By Kevin E. Noonan –

The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. § 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v. Sanofi.  This has not surprisingly generated a great deal of interest and amicus briefing.  While some of these briefs, for both Petitioners (see "Patent Law Academics File Amicus Brief in Amgen v. Sanofi"; "AbbVie Files Amicus Brief in Amgen v. Sanofi"; "GlaxoSmithKline Files Amicus Brief in Amgen v. Sanofi") and Respondents (see "Esteemed Scientists File Amicus Brief in Amgen v. Sanofi on Respondents' Behalf"; "Another Group of Law Professors File Amicus Brief in Amgen v. Sanofi"; "U.S. Government Files Amicus Brief in Amgen v. Sanofi") have been the subject of earlier posts prior to oral argument last month, in the interest of completeness and because there were interesting positions taken and arguments raised in the remaining briefs, a more succinct but not cursory review of these briefs is warranted.  Amicus briefs in support of the Petitioner are the subject of this post.

Amicus briefs in support of Petitioner

These briefs share many arguments in common, which is due noting but not belaboring.  These include that broad patent protection is necessary for innovation in biotech/pharma; the Federal Circuit's "full scope" test is unduly burdensome and will impede innovation in particular by on small companies and "start-ups" that are prevalent in biotechnology and pharma; and that the Supreme Court's decision in Materials Separation v. Hyde is the proper test for enablement.

The amicus brief filed by Fynder Group d/b/a Nature's Find (a small company that "produces foods from a high-protein fungi-based biomass material grown by a novel fermentation process"; novel food producer) argued that broad patent protection is necessary to support innovation and consistent with the constitution, the Patent Act, and prior precedent ("broad patent protection for pioneering inventions encourages further innovation and accelerates follow-on research and development").  The brief cited "Alexander Graham Bell's telephone, Samuel Morse's telegraph, Robert Noyce's monolithic integrated circuit chip, and Herbert Boyer and Stanley Cohen's recombinant-DNA technology" regarding such broadly claimed innovation.  The Federal Circuit's "full scope" test is characterized as being unduly burdensome and will impede innovation because the test requires innovators to "devote substantial time and resources to produce routine examples premised on their invention—merely to satisfy the Federal Circuit's concern about the "time and effort" needed to "reach the full scope of the claimed embodiments" which "will impede further innovation and will delay the disclosure of key technological improvements that are critically needed in the sustainability space."  And the alternative (trade secret protection) may impede innovation through non-disclosure.

A brief by Instil Bio Inc. (a self-described "clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte ('TIL') therapies for treating cancer patients," specifically "for the treatment of lung cancer, ovarian cancer, and kidney cancer") argued that companies like theirs are particularly vulnerable to the consequences of the Federal Circuit's decision, because as an early-stage company they rely on investors and not "substantial revenues from existing products" (they have none on the market at present).  The brief also recites three benefits of genus claims (also found in other amicus briefs), of patent protection for innovators, incentives for competitors to "design around," and reducing incentives for innovators to rely on trade secret protection.  This brief is also one of several that include policy arguments made by other small company amici regarding economic burdens on providing the additional disclosure they believe the Federal Circuit's standard requires.  The brief also sets out a Catch-22 dichotomy:

The full-scope enablement requirement discourages innovation by creating an obstacle to meaningful patent protection.  This is especially a problem for clinical-stage pharmaceutical companies that lack the revenues of larger, more mature, pharmaceutical companies.  Unlike those more-mature companies, smaller companies must rely on outside investors to fund their research-and-development and clinical trial efforts.  Due to limited resources, smaller companies are frequently unable to perform the research necessary to identify an exhaustive number of embodiments in a claimed genus so that their patents meet the full-scope requirement.  And without robust and predictable patent protection for their products, these companies are less likely to be able to attract outside investments.  Decreased investments necessarily result in a smaller pipeline of new, life-saving therapies for patients.  Worse, a lack of robust patent protection might incentivize companies to pursue less challenging therapeutics that are less risky, but also less innovative.

To ensure adequate patent protection under the Federal Circuit's full-scope enablement requirement, biotech and pharmaceutical companies are perversely incentivized to invest in unnecessary research to identify innumerable embodiments within a claimed genus that might never be therapeutically important.

A brief from the National Association of Patent Practitioners makes a simple argument:  the Federal Circuit's "full-scope" test is unworkable, and the Court's "reasonableness" standard from Materials Separation v Hyde is the proper enablement test.  To the extent that enablement is not enough to police overbroad claims, other provisions of the Patent Act (such as 112(f), 102, and 103) can achieve the necessary scope restrictions just as well or better than enablement can.  But the consequence of Federal Circuit's recent decisions is to "leave patent practitioners guessing about how to advise client-inventors regarding the extent of disclosure required in patent applications to satisfy the court-established standards for enablement under 35 U.S.C. § 112(a)."

