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  • Medytox, Inc. v. Galderma S.A. (Fed. Cir. 2023)

    By Kevin E. Noonan –

    Federal Circuit SealIt is not surprising that the Federal Circuit has taken the opportunity to apply the Supreme Court's recent precedent in Amgen v. Sanofi regarding the sufficiency of disclosure needed to satisfy the statutory enablement requirement under 35 US.C. § 112(a).  After all, the decision is a rare affirmance of Federal Circuit decision by the Supreme Court, and the legal rationale set forth is consistent with recent enablement jurisprudence developed by the Federal Circuit over recent years (see "Wyeth & Cordis Corp. v. Abbott Laboratories", "Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc.", and "Idenix Pharmaceuticals LLC v. Gilead Sciences Inc.").  But the decision, in Medytox, Inc. v. Galderma S.A., is itself significant because it adopts the analytical framework that the Patent and Trademark Office and district courts can be expected to follow going forward, for better or worse.

    The case arose in a post-grant review (PGR) proceeding against U.S. Patent No. 10,143,728 before the Patent Trial and Appeal Board pursuant to 35 U.S.C. § 321 et seq. and brought by Galderma et al.  The challenged claims were directed towards "the use of an animal-protein-free botulinum toxin composition that exhibits a longer lasting effect in the patient compared to an animal protein-containing botulinum toxin composition," which encompasses a Medytox product designated MT10109L in the opinion.  Substitute claim 19 was set forth in the opinion as representative:

    A method for treating glabellar lines a condition in a patient in need thereof, comprising:
        locally administering a first treatment of therapeutically effective amount of a botulinum toxin composition comprising a serotype A botulinum toxin in an amount present in about 20 units of MT10109L, a first stabilizer comprising a polysorbate, and at least one additional stabilizer, and that does not comprise an animal-derived product or recombinant human albumin;
        locally administering a second treatment of the botulinum toxin composition at a time interval after the first treatment;
        wherein said time interval is the length of effect of the serotype A botulinum toxin composition as determined by physician's live assessment at maximum frown;
        wherein said botulinum toxin composition has a greater length of effect compared to about 20 units of BOTOX®, when whereby the botulinum toxin composition exhibits a longer lasting effect in the patient when compared to treatment of the same condition with a botulinum toxin composition that contains an animal-derived product or recombinant human albumin dosed at a comparable amount and administered in the same manner for the treatment of glabellar lines and to the same locations(s) as that of the botulinum toxin composition; and
        wherein said greater length of effect is determined by physician's live assessment at maximum frown and requires a responder rate at 16 weeks after the first treatment of 50% or greater that does not comprise an animal-derived product or recombinant human albumin, wherein the condition is selected from the group consisting of glabellar lines, marionette lines, brow furrows, lateral canthal lines, and any combination thereof.

    (wherein the claim is presented with limitations removed from the substitute claim indicate by strikethrough and those added by underlining).  The compositions were disclosed in earlier applications incorporated by reference; this application newly provides in support of these method claims the results of two clinical trials that compared botulinum toxin stabilized with human serum albumin and animal-protein-free botulinum toxin composition.  One of these was results of a Phase III clinical trial making the relevant comparison between BOTOX® and the claimed MT10109L product (showing not surprisingly "significant improvement" with the Medytox product), and results of a Phase II clinical trial comparing the two products (showing consistent improved results with the Medytox product).

    The PTAB instituted a PGR against granted claims 1-10 of the '728 patent and Medytox filed a motion to amend by cancelling claims 1-10 and substituting claims 11-18.  Medytox also requested the Board to issue a Preliminary Guidance (as part of the PTO's Pilot Program regarding amendment practice in PGRs and other post-grant review proceedings) relating to the likelihood that the motion met statutory and regulatory requirements.  Galderma opposed the motion to amend on new matter grounds, and the PTAB issued a Preliminary Guidance that "Medytox had not shown a reasonable likelihood that it satisfied the statutory and regulatory requirements under 35 U.S.C. § 326(d) and 37 C.F.R. § 42.221(a)."  But the Guidance also contained the caveat that the Board would not be bound by this Guidance in its Final Written Decision, which would depend on the full record before the Board at the end of the proceedings.  In response, Medytox moved to cancel original claim 6 and substitute the remaining claims with new claims 19-27, which motion Galderma also opposed.

    The Board issued its FWD and cancelled original claims 1-5 and 7-10.  On the merits of the remaining claims at issue, the Board construed the term "responder rate" with regard to Galderma's (a range of 50-100%) and Medytox's (a minimum threshold of 50%) constructions, ultimately deciding that the responder rate limitation had an upper limit of 100% (a construction that differed from the one in the Preliminary Guidance).  The Board also found that Medytox's substitute claims introduced new matter in the responder rate limitation and thus failed to meet the requirements for its revised motion to amend.  The Board accordingly found that the proposed substitute claims were invalid for failure to satisfy the written description requirement (a finding not addressed by the Federal Circuit on appeal, in view of its other grounds for affirming the Board).  On the Board's decision that the substitute claims were also not enabled, the Board applied the factors set forth in In re Wands and, based in part on expert testimony, found that the full scope of the claims was not enabled because the specification would not have enabled the skilled worker to achieve a responder rate higher than 62% without undue experimentation.  All claims in the '728 patent were thus cancelled or replacement with substitute claims precluded by their being invalid.  This appeal followed.

    The Federal Circuit affirmed, in an opinion by Judge Reyna joined by Judges Dyk and Stark.  The opinion first discussed claim construction, the panel holding that the Board properly construed the "responder rate" limitation to be a range (Galderma also arguing that Medytox on appeal for the first time contended that its construction relied on intrinsic evidence in the specification rather than extrinsic, expert testimony understandably, in light of the substantial evidence standard of review of Board decisions based on factual determinations such as expert testimony).  The Court did not address Galderma's underlying forfeiture argument, asserting instead that the parties did not dispute that the "responder rate" limitation had an "inherent" upper limit of 100% and that "there appears to be no substantive difference in the claim construction proposed by the parties for the responder rate limitation," the Federal Circuit affirming the Board's construction on that basis.

    Turning to enablement, the Federal Circuit held that the Board had properly found the '728 specification did not satisfy the enablement requirement of § 112(a).  The panel rejected Medytox's argument that "the specification does not need to include a working example of 'every possible embodiment to enable the full scope of the claims,'" citing (somewhat anachronistically) Bayer Healthcare LLC v. Baxalta Inc., 989 F.3d 964, 982 (Fed Cir. 2021), and Medytox's reliance on expert testimony that there would require no undue experimentation because it was "routine to clinically confirm" whether a composition met the duration limitation (a "greater length of effect").  Galderma had argued that Medytox was required "to provide a clinical study for each formulation because clinical trials are not routine for 'determining whether pharmaceutical compositions fall within the scope of a patent claim.'"  The Federal Circuit agreed, cabining the extent of its agreement by asserting that "our caselaw may not require disclosure of every possible working example of responder rates" but noting that here the specification disclosed "at most three examples of responder rates above 50% at 16 weeks."  While citing earlier caselaw, including Wyeth & Cordis Corp. v. Abbott Lab'ys, 720 F.3d 1380, 1385–86 (Fed. Cir. 2013), and MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1381 (Fed. Cir. 2012), the panel based its decision on the Supreme Court rubric recently set forth in Amgen v. Sanofi that "[t]he more one claims, the more one must enable."  The opinion expressly states the basis for its analytical reasoning as also sounding in Amgen, that:

    Though a specification need not always "describe with particularity how to make and use every single embodiment within a claimed class," it must nevertheless "enable the full scope of the invention as defined by its claims," for example by "disclosing [a] general quality" of the class that may "reliably enable a person skilled in the art to make and use all of what is claimed."

