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Esteemed Scientists File Amicus Brief in Amgen v. Sanofi on Respondents' Behalf

By Kevin E. Noonan --

During oral argument before the Supreme Court on Monday in Amgen v. Sanofi, all three advocates (Jeff Lamken for Amgen, Paul Clement for Sanofi, and Colleen Sindzak for the United States) had reason to reference and discuss an amicus brief submitted on behalf of Nobel Prize-winning scientist Sir Gregory Winter and colleagues,* on the scientific questions raised in the case with regard to what is sufficient to satisfy the enablement requirement of 35 U.S.C. § 112(a).

The brief first extols the success of antibody technology as treatments for auto-immune inflammatory diseases and cancer that "has revolutionized the pharmaceutical industry." It characterizes Amgen's position as being that "because it was the first to determine the identity of the amino acids that make up the natural site on PCSK9 where LDL receptors bind (the alleged 'sweet spot') it should be entitled to patents covering any and all antibodies that bind there."  The scientists take issue with this assertion, as they have characterized it, because "Amgen did not invent the natural binding site, nor did Amgen even use its discovery of that alleged 'sweet spot' to make its own two lead antibodies," and contend that Amgen's invention is merely "a hindsight characterization of that which existed naturally.  Amgen attempts to monopolize the natural PCSK9 binding site by reciting the specific amino acid residues of that site."  Moreover, the scientists criticize Amgen for not teaching how to make and use the invention they have claimed.

The scientists state that they have filed their amicus brief to "provide[] information and scientific perspectives concerning several issues at the heart of this case"; these are:

"(1) the unpredictability of antibody design and engineering, including methods of generating and testing antibodies for a particular function;
(2) the lack of guidance provided by Amgen's patents, and indeed, the additional hurdles created by Amgen's claims to make and use the claimed class of antibodies; and
(3) the devastating impact of overbroad, purely functional claims like Amgen's on antibody development and innovation for pharmaceutical drugs."

An antibody's structure (its amino acid sequence) determines its structure ("a fundamental tenet of basic antibody science") but the reverse is not true, according to the brief.  Thus, knowing an antibody's function (such as binding PCSK9 at the "sweet spot") does not provide any information about its structure (which the scientists assert is "what it is," emphasis in the brief).  In addition, Amgen's claims do not encompass "a narrow class of specific antibodies," the scientists assert, but are broadly recited to encompass "any and all antibodies (of unspecified and unknown structure) that bind to a natural antigen at its natural interface with natural receptors."  Referencing undue experimentation (a bit obliquely in the argument), the scientists contend that these claims add to the undue burden of identifying PCSK9-binding antibodies by necessitating that scientists must "make, test, and characterize each one of potentially billions of antibodies to determine whether they are covered by Amgen's claims," i.e., bind to these specific residues in the sweet spot.  And permitting this situation to stand (rather, resurrecting it by reversing the Federal Circuit) would "stifle innovation and set a dangerous precedent for the scientific and pharmaceutical community at large."

The brief then dissects the scientific bases for its arguments.  After providing an "overview" of antibody structure and design, including the graphic:
and the amino acid sequence of the heavy chain variable region comprising CDRs from one of Amgen's antibodies:


the scientists assert that as a consequence of the complexity of antibody structure, antibodies having different amino acid sequences can bind to PCSK9, as illustrated by Respondent's "demonstrative exhibit" (as it was called by Justice Gorsuch during oral argument):

(which illustrates, importantly for Respondents' arguments, that while Amgen's antibodies contact only 2-3 amino acids in the sweet spot, the "competitor antibodies" contact nearly all of them, due purportedly to the different methods by which the competitors produced them).  These structural differences have functional consequence, according to the scientists, as illustrated by the topography of where Sanofi/Regeneron's Praluent antibody binds PCSK9:

(where "21B12" and "31H4" are Amgen's antibodies disclosed in Amgen's patent that bind on either side of the site to which Praluent binds).

The brief states that an antibody's amino acid sequence is the "recipe" for the antibody (a description used by the U.S. during oral argument) because it determines both what an antibody is and what it does (its function), which is dependent on "precise order of amino acids [that] dictates how they will interact, how the chains will fold and arrange, and, additionally, which amino acids will comprise the CDR loops that ultimately interact with antigens."  Consequently, according to the brief, changing even a single amino acid in the sequence "could turn an antibody that binds to an antigen into an antibody that does not bind to that same antigen" as attested at trial by Amgen's expert (a property that can be shared with chemical entities, the scientists asserts in a footnote).  As a consequence, the scientists remind that it is unpredictable how an amino acid sequence change will influence function (in an antibody's case, what it binds to and how well).  The scientists use this unpredictability to criticize Amgen's reliance on "conservative substitutions" as somehow enabling a scientist to modify the antibodies whose sequences are disclosed in Amgen's patent to produce other antibodies having the same PCSK9 binding capabilities.  The scientists attest that conservative substitutions "are by no means a 'shortcut' in antibody engineering for therapeutics" because "the impact of such substitutions remains highly unpredictable," the brief going on to criticize some of Amgen's assertions about such conservative substitutions.  "The only sure way to determine whether the function of an antibody tolerates an amino acid substitution is to make the substitution and test the resulting antibody" according to the scientists.  Nothing about an antibody is predictable, from having an antibody having the desired function to changing portions of the amino acid sequence of such an antibody, even by conservative substitutions.

The logical conclusion advanced by the scientists is that this feature of antibody structure makes obtaining antibodies other than those expressly disclosed by Amgen undue experimentation.  The degree of experimentation is more, not less, for antibodies that must bind to the identified amino acids in the PCSK9 sweet spot according to the brief.

The brief then makes the argument that Amgen's invention is the result of hindsight and that the elements (the existence of the sweet spot) was not invented by Amgen (nor according to the scientists did Amgen discover PCSK9 or how LDL receptors bind to it, the brief identifying by name those scientists who did, none of which "had any connection with Amgen").  And the scientists affirm Respondents' argument that Amgen's claims do not encompass a small genus but rather "cover the entire genus of antibodies that bind to specific amino acid residues on PCSK9 and block PCSK9 from binding" to the LDL receptors (quoting the Federal Circuit), despite not reciting any amino acid sequence limitations.  (The brief spends a considerable number of pages addressing and rebutting analogies made by Amgen and other amici.)

At the end of their legal arguments, the scientists assert that Amgen's disclosure does not satisfy the statutory "make and use" requirement because they "do not come close to teaching an antibody scientist how to make and use antibodies that bind to its claimed specific residues and block binding of LDL receptors."  With regard to Amgen's purported "roadmap" the scientists state that "[n]owhere in this 'roadmap' is any teaching or guidance that provides a practical shortcut to other scientists to make and use the claimed broad genus of antibodies without undue experimentation."

