Abstract
On November 4, 2022, the U. S. Supreme Court granted certiorari in the case of Amgen v. Sanofi. 1 This could be an historic event, since it marks the first time that the Court has addressed patent laws enablement requirement, or for that matter any of the adequate disclosure requirements of 35 USC 112(a), i.e., the written description and best mode requirements, since the enactment of the Patent Act of 1952.
A few days later, on November 7, the Supreme Court denied certiorari in Juno Therapeutics v. Kite Pharma, a case challenging the Federal Circuit's interpretation of the written description requirement. 2 The claims struck down for lack of adequate written description in Juno are strikingly similar to the claims that were invalidated under the enablement requirement in Amgen, being directed towards nucleic acids encoding chimeric T cell receptors (for use in Car T-cell therapy), comprising, inter alia, a functionally defined “binding element,” as exemplified by a single-chain antibody variable fragment (“scFv”).
The adequate disclosure requirements, and particularly the enablement requirement, which I would argue is the most fundamental of the three doctrines of patentability rooted in the first paragraph of § 112, are I believe the only statute-based requirements of patentability that have not been addressed by the Supreme Court since the enactment of the current Patent Act in 1952. In contrast, the patent eligibility requirement (which according to the Supreme Court is grounded in § 101, although many would argue that its current interpretation is essentially judge-made law) has been directly addressed by the Supreme Court on at least nine occasions since 1972. 3 The Court waited 15 years to take up the nonobviousness requirement of § 103, which made its first appearance in the statute with the enactment of Patent Act of 1952, but it did so in 1966 with the so-called Graham trilogy. 4 Post-Graham the Court has decided a number of cases involving the nonobviousness requirement, most recently in 2007 with its landmark KSR decision. 5 The Court has on several occasions considered aspects of § 102's novelty requirement, particularly with respect to the definition of prior art. 6 The Court addressed the utility requirement (grounded in §§ 101 and 112(a)) in its 1966 Brenner decision (it seems to me the utility doctrine is one that could rise up on the Supreme Court's radar at some point). 7
In short, one could argue that a grant of certiorari in a case involving the enablement requirement is overdue. In this Holman Report, I summarize the Federal Circuit decision that is the subject of the grant of certiorari, and then delve into some of the main arguments that were raised in: (1) Amgen's partially successful petition for certiorari (partial in the sense that the Court granted certiorari only with respect to one of the two questions presented); (2) Sanofi's brief in opposition to grant of certiorari; (3) GlaxoSmithKline's amicus curiae brief supporting grant of certiorari; (4) an amici curiae brief supporting grant of certiorari filed on behalf of a coalition including Association of University Technology Transfer Managers, Biogen, Bristol-Myers Squibb, Corning Inc., MerckSharp & Dohme, and St. Jude Children's Research Hospital; and (5) an amicus curiae brief filed on behalf of the U.S. government by the Solicitor General recommending that the Court not grant certiorari.
THE DECISION BELOW
The patent claims at issue in Amgen v. Sanofi are claims 19 and 29 of U.S. Patent 8,829,165 (the “’165 patent”) and claim 7 of U.S. Patent 8,859,741 (the “’741 patent”). The patents, which are owned by Amgen, describe antibodies that purportedly bind to the proprotein convertase subtilisin/kexin type 9 (“PCSK9”) protein, an enzyme that regulates the degradation of low-density lipoprotein (“LDL”) receptors. PCSK9 binds to LDL receptors and mediates their degradation, thus decreasing the number of LDL receptors on a cell's surface. Elevated LDL cholesterol is linked to heart disease, and antibodies that bind to and block PCSK9 are thought to lower LDL levels by protecting LDL receptors, allowing them to continue regulating the amount of circulating LDL cholesterol.
The patent claims recite isolated monoclonal antibodies defined solely by their ability to bind to the enzyme PCSK9 and thereby block the binding of PCSK9 to low-density lipoprotein receptors (LDLR). The ’165 and ’741 patents share a common written description, which discloses amino acid sequences for twenty-six antibodies, including the antibody (designated as “21B12”) with the generic name of evolocumab, marketed by Amgen as Repatha. The specification discloses three-dimensional structures for the antibodies designated 21B12 and 31H4 and shows where those antibodies bind to PCSK9. The claims at issue recite antibodies that bind to one or more of fifteen amino acids (i.e., “residues”) of the PCSK9 protein and block PCSK9 from binding to LDL receptors.
The relevant ’165 patent claims are:
1. An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR. 19. The isolated monoclonal antibody of claim 1 wherein the isolated monoclonal antibody binds to at least two of the following residues S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of PCSK9 listed in SEQ ID NO:3. 29. A pharmaceutical composition comprising an isolated monoclonal antibody, wherein the isolated monoclonal antibody binds to at least two of the following residues S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of PCSK9 listed in SEQ ID NO: 3 and blocks the binding of PCSK9 to LDLR by at least 80%.
The relevant ’741 patent claims are:
1. An isolated monoclonal antibody that binds to PCSK9, wherein the isolated monoclonal antibody binds an epitope on PCSK9 comprising at least one of residues 237 or 238 of SEQ ID NO: 3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR. 2. The isolated monoclonal antibody of claim 1, wherein the isolated monoclonal antibody is a neutralizing antibody. 7. The isolated monoclonal antibody of claim 2, wherein the epitope is a functional epitope.