Where they don't incorporate the reasoning set forth in the law professors' brief (discussed previously), and while the brief voices concerns regarding biotechnology and pharmacology-directed patents, these amici believe the Federal Circuit's decisions are harmful to patent law more broadly and affect many other technologies, indeed any technology that seeks genus claims. On a practical note the brief expresses fears that infringers will attack patents by proposing a hypothetical species that would be allegedly not enabled, stating that "non-enablement of phantom species" creates a "risk of mischief" because "a patent challenger can always conjure a hypothetical species that is arguably not enabled," leading amici to contend that "[a]n enablement standard that always permits an infringer to attack an asserted patent based on hypothetical and imagined species is unworkable." Further the brief cites Tilghman v. Proctor, 102 U.S. 707, 728-29 (1880) for the precedent that "The standard for enablement should not be overly burdensome and does not require the inventor to enumerate all species, particularly when the number of species is large. Instead, a standard of reasonableness should prevail," and reminds the Court that "[i]n response to more aggressive demands for enabling disclosure, the United States patent system upholds patent claims even though the claims cover (i) unforeseen future improvements, Catalina Marketing Intern. v. Coolsavings.com, 289 F.3d 801, 810 (Fed. Cir. 2002), (ii) inoperable embodiments, Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984), or (iii) multiple species that are not fully disclosed or described, Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568 (Fed. Cir. 1997)" (these citations suffering from their origins in the Federal Circuit, whose enablement jurisprudence is in fact at issue before the Court in this case).

The Chemistry & Law Division of the American Chemical Society (whose motion for participation at oral argument the Court denied) argues that Congress has the authority over requirements for patenting, not the courts, and that the Federal Circuit's "full scope" test is not supported by Congress, which did not change the statutory enablement standard under the patent law revisions enacted in the Leahy-Smith American Invents Act.

The heart of the argument these chemists make concerning for genus claims in biotech/pharma is that:

Those working in these fields often utilize genus claims, an important feature of patent law that allows patentees to protect their inventions where competitors could otherwise evade infringement liability by making minor changes that otherwise do not depart from the heart of the claimed invention.

Inventions in these arts require a robust and predictable patent system, they argument, based on "substantial investment" in research and development necessary in these fields.  The brief illustrates this argument citing the statistics recited by Jeffrey Lampken that new drugs cost $2.6 billion on average to develop, that the origins of many therapeutic drugs are with finding a biological target, and the high failure rate occasioned by finding molecules that bind or interact with the target.  As a result, finding a genus of chemical or biologic compounds is the first step in such discoveries and the genera produced thereby need reliable patent protection.  "Pioneering fields that work on the cutting edge, like pharmaceuticals and biotech, are often in a first-to-file race with millions, if not billions, of dollars on the line. Complying with an overly burdensome enablement requirement diverts resources that could have gone toward developing entirely new therapies into making and testing additional and unnecessary individual embodiments," the brief tells the Court.

The brief asks the Court to restore the conventional balance (mandated by the plain meaning of the statute) between disclosure and undue experimentation and to strike down the full scope test (which "violates the canons of statutory construction and contradicts established judicial precedent" and is "an unworkable standard"), reminding the Court of instances where the Justices had reversed the Federal Circuit for imposing "additional rigid and mandatory formulas" that are "inconsistent with [the text of the Patent Act]."  KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 407, 419, 428 (2007).

In a brief from the Alliance of US Startups and Inventors for Jobs (USIJ) and the Innovation Alliance (IA) (representing 22 startups, including AbbVie, Dolby Labs, and QUALCOMM) is the argument that some inventions can only be protected by genus claims.  This brief takes the position that Amgen's claims are fully enabled and that lowered enforceability in genus claims will result in a "significant shift" in investment.  The brief accuses the Federal Circuit of being "oblivious" to the consequences of its eligibility jurisprudence that render the patent system "a cruel hoax" (and in a footnote excoriates the Court for refusing to rehear cases in banc when important questions having "far-reaching implications well beyond the parties and the particular technology" are at issue).

The brief from Diversified Researchers and Innovators (which includes the Association of University Technology Managers (AUTM), Bavarian Nordic, Biogen, Bristol Myers Squibb, Corning, Merck, and 3M) relies on Materials Separation v. Hyde for the proper enablement standard and emphasizes the knowledge in the art in supporting the proper scope of enablement in genus claims.  The brief characterizes the Federal Circuit's rule as being a "special, atextual rule for certain types of claims – called genus claims. . . " that turns the enablement requirement into a "counting exercise" and does not account for the skilled artisan's perspective.  The brief also argues that the "full scope" standard engages in "prejudge[ment]" of these claims by recognizing them as "special" in the first place (something not in the statute), because some inventions are best claimed by functional language ("[c]laims should not start with a handicap simply because they contain functional language").  In addition, amici argue that the standard upsets the burden of proof between patentees and accused infringers by putting the burden on the patentee regarding whether the genus claim scope is supported by an enabling disclosure.