The brief ends on a policy note, the scientists asserting that letting Amgen's claims stand would "block innovation and access to new medicines."  Amgen provided the two expressly recited antibodies (defined by structure) but did not "create or alter any of these natural residues; they existed in nature before Amgen found them."  This strikes (for the scientists) the "warning bell" that permitting claims having Amgen's scope would inherently give Amgen patent protection over the naturally occurring structure of PCSK9, contrary to Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589-90 (2013).  Having an enablement standard that would permit disclosures such as Amgen's here to pass muster would "incentivize companies to use their considerable resources to block access to new therapies by essentially calling 'dibs' on anything that binds to a naturally occurring target of interest" according to the brief.  These scientists rebut arguments by Amgen's amici that claims like Amgen's promote innovation and state that the opposite is true, that "an arms race to patent natural interfaces or surfaces of targets involved in key interactions in a disease undermines scientific development and gives an unfair advantage to companies with unlimited resources."

The brief ends with this summary statement:

In sum, purely functional claims like Amgen's are enormously harmful to scientists who seek to understand, research, and develop new therapies for known targets, particularly where the technology at issue is complex and unpredictable.  No entity should be able to contribute only a few drops and claim ownership of the ocean.  The current enablement standard protects innovation and limits exclusivity to that which is truly inventive.  It should be upheld.

*This group of scientists were Sir Gregory Winter, who won a Nobel Prize in 2018 for methods of making fully human recombinant antibodies by antibody phage display technology; Timothy Springer, Ph.D., the Latham Family Professor of Biological Chemistry and Molecular Pharmacology at Harvard Medical School and Boston Children's Hospital, as well as the Principal Investigator in the Program of Cellular and Molecular Medicine, Division of Hematology/Oncology, Department of Medicine at Boston Children's Hospital, whose work has been in integrins; Robert Kamen, Ph.D., who is an advisory partner at Third Rock Ventures; Andrew Griffith, Ph.D., Professor of Biochemistry at École Supérieure de Chimie Industrielles de Paris (ESPCI Paris) in Paris and a founder of Cambridge Antibody Technology; Royston Jefferis, Ph.D., who is Professor Emeritus in the Institute of Immunology and Immunotherapy within the College of Medical and Dental Sciences at the University of Birmingham, UK, whose work is on antibody design; Nick Ray, Ph.D., Chief Scientific Officer of a UK drug discovery company, C4X Discovery, who has worked on oncology, respiratory diseases, inflammation, central nervous system, pain and metabolic disease and is a named inventor on over 75 patents; and David Manuta, Ph.D., current Board Chair of the American Institute of Chemists (AIC), "a national, non-profit organization founded in 1923 for emphasizing and promoting the relevance of the chemical profession and its practitioners to society at large."

Another Group of Law Professors File Amicus Brief in Amgen v. Sanofi

By Kevin E. Noonan --

The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35 U.S.C. § 112(a).  While these circumstances themselves might motivate amici to file briefs with the Court to weigh in on the Question Presented, the Federal Circuit's trend in recent years to apply more tightly the strictures of Section 112 to chemical and biotechnology inventions and to pharmaceutical cases has provided its own incentive for such briefing.

A total of thirty-four amicus briefs were filed, wherein twelve support Petitioner Amgen, seventeen support Respondents Sanofi and Regeneron, and five were filed in support of neither party.  One of the briefs in support of Respondents was filed by three law professors*, and it is this amicus brief that is discussed in this post.

The Question Presented in the Supreme Court's certiorari grant frames every brief and states:

Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to "make and use" the 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," Pet. App. 14a [emphasis in Question].

In arguing in support of Respondents, these professors' thesis is that the quid pro quo of patent law embodied in Section 112 has two facets.  The first, that an applicant must show possession of an invention, is commonly considered the province of the written description requirement.  In addition, however, the law has a second requirement, the professors argue, which is to disclose sufficient information for the skilled worker to be able to make and use the invention, which is mandated by the enablement requirement.  This second requirement necessitates disclosure of what the professors call "additional information," arrived at by inter alia a parsing of the language of the statute reminiscent of similar linguistic analyses performed by amici in Ariad v. Eli Lilly & Co. (see "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association" and "Amicus Briefs in Ariad v. Lilly: Regents of University of California et al." and in particular the brief filed by Dr. Roberta J. Morris) with regard to written description.  As a doctrinal framework this argument presents a reasoned basis for the statute containing both a written description and enablement requirement, which has been the law at least since the Federal Circuit's Ariad decision (there being both Federal Circuit judges and amici in that case who questioned this construction of the statute).  Whether the statute supports this interpretation is the task undertaken in their arguments.

The distinction frames the entire argument both explicitly and implicitly; the introduction to the Summary of the Argument asserts that "[f]or over two hundred years, the Patent Act has consistently required that an applicant for a patent actually conceive an invention and disclose what they have invented, in a manner that also enables skilled practitioners to make and use the invention conceived and disclosed" (the memes "conceived and disclosed" or "invented and disclosed" being repeated throughout to reinforce the distinction).  The invalidating deficiency in genus claims can arise from "the applicant [having] failed to disclose a sufficient structural-functional relationship" to satisfy the disclosure requirement, particularly where what is disclosed are members of the genus recited merely by their function, according to the professors.  When this happens, what an applicant has done is "shift[ed] to the public the burden of 'inventing' the claimed genus" because the applicant has failed to "provide sufficient information for the public to 'make and use' a properly disclosed and claimed genus invention."

The professors further argue that while the Federal Circuit's decision is "clearly correct" under existing precedent (In re Wands), the Supreme Court needs to provide "guidance" on the two aspects of the proper standard for satisfying the enablement requirement, because "[t]he current 'undue experimentation' standard in Wands . . . does not provide any meaningful referent to guide such analysis ('undue' compared to what?), and improperly conflates these two required inquiries."  The two aspects the professors believe the Court should address are:

First, how much of a structural-functional relationship must be disclosed to validly support a genus claim without improperly shifting the burden of inventing to skilled artisans?  Second, for an already invented and properly disclosed genus, how much additional information must an applicant provide to "enable" skilled artisans to "make and use" the claimed genus?  This second requirement must consider how much time, money, and effort can be imposed by applicants on skilled practitioners in regard to the scope of the invention actually claimed [emphasis in brief].