    Applying these principles, the Federal Circuit affirmed the Board's non-enablement decision based on substantial evidence that that "the arguments and evidence were insufficient to demonstrate enablement to a skilled artisan because said artisan 'would not have been able to achieve' responder rates higher than the limited examples provided in the specification."

    Procedurally, Medytox argued that the Board erred in changing its claim construction in the FWD from the construction in the Preliminary Guidance as a violation of the Administrative Procedures Act (APA) as being arbitrary and capricious under 5 U.S.C. § 706(2)(A).  Medytox's arguments focused on the Board's purported failure to consider intrinsic evidence and this had resulted in "inconsistent conclusions on a nearly identical record" [that] render[ed] its decision arbitrary and capricious," citing BASF Corp. v. Enthone, Inc., 749 F. App'x 978, 985 (Fed. Cir. 2018), and Robert Bosch, LLC v. Iancu, 778 F. App'x 871, 875 (Fed. Cir. 2019).  The Federal Circuit's assessment is in line with the arguments put forth by the Solicitor General on behalf of the Patent Office, that the Preliminary Guidance is preliminary and any contrary conclusions the Board may arrive at in its FWD is due to the further development of the record during the proceedings, something the Federal Circuit has held is an obligation falling on the Board, citing In re Magnum Oil Tools Int'l, Ltd., 829 F.3d 1364, 1377 (Fed. Cir. 2016).  Here, the panel held that the Board "provided a reasoned analysis for its ultimate claim construction" and consequently that the decision to change its construction of the claims with regard to the responder rate limitation was not arbitrary and capricious.

    Finally, Medytox argued that the Board's decision and the way it was arrived at denied them due process and was contrary to the APA.  The Federal Circuit considered the public notice in the Federal Register that the Pilot Program would product a preliminary guidance, and that the "initial" and non-binding nature thereof was evident.  Reviewing the procedural steps below the Court held that there was no irregularities or denial of due process.  Some caution is provided by the Court on the limits of the application of these processes, however:

    To be sure, the agency must inform the parties on procedures relevant to its practices, like the Pilot Program, and must respect the boundaries imposed by the APA.  There must be structural integrity to the program in ensuring that the patent owners who have requested such guidance be given an opportunity to be heard and due process.

    But on the record before the panel the Court held that these requirements were met.

    However this first foray into applying the Supreme Court's latest imperative on how patent law will be interpreted, it is hard to say whether it bodes well.  Perhaps it is the inevitable consequence of a generalist Court steeped in considerations of the "totality of the circumstances" as the reviewing court for an inferior court charged by Congress with interpreting and harmonizing a specific area of the law.  Perhaps it has something to do with that Court spending more than a decade objecting to precedent from the inferior court that attempted to provide such harmony by developing a jurisprudence that could be applied reliably to diverse circumstances and technologies with a minimum of uncertainty.  But as with so much of the Court's "guidance" (to both the courts, the Patent Office, and the patenting public) this one on enablement seems more attuned to the Potter Steward method of legal analysis, wherein "you know it when you see it."  In addition to being anathema to the vision Congress and the early judges had in establishing the Federal Circuit, its difficulty in putting the rubrics (such as they may be) into practice has created disharmony in other areas of the law (see, e.g., "An Analytic Approach to Patent Eligibility") that may now be the fate of enablement law.  The one thread to be grasped in the Court's Amgen decision is the possibility of "[a] general quality" of the class that may "reliably enable a person skilled in the art to make and use all of what is claimed."  Whether this thread can be woven into a fabric through which enablement law can be applied consistently of course remains to be seen.

    Medytox, Inc. v. Galderma S.A. (Fed. Cir. 2023)
    Panel: Circuit Judges Dyk, Reyna, and Stark
    Opinion by Circuit Judge Reyna

  • You Are Going to Hear A Lot More FUD about Patent Law, So Here Are Some Facts

    By Michael Borella —

    They may have known that it was coming.  Over the last several weeks, lobbying organizations and high-tech blogs have been slowly introducing the same old false, misleading, and deceptive arguments against patent law.  These propaganda screeds are once again claiming that the patent system is awash with bad actors belligerently patenting vague and obvious inventions, and then slowing scientific and technological progress by asserting these patents against the world.  The solution, in their minds, is to weaken patent law.

    Then, last month saw the introduction of the Patent Eligibility Restoration Act of 2023 (to address the inequities of 35 U.S.C. § 101) as well as the Promoting and Respecting Economically Vital American Innovation Leadership Act, conveniently acronymized as PREVAIL (to address abuses of the USPTO's Patent Trial and Appeal Board).  Both of these bills are modest reforms to strengthen areas of patent law that have been eviscerated by Congress and the Supreme Court.

    So let's take a step back and, with full awareness of Brandolini's Law, both rebut and pre-but the fear, uncertainty, and doubt (FUD) about patent law that is brewing.  Like many lies, the positions taken by the anti-patent crowd are often based on a kernel of truth.  But then this underlying truth is twisted and distorted beyond recognition into a harmful policy position.

    In other words, criticism of patent law often raises valid concerns.  However, it is essential to examine this discourse with balanced perspective that considers both the benefits and challenges associated with patents.

    Patents are intended to serve as incentives for innovation, providing inventors with exclusive rights to their creations for a limited term.  This exclusivity encourages inventors to invest substantial resources, money, time, and creativity in developing groundbreaking technologies — such as investment-heavy endeavors like advanced artificial intelligence models and pharmaceutical development.  By offering protection for this limited term, patents create an environment that rewards inventors and can stimulate further research and development.

    To that point, the patent system requires inventors to fully disclose their inventions in exchange for the right to exclude others from making, using, selling, or importing these inventions.  By making detailed information publicly available, patents contribute to the collective knowledge of society.  This knowledge sharing can serve as a foundation for future innovations, allowing others to build upon existing ideas and drive further progress.

    On the other hand, a weak patent system results in more inventions being held as trade secrets, potentially forever.  Maybe this is not a huge concern if the invention is a widget that makes automobiles a few percent more efficient.  But life-saving drugs and diagnostic methods may never enter the research phase if a potential patent is not available.

    Worries over the balance between exclusivity and accessibility are legitimate.  It is important to ensure that patents do not impede competition or creativity.  For example, an overly permissive patent system (in which just about anything would be patentable) would stifle innovation and establish gridlock in certain technologies.  But we do not live under such a regime.

    While the USPTO does grant patents that it should not from time to time, it also refuses to grant patents that it should.  The USPTO also makes the process to grant so lengthy and time consuming that some startups and small companies are effectively excluded from full participation in the system.

    A well-balanced patent system empowers U.S. companies to compete effectively in global markets.  Patents protect products and technologies from unauthorized use, giving U.S. businesses an advantage in the global arena against copyists from low-cost regions.  This protection fosters a culture of entrepreneurship, enabling U.S. companies to create unique products and maintain a competitive edge against foreign rivals.  Encouraging technological advancement and protecting American inventions helps U.S. industries continue to lead in areas such as biotechnology, pharmaceuticals, artificial intelligence, data science, communications, advanced computing, and other critical sectors.

