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

By Kevin E. Noonan --

It 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

Comments

[Kyle]

I don't see the problem with this decision (or Amgen). Any of these "wherein effect X is obtained" claims in the pharma space are devoid of innovative value; they're either inherent (it happens whenever you administer the API) or indefinite per se (it only happens in some compositions, and we have no idea which ones, other than the one we made). MOT claims are NOT devoid of innovative value, and arguably disclose the most critical efforts the patentee has made.

It would be clearer for everyone if 112 pinned patentees closer to their disclosure, and DOE could mop up any near misses as appropriate.