The policy reasons the professors set forth regarding the necessity for the Court to clarify these standards are that granting genus claims that do not disclose a "sufficient structural-functional relationship" between the species they encompass "provides a disproportionate reward to applicants."  In their view, an applicant should be entitled to the species explicitly disclosed, functionally equivalent species according to the doctrine of equivalents, and if and only if the applicant can "identify a common structural-functional relationship that sufficiently assures that other structures will perform the required functions" should such an applicant be permitted to claim species that they have not individually identified.  The professors also assert that granting genus claims that fail to satisfy these requirements is equivalent to permitting applicants to claim research plans, which "blocks sequential innovation and commercialization of additional structures that the applicant has not yet identified to possess the desired result or recited function, but has claimed using structural or functional language."  This negative consequence is exacerbated because there is a "constrained" experimental use exception under Madey v. Duke Univ., 307 F.3d 1351, 1355, 1362 (Fed. Cir. 2002), that precludes the public or successor inventors from producing such species without potential infringement liability (paradoxically, a consequence less likely for antibody species falling within the scope of the claims at issue here due to the safe harbor provisions of 35 U.S.C. § 271(e)(1)).

The brief characterizes as "a false dichotomy" the choice before the Court argued by Petitioners, between the statutory enablement standard under the strictures of "undue experimentation" and the Federal Circuit's putative "full scope" test.  Because the Constitution grants the patenting power to Congress for inventions, what constitutes an invention they argue "requires [(1)] subjective mental comprehension by applicants of what they claim to have invented; (2) . . . the completed, objectively disclosed inventions that must be enabled for others to "make and use"; and (3) the claims (to be proper) must correspond in scope to the inventions subjectively recognized by the applicant (i.e., what is "regarded" as the invention)."  (These categories correspond to the written description and enablement requirements of 35 U.S.C. § 112(a), respectively, and the "particularly point out and distinctly claim" requirement of 35 U.S.C. § 112(b).)  The professors argue that there is no actual dichotomy here because the "statutory standard requires enabling the invention actually conceived, disclosed, and claimed."  This is itself a "full scope" disclosure standard and not a new creation of the Federal Circuit in its opinion below.  And the professors challenge the assertion that the current Federal Circuit standard requires actual reduction to practice (i.e., to "physically make") all species in a claimed genus (which courts have "never required").  The question comes down to sufficiency in disclosing structure-function relationships between the species that identifies the genus as the invention and provides "additional information" to enable the genus to be made and used by others (where the "degree of time, money, and effort" that does not amount to undue experimentation is "undefined") (here, the professors abandon, as have many, the conventional belief that the amount of "time, money, or effort" is not undue to the extent that the experimentation required is routine and the outcomes predictable).

The professors' brief recites a historical litany of cases illustrating the various ways the Court has attempted to limit the scope of claims depending on the sufficiency of a supporting specification's disclosure, including O'Reilly v. Morse, 56 U.S. 62 (1853); Corning v. Burden, 56 U.S. 252, 269 (1853); Risdon Iron & Locomotive Works v. Medart, 158 U.S. 68 (1853); and Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1, 12-13 (1946).  The brief recognizes that Congress stepped in after the Halliburton decision by permitting functional claiming under a specific statutory provision, 35 U.S.C. § 112(f), but in doing so the statute "specified the permissible limits of structural genus claiming using functional language, limiting claim scope to equivalent species of embodiments actually invented by the applicant and disclosed in the specification."**  The brief cites Brenner v. Manson, 383 U.S. 519 (1966), a decision usually appreciated as being directed to the utility requirement under Section 101, as being consistent with the proscription against claiming a research plan, which is what in their view claiming a genus unsupported by sufficient disclosure amounts to.  (To be fair, Section 112(a) is also recognized as having a utility requirement; see In re Brana, 51 F.3d 1560 (Fed. Cir. 1995).)  The brief also acknowledges the application of the written description requirement to establish possession of an invention under Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc), but asserts that "the Federal Circuit has not yet clearly articulated when sufficient species have been disclosed or when a sufficient structural-functional relationship is identified to justify that the applicant subjectively 'possess[ed]' the genus of a claimed species, and thus invented rather than just claimed that genus."  And, according to the professors, the Supreme Court has also recognized a need for an applicant to identify and disclose "a sufficient structural-functional relationship of a claimed genus to qualify as an 'invention' under the 'enablement' doctrine," citing Consolidated Elec. Light Co. v. McKeesport Light Co., 159 US. 465 (1895) in support.  The brief distinguishes the Court's decision in Minerals Separation, Ltd. v. Hyde, 242 U.S. 261 (1916), a case cited by Amgen and some amici writing in support of their position, stating that in that case the Court "merely held that applicants need not reduce to practice (i.e., physically create) and enumerate in the specification all of the generically claimed species embodiments in order to show what species within the claims work best, when and only when disclosure of a limited number of embodiments was sufficient to demonstrate that the applicant had identified the required structural-functional relationship" (emphasis in brief).

Having set forth their arguments for the enablement requirement having two aspects of what needs to be disclosed to support a genus claim, the professors ask the Court to provide guidance on the proper application of both.  This requires guidance on how much of this structure-function relationship would be needed to satisfy the enablement requirement (a fact-specific question not apparently amenable to the type of broad pronouncements usually made by the Court for such principles).  The professors provide their interpretation of what such a pronouncement would provide from earlier precedent:  that species expressly not disclosed but falling within the scope of a genus claim be the product of "mechanical" rather than "inventive" skill; that the existence of any inoperative embodiments be per se invalidating; and the structure-function relationship must be a "'quality common to all of' the claimed species."  As part of this exercise the professors urge the Court to correct the deficiencies they perceive in how the lower courts and Patent Office have implemented the Wands factors, to the extent that the undue experimentation standard conflates whether the disclosure permits species falling within a claimed genus to be identified with whether these species can be made and used without "too much time, money, and effort" (wherein the first requirement has generally been assessed under the written description requirement).

The professors assert that both the Wands calculus and the Court's precedent (Minerals Separation's "reasonable[ness]" standard) "provide no basis to draw the line between insufficient instruction and sufficient instruction that 'leav[es] something to the skill of persons applying the invention.'"  That standard should depend on economic factors and "whether [it] promotes or restricts sequential innovation" in the professors' view, citing a variety of academic treatments of the question.