    Regarding patent quality, critics often point to the potential for abuse from broad and vague patents.  No one should question the need for rigorous USPTO examination processes to grant patents only for truly novel and non-obvious inventions.  Current USPTO examination procedures are inconsistent across art units and individual examiners.  Evaluation and improvement of these procedures can mitigate concerns regarding quality.  Additionally, mechanisms for post-grant review and opposition proceedings (even if the PREVAIL Act passes) currently serve and would continue to serve as a safeguard against errors by examiners.

    Another bogeyman raised ad nauseum by the anti-patent crowd is the specter of so-called patent trolls.  Trolls are non-practicing entities (NPEs) that exploit patents for litigation and licensing purposes rather than for protection of products and services.  While they pose a legitimate concern and can be annoying and expensive to deal with, it is important to note that their activities represent a distortion of the patent system rather than a fundamental flaw in the system itself.  Efficient legal mechanisms, such as early dismissal of meritless cases and fee-shifting provisions, can help alleviate their impact.  Other options including limiting the damages afforded to aggressive litigators.

    But we need to keep in mind that some of the most active entities in development of scientific and technological advances are NPEs — our university systems.  Any attempt to address "trolls" needs to recognize that academics should be able to benefit from the patent system through licensing rather than forcing them to start and run companies.

    Finally, some detractors simply do not like software patents.  Their rationale has never been clear but it seems to be based on one or more of the false assumptions that all software patents are too broad (they are not), that it is obvious to invent software based processes (not ones that are patentable), programming is an administrative activity that does not warrant patent protection (you try writing non-trivial bug-free code), or that the patent system should not protect non-physical inventions (software requires physical hardware to run).  None of these positions have any legal or technical credibility.

    Over the next few weeks and months, apply a skeptical eye to criticisms of the patent system.  Many have and will come from individuals who are not well-versed in patent law — journalists, commentators, hyper-libertarian tech bros with an axe to grind, or even lawyers who do not practice in the patent space.  Be cautious and do not fall victim to their prevarications.

  • Senator Coons And Co-Sponsors Introduce the PREVAIL Act

    By Kevin E. Noonan –

    Washington - Capitol #5In addition to his efforts regarding patent subject matter eligibility law (see "Senate Bill Proposed to Provide Subject Matter Eligibility Solution", co-sponsored with Senator Tillis), Senator Coons, joined by Senators Tillis, Durbin, and Hirono, introduced the ''Promoting and Respecting Economically Vital American Innovation Leadership Act'' (the ''PREVAIL Act'') last month.  This legislative effort is directed towards amending portions of the Leahy-Smith America Invents Act, particularly with regard to the Patent Trial and Appeal Board and post grant review (PGR) and inter partes review (IPR) provisions of the Act.

    The bill recites in Introductory Section 2 "Findings" that "United States inventors have made discoveries leading to patient cures, positive changes to the standard of living for all people in the United States, and improvements to the agricultural, telecommunications, and electronics industries, among others."  It also raises the specter of Chinese competition, stating that "the People's Republic of China is leveraging and exploiting intellectual property as a critical tool within its national strategies for emerging technologies" (Section 2:7(A)) and "the United States has failed to similarly recognize the importance of intellectual property in securing its own national security, economic interests, and technological competitiveness" (Section 2:7(B)).  Section 2:(8) raises national security concerns that "the United States needs reliable and effective patent protections to safeguard national security interests and maintain its position as the most innovative country in the world."

    The more frankly political aims of the bill are stated in Section 2:(10) regarding "unintended consequences" of the Leahy-Smith America Invents Act in 2011, "including the strategic filing of post-grant review proceedings to depress stock prices and extort settlements, the filing of repetitive petitions for inter partes and post-grant reviews that have the effect of harassing patent owners, and the unnecessary duplication of work by the district courts of the United States and the Patent Trial and Appeal Board, all of which drive down investment in innovation and frustrate the purpose of those patent reform laws."  Finally, in Section 2:(11) the bill places the blame for current circumstances on "[e]fforts by Congress to reform the patent system without careful scrutiny [that] create a serious risk of making it more costly and difficult for innovators to protect their patents from infringement, there-by— (A) disincentivizing United States companies from innovating; and (B) weakening the economy of the United States."

    Turning to the substantive provisions of the bill, Section 3 concerns amendments to the PTAB provisions of the AIA.  The first amendment in this section of the bill concerns a Code of Conduct for PTAB members, to be established by the Director (Section 3(b)).  The bill directs that this Code be patterned after the Code of Conduct for United States Judges to the extent these provisions can be applied to PTAB judges.  Other provisions include the composition of PTAB panels, which should include at least three members designated by the Director (Section 3(b)(3)) and towards which any "officer who has supervisory authority or disciplinary authority with respect to an administrative patent judge" shall (mandatory) "refrain from communications with the panel that direct or otherwise influence any merits decision of the panel."  The bill also precludes any member of a PTAB panel involved in a decision to institute an IPR or PGR from being eligible to hear the review.

    Section 4 is specifically directed to amendments in IPR proceedings.  Section 311 of 35 U.S.C. is amended to define "charged with infringement" to mean "a real and substantial controversy regarding infringement of a patent exists such that the person would have standing to bring a declaratory judgment action in Federal court," thus restricting the scope of individuals having standing to bring IPR petitions, being a person "sued for infringement of the patent" or "charged with infringement of the patent" (Section 4(a)).  The definition of a "real party in interest" is expanded to include "a person that, directly or through an affiliate, subsidiary, or proxy, makes a financial contribution to the preparation for, or conduct during, an inter partes review on behalf of a petitioner shall be considered a real party in interest of that petitioner."  Section 314 is amended, adding a 45-day limitation to Director consideration of "any request for reconsideration, rehearing, or review," except that the Director can extend that period for an additional 30 days "for good cause shown" (Section 4(b)).

    Perhaps one of the more significant proposed changes (Section 4(c)) is directed towards eliminating repetitive proceedings by amending Section 315 of the statute, wherein the time period limitation shall raise a rebuttable presumption against joinder and by restricting validity challenges to a "single forum," i.e., once an IPR is instituted a "petitioner, a real party in interest, or a privy of the petitioner" can neither file or maintain an action in district court nor the ITC under Section 337 of the Tariff Act, or assert "a claim, counterclaim, or affirmative defense . . . on any ground defined in Section 311(b)" and the Director may reject an IPR petition should the petitioner have filed or maintained such a claim or counterclaim in these alternative fora.  The capacity for the Director to grant joinder is maintained, but while the Director may permit a party that rebuts the presumption against joinder under Section 315 as amended such a party would be precluded from serving as lead petitioner or maintain the IPR should a lead petitioner that satisfied the time limitations fail to remain in the IPR (Section 4(d)).

    The Director is directed to reject petitions asserting prior art submitted to the Office in other remedial proceedings such as reissue (Section 4(e)).  The scope of estoppel (Section 4(f)) against a petitioner with regard to petitioning for subsequent IPRs is expanded to include any ground of invalidity that the petitioner raised or could have raised, unless the petitioner, after filing a first petition, is charged with infringement of additional claims of the patent, or the subsequent petition is directed to such additional claims that are the subject of accused infringement, and the petition is accompanied by a request for joinder to the earlier-filed IPR (and overcomes the presumption of untimeliness).  These estoppel provisions also apply to any party or real party in interest or in privity therewith that is joined to an IPR and arise upon filing instead of after Final Written Decision.