Considering the expected (negative) consequences of the Federal Circuit's test, the brief argues that the public loses when inventors/applicants delay in order to disclose further embodiments to bolster the scope of enablement; alternatively, if narrower protection is sought this stratagem "limit[s] innovation-adjacent insights that might otherwise benefit the public but are unnecessary to enable narrow patent claims."  This behavior also diverts resources that could be used for further innovation to be used to produce "redundant examples."  The brief also emphasizes the requirement that the disclosure be concise and that the "specification need not disclose what is well known in the art," citing Lindemann Maschinenfabrik v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1463 (Fed. Cir. 1984).

The brief also argues that any test about drawing lines on what is needed to satisfy the enablement standard (whatever it may be) must take into account the judgment of the skilled artisan, illustrating the undue experimentation standard in Bene v. Jeantet, 129 U.S. 683, 686 (1889), a chemical case.  "The Federal Circuit's apparent concern over unpredictability in the chemical arts in particular has led to an impossible-to-meet standard divorced from what is actually claimed," these amici assert, detecting an "overt hostility" from the Federal Circuit to use of functional language in claims.  But, amici argue, the use of functional language does not turn these claims into "single-means claims" under circumstances where such language is used "in conjunction with other language anchoring the functional attributes to members of a genus sharing certain structural attributes (emphasis in brief)."

"The Federal Circuit's approach is backwards," amici argue, stating there should be a balance in the (any) enablement standard and how it is applied:

Extremes in either direction undermine the patent system's design.  On the one hand, a disclosure that is nothing more than a research plan is unlikely to enable a yet-to-be identified species with desired properties, let alone a broad genus claim.  Such patents improperly put the burden of inventive research and experimentation on other skilled artisans, particularly when it requires solving undisclosed challenges, developing new materials or methods, or engaging in significant experimental work whose results cannot be reasonably predicted.

On the other hand, it is equally improper to "limit[]" claims "to the 'concise and exact terms' in which the specifications ordinarily describe a single example of the invention" when the patent discloses a broader inventive contribution.  Philip A. Hunt Co. v. Mallinckrodt Chem. Works, 177 F.2d 583, 585 (2d Cir. 1949).  Doing the latter allows others to easily bypass the investments and efforts of the innovator through routine and non-inventive work, and "few, if any, patents[] would have value."  Id.

By Kevin E. Noonan –

The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. § 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v. Sanofi.  This has not surprisingly generated a great deal of interest and amicus briefing.  While some of these briefs, for both Petitioners (see "Patent Law Academics File Amicus Brief in Amgen v. Sanofi"; "AbbVie Files Amicus Brief in Amgen v. Sanofi"; "GlaxoSmithKline Files Amicus Brief in Amgen v. Sanofi") and Respondents (see "Esteemed Scientists File Amicus Brief in Amgen v. Sanofi on Respondents' Behalf"; "Another Group of Law Professors File Amicus Brief in Amgen v. Sanofi"; "U.S. Government Files Amicus Brief in Amgen v. Sanofi") have been the subject of earlier posts prior to oral argument last month, in the interest of completeness and because there were interesting positions taken and arguments raised in the remaining briefs, a more succinct but not cursory review of these briefs is warranted.  Amicus briefs in support of neither Party are the subject of this post.

Amicus briefs in support of neither party

The amicus brief filed by the Intellectual Property Owners (IPO) argued that the enablement requirement "strikes a balance" on claim breadth with regard to the quid pro quo, from the perspective of the person of ordinary skill in the relevant art, and that it is important that the inquiry be based on the language of the statute.  But even with these policy goals in mind, "an applicant is not required to describe in the specification every conceivable possible and future embodiment of his invention" they argue, citing Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003), and In re Angstadt, 537 F.2d 498, 503 (C.C.P.A. 1976).

Undue experimentation is the proper standard which is a fact-intensive inquiry that is helped but not limited to the Wands factors.  However the inquiry is made, it must be applied in a predictable and fair manner that is consistent with the statutory language and longstanding precedent and should not "disrupt the settled expectations of the inventing community."  See Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002), these amici argue.  Also emphasized in their brief is the statutory presumption of validity that can only be overcome by clear and convincing evidence.  When enablement does arise as an invalidity defense in federal district court, the burden always rests on the patent challenger to prove lack of enablement by clear and convincing evidence, under Microsoft Corp. v. i4i Limited P'ship, 564 U.S. 91, 100-03 (2011).  On appellate review, courts " give due deference to the fact-finder's credibility determinations in weighing competing expert evidence," citing Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 611 (1950).  All this to say is that the IPO's brief hews the course of its neutrality regarding either party in the dispute by sticking to these eternal verities of enablement law.