Amgen filed suit against Sanofi, Aventisub LLC, Regeneron Pharmaceuticals Inc., and Sanofi-Aventis U.S. LLC (collectively, “Sanofi”) on October 17, 2014, alleging infringement of multiple U.S. patents, including the ’165 and ’741 patents. Amgen and Sanofi stipulated to infringement of selected claims (including ’165 patent claims 19 and 29 and ’741 patent claim 7) and tried issues of validity to a jury in March 2016. During the trial, the district court granted judgment as a matter of law (JMOL) of nonobviousness and of no willful infringement. At the close of the trial, the jury determined that the patents were not shown to be invalid for lack of enablement and written description.
Sanofi appealed to the Federal Circuit, which held in Amgen I that the district court erred in its evidentiary rulings and jury instructions regarding Sanofi's defenses that the patents lack written description and enablement, and remanded for a new trial on those issues. 8
On remand, the parties tried the issues of written description and enablement to the jury. The jury again found that Sanofi failed to prove that the asserted claims were invalid for lack of written description and enablement. Sanofi moved for JMOL. The district court granted Sanofi's Motion for JMOL for lack of enablement and denied the motion for lack of written description. This decision was appealed, resulting in a second Federal Circuit decision, Amgen II, the decision that is the subject of the grant of certiorari. 9
On appeal, Amgen asked the Federal Circuit to reverse the district court's decision holding ’165 patent claims 19 and 29 and ’741 patent claim 7 invalid for lack of enablement, arguing that, under a proper analysis of the Wands factors, the claims at issue were enabled because no undue experimentation is required to obtain antibodies fully within the scope of the claims. Amgen pointed to expert testimony purportedly showing that a person of skill in the art can make all antibodies within the scope of the claims by following a roadmap using anchor antibodies and well-known screening techniques as described in the specification or by making conservative amino acid substitutions in the twenty-six examples. Amgen further contended that the district court erred by focusing on the effort required to discover and make every embodiment of the claims, while failing to recognize that Sanofi could not identify any antibody that cannot be made by following the specification's teachings. Furthermore, Amgen argued that the embodiments in the patent are structurally representative for the purpose of fulfilling the written description requirement, and such evidence is sufficient to indicate a structure/function correlation establishing enablement.
Sanofi, in turn, argued that the district court had properly concluded based on the Wands factors that the claims are not enabled because they require undue experimentation. As support for its position, Sanofi asserted that there are millions of antibody candidates within the scope of the claims, the disclosures do not provide sufficient guidance, antibody generation is unpredictable, and practicing the full scope of the claims would require substantial trial and error. Sanofi contended that Amgen's argument improperly focused on “the number of antibodies actually known to satisfy the claims, when this court's precedents require examining the number of candidates that must be made and tested to determine whether they satisfy the claimed function.”
The Federal Circuit began its analysis by considering In re Wands, a case that also involved claims relating to antibody technology, which the court characterized as the “go to” precedent for guidance on enablement. 10 The court pointed out that the broadest claim at issue in Wands “involve[d] immunoassay methods for the detection of hepatitis B surface antigen by using high-affinity monoclonal antibodies of the IgM isotype.” Wands, 858 F.2d at 733. The U.S. Patent and Trademark Office Board of Patent Appeals and Interferences had found that undue experimentation would be required for one skilled in the art to make the claimed antibodies used in the methods because “production of high-affinity IgM anti-HBsAg antibodies [was] unpredictable and unreliable.” In Wands the Federal Circuit found, reviewing the facts, that the disclosure adequately taught using hybridoma technology to produce the needed claimed antibodies. The court stated that “no evidence was presented by either party on how many hybridomas would be viewed by those in the art as requiring undue experimentation to screen,” and accordingly held that the specification fully enabled the claimed invention.
The Amgen II court emphasized that although Wands gave birth to its eponymous factors, Wands did not proclaim that all broad claims to antibodies are necessarily enabled. Rather, when the Federal Circuit applies Wands “the facts control, as does the standard of review.” The Federal Circuit noted with approval that, in applying Wands to Amgen's claims, the district court had compared the facts of this case to other recent cases in which the Federal Circuit found lack of enablement due to the undue experimentation required to make and use the full scope of the claimed compounds that require a particular structure and functionality, i.e., Wyeth, 11 Enzo, 12 and Idenix, 13 and found that these decisions all supported its conclusion that the claims at issue were invalid for lack enablement.
Wyeth held that claims covering methods of preventing restenosis with compounds having certain functionality requirements were invalid for lack of enablement. The Federal Circuit identified as particularly significant the court's holding that, due to the large number of possible candidates within the scope of the claims and the specification's corresponding lack of structural guidance, it would have required undue experimentation to synthesize and screen each candidate to determine which compounds in the claimed class exhibited the claimed functionality.
Similarly, in Enzo the court found that the claims were similar to those at issue in Wyeth in that they required both a particular structure and functionality, and held that the specification failed to teach one of skill in the art whether the many embodiments of the broad claims would exhibit that required functionality.
In Idenix, the Federal Circuit affirmed the district court's determination that the claims had both structural and functional limitations, and that undue experimentation would have been required to synthesize and screen the billions of possible compounds because, given a lack of guidance across that full scope, finding functional compounds would be akin to finding a “needle in a haystack.”
In Amgen II the court found that its precedent, as exemplified by the decisions reviewed by the district court, stood for the proposition that:
the enablement inquiry for claims that include functional requirements can be particularly focused on the breadth of those requirements, especially where predictability and guidance fall short. In particular, it is important to consider the quantity of experimentation that would be required to make and use, not only the limited number of embodiments that the patent discloses, but also the full scope of the claim. *** In cases involving claims that state certain structural requirements and also require performance of some function (e.g., efficacy for a certain purpose), we have explained that undue experimentation can include undue experimentation in identifying, from among the many concretely identified compounds that meet the structural requirements, the compounds that satisfy the functional requirement.