Finally, the professors argue the enablement requirement's importance in preventing applicants from obtaining claims to a mere "research plan."  Much of their contentions in this regard, that confining the scope of genus claims too narrowly would not harm innovation, is based on a patentee's ability to rely on the doctrine of equivalents for species falling outside the literal scope of what is claimed (regardless of the unpredictability of such reliance and the limitations otherwise imposed on exercise of the doctrine).  The policy (or doctrinal) position stems from the belief that overbroad claiming (to the extent the Court is persuaded by the argument) "blocks sequential innovation and commercialization of additional structures that the applicant has not yet identified to possess the required function," which was the Court's concern in Halliburton.  And the professors in this context remind the Court of the "constrained experimental use" exception under Madey v. Duke Univ., 307 F.3d 1351 (Fed. Cir. 2002), because under this interpretation of the law "no sequential innovator may seek to discover any additional, functional species within the scope of the claims by making and testing embodiments of the claimed genus."  The professors use the history of antibody claiming, as explicated in S. Sean Tu & Christopher M. Holman, Antibody Claims and the Evolution of the Written Description/Enablement Requirement, 63 IDEA 84, 96 (2021), to illustrate how permitting claims based on function (antigen binding) would have stifled innovation into "the many medically useful alternatives and the variety of antibody options that were developed, some of which are at issue in this case" (although it must be borne in mind that the technology at the time prevented "better" disclosure of antibody species, inter alia, by amino acid sequence).

The brief ends with a call for the Court to decide this "easy case" by affirming the Federal Circuit, while also reiterating the professors' request for the Court's guidance on how to implement the enablement requirement to achieve the policy goals they advocate in their brief.  Their argument boils down to where to draw the line on the scope given to genus claims, and the professors believe innovation is better served in preventing applicants from obtaining claims having a scope that is greater than what an applicant can reliably demonstrate at the time of filing, with invalidation being the price for inadvertent inclusion of inoperative embodiments, no matter how infrequent or easy to discern.  Whether this level of stringency is consistent with innovation will become evident only if the Court were to adopt the standards proposed in the professors' brief, with equally deleterious consequences being possible in either event.

* Professor Joshua D. Sarnoff, DePaul University School of Law; Professor Sharon K. Sandeen, Mitchell Hamline School of Law; and Professor Ana Santos Rutschman, Villanova University, Charles Widger School of Law.

** The brief also notes that Graver Tank & Mfg. Co. v Linde Air Prods. Co., 336 U.S. 271 (1949), an earlier case related to its more famous relative that established the doctrine of equivalents, invalidated a patent to a genus "defined by structure that contained inoperative embodiments," thereby claiming a result rather than an invention (as the professors understand the Court's reasoning).

U.S. Government Files Amicus Brief in Amgen v. Sanofi

By Kevin E. Noonan --

The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35 U.S.C. § 112(a).  While these circumstances themselves might motivate amici to file briefs with the Court to weigh in on the Question Presented, the Federal Circuit's trend in recent years to apply more tightly the strictures of Section 112 to chemical and biotechnology inventions and to pharmaceutical cases has provided its own incentive for such briefing.

A total of thirty-four amicus briefs have been filed, wherein twelve support Petitioner Amgen, seventeen support Respondents Sanofi and Regeneron, and five were filed in support of neither party.  One of the latter briefs was filed by the Solicitor General representing the U.S. Government, and it is this amicus brief that is discussed in this post.

The Question Presented in the Supreme Court's certiorari grant frames every brief and states:

Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to "make and use" the 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," Pet. App. 14a [emphasis in Question].

It will be recalled that the Supreme Court issued a Call for the Views of the Solicitor General (CVSG) last year, and in their responsive brief, the government urged the Court not to grant certiorari (for many of the same reasons set forth in their amicus brief).*

The brief's explication of the proceedings below focused on a few key points.  First, the Solicitor General asserted the determination by the District Court that the claimed invention required that the "millions" of antibodies produced according to the methods disclosed in the specification would need to be tested to determine whether they would be functional (i.e., in preventing binding of PCSK9 to LDL receptors in vivo).  The SG then asserted that there was great uncertainty in the art as to whether an antibody that bound PCSK9 would prevent LDL receptor binding and what the brief stated was a lack of explicit guidance regarding what sequence alterations would result in having or lacking such neutralizing activity.  Making these determinations would take "substantial time and effort" which, the SG contends, could amount to undue experimentation even under the conventional test from In re Wands, particularly at what the Federal Circuit had characterized to be the "far corners of the claimed landscape."  Amgen had chosen to disclose its claimed antibodies by function rather than structure, according to the SG, which as a consequence required such extensive characterization.  In addition, the SG contended that functional descriptions raise "special problems" for enablement, including that a skilled artisan or member of the public can only know whether an antibody falls within the scope of the genus after it is made and tested.  "A specification does not enable a person skilled in the art to make and use a product if the person is compelled to engage in the same trial-and-error process the inventor undertook to produce her innovation in the first place" (emphasis added) according to the brief, and this is the situation here.

In something reminiscent of the "quacks like a duck" test, the SG says that this specification, limited to 26 exemplified antibodies (a calculation Amgen disagrees with in its Reply brief) and perhaps some derivatives cannot support the breadth of the claims, particularly when its "roadmap" essentially instructs to "make the antibody pool and fish for the useful ones."  Taking recourse in a baking analogy (to be repeated later in the brief, perhaps thinking it might resonate with the Court), the SG states in this regard that "Petitioners may not evade an undue-experimentation problem merely by baking the need for experimentation into their roadmap."  The brief makes a comparison between Amgen's 26 exemplars and "structural diversity within the class" of PCSK9-binding antibodies, asserting that Amgen's 26 exemplars "do not even capture the structural diversity represented among the antibodies that petitioners' competitors have already created."

The SG argues that these factual circumstances support the Federal Circuit's decision that the claims were invalid for lack of enablement.  The brief rejects Amgen's characterization of the decision as creating a "full-scope" enablement test, and provides a synopsis of the means an inventor can protect an invention of a genus:

Where an inventor develops an innovative process that may be applied across multiple contexts, she can protect it with a process patent.  Where she invents an innovative product and others attempt to market that product with insignificant alterations designed to evade an infringement suit, the inventor may use the doctrine of equivalents to enforce her patent against those copyists.  But an inventor whose novel product achieves a widely-shared research goal may not obtain a patent for the entire genus of products that perform the same function, thereby foreclosing others from inventing potentially better products that achieve the same goal, unless she provides the information necessary to enable others to make and use the full range of products within the genus.