The Regenexbio, IGM Biosciences, and Adapative Phage Therapeutics brief was filed by a self-described group of "small to mid-sized biotech companies currently pursuing innovation across multiple platforms," wherein Regenexbio is developing gene therapy approaches for treating "retinal, metabolic, and neurodegenerative diseases"; IGM Biosciences is developing IgM-based immunotherapies against "cancer, infectious diseases, and autoimmune and inflammatory diseases"; and Adapative Phage Therapeutics is developing bacteriophage banks that "provide evergreen, broad spectrum, and polymicrobial coverage."

Their expressly asserted reason for filing their amicus brief is a concern that the Federal Circuit's application of the enablement standard "threatens innovation in the life sciences" by "shift[ing] the burden from the challenger to the patentee to prove enablement of its issued patents" and "makes the burden of proving enablement nearly insurmountable for innovative start-ups, small-to-medium-sized companies, universities, and other innovators with limited resources."  This test will make innovators "waste precious resources by forcing them to reduce to practice not just instructive and illustrative examples but an undefined number of individual species that embody every 'corner' of the claims" they argue, which will be prejudicial to smaller companies.  Accordingly, amici address the Court seeking "reasonable disclosure standards" for enablement.

Their arguments rely on the presumption of validity:

Amici rely on the statutory presumption of validity that adheres to every patent claim after the Patent Office examines and issues the patent.  The presumption ensures that the innovative value captured by the claims will not be wiped away on a dubious or speculative case.  It does so by placing the burden of proof on the patent challenger.  And by requiring the challenger to meet that burden with clear-and-convincing evidence.

The reach-the-full-scope standard undermines that presumption.  The Federal Circuit acknowledges this when it "raises the bar" or sets "high hurdles" for particular claims.  These phrases lay the burden of proof on the patentee as soon as the court reads the claims.  Further, they show that the court is adjusting the standard of proof to be higher for the patentee (or, more properly, lower for the patent challenger) than the standard codified in the statute.

Amici also argue that the Federal Circuit's full scope test is inconsistent with constructive reduction to practice.

The Intellectual Property Law Association of Chicago (IPLAC — amici asserting that they are "the country's oldest bar association devoted exclusively to intellectual property matters") in their brief ask the Court to vacate and remand because the case can be settled by the application of the statute and stare decisis.  "Enablement is not, because it never has been and never should be—but for decisions such as the reviewed one—a matter of whether the specification has catalogued all possible embodiments of invention and taught each of them; that is not the law" they assert.  The brief relies heavily on the Karshtedt et al. law review article, and one by Jason Rantanen, The Doctrinal Structure of Patent Law's Enablement Requirement, 69 Vanderbilt L. Rev. 1679, 1680 (2019).  Both stand for the proposition that the Federal Circuit has recently "varied greatly from deciding enablement in a proper manner and muddled their own jurisprudence on the issue."  Their brief also criticizes In re Wands for leaving the definition of undue experimentation "amorphous"

The brief suggests that the Court's decision in Consol. Elec. Light Co. v. McKeesport Light Co. (Incandescent Lamp), 159 U.S. 465 (1895), sets the standard for undue experimentation (albeit it should be recognized that this takes the definition from the extreme, where >6,000 failed attempts constitute undue experimentation; while that is certainly the case it seems unlikely to be encountered routinely).  The brief distinguishes the Consol. Elec. standard with the facts below, where Respondent did not identify any antibody that would/could not be obtained using Amgen's disclosure (the "roadmap").

And In a sad or amusing footnote (depending on your prejudices) the brief sets forth a "list of areas of patent law in which this Court has overturned the Court of Appeals [that] is long, and the frequency of the overrulings notorious"; with two exceptions these cases were all decided in this century and over 80% since 2010.

Another local intellectual property law group, the New York Intellectual Property Law Association (NY IPLA) argued in its brief that the Federal Circuit has gone beyond the requirements of the plain language of the statute, which has been the standard applied by the court since In re Hyatt, 708 F.2d 712, 714 (Fed. Cir. 1983).  But as applied to biotechnology inventions amicus argues that genus claims have required "disclosure of every species in the genus," citing Wyeth v. Abbott Laboratories, 720 F.3d 1380, 1385 (2013), Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928 F.3d 1340, 1345–48 (Fed. Cir. 2019), and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149, 1160–63, 1165 (Fed. Cir. 2019), based on the court's perceptions regarding "the uncertainty of the science and the required functionality."  The NYIPLA contend that "the requirement for enablement of the full scope of the claimed invention is not supported by the plain language of the statute and is contrary to th[e] Court's holding as Minerals Separation v. Hyde, 242 U.S. 261, 270-71 (1916)."

Although the brief recognizes that there is a valid concern at issue, that an inventor not be "granted patent claim coverage that exceeds what the inventor has invented," amici predict a severe adverse impact that would arise should the Court affirm the Federal Circuit test, specifically that "could lead inventors to disclose less than what they discovered, such as a functional relationship at the heart of why the invention works.  Although the amicus appreciates the potential inequities that could be occasioned by claims like Amgen's, on balance the consequences of affirming the Federal Circuit's "full scope" test are worse due to the inherent unpredictability of the chemical and biotechnological arts, amicus argues, citing In re Fisher, 427 F.2d 833, 839 (CCPA 1970), for the principle that "the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.")  Affirming the Federal Circuit would create a situation wherein "the inventor will have no incentive (or duty) to disclose the genus, which perhaps comprises the most important part of the discovery" and "[t]he rest will be kept from the public as a trade secret," until such time that the patentee develops another species that can be subject to its own 20-year term.