The court then explained that the same reasoning applied in the present case, observing that:
while functional claim limitations are not necessarily precluded in claims that meet the enablement requirement, such limitations pose high hurdles in fulfilling the enablement requirement for claims with broad functional language. Each appealed claim in this case is a composition claim defined, not by structure, but by meeting functional limitations. We agree with the district court's finding that the specification here did not enable preparation of the full scope of these double-function claims without undue experimentation. The binding limitation is itself enough here to require undue experimentation.
Turning to the Wands factors, the Federal Circuit agreed with the district court's assessment that the scope of the claims is indisputably broad. The court explained that the inquiry is not concerned simply with the number of embodiments, but also with their functional breadth, and that regardless of the exact number of embodiments encompassed by the claims, they were clearly far broader in functional diversity than the disclosed examples. If the genus were to be analogized to a plot of land, the court found that the disclosed species and guidance “only abide in a corner of the genus.” 14 The court further opined that the use of broad functional claim limitations raises the bar for enablement.
The Federal Circuit in Amgen II also agreed with the district court that the claimed invention is in an unpredictable field of science with respect to satisfying the full scope of the functional limitations. One of Amgen's expert witnesses admitted that translating an antibody's amino acid “sequence into a known three-dimensional structure is still not possible.” Another of Amgen's experts conceded that “substitutions in the amino acid sequence of an antibody can affect the antibody's function, and testing would be required to ensure that a substitution does not alter the binding and blocking functions.” And while some need for testing by itself might not indicate a lack of enablement, the court noted the conspicuous absence of nonconclusory evidence that the full scope of the broad claims can predictably be generated by the described methods.
While acknowledging that the specification provides some guidance, including data regarding certain embodiments, the Federal Circuit agreed with the district court that “[a]fter considering the disclosed roadmap in light of the unpredictability of the art, any reasonable factfinder would conclude that the patent does not provide significant guidance or direction to a person of ordinary skill in the art for the full scope of the claims.” The court found that no reasonable factfinder could conclude that there was adequate guidance beyond the narrow scope of the working examples that the patent's “roadmap” produced.
The Federal Circuit further agreed with the district court's determination that the only ways for a person of ordinary skill to discover undisclosed claimed embodiments would be through either “trial and error, by making changes to the disclosed antibodies and then screening those antibodies for the desired binding and blocking properties,” or else “by discovering the antibodies de novo” according to a randomization-and-screening “roadmap.” Either way, the court agreed that the required experimentation “would take a substantial amount of time and effort.”
The Federal Circuit emphasized that it was not holding that the effort required to exhaust a genus is dispositive. It is appropriate, however, to look at the amount of effort needed to obtain embodiments outside the scope of the disclosed examples and guidance. The court found that the functional limitations at issue in this case are broad, the disclosed examples and guidance are narrow, and no reasonable jury could conclude under these facts that anything but “substantial time and effort” would be required to reach the full scope of claimed embodiments.
After weighing the Wands factors, the Federal Circuit ultimately concluded that the district court did not err in concluding that undue experimentation would be required to practice the full scope of Amgen's claims.
AMGEN'S PETITION FOR CERTIORARI
Here are the questions presented in Amgen's petition for certiorari:
1. Whether enablement is “a question of fact to be determined by the jury,” Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846), as this Court has held, or “a question of law that [the court] review[s] without deference,” as the Federal Circuit holds. 2. Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “time and effort.”
15
The Supreme Court granted certiorari only with respect to the second question, essentially challenging the Federal Circuit's interpretation of the enablement requirement. Nonetheless, this section of the article will review some of the arguments made by Amgen in connection with both Question 1 and Question 2.
Question 1
In a nutshell, Amgen argues that there is a conflict between the Federal Circuit's position that the enablement requirement is a question of law, to be reviewed without deference, and the Supreme Court's historical practice declaring enablement “a question of fact to be determined by the jury.” According to Amgen, the law has been clear for more than 150 years that enablement is a factual determination for a jury.
Amgen points to the Supreme Court's 1854 decision in Battin v. Taggert, in which the Court reversed a directed verdict because “[i]t was right of the jury to determine, from the facts in the case, whether the specifications… were so precise as to enable any person skilled in the [art] to make the [invention] described. This the statute requires, and of this the jury are to judge.” 16
Amgen goes on to argue that in a still earlier decision, Wood v. Underhill, the Supreme Court explained that the patent specification must “enable anyone skilled in the art” to “use the invention,” and that “the sufficiency of the description must, in general, be a question of fact to be determined by the jury.” 17 The petition quotes passages from a number of other decisions of the Supreme Court and circuit courts dating back to the early 19th Century which purportedly bolster its argument that the enablement requirement has historically been treated as a question of fact for the jury. Amgen's petition further argues that early patent treatises expounded this same interpretation of the law. 18 The petition then argues that, prior to the creation of the Federal Circuit, courts of appeal overwhelmingly took the same position. 19
Amgen goes on to argue that “Framing-era English practice” reflects the same rule. The petition cites to the Supreme Court's 1996 decision in Markman v. Westview Instruments for the proposition that patent litigation in that era was “typified by… ‘enablement’ cases, in which juries were asked to determine whether the specification describe the invention well enough to allow members of the appropriate trade to reproduce it.” 20 The petition points to a number of decisions from that era that purportedly support Amgen's position that juries decided enablement is a question of fact, and that such jury determinations were virtually conclusive. Amgen's petition cites Markman for the proposition that the Supreme Court applies a “historical test” to determine whether an issue is a fact question for juries or question of law for courts. 21 According to Amgen, the clear historical evidence shows that enablement was regarded as a factual issue for a jury under English practice at the Framing, and the 7th Amendment of the U.S. Constitution precludes courts from re-examining any such fact tried by a jury except according to the rules of the common law.