The SG's legal arguments parallel others who support the Federal Circuit's application of the enablement standard, emphasizing the quid pro quo relationship between patent exclusivity for a limited time and providing an enabling disclosure, as well as encouraging follow-on innovation and ensuring post-expiry that the public has the benefit of the quid pro quo bargain.  The brief cites Supreme Court precedent, including Consolidated Electric Light Co. v. McKeesport Light Co., 159 U.S. 465, 476 (1895) (requiring the disclosure to enable the full scope of the claims prevents an "unwarranted extension of [the] monopoly"), stating that "a patent generally cannot satisfy the enablement requirement when its specification references a broad class of substances without giving a person skilled in the art a means of discerning whether and to what extent each substance will produce a working invention."  Regarding undue experimentation, the SG argues that it will "generally depend not on any bright-line rule but on a flexible inquiry that takes into account the nature of the claimed invention and the field in which it arises," making the first of two baking analogies regarding a cake recipe that provides merely a list of ingredients and leaves it to the baker to determine how to apportion them in making a cake (non-enabling).  The brief then compares baking a cake with making a stew, where it is permissible to instruct the cook to "season to taste" "because similar instructions are standard in recipes, and a more precise instruction is generally impossible given natural variations in ingredients and sodium tolerances."  Finally, the SG argues that seasoning (at least with regard to adding salt) would not be permissible for a bread recipe, because the variable ingredient (salt) has a functional consequence to whether the bread is successfully baked; as a consequence the SG asserts that bread recipes "almost invariably specify the precise quantity necessary to produce the chemical reaction that makes the bread rise."

Returning to situations frankly concerned with enablement, the brief cites Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846), for situations where what counts is the "degree of vagueness and uncertainty" of the disclosure to the expected/desired outcome, wherein there can be some accommodation to naturally occurring variances (in Wood, the variable compositions of clay used in making bricks).  Minerals Separation, Ltd. v. Hyde, 242 U.S. 261 (1916), is cited for the existence of a "reasonableness" standard in the application of the enablement requirement, again dependent on the subject matter of the claimed invention (backed by an impossibility standard for any more precise definition, where it is "obviously impossible to specify in a patent the precise treatment which would be most successful and economical in each case").  But even with these cases the brief asserts there must be a balance between these realities (of inherent uncertainties arising from the subject matter) and the need that "the degree of experimentation required may not be so great as to defeat the basic command of the enablement requirement by forcing others skilled in the art to retrace the patentee's research steps."

The SG also contends that there should be "some general quality" in the members of a claimed genus, which for example was not found among the claimed light filaments asserted against Edison's bamboo filament in Consolidated Electric, as an illustration of how a genus claim can be adequately supported by a generic disclosure.  The SG further uses Consolidated Electric to illustrate undue experimentation arising from the need for Edison to exercise "the most careful and painstaking experimentation" that distinguished his light bulb from what had been disclosed and claimed in his competitor's patent, a good but extreme definition of the undue experimentation principle.  The brief also set forth Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928), as an example of insufficient disclosure for enablement, where starch-based glues were found to be equivalent to animal-based glues when combined at specific proportions with water.  In this case the specification provided no characterization of which starches to use or how to select them except by finding that they work when practiced according to the claims, meaning experimentation was required both to practice and avoid practicing the claimed invention.  The SG crafts a rule from these cases, that a "specification cannot satisfy Section 112(a)'s enablement requirement merely by providing an example of the products that fall within the class and a generalized description that captures other products similar to the example."  Rather, "the patent must describe, with enough particularity to avoid the need for undue experimentation, the structural features that distinguish the genus."  (While perhaps helpful it will be immediately appreciated that the enablement devil will be very much in the details of how the rule is applied.)

With regard to the application of these rubrics to Amgen's patents, the SG perceives two types of undue experimentation here:  first to find antibodies that bind to the PCSK9 "sweet spot" comprising 16 specific amino acids in PCSK9 itself and then to identify those antibodies that prevent LDL receptor binding, equivalent to requiring independent invention to determine which antibodies are which.**  The SG maintained that Amgen's specification fails the test she has crafted because the specification does not identify common structural characteristics "running through" the claimed antibody.***  The SG's brief discounts Amgen's "roadmap" disclosure on the basis that these methods merely produce antibodies but do not necessarily (or with enough certainty) produce antibodies having the functions of the claimed antibodies.  And the SG asserts an unsupported speculation (denied by Amgen in its Reply brief), to the effect that "given petitioners' incentive to create and disclose as broad a range of antibodies as possible to bolster their claims, the specifications' inclusion of only 26 antibodies suggests that petitioners do not know how to produce and describe additional exemplars without undue experimentation."  The SG supports this argument with comparisons between Amgen's exemplars and competitor antibodies (and the number of sweet spot amino acids they bind to) which suggests to SG that Amgen wasn't able ("did not know how") to make any others.  The SG's conclusion is that even for Amgen production of these other antibody species would have required the exercise of undue experimentation.

The brief concludes by more summarily asking the Court to reject Amgen's other arguments, e.g., on the impropriety of the Federal Circuit's "full scope" test, based on the SG's interpretation of Federal Circuit dicta, and that the policy goals Amgen asserts can be better served through other means, including using method claims (suggesting patenting the roadmap, which has the advantage of permitting antibodies to be made by other methods) and resort to the doctrine of equivalents.

The government's amicus brief explicated the history of the proceedings below, including that after two trials the jury in each rendered a verdict that the patents-in-suit had not been shown to be invalid for failing to satisfy the enablement requirement, and that in both instances the Federal Circuit had held otherwise (in this case upholding the District Court's grant of JMOL that the claims were invalid for lacking enablement).  Practitioners before the Supreme Court have noted that there is a belief among some that the Supreme Court respects the jury process and the wisdom that can arise from its exercise.  The government's brief emphasizing these procedural aspects of the question may put any such faith to the test.

* Amgen in its Reply brief noted that the government's brief mistakenly used the grant date of at least some of Amgen's patents for their filing dates, creating the incorrect impression that Amgen had filed these patents after at least some of their competitors' application filings.

The actual dates for these Amgen patents are:
USP 8,030,457 (granted Oct. 4, 2011), filed Aug. 22, 2008, priority to Aug. 23, 2007
USP 8,829,165 (granted Sept. 9, 2014) filed 4/10/2013, priority to Aug. 23, 2007
USP 8,859,741 (granted Oct. 14, 2014), filed 4/24/2014, priority to Aug. 23, 2007

To be fair, the SG's brief made the same error in at least one of Sanofi's patents:
USP 8,062,640 (granted Nov. 22, 2011), filed 12/15/2009, priority to Dec. 15, 2008

** There was a certain amount of scientific misunderstanding in this portion of the brief, which asserts:  "For the remaining 24 exemplars, the specifications provide only the amino acid sequences.  Nonetheless, this kind of structural information is generally sufficient to permit a scientist to 'make and use' any of the exemplars she chooses through standard laboratory techniques that allow scientists to use an antibody's amino acid sequence to reverse-engineer additional antibodies with the same sequence"; perhaps the SG meant antibodies with equivalent amino acid sequences.