    The amendments also include a prohibition against an IPR of a patent claim for which a district court or the ITC has entered a final judgment on validity based on any ground as described in Section 311(b).  Conforming amendments to Section 316(a) of the statute set forth provisions for the conduct of IPRs, including ones for discovery, depositions, evidence for identifying the real party of interest, allowing the patent owner to move to amend the claims and revise such claims after the PTAB provides "guidance" on such amendments, and "ensuring that any information submitted by the patent owner in support of any amendment entered under subsection (d), and any guidance issued by the Patent Trial and Appeal Board, is made available to the public as part of the prosecution history of the patent."  Amendments to Section 316(e) specify evidentiary standards, including ones regarding the presumption of validity (i.e., which is specified to apply to challenged claims), burden of proof (consistent with the presumption, raised to the clear and convincing evidence standard), and Section 316(f) amendments that establish a statutory basis for claim construction following the Philips factors used in patent litigation before a district court (including having the PTAB "consider" any claim construction made in a civil action).

    Section 317(a) is amended to strike the sentence that reads "If the inter partes review is terminated with respect to a petitioner under this section, no estoppel under section 315(e) shall attach to the petitioner, or to the real party in interest or privy of the petitioner, on the basis of that petitioner's institution of that inter partes review."  Amendments regarding timing of issuing trial certificated and decisions on rehearing are also included.

    Another significant amendment is set forth in Section 4(f) on Director review.  Regarding "re-hearing, reconsideration, or review of a decision by the Patent Trial and Appeal Board" by the Director any decision shall be issued in a separate written opinion that is part of the public record and sets forth the reasoning of the re-hearing, reconsideration, or review, which will be considered a Final Written Decision and subject to the appellate review proceedings under Section 141.  Decisions on remand from appellate review shall be rendered no later than 120 days from the date a mandate issues, which deadline can be extended by not more than 60 days by the Director for good cause shown.

    Section 5 of the bill applies many of these same amendments to the portion of the statute governing post-grant review proceedings (35 U.S.C. § 321 et seq.), particularly with regard to single forum, multiple proceedings, estoppel, joinder, presumption of validity, burdens of proof, claim construction, settlement, conduct of post-grant review proceedings, and review by the Director.

    Section 6 of the bill is concerned with re-examination under 35 U.S.C. § 302 et seq.  Significant amendments include that that reexamination request must identify all real parties in interest (Section 6(a)) and is barred "if the request for reexamination is filed more than 1 year after the date on which the requester or a real party in interest or a privy of the requester is served with a complaint alleging infringement of the patent," which is to be applied to any person "that directly or through an affiliate, subsidiary, or proxy makes a financial contribution to the preparation for, or conduct during, an ex parte re-examination on behalf of a requester" (Section 6(b), amending 35 U.S.C. § 303 by adding new subsection 303(d)).  The Director is mandated to reject any re-examination request that relies on "prior art or an argument that is the same or substantially the same as prior art or an argument that previously was presented to the Office" (added § 303(e)(1)) and may reject any request that, at the Director's determination, "has used a prior Office decision as a guide to correct or bolster a previous deficient request filed under this chapter or a previous deficient petition filed under chapter 31 [inter partes review] or 32 [post-grant review]."  Section 304 is amended to take into consideration the Director's ability to reject a re-examination request under §§ 303(d) or 303(e).

    Section 7 mandates elimination of diversion of USPTO fees, a frequent temptation for Congress to obtain monies for other governmental activities and largess.  This prohibition would apply to fees for service by PTO (Section 7(a)) and the Innovation Promotion Fund (Section 7(b)), and such fees are to be used to defray expenses of USPTO activities until such activities are carried out (Section 7(c)).  Such fees include patent fees (Section 7(b)(2)(A)) and trademark fees (Section 7(b)(2)(B)).  The bill establishes in the U.S. Treasury a revolving fund (the "United States Patent and Trademark Office Innovation Promotion Fund") for these purposes and provide a substitution for the  Patent and Trademark Fee Reserve Fund, which will be terminated (Section 7(b)).

    Finally, Section 8 (institutions of higher education) and Section 9 (U.S. Small Businesses) contain provisions for providing financial benefits as a microentity (universities) and free on-line availability of public research facility materials (small businesses).

    Many of the provisions of the PREVAIL act are reminiscent if not identical to those in the STRONGER Act which was introduced in an earlier Congresses in 2015, 2016, 2017, 2018, and 2019 (see "The STRONGER Patents Act of 2019: Weakening Post-Grant Proceedings"), although some seem to have been left out (such as provisions for overturning the Supreme Court's eBay decision regarding standards for injunctive relief).  This bill apparently has as much chance for passage as the STRONGER Act did; however, there may be other considerations at play.  As suggested by Scott McKeown (see "New PTAB Bill to Drive 101 Compromise?"), one possibility may be that this bill and the subject matter eligibility bill also introduced by Senators Coons and Tillis (see "Senate Bill Proposed to Provide Subject Matter Eligibility Solution") may be part of a broader legislative strategy.  As posited by Mr. McKeown, the PREVAIL Act is something of an anti-tech "stick" that might be used to obtain concessions from the high-tech industry on its subject matter eligibility position (which has been that that industry segment is quite content with the status quo).  This analysis brings to mind an episode of "The West Wing," ("Hartsfield Landing," Season 3, Episode 15, first aired February 27, 2002) where in the context of chess matches with his staff President Bartlett illustrates the need to "see the whole board" in a geopolitical chess match with China over Taiwan, caused by a U.S. offer to supply advanced weapons systems that Taiwan couldn't afford and the U.S. could not risk falling into mainland Chinese hands.  It is unclear whether Mr. McKeown is onto something concerning the political machinations between pharma/biotech and the high-tech industry with regard to patent reform.  But to many, anything that makes more likely some solution to the current subject matter eligibility "chaos" occasioned by recent Supreme Court jurisprudence would be welcome (and for political junkies, if Mr. McKeown is right, perhaps somewhat entertaining to boot).

  • In re Couvaras (Fed. Cir. 2023)

    By Kevin E. Noonan –

    Federal Circuit SealThe Federal Circuit provided a reminder last week that merely identifying an unappreciated consequence of a prior art method cannot confer non-obviousness on practice of methods that did not acknowledge that consequence, in In re Couvaras.

    The appeal arose from a Patent Trial and Appeal Board affirming an Examiner's rejection that the claims of U.S. Application No. 15/131,442 were obvious.  The claims were directed to a method for increasing prostacyclin release in systemic blood vessels when administered to a human having essential hypertension; the consequence was improved vasodilation.  How this beneficial outcome was achieved as claimed was by co-administration of two art-recognized antihypertensive agents:  a GABA-a agonist and an Angiotensin II Receptor Blocker ("ARB").  Claim 11 was included in the opinion as representative:

    11.  A method of increasing prostacyclin release in systemic blood vessels of a human individual with essential hypertension to improve vasodilation, the method comprising the steps of:
        providing a human individual expressing GABA-a receptors in systemic blood vessels due to essential hypertension;
        providing a composition of a dosage of a GABA-a agonist and a dosage of an ARB combined into a deliverable form, the ARB being an Angiotensin II, type 1 receptor antagonist;
        delivering the composition to the human individual's circulatory system by co-administering the dosage of a GABA-a agonist and the dosage of the ARB to the human individual orally or via IV;
        synergistically promoting increased release of prostacyclin by blockading angiotensin II in the human individual through the action of the dosage of the ARB to reduce GABA-a receptor inhibition due to angiotensin II presence during a period of time, and
        activating the uninhibited GABA-a receptors through the action of the GABA-a agonist during the period of time; and
        relaxing smooth muscle of the systemic blood vessels as a result of increased prostacyclin release.