While amicus argues that the Federal Circuit's decisions "goes beyond the literal requirements of the statute's plain language," the brief also gives little credence to Amgen's arguments that the Federal Circuit had only recently imposed an unnecessarily stringent enablement standard, citing earlier precedent to the same effect, including In re Fisher, 427 F.2d 833, 839 (CCPA 1970); In re Hyatt, 708 F.2d 712, 714 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1212, (Fed. Cir. 1991); In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993); and Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997).

Their solution:  requiring disclosure of a "reasonable number of species" test for prosecution before the USPTO that could be limited at trial by claim construction and having undue experimentation be a defense against infringement species by species, the patentee being protected by the clear and convincing evidence standard (to the extent it is respected by district courts and the Federal Circuit in deciding JMOL motions).

As for disposition, the brief advises that "[i]n the present case, respectfully the Court should remand the case for a determination of whether the Sanofi antibody was obtainable from the disclosure in the Amgen patents with some — but not undue — experimentation at the time of the filing of the Amgen application."

By Kevin E. Noonan –

The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v. Sanofi.  This has not surprisingly generated a great deal of interest and amicus briefing.  While some of these briefs, for both Petitioners (see "Patent Law Academics File Amicus Brief in Amgen v. Sanofi"; "AbbVie Files Amicus Brief in Amgen v. Sanofi"; "GlaxoSmithKline Files Amicus Brief in Amgen v. Sanofi") and Respondents (see "Esteemed Scientists File Amicus Brief in Amgen v. Sanofi on Respondents' Behalf"; "Another Group of Law Professors File Amicus Brief in Amgen v. Sanofi"; "U.S. Government Files Amicus Brief in Amgen v. Sanofi") have been the subject of earlier posts prior to oral argument last month, in the interest of completeness and because there were interesting positions taken and arguments raised in the remaining briefs a more succinct but not cursory review of these briefs is warranted.  The remaining amicus briefs in support of Respondents are the subject of this post.

Amicus briefs in support of Respondents

Like the amicus briefs in favor of the Petitioner, the briefs for Respondents recite some themes in common.  These include that permitting patenting of Amgen's claims (and those like them) would upset the "balance" between disclosure and claim scope to the public's detriment.  Many of the briefs discuss the history of the discovery of PCSK9, its biological activity and binding to the live LDL receptor, and how blocking this binding was effective in lowering serum cholesterol; Amgen did not invent or discover any of these relationships or uses for PCSK9 antibodies.  Several briefs mentioned 35 U.S.C. 112(f) as an alternative for functional claiming of PCSK9 antibodies, and Consolidated Electric Light Co v. McKeesport Light Co., 159 U.S. 465, 472-76 (1895), was recognized as a seminal case supporting Respondent's position.

Fresenius Kabi ISA LLC's amicus brief argues that enablement provides balance to the public, and overbroad patents disrupt the balance to the public's detriment.  The amicus is concerned about gamesmanship by which patentees will withhold disclosure in favor of broad, functionally claimed patents with staggered specific disclosures.  Citing Consolidated Electric Light Co v. McKeesport Light Co., 159 U.S. 465, 472-76 (1895) (the lead case for respondent), amicus argues that there must be a robust enablement standard, and Petitioner's standard will "negatively affect competition" because patentees will use "broad, nonspecific patent disclosures to block entire fields of innovation."

The brief recites "tensions" between innovators and the public, accusing biopharma companies of disclosing a "drug peptide sequence" and holding back "details that are required by competitors to expand on and further innovate—or even actually use the peptide—based on the work of the initial application invention" (e.g., "details on physicochemical or functional properties of the drug" such as "glycan profile, charge profile, variants profile, impurity profile, immunochemical properties, and functional activities"), which amicus calls "gam[ing] the system."  These allegations of claim shenanigans against biopharma companies extend to including claim language directed towards "therapeutically effective amount" and "excipients, adjuvants, or diluents" that may be capable of overextending patent protection inequitably (although such terminology certainly did not arise with biotechnology patents).  Functional claiming is available, if desired, under 35 U.S.C. 112(f), says this amicus, which does not have the aforementioned negative impacts on innovation because it has consistently been construed to "limit the scope of the claim to only those specific structures described in the specification," citing Traxcell Techs., LLC v. Spring Commc'ns Co., 15 F.4th 1121, 1134 (Fed. Cir. 2021).

