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.
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