Amgen then argues that, notwithstanding historical precedent, the Federal Circuit in 1983, in a footnote in Raytheon v. Roper, adopted its current rule that the enablement requirement is a “question of law to be reviewed without deference.” 22 According to the petition, Raytheon provided no analysis to justify this rule. In particular, Amgen argues that in Raytheon the Federal Circuit failed to perform the “historical test” set forth in Markman, and addresses neither the decisions of the regional Courts of Appeal nor the Supreme Court precedent such as Battin and Wood. Instead, the Federal Circuit cited decisions from its predecessor, the U. S. Court of Customs and Patent Appeals (C.C.P.A.), which assumed in cases such as In Re Hogan that enablement is a “legal question.” 23 But according to Amgen, the C.C.P.A. also failed to offer any analysis for this assertion. The petition notes that, given the nature of its jurisdiction, the C.C.P.A. did not review jury verdicts, only appeals from the United States Patent and Trademark Office (PTO).
Amgen points to a statement by the Federal Circuit purportedly conceding that “[o]ne can reasonably ask, as Amgen does, why enablement is a question of law,” but then proceeding to conclude that its own precedent to the contrary was too “long in the tooth” to disturb. But Amgen argues that the historical precedent supporting its position is even longer in the tooth, and that the Federal Circuit's rule is inherently incoherent, in that it treats the written description requirement as a question of fact, and enablement requirement as a question of law, even though both requirements are closely related and derived from the same sentence in 35 USC § 112. Amgen's petition argues that the Federal Circuit has never explained why written description, which involves an “objective inquiry into the four corners of the specification,” 24 is a question of fact, while enablement, which turns “upon the evidence of person skilled in the art,” 25 is a question of law. Amgen points to a statement of the Federal Circuit's Judge Gajarsa to the effect that the “Federal Circuit's determinations regarding which issues are factual and which are legal are simply inexplicable.” 26
Amgen concludes the Question 1 section of its petition by arguing that the issue is of exceptional importance. The petition argues that protecting the right of litigants to have the issue of enablement tried to a jury is “[c]ritical to the fairness and integrity of our judicial system,” particularly given the fact-driven nature of the enablement inquiry. Amgen asserts that juries are well-suited to decide the question, by weighing the conflicting testimony of experts and making credibility determinations. Taking this determination out of the hands of the jury, Amgen argues, has wrought profound harm to the judicial system. According to Amgen, “it is widely perceived that by redefining many issues of law rather than fact the Federal Circuit has become a second jury by substituting its opinion for the jury verdict.” It also argues that the “prominent” perception is that the outcomes in patent cases depend not on the law or the record, but on whether one draws pro-patent or anti-patent judges.
Amgen's petition goes on to argue that treating enablement as a legal question invites doctrinal uncertainty, as the Federal Circuit in successive cases creates new tests when deciding enablement as a legal question. This has purportedly created a “mutating body of law” that inventors cannot rely on, since the Federal Circuit applies it to patents that were filed long before inventors had an opportunity to address the Federal Circuit's evolving “extra-statutory requirements.”
The petition argues that the Federal Circuit has created divergent enablement standards that depend upon the nature of the specific patent claim at issue:
For some, it demands the party challenging enablement provide “concrete identification of at least some embodiment” that cannot be made without undue experimentation. McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091, 1100 (Fed. Cir. 2020). As explained [later in the petition], for genus claims like Amgen's, it has created a different, heightened standard, asking whether “substantial time and effort would be required to reach the full scope of claimed embodiments.” Examining the cumulative effort to make the full scope of embodiments diverges dramatically from inquiring whether skilled artisans can make and use individual embodiments. The Federal Circuit's standard for genus claims imposes a high hurdle found nowhere in § 112.
Question 2
Turning to Question 2, Amgen's petition argues that the Federal Circuit has created an atextual enablement standard that “raises the bar” for certain claims. For genus claims like Amgen's, in particular, Amgen alleges that the Federal Circuit does not ask whether skilled artisans can “make and use” the invention, as § 112 and this Court's precedents require, but instead invalidates genus claims if it believes “substantial time and effort” would be required to reach the full scope of claimed embodiments, i.e., “to identify and make all or nearly all possible embodiments of the invention.” It argues that the alleged standard frustrates the purposes of patent law by invalidating patents for breakthrough inventions, demanding disclosure about theoretical “far corners,” in a manner that contributes nothing to progress of the useful arts. Amgen's petition argues that this has had devastating consequences for innovation, particularly in the biotech and pharmaceutical sectors.
The petition argues that over the past 200 years the Supreme Court has described the enablement standard in a manner consistent with the text of § 112, i.e., the patent's disclosures satisfy the law if they are sufficiently definite to guide those skilled in the art to the successful application of the invention, 27 teach skilled artisans to practice the invention, 28 or point out some practicable way of putting the invention into operation. 29 In contrast, according to Amgen, the Federal Circuit has adopted a different enablement test for genus claims such as those at issue in this case, claims that often use “functional aims” or “formulas” to encompass a class of “embodiments” that employ the inventive feature. In such cases, the Federal Circuit purportedly does not ask whether there are actual embodiments skilled artisans cannot “make and use,” but whether “substantial time and effort” would be required to reach the full scope of the claimed embodiments.
Amgen argues that not only is the Federal Circuit's purported “reach-the-full-scope test” atextual, it is foreclosed by the Supreme Court's decision in Minerals Separation v. Hyde.