The brief contains a litany of opportunities for patentees to "control" patent prosecution and claim scope, including continuation applications (but warns of these being abused too, stating that "[w]ithout a robust enablement standard, continuation applications can be used to continually expand the scope of exclusionary patent rights unfairly by encompassing embodiments not appreciated or even discovered at the time of filing the original application") and suggests that continuation-in-part applications provide an avenue for any such desired (and deserved) protections (which might be at least a trifle unrealistic).

Finally, the brief uniquely argues that the change to a "first inventor to file" regime under the AIA has increased the risk of loosened enablement standards, because under the "first to invent" provisions of earlier U.S. patent law broadened claims could be challenged by earlier inventors but no more.

Eli Lilly & Co., Ipsen Bioscience, Inc., and Innovent Biologics, Inc. filed an amicus brief arguing that Amgen's claims violated the "letter, logic, and purpose" of the enablement requirement because they recited purely functional results.  The patent bargain was raised as a basis for such claims to be invalid and amici accused Amgen of attempting to "control all antibody therapeutics to a particular target" which would be "indisputably detrimental to the public."  The brief provides various calculations for the number of antibodies falling within the claim scope, noting the conventional "millions" in the argument but reciting in a footnote 20⁶⁰ (1 x 10⁷⁸) based on 6 CDRs and 10 amino acids/CDR and 20 amino acids.

Amici asserted that claims are "nothing more than a hunting license" contrary to Brenner v. Manson, 383 U.S. 519, 536 (1966), and that they are also not properly considered to be genus claims because they do not disclose a structural similarity between them, just their function in blocking PCSK9 binding to LDL receptor.

And amici countered Amgen's (actually GSK's) R&D efficiency argument with the hypothetical that a troll with Amgen's claims could "dramatically undermine resource allocation efficiency" and Amgen's airplane analogy to permit claiming all airplanes using the Bernoulli principle, saying that this illustrates the "perennial preemption problem" created by functional claims.

These amici also argue that the Federal Circuit's enablement jurisprudence comports with the legal tenets under Consol. Elec. and Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245, 256-257 (1928), that the boundaries of what is claimed should be clear, and distinguish Minerals Separation v. Hyde, based on Amgen not providing anything to optimize the claimed antibodies but rather encompassing "a virtually limitless universe of other, non-conservative antibodies," stating that "[t]o hold such paltry disclosure sufficient to enable claims preempting an entire technological field would turn the patent quid pro quo on its head," citing Ex parte Sloane, 22 U.S.P.Q. 222 (P.O.B.A. Jan. 18, 1934); In re Angstadt, 537 F.2d 498, 500, 503 (C.C.P.A. 1976); and Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984).

This brief also argues regarding the use of 35 U.S.C. 112(f) for functional claims such as Amgen's, because that portion of the statute "creat[ed] a limited exception to this Court's prohibition against functional claiming," citing Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 28 (1997) (but even that doesn't save Amgen's claims amici say because "none of Amgen's claims at issue are a combination of structural and functional elements" because reciting "monoclonal antibody" does not import sufficient structure).

Turning to patent policy, amici challenge Amgen and amici supporting Amgen's position with regard to the Federal Circuit's test harming the U.S. biotechnology and pharma industries, asserting that U.S. Biotech and pharma will continue global leadership using current interpretations of enablement law, based on assertions that the sector is "booming" and accuses Amgen of trying to "upend the legal regime that has empowered that growth, innovation, and undeniable benefit to the public" by upending the full-scope standard (!) "under the guise of an 'innovation' imperative."  The brief sets forth as an example antibodies to cell surface marker CD20, wherein "four innovators developed six different antibody therapies for three different illnesses while targeting the same protein."  They warn "if Amgen's interpretation of the Patent Act were the law of the land, the first party to obtain a functional claim to all antibodies that inhibit binding to a target could prevent market entry and/or extract rents from all future innovators for twenty years."

Pfizer filed a brief supporting Respondents, again reciting the quid pro quo patent bargain and that permitting claims such as Amgen's would preempt future research.  While acknowledging that genus claims can provide important patent protection Amgen's claims went too far into purely functional claiming without sufficient structure to support them.  "[I]t is the undue breadth of the claims and the exclusive rights [Amgen] seek['s] to encompass, rather than a heightened standard for enablement of genus claims, which led the district court and the Federal Circuit to conclude that the claims are invalid as a matter of law."  The brief also calls these claims "a naked attempt to preempt future innovation and an unwarranted extension of the patent monopoly."

Another group of biotech and pharma companies, including Genentech, AstraZeneca Pharma, Bayer AG, Gilead Sciences, and Johnson & Johnson, filed an amicus brief where they argue that the Federal Circuit upholds genus claims that are supported by disclosure having appropriate scope using a flexible standard that is consistent with Supreme Court and its own precedent, including O'Reilly v. Morse, 56 U.S. 62, 120-21 (1853); Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245, 257-58 (1928); Consol. Elec. Light Co. v. McKeesport Light Co., 159 U.S. 465, 476 (1895).  But that is not the case here, they argue, and the Federal Circuit properly invalidated the claims on enablement grounds.  Their brief particularly decries arguments that merely showing how to make and use one embodiment could be enough, asserting that "[a] patentee who chooses to claim a broad functional genus, unlimited by claim language delineating the specific structures that achieve that function, will necessarily have to disclose more than a patentee claiming certain specified structures or species within that genus" (and that one of the Wands factors is claim breadth).

