inherently adjudicatory procedure is key to public confidence in the judiciary, where free and open access is "not unlike the right of an accused defendant to a public trial," citing a dissent in United Press Associations v. Valente, 123 N.E.2d 777, 786 (N.Y. Ct. App. 1954), based on English Common Law tenets going back to the years immediately after Magna Carta and prevailing in this country's colonies prior to the nation's founding.  Accordingly, the brief asserts that "the common law and the First Amendment guarantee the right to open access to judicial proceedings," citing Nixon v. Warner Commc'ns, Inc., 435 U.S. 589, 597 (1978), relying on Ex parte Drawbaugh, 2 App.D.C. 404 (1894).  In addition to the common law right to an open trial, amici find support in the First Amendment right of freedom of the press as well as the public "to attend and observe criminal proceedings," citing Press-Enter. Co. v. Superior Court, 478 U.S. 1, 9 (1986), and  Globe Newspaper Co. v. Superior Court, 457 U.S. 596, 603 (1982).  Indeed, "every circuit to consider the issue" has found these rights extend to civil proceedings, exemplified in Dhiab v. Trump, 852 F.3d 1087, 1099 (D.C. Cir. 2017), the brief providing an extensive history of the importance of open access to judicial proceedings in civil matters.

    These considerations should apply to administrative proceedings like this one, the brief argues, based on the same common law and First Amendment principles.  Consistent with this contention is their application to the Executive Branch "in a variety of [administrative agency] contexts."  Due to the "quasi-judicial" character of the proceedings against Judge Newman, the brief argues that similar due process considerations apply to her (in addition to the public's right to access:  "the public has an interest in open access to adjudicatory decision-making" as being "key to public confidence in the judiciary").

    The practices and applications of the administrative procedures provided by the Judicial Conduct and Disability Act here, that have permitted "the adjudicator to determine what documents can and cannot be accessed, despite the accused judge's consent, is inconsistent with the idea of open access" according to amici.  The brief terms judicial protection of privacy rights (in context, that of the Judicial Council and the witnesses asserted in support of Judge Newman's suspension) to be "the exception, not the rule," citing In re Sealed Case, 931 F.3d 92, 96 (D.C. Cir. 2019), and Washington Legal Found. v. U.S. Sentencing Comm'n, 89 F.3d 897, 899 (D.C. Cir. 1996).  The appropriate test has been a balancing test, amici contend, between "the litigant's legitimate interest in anonymity against countervailing interests in full disclosure" under Sealed Plaintiff v. Sealed Defendant, 537 F.3d 185, 189 (2d Cir. 2008).  But here, amici assert that the Act "begins with the notion that all documents, except for some final opinions, should not be publicly available" with a few narrow exceptions.  While permitting accused judges to request that documents related to an investigation be released that request can (as here) be denied by the court's chief judge at her discretion.  This is improper, the brief contends, because the correct presumption (consistent with the law) should be one of openness.  The brief sets forth five factors to be applied for determining whether cases within the purview of the Act should proceed anonymously, and six factors relating to release of documents.  In this case,the brief contends that "[t]he judge adjudicating this matter, who was also the complainant, has not attempted to satisfy any of the above[-cited] elements for keeping the proceedings or other information secret" (emphasis added).  Even though Judge Newman's request for the documents to be released significantly reduced the judiciary's claim of a privacy interest, the brief accuses the Act and how it has been implemented by this Judicial Council of "put[ting] secrecy over the public's right to access," which is "not only inconsistent with the JCDA's purpose of formalizing the complaint process to provide some—but very limited—public access, but it is inconsistent with hundreds of years of open access to the judiciary so that the public can be confident that its inner workings are fair, and how the judiciary handles other privacy concerns."  In making these arguments, amici take away issues of personal animus towards or injury to Judge Newman and ground their argument in the injury to the public in keeping these proceedings secret.