30
According to its petition:
In Minerals Separation, the patent involved “improvements in the process for the concentration” of metallic ores. The invention involved adding oil to the ore and agitating the mixture. This Court recognized that the “amount of oil and the extent of agitation necessary in order to obtain the best results” would vary for each type of metal. But the patent did not explain how to alter those variables for the “infinite” varieties of ore, and skilled artisans would have to conduct “preliminary tests” to identify the “precise treatment” for each.
31
According to Amgen, the Minerals Separation patent would have been invalid under the Federal Circuit's purported “reach-the-full-scope test,” since the time and effort necessary for skilled artisans to reach the full scope of the claimed embodiments, i.e., the iterations for the infinite ore varieties, would have been enormous. In contrast, the Supreme Court upheld the claims, explaining that “it is obviously impossible to specify in a patent the precise treatment” for each variation. It was sufficient that skilled artisans could apply the process to particular ores as needed. Amgen argues that the Supreme Court has regularly reached similar conclusions when addressing patent claims covering a large number of potential embodiments. 32
Amgen's petition goes on to argue that the reach-the-full-scope standard serves no patent law policy, abandoning a practical focus on whether others can make use of the claimed invention in favor of a “fruitless search for the exact boundaries of that invention.” According to Amgen, there is no reason to demand that skilled artisans be able to identify and make all potential embodiments encompassed by a patent claim with minimal time and effort.
The petition further argues that the Federal Circuit's disclaimer in the decision below that the effort required to exhaust a genus is not “dispositive” is at odds with its holding in the case, i.e., that Amgen's patents are not enabled because substantial time and effort would be required to reach the full scope of the claimed embodiments. Amgen argues that the Federal Circuit's test is not necessary to address that courts expressed concern that, in the absence of such a rule, patentees would be able to claim more than they had invented through claims that are “far broader in functional diversity than” the examples disclosed by the patent, effectively “drawing a broad fence around subject matter, without filling in the holes.” According to Amgen, if a claim truly exceeds what the patent enables, a patent challenger will be able to provide “concrete indication” of at least some actual embodiments that cannot be made or used without undue experimentation. In the decision below, Amgen argues, the patent challenger failed to identify any actual embodiment, i.e., an antibody falling within the scope of the claims, that cannot be generated using the patent's disclosure.
Addressing the Federal Circuit's related expressed concern about patents that leave skilled artisans “searching for a needle in a haystack” to determine which, of a potentially huge number of candidates, performed the claimed function,
33
Amgen acknowledged that a claim may not be enabled when the number of inoperative combinations covered by the claim becomes significant,
34
but argued that:
no specialized sub-test is required to address that concern. Such claims would not be enabled under [the Supreme] Court's standard, because a specification that effectively sends skilled artisans on a research mission is not sufficiently definite to guide those skilled in the art to the successful application of the invention. Minerals Separation, 242 U.S. at 271. But again, that was not the case here—the jury heard testimony that Amgen's roadmap generates antibodies within the claims every time. The Federal Circuit's reach-the-full-scope test is a court-made solution to a non-existent problem. This Court has repeatedly overturned the Federal Circuit's efforts to supplant commonsense statutory standards with specialized tests of its own devising. See, e.g., Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901, 910 (2014)(“insolubly ambiguous” test for indefiniteness); KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415, 419 (2007) (“teaching, suggestion, or motivation” test for obviousness). Review is warranted once again.
Amgen concludes this section of its brief by stressing the “exceptional importance” of this issue for innovators, particularly in the pharmaceutical and biotech sectors. Amgen argues that in these industries:
significant breakthroughs often involve identifying the mechanism for producing a desired effect in making a working embodiment. That mechanism, however, may have the same effect when implemented in any number of structurally similar compounds. The central feature of patent law in those fields thus is the genus claim—patent claims that use functional language or generic formulas to cover embodiments of the invention (species) that share a common attribute or property. Such claims are essential to offering patent protection commensurate with the invention's scope. Drawing claims to cover only particular embodiments does not provide patent protection on the fruits of the inventor's investments. Copyists could avoid infringement by making a minor change while still exploiting the benefits of the invention. And requiring inventors to obtain a patent on every individual variation of a genus would be impractical and wasteful.
Amgen argues that it appears impossible to satisfy the Federal Circuit's “reach-the-full-scope test” in any case in which a genus claim covers a nontrivial number of embodiments, and cites the Federal Circuit's Judge Bryson for his purported view that “[s]uch a rule would invalidate all broad claims for lack of enablement.” 35 Amgen asserts that the Federal Circuit's enablement standard for genus claims has already had severe consequences, particularly for pharmaceuticals and biotechnology. 36
SANOFI'S BRIEF IN OPPOSITION
This section of the article summarizes Sanofi's arguments in opposition to Amgen's petition for certiorari. 37
Question 1
Regarding the first question, Sanofi argues that Amgen is incorrect in its assertion that the Federal Circuit has diverged from Supreme Court precedent, and that in fact the Federal Circuit's treatment of enablement is consistent with the Supreme Court's treatment of patent validity issues in general. Rather than focusing specifically on the enablement requirement, Sanofi argues that as a general matter the Supreme Court has treated patentability as a question of law with underlying factual questions, explaining that:
This Court has long held that patent validity is a question of law with underlying factual questions. Thus, the Court held in Microsoft Corp. v. i4i Ltd. Partnership, 564 U.S. 91 (2011), that “the ultimate question of patent validity is one of law,” with “the same factual questions underlying the PTO's original examination of a patent application” also “bear[ing] on an invalidity defense in an infringement action.” Id. at 96-97. Similarly, in Sakraida v. Ag Pro, Inc., 425 U.S. 273 (1976), which addressed the invalidity defense of obviousness, the Court explained that “[t]he ultimate test of patent validity is one of law, but resolution of the obviousness issue necessarily entails several basic factual inquiries.” Id. at 280 (citation omitted); accord KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 427 (2007). The Court likewise observed in Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966), that “patent validity” is “ultimate[ly]” a question “of law,” but one that “lends itself to several basic factual inquiries.” Id. at 17. In short, “[t]he Supreme Court's modern case law clearly and consistently holds that patent validity is a question of law based on underlying findings of fact.” Paul R. Gugliuzza, Law, Fact, and Patent Validity, 106 Iowa L. Rev. 607, 615 (2021).