The brief states that "Amgen and its amici desire a regime where patentees can jump the gun, rushing to the patent office with broad functional genus claims before they have discovered and can explain how to make and use, without excessive brute-force experimentation, vast swaths of the genus claimed, including structurally dissimilar species which may vary substantially in how they perform the claimed function.  But such unsupported broad claims "discourage rather than promote invention" by allowing a patentee to "foreclose efforts to discover other and better types" within the genus.  Holland Furniture, 277 U.S. at 257; accord Consolidated Elec., 159 U.S. at 476."

Curiously, most of the scholarly works cited in support of the arguments made by amici are at least 10 years old and some are significantly older.

Another collection of industries, the Small and Medium Biotechnology Companies (which includes ABL Bio (USP 11,261,259), Kiniksa, OPKO Health, and SK bioscience) say the Court should adopt an "if it ain't broke, don't fix it" principle and emphasized the reliance interest on the Federal Circuit's enablement jurisprudence, stating "[t]he longstanding enablement standard is consistent with text and precedent.  The balance it strikes promotes innovation and saves lives.  And departing from the status quo would unleash harmful consequences for industry participants like Amici, for patients, and for the public."  The Wands factors "are drawn from, and reflect" a century and a half of Supreme Court case law on enablement, and have been applied "evenhandedly" "for decades" they assert.  The brief cites a number of "incumbent and follow-on innovators," illustrated by Humira®, Remicade®, Cimzia®, and Simponi®, all of which are TNF-alpha inhibitors and Skyrizi®, Tremfya®, and Illumya®, which inhibit IL-23, for the purported benefits of permitting patent protection for both types of innovation.

The same curious reliance on scholarly works cited are at least 10 years old and some significantly older is the case here as in Pfizer's brief.

In addition to the legal academics' amicus briefs that were the subject of previous posts, a collection of IP Law Professors (including Sean Tu, Arti Rai, Oskar Litvak, Kevin Collins, and Bernard Chao) filed a brief and argued that claims should be limited to what is disclosed because that is what is invented.  In their view, "[t]rial-and-error inventing" (like Amgen's here, in their view) is inherently narrow, as evidenced by Amgen's "roadmap" disclosure, and the professors draw a distinction between trial-and-error to find the invention and trial-and-error in making and using what has been invented.  Countering some of the more heated rhetoric from Amgen and its amici (by asserting "[t]here is no paradox, no death of anything or otherwise a need for alarm"), the professors write that "[t]his case presents a classic example of a narrow invention that is coupled to overbroad claims," which are overbroad because a patent applicant "can claim broadly only when [they have] disclosed structural features that unify different species."  The brief cites several examples of competing antibodies that (putatively) would be precluded by grant of broad genus claims as Amgen advocates and the professors make the case that narrow antibody claims are more conducive to innovation in this area.

Much of the argument is taken from S. Sean Tu and Christopher M. Holman, Antibody Patents: Use of the Written Description and Enablement Requirements at the Patent & Trademark Office, 38 Berkeley Tech. L. J. (Figure 8) (2023 forthcoming) (available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4025167).

In her brief, Professor Robin Feldman takes the extreme position that "[t]his Court's precedent holds that the correct standard here is not undue experimentation but rather any experimentation," based on Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1847), which can be read this way, and Consolidated Electric Light Co. v. McKeesport Light Co., 159 U.S. 465, 474-75 (1895).  She writes that overbroad claiming "could bar scientists and competitors from those building blocks of invention" (notice conditional phrase) and that the certiorari grant was improvident because the Supreme Court could validate the undue experimentation standard.

The AIPLA (whose brief "suggest[s]" affirmance) argues that the Federal Circuit applied established law but that while enablement does not require disclosure of all embodiments Wands is the correct legsal and analytical framework.  The brief cites as examples the seemingly settled principle that one non-enabled embodiment is not enough to be undue experimentation and states that Amgen's argument that the Federal Circuit had developed a new "full scope" test is a "facile strawman."

The Association for Accessible Medicines filed an amicus brief wherein they argued that the Federal Circuit's decision aligns with statutory text and with the structure and purpose of the Patent Act, and that Amgen's theory will inhibit competition in the pharma industry.  As in other briefs discussed above this brief emphasizes the patent bargain, the dangers of permitting overbroad claiming, and the availability of Section 112(f) for such claims (consistent with its enactment in response to the Supreme Court's Halliburton Oil Well Cementing Co. v. Walker decision, 329 U.S. 1 (1946).  The brief focuses on the interplay between Sections 112(a) and 112(b) (wherein the latter defines the invention) and that the existence of the "using" requirement in Section 112(a) mandates disclosing how to use the invention, i.e., which species are operable.