    (wherein the underlined limitations illustrate the distinctions relied upon by the patent applicant).

    It was not disputed (before the Board or the Federal Circuit) that the two co-administered compounds were known in the art as treatment for essential hypertension ("for many, many decades"), supported if not compelled by the Examiner's citation of 10 prior art references disclosing such use.  The Examiner rejected all pending claims based on his determination that the claimed results of the recited method ("increased prostacyclin release, activation of uninhibited GABA-a receptors, and smooth muscle relaxation") "naturally flowed from the claimed administration of the known antihypertensive agents."

    The Board agreed and affirmed the rejection, unpersuaded by Applicant's argument that prostacyclin release was an unexpected result of the claimed methods.  The Board also held that the claimed distinction was an inherent result from co-administration of the two known antihypertensive agents.

    The Federal Circuit (not surprisingly) affirmed, in an opinion by Judge Lourie joined by Judge Dyk and Stoll.  The opinion addresses three Appellant arguments:  first, that the Board erred in affirming that the skilled worker would have had a motivation to combine the asserted prior art (and a reasonable expectation of success in doing so); second, that the claimed method of action would have been unexpected and that the Board improperly discounted the resulting patentable weight this fact was entitled to; and third, that prostacyclin production as a consequence of co-administration should have been weighed under the objective indicia rubric of Graham v. John Deere (and considered to overcome the asserted prima facie obviousness determination by the Examiner).

    Applicant's first argument failed to persuade the panel that the Board erred on the principle that "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose," citing In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).  In addition, the Board relied on a prior art reference that taught "the use of ARBs 'in combination with other classes of antihypertensive agents to lower blood pressure,' but also that various guidelines 'acknowledge the need for multiple drug therapy in many patients to adequately lower blood pressure.'"  The specificity of the motivation to combine arising from this reference satisfied the requirement, according to the opinion (and Applicant's arguments regarding whether the skilled worker would have had a reasonable expectation of success were waived in the Court's view because they had not been properly asserted or preserved below).

    Regarding the second argument, that the Board had improperly "downgraded" the weight give the prostacyclin-releasing effect of co-administration because it was inherent, the panel rejected Applicant's reliance on Honeywell International Inc. v. Mexichem Amanco Holdings S.A., 865 F.3d 1348, 1355 (Fed. Cir. 2017), because in that case the Federal Circuit had held "unexpected properties may cause what may appear to be an obvious composition to be nonobvious" (emphasis in opinion) which was not the same as Applicant's assertion here that "unexpected mechanisms of action must be found to make the known use of known compounds nonobvious."  In the panel's view the mechanism of action "naturally flows" from co-administration and the "ultimate result" (decreasing blood pressure) was the same.  Citing In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012) and In re Huai-Hung Kao, 639 F.3d 1057, 1070–71 (Fed. Cir. 2011), the opinion states as settled law that "[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent."  Consequently, the panel held that the Board had properly determined that "the recitation of various mechanistic steps in the pending claims [were] insufficient to overcome the prima facie obviousness of the claimed methods."

    Finally, the Federal Circuit rejected Applicant's arguments relating to the objective indicia, inter alia, because they did not show any unexpected benefits, such as "better control of hypertension, less toxicity to patients, or the ability to use surprisingly low dosages."  The panel also agreed that the evidence presented by Applicant regarding any of the other objective indicia (teaching away, failure of others, and the length of time between teaching co-administration of antihypertensive compounds in the art and the claimed invention) did not support overcoming the asserted prima facie obviousness case raised by the Examiner and affirmed by the Board.

    In re Couvaras (Fed. Cir. 2023)
    Panel: Circuit Judges Lourie, Dyk, and Stoll
    Opinion by Circuit Judge Lourie

  • Senators Tillis and Coons Once More Attempt to Fix Patent Eligibility

    By Michael Borella —

    Washington - Capitol #5Patent eligibility is broken.

    The only semi-cogent arguments that I have ever heard in support of the status quo is that the U.S. Patent and Trademark Office issues too many broad, vague patents, and that 35 U.S.C. § 101 affords defendants a low-cost way of quickly invalidating bad-faith patent assertions on the pleadings.  The rest boil down to "I don't like patents."

    While the former point has a grain of truth, in that the USPTO does grant patents that it should not from time to time, the law's current remedy based on Alice v. CLS Bank Int'l has the nuance of a high-energy shrapnel bomb.  Collateral damage has already impacted plenty of narrowly-scoped and useful inventions.  And the latter is equivalent to saying "I'm fine with bad laws being on the books as long as they help me."

    To make an admittedly stark analogy, the Department of Justice has estimated that about 75% of violent crime in the U.S. is perpetrated by men.[1]  If a societal goal is to reduce violent crime, then incarcerating all men would cause the violent crime rate to drop dramatically and would eliminate the difficulty and cost of determining whether suspects were guilty or innocent through investigation, arrest, pleadings, trial, and so on.  Such a proposal is outrageous.  But not granting or invalidating certain types of patent matters on arbitrary grounds and with conclusory reasoning should generate at least a modicum of outrage.

    In any event, both of the arguments above can be addressed in a more equitable and logical fashion with narrowly-tailored legislation.  Enter Senators Tillis and Coons.

    This is the third time that one or both of the senators have proposed or introduced a bill to revise § 101.  The first two attempts garnered discussion but little tangible progress.  At this point, the patent community is feeling like Charlie Brown repeatedly getting the football yanked away.

    Nonetheless, such proposals are worth of consideration, so let's take a look at the bipartisan Patent Eligibility Restoration Act of 2023.

    First off, like previous proposals, the bill initially addresses definitions in § 100.  Notably:

    (k) The term 'useful' means, with respect to an invention or discovery, that the invention or discovery has a specific and practical utility from the perspective of a person of ordinary skill in the art to which the invention or discovery pertains.

    Cool.  A POSITA gets to decide what has "specific and practical utility".  Keeping that in mind, here is the meaty part (and I will focus on the impact to engineering and computing innovations, as we have already published an analysis from the life sciences perspective):

    § 101. Patent eligibility

    (a) IN GENERAL.—Whoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefor, subject only to the exclusions in subsection (b) and to the further conditions and requirements of this title.

    (b) ELIGIBILITY EXCLUSIONS.—

    (1) IN GENERAL.—Subject to paragraph (2), a person may not obtain a patent for any of the following, if claimed as such:

    (A) A mathematical formula that is not part of a claimed invention in a category described in subsection (a).

    (B)    (i) Subject to clause (ii), a process that is substantially economic, financial, business, social, cultural, or artistic, even though not less than 1 step in the process refers to a machine or manufacture.

    (ii) The process described in clause (i) shall not be excluded from eligibility for a patent if the process cannot practically be performed without the use of a machine or manufacture.

    (C) A process that—

    (i) is a mental process performed solely in the human mind; or

    (ii) occurs in nature wholly independent of, and prior to, any human activity.

    (D) An unmodified human gene, as that gene exists in the human body.

    (E) An unmodified natural material, as that material exists in nature.

    (2) CONDITIONS.—For the purposes of subparagraphs (D) and (E) of paragraph (1), a human gene or natural material shall not be considered to be unmodified if the gene or material, as applicable, is—

    (A) isolated, purified, enriched, or otherwise altered by human activity; or

    (B) otherwise employed in a useful invention or discovery.