Sanofi, after pointing out that the Supreme Court decisions cited in Amgen's petition all predate the Civil War, proceeded to offer its own characterization of the precedent cited by Amgen, pointing out, for example that in Amgen's leading case, Wood v. Underhill, although the Court states that while the “efficiency of the description” is “in general” a question of fact, “when the specification of a new composition of matter gives only the names of the substances which are to be mixed together, without stating any relative proportion, undoubtedly it would be the duty of the court to declare the patent… void.” In Evans v. Eaton, Sanofi asserts that enablement was “not disputed,” so the Court had no occasion to assess the interplay of the jury's fact-finding with the court's ultimate conclusion. Sanofi goes on to point out that in other cases cited by Amgen, 38 “the factual issue for the jury related to the capabilities of a person skilled in the art,” which is simply one of the Wands factors for determining enablement, i.e., “the relative skill of those in the art,” which is an example of an underlying factual finding that, under the Federal Circuit approach, goes toward the ultimate question of law regarding enablement.
Sanofi's brief argues that not only does Amgen mischaracterize Federal Circuit precedent, by selective quoting from a handful of decisions, it even mischaracterizes the decision on appeal, by repeatedly contending that the panel merely observed that enablement is a “question of law” that it “reviews without deference,” while failing to mention that the panel proceeded to say in that very same sentence: “although the determination may be based on underlying factual findings, which we review for clear error.”
Regarding the dichotomy between the treatment of the written description requirement as a question of fact and enablement as a question of law, Sanofi argues that, if anything, it is the Federal Circuit's approach to written description that is the outlier. Sanofi quotes the following sentence from a law review article authored by Professor Paul Gugliuzza: “The notion that written description is a question of fact is… inconsistent with Supreme Court precedent stating that patent validity is ultimately a question of law.” 39
Sanofi's brief goes on to argue that the issue presented by Question 1 is not sufficiently important to warrant certiorari. Sanofi notes that in the overwhelming majority of cases in which the Supreme Court grants certiorari in a case involving patent law, the decision below had generated a panel dissent, en banc proceedings, or at least a call for rehearing en banc, none of which applies in this case. 40
The brief argues that Amgen vastly overstates the importance of the “question of law or fact” issue. If, as Amgen asserts, the Federal Circuit's purported “rule” has been in place nearly 40 years, while generating but a handful of petitions for certiorari, then that suggests that not only is it “a stale legal principle in no urgent need of this Court's review,” but that it lacks any “hallmark of a legal principle that supposedly departs from this Court's precedents and historical practice, create[ing] doctrinal uncertainty, and routinely lay[ing] waste to innovative patents.”
As to Amgen's contention that “[b]y deeming enablement a question of law, the Federal Circuit licenses courts to substitute their judgments … on disputed issues that it was the right of the jury to determine,” Sanofi responds that in the cases cited by Amgen where Federal Circuit panels or district courts purportedly “exercis[ed] their own judgment to hold patents not enabled,” the judgments simply reflected a judicial conclusion that the evidence could not reasonably support a determination that a patent was enabled. Sanofi argues that these outcomes are indistinguishable from a host of other cases, many of which involve purely factual issues, in which the court declares summary judgment or other judgment as a matter of law based on an insufficient evidentiary showing. 41 Sanofi specifically points to Wood (which Sanofi characterizes as Amgen's leading case) as an example of a decision that makes clear that if the undisputed evidence demonstrates that a patent does not sufficiently enable an invention, “undoubtedly it would be the duty of the court to declare the patent void.” 42
According to Sanofi, this is what occurred in the decision below, explaining that:
Both the district court and the Federal Circuit panel concluded, based on the undisputed relevant facts, that no reasonable juror could conclude that Amgen's claims are enabled, because “undue experimentation would be required to practice the full scope of [Amgen's] claims.” Amgen contends that the panel “inva[ded] … the jury's role,” but the panel repeatedly emphasized that its decision was based on undisputed facts. Again, this is no different from any court concluding, as a matter of law, that a verdict cannot be sustained given insufficient evidence under the applicable law. And, given that the lower court decisions are rooted in undisputed facts, the outcome would have been the same regardless of the standard of review.
Question 2
As to Question 2, Sanofi begins by suggesting that Amgen's “cumbersome formulation” of the question belies the fact that the question is in fact “nothing more than a request for fact bound error correction dressed up as a supposedly legal dispute.” While Amgen accuses the Federal Circuit of having “created a special test” for genus claims that has “rewritten substantive enablement standard,” Sanofi responds that the panel in fact “repeatedly eschewed any bright-line rules are tests,” arguing that:
the panel reached its conclusion that Amgen's claims required “undue experimentation” after a case-specific “weighing [of] the Wands factors” that the Federal Circuit has long used to evaluate enablement. Amgen does not challenge the use of the Wands factors, and it does not dispute that one of the Wands factors is the “breadth of the claims.” That factor, moreover, reflects decades of Federal Circuit precedent explaining that to meet the enablement requirement, the “disclosure of the specification [must] be commensurate in scope with the claim under consideration.” In re Hyatt, 708 F.2d 712, 714 (Fed. Cir. 1983); see Crown Operations, Int'l, Ltd. v. Solutia Inc., 289 F.3d 1367, 1378-79 (Fed. Cir. 2002) (noting enablement must be “to a degree at least commensurate with the scope of the claims”).