*** It should be noted that the specification discloses the crystal structure of two of Amgen's antibodies and it is possible that Amgen might have been able, but did not, to extract sufficient common structural characteristics to satisfy the SG's test.

AbbVie Files Amicus Brief in Amgen v. Sanofi

By Kevin E. Noonan --

The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35 U.S.C. § 112(a).  While these circumstances themselves might motivate amici to file briefs with the Court to weigh in on the Question Presented, the Federal Circuit's trend in recent years to apply more tightly the strictures of Section 112 to chemical biotechnology, and pharmaceutical cases has provided its own incentive for such briefing.

Nearly three dozen amicus briefs were filed, with twelve supporting petitioners, seventeen supporting respondents, and five filed in support of neither party (although one of them, filed on behalf of the High Tech Inventors Alliance and the Computer and Communications Industry Association argues that the Federal Circuit's decision below was correct and consistent with settled law); these amici include AbbVie; Glaxo Smith Kline; Instil; a combined brief on behalf several pharmaceutical and other companies, and the Association of University Technology Managers; patent law associations, including the NY Patent Law Association, the Intellectual Property Lawyers Association of Chicago, and the National Association of Patent Practitioners; the Intellectual Property Owners association; the American Chemical Society; and more than a dozen intellectual property law professors (with Mark Lemley as Counsel of Record).

The Question Presented in the Supreme Court's certiorari grant frames every brief and states:

Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to "make and use" the 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," Pet. App. 14a [emphasis in Question].

AbbVie's brief is directed at the consequences of the Federal Circuit's recent foray into restricting the scope of so-called "genus" claims to what an applicant has expressly disclosed in her specification.  And those consequences are to "chill investment and innovation" for subject matter like chemicals, pharmaceuticals and biotechnology inventions AbbVie argues.  The Federal Circuit's decisions are contrary to both the text of the statute as well as how enablement interacts with the rest of patent law and is contrary to the Supreme Court's "longstanding patent precedent" in AbbVie's view and should be overturned.

With regard to AbbVie's "innovation and investment" argument the brief extols the genus claim as a way for an inventor to obtain protection not only for the species expressly disclosed but for related compounds that "shar[e] the same innovation."  And this scope of patent protection is what a "pioneering inventor" who discloses "a breakthrough invention with broad applicability" deserves, the brief argues, not just for the inventor's benefit but to "promote the progress of science " (technically, the Useful Arts).  As with many of the briefs this one cites the Federal Circuit's statement that it was "rais[ing] the bar for enablement" in its decisions (emphasis in brief).  This test requires that "patent specifications for genus claims with functional limitations do not comply with the enablement requirement of 35 U.S.C. § 112 unless they enable those skilled in the art 'to reach the full scope of claimed embodiments' experimentation," which in practice means an inventor must "enable a person having ordinary skill in the art . . . to cumulatively identify and make the various embodiments of the invention without 'substantial time and effort.'"  This standard is to be applied to the "full scope" of the claim (which for chemical, biotechnological and pharmaceutical claims could easily encompass millions of compounds), making the requirement into an "insuperable" hurdle to patenting claims having functional language applicable to a broad genus, the brief argues.  The consequence of this standard is to "destroy[] the basic 'bargain' of patent law" by "not giv[ing] pioneering inventors adequate range of patent protection for breakthrough inventions with broad applicability" according to AbbVie.  This affects (negatively) "investment and innovation" because the type of chemical, biotechnological and pharmaceutical inventions having severely reduced scope under this test are also those that "typically require significant risk, substantial investment, and years of research" and thus patent protection for these inventions is particularly vulnerable to the reduced scope the Federal Circuit's test that has "invalidated genus claim after genus claim" in these arts.  As a result, competitors have been able to "design around" claims to such inventions and "captur[e] a patent's economic returns."

On the law, the brief argues that there is nothing in the statutory language suggesting much less mandating that "enablement depends on the cumulative time and effort required to make virtually all variations of the invention," which in the context of the case before the Court amounts to "whether the specification enables virtually every species within the genus without undue experimentation" (emphasis in brief).  In re Wands is the relevant (and correct) standard for enablement, AbbVie argues, and the Supreme Court should affirm its primacy (which of course the Court has never taken the opportunity to do).

The brief casts the question in terms of the "carefully crafted bargain" between the inventor and the public, trading an enabling disclosure of the invention for the exclusivity term of the patent grant, relying on Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 480-81 (1974), and Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 63 (1998), for these principles, and emphasizing the public benefit of an increase in scientific progress, economic competition, and prompt delivery of advances in the art from which subsequent inventors can build.  AbbVie argues that the Federal Circuit's test "does not further the fundamental purposes of the enablement requirement" but rather "disrupts the patent bargain, chills investment in new discoveries and innovation, and creates uncertainty and litigation by adding an unnecessary layer of analysis to the settled Wands factors for determining enablement."

This disruption is not limited to the chemical, biotechnological, and pharmaceutical arts AbbVie reminds the Court, because "nearly every field" uses genus claiming to seek broader claim scope than the species expressly disclosed. But genus claims are particularly important to  inventions in the chemical, biotechnological, and pharmaceutical arts because in these disciplines "breakthrough innovations invariably require very significant investments of time and money" that would lose the incentive to be pursued without patent protection of adequate scope (with concomitant loss of scientific progress according to AbbVie).  Taking extensively from the late Dmitriy Karshtedt's paper entitled The Death of Genus Claims (Dmitry Karshtedt, Mark A. Lemley & Sean B. Seymore, The Death of the Genus Claim, 35 HARV. J. L. & TECH. 1, 23-35 (2021), the brief catalogs the Federal Circuit's recent case law applying the "full scope" principle to chemical, biotechnological, and pharmaceutical patent claims, contrary to earlier precedent like In re Angstadt, 537 F.2d 498, 502-03 (C.C.P.A. 1976), as well as Wands.  Illustrating the negative consequences arising from this doctrine, the brief notes that trade secret law is not an available option, for example for claims reciting active pharmaceutical ingredients and in any event the Court recognized it to be a "much weaker choice" in Kewanee Oil.

The full scope test is also unnecessary insofar as it does not "further the purpose of the enablement requirement because it departs from the practical inquiry of what a PHOSITA needs to know in order to make and use an invention," something the Supreme Court recognized to be the purpose of the enablement requirement in The Telephone Cases, 126 U.S. 1, 536 (1888), and Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 271 (1916).  The Wands test has "provided a predictable framework for analyzing enablement and undue experimentation" since 1987, is "derived from [the] Court's precedent" (citing cases in a long footnote) and has "demonstrated a time-tested ability to operate effectively for all kinds of claims" based on case-specific facts.  For these reasons, AbbVie urges the Court not to "engraft" the full scope test onto the Wands analysis, which is a "context-specific, case-by-case method [that] provides a balanced and workable enablement test" and should be preserved, AbbVie's brief urges.