    (c) ELIGIBILITY.—

    (1) IN GENERAL.—In determining whether, under this section, a claimed invention is eligible for a patent, eligibility shall be determined—

    (A) by considering the claimed invention as a whole and without discounting or disregarding any claim element; and

    (B) without regard to—

    (i) the manner in which the claimed invention was made;

    (ii) whether a claim element is known, conventional, routine, or naturally occurring;

    (iii) the state of the applicable art, as of the date on which the claimed invention is invented; or

    (iv) any other consideration in section 102, 103, or 112.

    (2) INFRINGEMENT ACTION.—

    (A) IN GENERAL.—In an action brought for infringement under this title, the court, at any time, may determine whether an invention or discovery that is a subject of the action is eligible for a patent under this section, including on motion of a party when there are no genuine issues of material fact.

    (B) LIMITED DISCOVERY.—With respect to a determination described in subparagraph (A), the court may consider limited discovery relevant only to the eligibility described in that subparagraph before ruling on a motion described in that subparagraph.

    Now let's break this down into a few bite-sized chunks.

    Part (b)(1)(A):  This provision seems to be stating that inclusion of or reference to mathematical formulas in claimed inventions does not impact eligibility, but a claim to a formula itself and in isolation would be ineligible.  Under that assumption, this language seems fine and would get us out of the current situation where the Supreme Court tells us in Alice that the claim of Diamond vs. Diehr is still eligible but gives us a test vague enough to invalidate that claim.

    Part (b)(1)(B):  Here we have some problems.  Specifically, what is "a process that is substantially economic, financial, business, social, cultural, or artistic?"  How "substantially" does the process need to involve these excluded categories?  And does this provision only apply to process claims and not machine (e.g., device, system) or article of manufacture claims (e.g., computer readable media)?  As an example of the problems we can expect from use of vague terms like "artistic", what if my invention is an algorithm used by a digital camera to sharpen images?  The process might be technical but the outcome can be viewed as artistic.  Nonetheless, section (ii) seems to provide an out so long as the inventions can only be practically performed by computer.  This would positively impact patentees in the artificial intelligence and machine learning space where inventions often require training with large data sets.

    Part (b)(1)(C):  This provision seems to shut the door on the mental process exception, one that is remarkably problematic in practice, not to mention completely illogical.  In short, some USPTO examiners and judges have taken the position that anything that could be done in theory by a human with the help of a computer or other tools, even if doing so would take millions of years, is an ineligible mental process.  If the legislation would make it such that a computer-implemented process is by definition not a mental process, then that is progress.

    Part (c)(1):  This language is similar to that of Senator Tillis's proposed § 101 fix from last year, in that it is saying that "you need to consider the claim as a whole, and we really mean it".  Additionally, it reverses the ambiguity introduced when Alice and Mayo v. Prometheus misappropriated notions of §§ 102, 103, and 112 and shoved them into the § 101 inquiry.

    Part (c)(2):  And here we have a bone for fans of the quick kill.  A court can, at any time and based on its own discretion, allow § 101 invalidity arguments with limited discovery.  Hopefully that is enough to keep some stakeholders happy.

    So is this legislation perfect?  No.  There are still some ambiguities, mostly surrounding what we commonly refer to a business method inventions or hybrid business / technical inventions.  If litigated or left to USPTO interpretation, it is likely that we would end up right back where we are with the overly broad exception for "methods of organizing human activity" being used as a cudgel against claims with non-business merit.

    But as they say, perfection is the enemy of good enough.  So it may be best to hold our noses and support this legislation, as it is does seem to be an incremental improvement over the current eligibility mess.

    [1] https://bjs.ojp.gov/content/pub/pdf/cvus0702.pdf, table 38.

  • Webinar on Clinical Trial Dilemma

    J A KempJ A Kemp will be offering a webinar entitled "The Clinical Trial Dilemma: Update on the EPO Position" on June 27, 2023 at 16:00 pm (BST).  Amanda Simons and Tanja Preissner of J A Kemp will provide an update on recent developments in EPO case law in relation to clinical trials, and their impact on the validity of patent claims, and discuss possible strategies for filing patent applications in light of a planned or existing clinical trial.  The webinar will address the following topics:

    • Is a disclosure of a proposed clinical trial relevant to novelty and inventive step?
    • Filing strategies for applications relating to clinical trials.
    • Is a clinical trial confidential for patent purposes?

    There is no registration fee for this webinar.  However, those interested in registering for the webinar, should do so here.

  • IPO Webinar on Use of Patent Agents

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Effective Use of Patent Agents for In-House and Outside Counsel — Part 1," on June 29, 2023 from 1:00 pm to 2:00 pm (ET).  Karen Cochran of Shell USA, Inc.; Carey Jordan of Vorys; Kelly McGlashen of Robert Bosch LLC; Valerie Moore of Kilpatrick Townsend; and Angela Parsons of Fish & Richardson will address the benefits of having a patent agent program including how patent agents can support legal/business work outside of preparation and prosecution.  The panel will also discuss unique benefits to staffing with patent agents, including contributing to your organization's diversity.

    There is no registration fee for the webinar.  However, those interested in attending the webinar should register here.

  • Senate Bill Proposed to Provide Subject Matter Eligibility Solution

    By Kevin E. Noonan –

    Washington - Capitol #6Through the vicissitudes of the continuing chaos of subject matter eligibility, Senators Coons and Tillis have been steadfast in attempting to provide a legislative solution.  They chaired a series of Congressional hearings in 2019 (see "Senators Tillis and Coons Release Statement on Recent Patent Reform Hearings"), have asked the Patent and Trademark Office for its statistics and other information on patent eligibility (see "Senators Request USPTO to Provide Information on Subject Matter Eligibility"), and have proposed several bills providing various iterations of these solutions (see "Senator Tillis Proposes Patent Eligibility Reform (Again)").  Today, they co-sponsored the latest attempt, entitled "The Patent Eligibility Restoration Act of 2023."

    The bill contains a preamble of "Findings" that amount to a litany of all the reasons why Supreme Court decisions and how they have been implemented by district courts, the Federal Circuit, and the Patent and Trademark Office have "led to extensive confusion and a lack of consistency" regarding eligibility.  This portion of the bill reads as a justification (to the Senators' colleagues, the judiciary, and the public) of the need for subject matter eligibility reform by Congress; it cites for example an "increasing number of inventions ineligible for patent protection" as a consequence of creation of the "judicial exceptions" by the Supreme Court and other courts.  It also asserts that "[m]any judges of the United States Court of Appeals for the Federal Circuit and of various district courts of the United States have explicitly expressed the need for more guidance with respect to the meaning of section 101 of title 35, United States Code" as well as "many patent owners, and persons that engage with patent owners, complain[ing] that the interpretation of that section is extremely confusing and difficult to discern and apply with any confidence."  The cosponsors' intentions with these amendments are plainly set out, starting with the elimination of all judicial exceptions and that "any" invention or discovery in the statutory categories (process, machine, manufacture, or composition of matter) be eligible for patenting apart from explicitly recited exceptions recited in the statute.  Also recited in this Findings section is that the other statutory requirements under Section 102, 103, and 112 are not to be used to determine patent eligibility.

    The bill provides then provides specific modifications to the patent statute.  These begin with the provisions defining a "process" (Section 100), which are amended by deleting the phrase  ''includes a new use of a known process'' and inserting ''includes a use, application, or method of manufacture of a known or naturally-occurring process."  Also provided is a definition of the word "useful" to mean "with respect to an invention or discovery, that the invention or discovery has a specific and practical utility from the perspective of a person of ordinary skill in the art to which the invention or discovery pertains.''