Sanofi's brief further asserts that the Federal Circuit's approach to enablement for broad functional claims, or broad claims of any kind, is consistent with Supreme Court precedent, pointing to examples such as Consolidated Electric Light Co. v. McKeesport Light Co., an 1895 decision in which the Court invalidated a claim to “the use of all fibrous and textile materials for the purpose of electric illuminations” where the patent left others to engage in “painstaking experimentation” among “different species of vegetable growth, for the purpose of ascertaining the one best adapted to an incandescent conductor.” 43 In a 1928 decision, Holland Furniture Co. v. Perkins Glue Co., the Court invalidated a claim to all starch glues functioning like animal glue because the patent described only “a particular starch glue” and others could be found only “after elaborate experimentation.” 44 And in Béné v. Jeantet, the Court invalidated a claim to a method of shrinking coarse hair by “subjecting it to the action of chemicals” because the patent merely disclosed one chemical “solution” and did not “enable [a person skilled in chemistry] to use the invention without having to resort to experiments of his own to discover those [other] ingredients.” 45
Sanofi goes on to challenge Amgen's contention that the decision below conflicts with Minerals Separation Ltd. v. Hyde. Its brief argues that, for one thing, the part of Minerals Separation that Amgen invokes concerned indefiniteness, pointing out that in a 2014 definiteness decision, Nautilus v. Biosig Instruments, the Court cited Minerals Separation as in accord with the standard for compliance with the definiteness requirement announced in Nautilus.
46
Beyond that, even viewing Minerals Separation as relating to enablement, Sanofi argues there is no conflict, noting that:
The claims at issue there covered a process for separating metals from ores using oil and air bubbles. There was no dispute that all “variation[s] of treatment” worked and were within the “scope of the claims,” and experimentation was required merely to determine the variables that “would be most successful and economical in each case” in order “to obtain the best results.” Unlike Minerals Separation, Amgen's claims do not implicate a question of optimization of known variables. Rather, as the panel explained, “the only ways for a person of ordinary skill to discover undisclosed claimed embodiments would be through either ‘trial and error’ … or else ‘by discovering the antibodies de novo.’”
Sanofi's brief further argues that Amgen vastly overstates the importance of Question 2, pointing out that its argument that the Federal Circuit's purported rule will have “profound impacts on innovation” and produce “severe consequences,” especially for pharmaceuticals and biotech, relies primarily on news articles published shortly after the Federal Circuit's decision, and that even those articles acknowledge that the Federal Circuit “left the door open” to the sort of claims that Amgen has asserted.
The brief concludes by asserting that, contrary to Amgen's contention that the decision below deals a devastating blow to biotech and pharma, the panel below was in fact entirely correct when it observed in its opinion respecting en banc denial that “[g]enus claims, to any type of invention, when properly supported, are alive and well.” Sanofi notes than in the year-plus since the Federal Circuit's decision, pharmaceutical companies continue to innovate groundbreaking, lifesaving antibody treatments. 47 Sanofi argues that the real “chilling impact on innovation” would have occurred if Amgen had prevailed, because that would have left other companies with no incentive to develop new therapeutics within the scope of Amgen's broad functional claims—even if those therapeutics might ultimately prove more effective for patients. 48
Thus, to the extent the decision below or other Federal Circuit precedent is used to “den[y] patent rights,” see, e.g., Baxalta Inc. v. Genentech, Inc., 2022 WL 420479 (D. Del. Jan. 13, 2022) (invoking decision below in determining that patent was not enabled), that is the natural and salutary consequence of requiring “a disclosure commensurate with the scope of the genus,” which prevents the “evil” of an inventor “claim[ing] more than he has invented” and impeding innovation, O'Reilly, 56 U.S. (15 How.) at 120.
BRIEF OF GLAXOSMITHKLINE PLC AS AMICUS CURIAE IN SUPPORT OF PETITIONERS
GlaxoSmithKline plc (“GSK”), which characterizes itself as one of the largest pharmaceutical and consumer-health care companies in the world, filed an amicus curiae brief in support of the petitioner in order to “educate the Court on the importance of genus claims to continued innovation,” particularly in the chemical, pharmaceutical, and biotechnological arts. 49
GSK asserts in its brief that in a case in which the patent claim is too narrow the exclusivity of the patent is illusory, allowing an unscrupulous competitor to circumvent the literal scope of the claimed with only minor modifications in order to unfairly benefit from the true inventors' advancement to science. GSK emphasizes that it is particularly challenging to secure meaningful exclusivity in chemistry and biotechnology using only narrow, specific claims, given that known techniques can permit competitors to circumvent the literal scope of a claim by making in substantial changes to the chemical compound or biological molecule. The brief explains that:
For each discovered compound, for example, thousands of close analogues may have similar desired properties and may be suitable for the same utility (e.g., efficacy for treating a disease). Using routine laboratory approaches, a competitor may efficiently synthesize and test variants of the patentee's product, avoiding the need to invest in initial discovery. *** Allowing for a wide breadth of protection based on a genus is, as a practical matter, the only means to ensure that an inventor in these arts actually receives a commercially meaningful period of exclusivity contemplated by our patent system. And because a subsequent innovator who discovers unexpected properties of an included species may still obtain a patent on that discovery, others remain incentivized to build upon past innovations. Genus claims do not preempt the continuing progress of science.
GSK's brief emphasizes the huge amount of investment required to bring innovative new therapies to the market, and the high failure rate associated with drug development.