Finally, the brief argues that the test is contrary to the statutory language and Supreme Court precedent (finding not surprisingly no mention of the "full scope" test in the statute) and comparing the required disclosure for enablement with what is required for priority (i.e., a single embodiment) (but to be fair these requirements are directed at two different aspects of patent law).  The brief argues that other sections of the Patent Act police overbroad claiming, such as Sec. 101 and 103 and Sec. 112(a) itself, in the written description requirement (something the Court has also not opined upon and affirmatively avoided doing so in denying certiorari in Juno v. Kite).  Regarding the Court's putatively contrary precedent, the brief recites (in addition to The Telephone Cases and Minerals Separation; Mowry v. Whitney, 81 U.S. 620 (1871); Tilghman v. Proctor, 102 U.S. 707 (1880); Expanded Metal Co. v. Bradford, 214 U.S. 366, 380 (1909); and Eibel Process Co. v. Minn. & Ontario Paper Co., 261 U.S. 45, 65-66 (1923).

Only rarely (Graver Tank and Bowman v. Monsanto) has the Supreme Court been persuaded by the types of arguments AbbVie makes in its brief, particularly with regard to the negative economic consequence of permitting an "unscrupulous copyist" to reap the benefits of a claimed invention.  The Court can be inscrutable regarding the reasons the Justices decide to take a case and have been known to appear to be sensitive to arguments of questionable provenance but ample public passion (see Assoc. Molec. Pathol. v. Myriad Genetics as an example).  Similar passions are at play here, regarding for example increasing drug costs, and how the Court ultimately decides the issues before it in this case, in the face of these extralegal considerations, may not depend as much AbbVie might hope on the arguments and precedents set forth in its brief.

GlaxoSmithKline Files Amicus Brief in Amgen v. Sanofi

By Kevin E. Noonan --

The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35 U.S.C. § 112(a).  While these circumstances themselves might motivate amici to file briefs with the Court to weigh in on the Question Presented, the Federal Circuit's trend in recent years to apply more tightly the strictures of Section 112 to chemical, biotechnology, and pharmaceutical cases has provided its own incentive for such briefing.

Nearly three dozen amicus briefs were filed, with twelve supporting petitioners, seventeen supporting respondents, and five filed in support of neither party; these amici include AbbVie; Instil; a combined brief on behalf several pharmaceutical and other companies, and the Association of University Technology Managers; patent law associations, including the NY Patent Law Association, the Intellectual Property Lawyers Association of Chicago, and the National Association of Patent Practitioners; the Intellectual Property Owners association; the American Chemical Society; and more than a dozen intellectual property law professors (with Mark Lemley as Counsel of Record), and the subject of this post, GlaxoSmithKline (GSK).

The Question Presented in the Supreme Court's certiorari grant frames every brief and states:

Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to "make and use" the 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," Pet. App. 14a   in Question].

After establishing its bona fides as a leading biopharmaceutical company, GSK begins its brief by focusing on genus claims per se and their importance for protecting and fostering development of its products and the concomitant benefit to the public that comes from those products.  According to GSK, genus claims often are directed to "major scientific breakthroughs, establish first-in-class medicines, and encourage downstream improvements that can themselves be patented."  The importance of genus claims, GSK explains, is that they encompass "closely related species of modifications" that can be exploited by competitors to expropriate "the heart of the invention" unless the innovator has a genus claim that prevents such expropriation.  And of course if the invention cannot be protected from copying by a competitor the incentive to innovate and bring an innovative compound to market is diminished.  An innovator would be motivated instead "to maintain secrecy over the breadth of her breakthrough for as long as possible" and as a result "[t]he public's ability to build on the collective knowledge of discoveries and inventions would suffer and, most importantly, patients would have access to fewer vital medicines."

GSK also reminds the Court that genus claims encourage further innovation, including for example improved species in the genus that are independently patentable due to "non-obvious benefits or unexpected properties."  This situation can provide access to better medicines even if these downstream products while patentably distinct are not independently patentable, due to the "safe harbor" under 35 U.S.C. § 271(e)(1) during development and regulatory exclusivities thereafter.

GSK argues (as does Amgen as well as other amici) that the proper test is the "undue experimentation" test of inter alia In re Wands and not the "full scope" test purported to have been created below by the Federal Circuit in this case.  This is due to the quid pro quo bargain between patentee (who obtains exclusivity limited in time) and the public (that gains the unfettered right to make, use, sell, offer to sell and import after the term of the patentee's exclusive right has expired).  The enablement requirement has been developed to keep that bargain balanced so the public can understand how to make and use the claimed invention when the patentee's  exclusivity has expired.  But, GSK argues, this does not require the patent to "literally teach every variation of an invention to satisfy the enablement requirement" and the claims' breadth should not be dispositive, according to GSK (and this is true "even if the variations included in the scope are numerous or infinite").  GSK asserts that this is once again another inflexible Federal Circuit test that "den[ies] recourse to common sense" that the conventional undue experimentation standard supplies.  And to make matters worse, the "full scope" test is "atextual," punishes life sciences innovators and usurps Congress's role over patent law, according to the brief which characterizes the "full scope" test as a "domain-specific patentability rule" that has recently resulted in "focused, unfavorable treatment" of biotechnology and pharmaceutical claims by the Federal Circuit.

GSK then makes four related, more detailed arguments in support of its urging the Court to reject the Federal Circuit's analysis and reverse the judgment below.  The first of these is in both practical and doctrinal terms the "critical importance" of genus claims (which the brief apprehends the Court recognized by granting certiorari on this Question Presented and not on the alternative, i.e., whether enablement is a question of fact or law).  This question is important not just in the chemical, biotechnological and pharmaceutical arts, GSK argues (although conceding that these claims have the greatest impact in those disciplines, citing a law review article by the late Dmitry Karshtedt (Karshtedt, Lemley & Seymore, The Death of the Genus Claim, 35 HARV. J.L. & TECH. 1 (2021)) that genus claims are "[t]he central feature of patent law in the chemical, biotechnology, and pharmaceutical industries." (emphasis added in brief).  Genus claims are also important "to protect a class of apparatuses or methods sharing the common advancement of the invention against unscrupulous competitors seeking to evade the literal scope of the claims" in all arts according to the brief, setting forth illustrations of other technology areas where patents are drafted to claims a class, including Edison's lightbulb (Patent No. 223,898) that was claimed broadly enough to ensnare "copycat lightbulbs."  However, the brief stays focused on the importance of genus claims in life sciences patenting for chemical compounds having a use (for treating disease, for example) because related analogues to a particular chemical species are likely to have similar properties.  This produces the risk of copyists that genus claiming solves, evidence for this being that genus claims are "ubiquitous" in life science patents, citing Sean B. Seymore, Patenting the Unexplained, 96 WASH. U.L. REV. 707, 729 (2019).