    Section 101 is amended to abrogate the so-called "judicial exceptions" by enumerating an explicit and exclusive set of ineligible subject matter.  These exceptions include and are limited to:

    • a mathematical formula that is not part of a claimed invention in a statutory category [of process, machine, manufacture, or composition 16 of matter, or any useful improvement thereof];

    • a process that is substantially economic, financial, business, social, cultural, or artistic, even though not less than 1 step in the process refers to a machine or manufacture, but not if the process cannot be cannot practically be performed without the use of a machine or manufacture;

    • a mental process performed solely in the human mind, or that occurs in nature wholly independent of and prior to any human activity;

    • an unmodified human gene as it exists in the human body; or

    • an unmodified natural material as that material occurs in nature.

    Importantly, the term "unmodified" as it is used with regard to human genes or natural products is defined in the statute not to include embodiments that have been "isolated, purified, enriched, or otherwise altered by human activity" or "otherwise employed in a useful invention or discovery."

    The amendments to Section 101 also include a section on how eligibility is to be determined which includes:

    • 'by considering the claimed invention as a whole and without discounting or disregarding any claim element'; and

    • without regard to "the manner in which the claimed invention was made," "whether a claim element is known, conventional, routine, or naturally occurring," "the state of the applicable art, as of the date on which the claimed invention is invented," or any other considerations in the other statutory sections (specifically Section 102, 103, or 112).

    Finally, the amendments provide that in infringement actions, eligibility can be addressed by motion of a party when there are no genuine issues of material fact, and that a court can consider permitting "limited discovery" before ruling.

    As is frequently the case, introduction of the bill was accompanied by a press release, with the Senators joining in announcing their bill and the necessity for it.  In his statement, Senator Coons said:

    More than a decade after the Supreme Court waded into patent eligibility law, uncertainty remains about which areas of innovation are eligible for patent protection.  Critical technologies like medical diagnostics and artificial intelligence can be protected with patents in Europe and China, but not in the United States.  The Supreme Court has repeatedly failed to clarify the law, so Congress must act.  I'm proud to join Senator Tillis' bill that would reform patent eligibility law to bring vital clarity for inventors and innovators and ensure the United States maintains its competitive edge.  I look forward to working with all stakeholders as we move this bill in Congress to restore confidence in our patent system.

    For his part Senator Tillis's statement reads:

    I have long said that clear, strong, and predictable patent rights are imperative to enable investments in the broad array of innovative technologies that are critical to the economic and global competitiveness of the United States, and to its national security.  Unfortunately, our current Supreme Court's patent eligibility jurisprudence is undermining American innovation and allowing foreign adversaries like China to overtake us in key technology innovations.  This bipartisan legislation with Senator Coons maintains the existing statutory categories of eligible subject matter, which have worked well for over two centuries, and addresses concerns regarding inappropriate eligibility constraints by enumerating a specific but extensive list of excluded subject matter.  I look forward to continuing to work with all interested stakeholders on this important matter.  Passing patent eligibility reform remains one of my top legislative priorities during my second term.

    Also set forth in Senator Coons' official website is a statement from two former Directors of the U.S. Patent and Trademark Office, David Kappos and Andrei Iancu, now Co-Chairs of the Council for Innovation Promotion (C4IP), who said:

    C4IP applauds Senators Tillis and Coons for introducing critically important legislation to correct patentable eligibility law.  The Patent Eligibility Restoration Act of 2023 is much-needed legislation to foster the development of next-generation technologies across many innovative industries, including artificial intelligence, medical diagnostics, quantum computing, and telecommunications, to name a few.  With products in these sectors currently categorically ineligible for patent protection, the United States is losing its standing as the world's innovation leader.  By introducing this legislation, Senators Tillis and Coons are standing up for American inventors and ingenuity, and are positioning the United States to continue its leadership in these technologies of the future.

    The draft bill has two immediate impediments to passage (others will no doubt arise during the legislative process).  The first and perhaps most significant is that to the extent the Supreme Court has based its subject matter eligibility jurisprudence as an exercise in its role in limiting Congress to the constraints in the Constitution, that its power to grant patents must "promote progress," it is likely to strike down any law that abrogates its judicial exceptions as being ultra vires of the proper exercise of Article I power.  Two generations ago Giles Sutherland Rich (and P.J. Federico) were able to introduce obviousness into the statute by casting it as an enactment of Supreme Court precedent reaching back to Hotchkiss that patentability required something more than novelty.  It was the Supreme Court's variable ex post facto definitions of what that ineluctable something was (flash of genius, etc.) that had made "the only patent that is valid . . . one which [the] Court [had] not been able to get its hands on" and that provided the impetus for introducing obviousness as a statutory requirement.  But how later-Judge Rich effected this enactment was done with sufficient subtlety and obeisance to the Court's precedent that in Graham v John Deere the Supreme Court opined that Section 103 was just that, codification of the principle it had enunciated all along.  This bill lacks that subtlety and accordingly is much less likely to pass supreme judicial muster.

    The other aspect of the bill likely to face stiff political rather than judicial opposition is in the changes to patent eligibility of human genes and natural products.  It is extremely likely that some groups, particularly the American Civil Liberties Union and its allies in the Myriad case will argue that the definition of "unmodified" would permit patenting of isolated human genes and oppose the bill on that basis (as they have in other embodiments of reform bills from the Senators (see "ACLU (Predictably) Opposes Patent Subject Matter Eligibility Proposal").

    Neither of these impediments are incapable of being overcome by amending the scope of the statute, of course but their existence makes less likely from the outset that the bill will provide the solution the Senators seek.

  • Federal Circuit Special Committee Responds to Judge Newman’s Counsel’s Request for Clarification Regarding Misconduct Hearing

    By Kevin E. Noonan –

    Federal Circuit CourtroomResponsive to the letter from Judge Pauline Newman's counsel sent June 15th (see "Judge Newman Matter Continues"), the Special Committee directing the Federal Circuit's inquiry regarding Judge Newman's fitness for continued service on the Court (consisting of Chief Judge Moore, former Chief Judge Prost, and Judge Taranto) issued a per curiam response.

    The response sets forth the basis and scope of the June 1st Order which identified Judge Newman's refusal to comply with the Committee's demands, including to "undergo medical examinations, to provide medical records, and to sit for an interview with the Committee" set forth in prior Order, as in itself judicial misconduct under Rule 4(a)(5) ("Cognizable misconduct includes refusing, without good cause shown, to cooperate in the investigation of a complaint or enforcement of a decision rendered under these Rules.")   The response provides a recitation of the Committee's previous orders that parallels the history set forth in counsel's letter, with certain differences in characterization thereof.  For example, regarding their April 6th Order, the response characterizes the issue as "Judge Newman's disclosure of a confidential employment dispute matter and statements made in regard to that matter."  The April 20th Order, according to the response, was expanded to include potential misconduct related to "Judge Newman's alleged retaliatory, unprofessional, and abusive behavior towards her own and other court staff."  Not included in counsel's letter were Orders dated April 17th, May 3rd, and May 16th regarding the Committee's demands that Judge Newman provide medical records and undergo medical testing including "neurological and neuropsychological testing."