The brief claims that the Federal Circuit's trend of erecting “high hurdles” for genus claims is already undermining protection for chemical, pharmaceutical, and biotechnology inventions, and that “the shockwaves undermine the patent systems incentives for research-oriented companies, like GSK, to invest in new discoveries.” GSK argues that inventors have been induced to disclose their innovations, describing them in such detail as to enable others to make and use the invention, but that now these inventions are threatened by the Federal Circuit's purported shift enablement law.
According to GSK, this purported heightened enablement standard:
forces a reallocation of resources from discovering breakthrough therapeutics in developing commercial products for the public, toward running experiments for the purpose of writing a patent disclosure. Inventors would turn toward stuffing their patent applications with embodiments, experimental results, and known principles. The rule turns innovators from research scientists into draftsman. And even then, those disclosures may not be enough to survive the rigid “full scope” test. Alternatively, entrepreneurs may choose to forgo patent protection altogether to avoid the risk that they make a fulsome disclosure of their secrets only to face judicial invalidation. That is harmful to the public and the progress of science. It stunts the pace of progress by preventing scientists rebuilding each other's discoveries.
BRIEF OF AMICI CURIAE ASSOCIATION OF UNIVERSITY TECHNOLOGY MANAGERS ET AL.
This brief was filed by a “diverse group of innovators” including Association of University Technology Managers, Inc. (“AUTM”), Biogen Inc., Bristol-Myers Squibb Company, Corning Inc., Merck Sharp & Dohme Corp., and St. Jude Children's Research Hospital, Inc (referred to collectively herein as “AUTM”). 50 This brief to a large extend echoes GSK's concern “[i]f left unchanged, the decision below could slow the pace of research and development and hinder innovation, to the detriment of patients and the public at large.”
The AUTM brief argues that the Federal Circuit's “new rule” will eviscerate the presumption of validity statutorily conferred on patents 51 by requiring the patentee to carry the affirmative burden of showing that something less than “substantial time and effort would be required to reach the full scope of the claimed embodiments,” no matter how routine a predictable the process of making embodiments might be.
The brief argues that in the case of pharmaceuticals, such as therapeutic antibodies, once an innovator blazes the path of discovery, e.g., by deducing the link between a cellular target and a disease, developing a novel antibody that targets that link, and proving that the antibody can be safely and effectively used in humans, others can easily replicate the innovators path.
BRIEF FOR THE UNITED STATES AS AMICUS CURIAE
In its brief filed on behalf of the United States government, the Solicitor General advised the Supreme Court that neither of Amgen's questions for appeal warranted further review, and recommended that the petition for certiorari be denied. 52 This section summarizes the basis for the Solicitor General's position.
With respect to Question 1, the Solicitor General (“SG”) begins by asserting that Amgen's contention that “[e]nablement is a factual determination for a jury” is overly simplistic, and that in fact the determination of whether an invention is adequately enabled includes both legal and factual components.” According to the SG, “construing the Patent Act is a quintessential legal task committed to the court, not the jury.”
The SG argues that Amgen's Question 2, requesting that the Court clarify the governing enablement standard belies its claim in Question 1 that enablement turns exclusively on “factual determinations,” effectively conceding that the meaning of the statutory enablement requirement is a question of law. The brief further argues that the Federal Circuit decisions cited by Amgen in support of its assertion that the Federal Circuit has systematically usurped the jury's role by characterizing enablement as a question of law in fact do not support that contention, because the court in those cases deemed JMOL appropriate only after determining that a reasonable jury would not have had a legally sufficient basis to find “the claims enabled without” undue experimentation.
As to Amgen's assertion that the Federal Circuit's standard is “impossible to satisfy any time a genus claim covers a nontrivial number of embodiments,” the SG argues that this concern is overstated, pointing out that in recent years the Federal Circuit has repeatedly rejected enablement challenges to genus claims. 53 The brief further rejects Amgen's argument that the Federal Circuit applies “a different,” more stringent “enablement test for genus claims” than for other types of claims. The SG points out that the key decision cited by Amgen for the proposition that the Federal Circuit applies a lower enablement threshold to non-genus claims, McRO, Inc., itself involved a genus claim. 54 As to statements in Amgen II observing that the use of broad functional claiming “pose[s] high hurdles,” and “raises the bar for enablement,” the SG argues that those comments simply reflect the fact that a disclosure must be “commensurate with the scope of the claims.” 55
CONCLUDING THOUGHTS
On its face, the question for review in Amgen focuses solely on the enablement requirement. Thus, should the Court decide to lower the bar for compliance with the enablement requirement, the ruling would presumably have no direct impact on the written description requirement, which has conventionally been thought of as imposing an even-higher bar for the sort of claim at issue in the case, e.g., functionally defined chemical genus claims. As noted above, the Court followed up its grant of certiorari in Amgen with a denial of certiorari in Juno v. Kite, a written description case involving claims quite analogous to Amgen's monoclonal antibody claims
In fact, it seems to me that the Federal Circuit's decision in Juno is significantly more problematic from an innovation policy perspective than Amgen II, as explained in an earlier Holman Report. 56 One wonders if it might have made more sense for the Court to have taken up the issue of adequate disclosure in a case like Idenix v. Gilead, where the Federal Circuit explicitly addressed both the enablement and written description requirements in the context of functionally defined chemical genus claims. 57
While it is relatively easy to point out the shortcomings in the Federal Circuit's current § 112(a) jurisprudence, I think it is much harder to come up with an effective alternative. Unfortunately, I suspect that it will be difficult for the Supreme Court to make a positive contribution to the law of adequate disclosure without also tackling Ariad and the Federal Circuit's current interpretation of the written description requirement.