The brief cites the usual litany of prior Supreme Court cases, such as O'Reilly v. Morse, Consolidated Electric, and Holland Furniture, and distinguishes cases Amgen cites by stating that "the issue in each case was that an operator seeking to use the invention would need to fill in some gaps in the patent's instructions to achieve the invention's desired outcome.  This Court held in each case that the specification contained sufficient information for a skilled artisan to fill in those gaps."  Which is not the case here, they argue.

The brief concludes by exhorting the Court to restrict "therapeutically effective amount" language and excipient claims (also argued by Fresenius Kabi ISA LLC, see above), citing biologic drugs with "secondary" characteristics not disclosed or claimed in protein composition of matter-claiming patents based on failure to disclose how to use a claimed biologic drug.

A sole generic drugmaker, Viatris Inc. filed an amicus brief making many of these same arguments, for example about the quid pro quo and the patent bargain, and asserts that deviating from the Wands precedent would destabilize U.S. patent law and innovation.  Uniquely this brief also argues that changes in the enablement standard would have a "major ripple effect" into other areas of patent law including obviousness.  This brief also ties enablement under 112(a) with the statutory requirements of defining an invention by claims in 112(b) as the basis for the scope of the claim be commensurate with the "full scope" of the invention as claimed.  Asserting the crux of their argument the brief recites:

Accordingly, this Court has long held that the specification—"[a]ddressed as it is to those skilled in the art"—"may leave something to their skill in applying the invention" (Mowry v. Whitney, 81 U.S. 620, 644 (1872)), provided the requisite experimentation is routine rather than "painstaking" (Consol. Elec. Light Co. v. McKeesport Light Co., 159 U.S. 465, 475 (1895)) or "elaborate" (Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245, 256-257 (1928)).

A group of medical doctors and affiliated groups, styled in the caption as Arnold Ventures, National Centers for Health Research, and Certain Medical Doctors, filed an amicus brief whose arguments are directed to perceived negative consequences on innovation and competition in pharma, citing reports about high drug costs, many by the "certain medical doctors" themselves.  They argue (as have others) that functional genus claims would permit pharma companies to use such claims to prevent other companies from developing different drugs to the same target.  The brief cites four ways that adopting Amgen's position would hurt patients:

1) "multiple treatment options will be delayed in development and approval, or not available at all" (e.g., if the claimed drug fails in the clinic);
2) "patients will be forced to take medicine that may be either more risky or less efficacious—or both—than an alternative." (when first-to-market drugs are not the most efficacious);
3) "patients may not have the treatment option that works best for their specific circumstances" (when humans have differential responses to different drugs to the same target); and
4) "competition between innovators, under the right circumstances, can lower spending on brand-name drugs," stating that "[h]igh drug prices are a major cause of lack of patient access, or of long-term non-adherence to treatments, which contributes to thousands of excess hospitalizations and deaths annually."

The brief provides an informative schematic showing the timeline of PCSK9 research, which throws shade on Amgen's entitlement to a patent in view of what they contend Amgen did not invent:

and provides a series of tables showing "second to market" drugs that could have been precluded if Amgen's enablement position had been the standard:

The amicus filed by Unified Patents illustrated the concerns the enablement issue raised for patentees outside the biotech and pharma industries.  This brief argues that functional claims impede innovation regardless of technology and that the "full scope" test is needed to prevent this negative outcome.  In addition, the brief argues that the "full scope" test is not new but instead is supported by established precedent which Amgen's proposed test would overturn, citing Morse, Béné v. Jeantet, The Incandescent Lamp Patent, Corona Cord Tire Co. v. Dovan Chem. Corp., Holland Furniture and CCPA/Federal Circuit precedent and stating that:

The Court has identified three relevant factors: (1) whether the patent involves an area of invention where results are unpredictable; (2) whether the claim breadth vastly outstrips the disclosures in the specification; and (3) whether the patentee has demonstrated that the proven function of disclosed embodiments can be reliably extrapolated to non-disclosed embodiments within the claim scope.

For this amicus the greatest threat raised by Amgen's argument is the issuance of overbroad "high-tech" patents, devoting an entire section of the brief to this "problem" and stating that  such broad functional claims would have an in terrorem effect on the public.  The brief also provides a footnote asserting that a study of patent litigations estimated that 100% of NPE-asserted software patents and 50% of non-NPE asserted software patents utilized functional patent claiming.  Colleen V. Chien and Aashish R. Karkhanis, Functional Claiming and Software Patents (Santa Clara Univ., Working Paper No. 06-13, 2013), https://ssrn.com/abstract=2215867).

The Court at oral argument and the parties cited amicus briefs they hoped would resonate with the Justices.  It will be interesting to see if any of those briefs or the ones discussed herein have any influence on how the Court will rule.