    Counsel's letter purported to ask the Committee for "clarification" regarding the status of the grounds for misconduct asserted in these various Orders, characterizing them as 1) allegations of mental or physical disability; 2) improper behavior towards staff; and 3) failure/refusal to cooperate.  The Committee's Order makes plain that:

    All the foregoing aspects of the investigation remain open and pending before the Committee.  No part of the investigation has been terminated.  In particular, the investigation into whether Judge Newman suffers from a disability that impairs her ability to perform the duties of her office remains ongoing.

    But the Committee's response also makes plain that these various grounds of complaint cannot substantively go forward without Judge Newman's cooperation (or compliance) which is not forthcoming.  Accordingly the Committee has Ordered briefing by July 5th and a hearing on July 13th to address the somewhat meta (or Kafkaesque) question of whether Judge Newman's refusal to comply with these Orders is itself judicial misconduct.  This question unavoidably presents the due process and Constitutional issues raised in Judge Newman's complaint to the D.C. District Court (see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit") but which (apparently) will not be addressed in the upcoming briefing and hearing.  The Committee's asserted basis for this course of action is that:

    [T]he Committee's investigation into whether Judge Newman suffers from such a disability has been seriously impeded by Judge Newman's refusal to undergo neurological and neuropsychological examinations, to provide medical records, and to sit for an interview with the Committee.  Her refusal to cooperate in those respects impairs the ability of the Committee to gather sufficient information to come to a definitive conclusion and recommendation for the Judicial Council on the disability issue.

    The consequences to Judge Newman are clearly laid out in the response, wherein the Committee asserts its rationale that "it would be most efficient for the Committee to focus immediate proceedings on a more discrete issue on which the Committee could likely reach a conclusion and make a final recommendation to the Judicial Council despite Judge Newman's lack of cooperation," i.e. a finding of judicial misconduct without needing to establish the purported prerequisites of mental, psychological, or physical disability that was the presumed basis for the Special Committee's actions in the first place.

    The response also denies Judge Newman's counsel's request that the hearing be open to the public.  The reason for this decision is that traditionally such inquiries on judicial fitness are kept confidential under the Judicial Conduct and Disability Act of 1980 and by the Rules for Judicial-Conduct and Judicial-Disability Proceedings, according to the Committee.  This creates a "strong presumption" for the Committee that the proceedings should remain confidential.  As a practical matter, the response asserts that confidentiality "facilitates the investigative process" and its beneficial effects in this regard "ha[ve] been almost universally accepted," citing First Amendment Coalition v. Judicial Inquiry & Review Bd., 784 F.2d 467, 475 (3d Cir. 1986).  In particular, despite there having been "a great deal about the current proceedings" that have been open to the public the Committee "has taken particular care to ensure that publicly released material does not identify witnesses or confidential details of witness statements and that the public releases would not compromise the investigative process."  Opening the hearing to the public would pose "grave risk[s]" of "inadvertent" disclosure of such information in the Committee's view.  The response also contends that there is no prejudice to Judge Newman by maintaining this confidentiality because "all affidavit and deposition transcripts" have been turned over to the Judge's counsel (thus making their existence public knowledge).  Because this evidence has provided the basis for the various Orders by the Special Committee, and whether Judge Newman's non-compliance therewith constitutes judicial misconduct raises the possibility that argument on this points might result in disclosure of at least some of this evidence, which the Committee does not want to happen.  And in attempts to prevent such disclosure the Committee asserts their fears that witnesses will "censor themselves in real time" to prevent disclosure.

    The response also provides the Committee's rebuttal to the case law cited by Judge Newman's counsel.  Waller v. Georgia is inapposite, the response asserts, because that was a criminal case, and thus precluded from being held in private based on a defendant's Sixth Amendment right to a public trial.  The response also contradicts Judge Newman's counsel's argument that the hearing will be based on the paper record, because inter alia "the entire record has not been made public" (although they have been provided to counsel).

    Nevertheless, the Committee "will consider" releasing a transcript redacted as to witness identities and other confidential material in due course after the hearing is held.  This would permit "some public transparency" and "allow a more considered approach to redacting [confidential] material" than could be achieved at a live hearing, while at the same time it would "not hamper the efficiency of the Committee's investigation by impeding the flow of the argument itself."

    Briefing will be submitted by July 5th and a hearing transcript sometime thereafter (although it is unlikely that there will be publication of the recorded hearing in view of the Committee's discussion in its response).

  • Judge Newman Matter Continues

    By Kevin E. Noonan –

    Federal Circuit CourtroomThe Federal Circuit's Special Committee released two documents relevant to their continuing assessment of Judge Pauline Newman's fitness for the bench today, neither of which can be considered comforting to the patent community or those concerned about the Judge or the Court.

    The first is a letter from Judge Newman's counsel in the action brought by the Judge's complaint filed in D.C. District Court last month.  Counsel's letter was sent "in response to the Special Committee's Orders of June 1, 2023" that the Committee's investigation is not directed to the substantive issues initially raised but is now focused on whether the Judge's "refusal to cooperate" with the investigation is itself misconduct.  (Those familiar with the complaint will realize that the refusal was with the manner in which the investigation was to be performed and not a blanket refusal to cooperate.)

    The letter is appropriately deferential and respectful while at the same time managing to set forth the expanding scope of the investigation from its initiation.  These include the April 6th Order, expanding the investigation to include Judge Newman's alleged (mis)conduct related to an "employment dispute" in her chambers.  This was followed, on April 13th, by an Order that included Judge Newman's alleged "failure to cooperate" by refusing to accept service of Orders issued under Rule 15(a)91)(b).  Then on April 20th, the letter asserts that the scope of the investigation was expanded again to include "retaliatory statements and conduct toward and about" a staff member in the Judge's chambers, the Judge's refusal to allow one of her clerks to be reassigned to a different judge and "requiring the clerk to 'stay or resign,'" and the Judge's alleged conduct towards the IT department.  Lastly, the letter describes the Order of May 26th that was directed to Judge Newman's alleged refusal to cooperate with "ordered neurological and neuropsychological testing, to produce certain medical records, and to meet with the Committee for a recorded interview."  The letter summarizes the categories of allegations in the various letters to be 1) allegations of mental or physical disability; 2) improper behavior towards staff; and 3) failure/refusal to cooperate.

    Turning to the Special Committee's June 1st Order, the letter states that the Committee decided it will not pursue the first category of allegations (due to the impracticalities occasioned by the Judge's refusal to cooperate) but would focus its inquiries on the third category.  The letter requests the Committee for "formal clarification" of its intentions regarding the second category, improper behavior towards Court staff, "out of an abundance of caution and to protect Judge Newman's rights."  The letter also asks the Committee to clarify whether it is continuing its investigation into the Judge's alleged failure to cooperate with the Rule 15(a)(1)(b) orders and if the current status of these allegations is also in abeyance.

    The final request in the letter is for any oral argument on the matter be made public, i.e., that the public be allowed to attend the hearing scheduled for 2:00 pm on July 13th.  One basis for the request is the Committee's statement that there are no fact witnesses necessary and the argument will be based on the "paper record" and legal argument.  Insofar as all the factual evidence has been disclosed to the public, counsel contends that there is "no weighty reason" for the hearings to be behind closed doors.  The letter cites Supreme Court precedent to support holding the hearings in public absent reasons not present here.  There is also no danger to Judge Newman's reputation, counsel notes, because "the sum and substance of the allegations have already been released to the public," and "[p]ermitting public participation in the upcoming hearing will serve only to increase the public's confidence in Judge Newman's abilities and the disciplinary process."

    Discussion of the Court's Order will be the subject of a following post.