As a consequence, according to GSK's brief, if genus claims are not allowed (i.e., are not considered to be enabled absent a recitation of an impossible number of species) the incentive to innovate will be harmed, citing Karshtedt that the "full scope" test is a trap because it is impossible to satisfy the test so the choice is to disclose the invention claimed narrowly and thus invite copycat competitors or perform "impractical, wasteful experiments" to support a genus claim.  GSK argues that the futility of the latter approach was recognized by the CCPA in In re Angstadt, 537 F.2d 498, 502 (C.C.P.A. 1976), because even then (should an applicant attempt to disclose a multitude of species) a court could decide that "in the far corners of the genus" there could be species that were too difficult to make to support the genus and thus invalidate the claim.  The brief also asserts that the Federal Circuit's decision if allowed to stand will have a disastrous, retroactive effect on already-disclosed innovation in life sciences claims.

GSK's second argument is that, perhaps counterintuitively to the casual observer genus claiming encourages follow-on innovation.  The very risk the Federal Circuit recognized as a policy basis for its decision paradoxically (according to GSK) is more likely to be caused by the decision.  The reason for this outcome is that genus claims to an invention do what all claims do: provide an incentive for additional innovation, here to species within the genus that are separately patentable, being "non-obvious improvements to past discoveries, including for species with unexpected properties that fall within the genus claims of a preexisting patent," citing Abbvie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1379 (Fed. Cir. 2014); accord, Prometheus Labs., Inc. v. Roxane Labs., Inc., 805 F.3d 1092, 1098 (Fed. Cir. 2015); Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1321–22 (Fed. Cir. 2004); Eli Lilly & Co. v. Bd. of Regents of Univ. of Wash., 334 F.3d 1264, 1270 (Fed. Cir. 2003); In re Petering, 301 F.2d 676, 683 (C.C.P.A. 1962).  This provides the patent incentive to patentably distinct species which will  (of course) be subject to the dominating effect of the genus patent.  As a result "[m]arket forces then encourage cooperation" in the form of cross-licensing.  These incentives are even more compelling in pharmaceutical and biotechnology inventions because seeking (and obtaining) injunctions can be "untenable" for important medicines, GSK argues.  And the patent does not provide a disincentive to "downstream" innovators because their efforts are protected from infringement liability (at least for regulated products like drugs) by the safe harbor of 35 U.S.C. § 271(e)(1).

GSK's third argument focuses on the undue experimentation test and its rationale.  This portion of the brief recapitulates arguments by others that the enablement requirement is part of the patent quid pro quo under Supreme Court precedent, citing Evans v. Eaton, 20 U.S. (7 Wheat.) 356, 418 (1822); Kellogg Co. v. Nat'l Biscuit Co., 305 U.S. 111, 120 (1938); Universal Oil Co. v. Globe Co., 322 U.S. 471, 484 (1944); Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 480–81 (1974).  But, GSK argues, "artisans are not automatons" (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007)) and "[u]ntil recently, courts have recognized the folly of counting the number of species included within the scope of a claim for determining its validity (In re Cavallito, 282 F.2d 357, 361 (C.C.P.A. 1960)), culminating in the "undue experimentation" analysis set forth in In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), that GSK asserts provides the proper standard for enablement. In the face of this precedent the brief characterizes the Federal Circuit's decision under review as a "rigid and inelastic" one that "leave[s] no room for nuance and den[ies] factfinders recourse to common sense," citing KSR.  And this test is "untethered" to the reason enablement is part of patent law, again citing Professor Karshtedt's The Death of Genus Claims law review article.  Moreover, GSK argues, the law already contains limits on the scope of genus claiming, such as O'Reilly v. Morse, 56 U.S. (15 How.) 62, 135 (1853), making the Federal Circuit's "more stringent" test unnecessary in GSK's view.

Finally, GSK argues that the test punishes pharmaceutical and biotechnology companies.  According to the brief, the Federal Circuit's test is an example of a "domain-specific" rule because its effects will largely fall on life-science inventions, citing Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380, 1382 (Fed. Cir. 2013), and Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1153–54 (Fed. Cir. 2019).  The reason for this situation is "no accident," because biotech and pharma inventions depend, perhaps disproportionately on genus claims.  This is because the nature of chemical and biological science is that there are large but finite ("countable") numbers of species within the genus of many inventions in these disciplines (noting that in the patents before the Court there are 97,000 antibody species that can be envisioned using the amino acid substitutions in Table 1 in these patents).  If it is truly necessary to "fine-tune intellectual property law and incentives for particular industries," GSK asserts, then that should be up to Congress, not the courts, using the Hatch-Waxman Act, the Plant Variety Protection Act, the and the Biologics Price Competition and Innovation Act (BPCIA) as examples of Congress doing such fine-tuning.

For all these reasons, GSK urges the Court to reverse the Federal Circuit's decision below.

Webinar on Priority Entitlement in Europe

J A Kemp will be offering a webinar entitled "Priority Entitlement in Europe -- Current Best Practice" on March 21, 2023 at 16:00 pm (GMT).  Andrew Clark and Guy Brain of J A Kemp will review European case law and practice in this area and outline practical steps and measures that can be taken by applicants to help safeguard priority claims in Europe, and look forward to potential developments in the assessment of priority entitlement at the EPO in view of the referrals of the Enlarged Board of Appeal pending as G 1/22 and G 2/22.  The webinar will address the following topics:

• Keeping track of who holds the right to claim priority as a procedural right
• A round-up of key cases at the EPO on law and practice relating to priority entitlement
• The background leading to EPO Enlarged Board referrals G 1/22 and G 2/22
• Practical advice to help mitigate against attacks on priority claims in Europe

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

Webinar on Obtaining and Managing REMS Patent

Strafford will be offering a webinar entitled "Obtaining and Managing REMS Patents: What Patent Prosecutors Need to Know, USPTO and FDA Policies and Rules" on March 21, 2023 from 1:00 to 2:30 pm (EDT).  Joanna T. Broughet of BioPharma Law Group and Mark J. Feldstein, Thomas L. Irving, and Adriana L. Burgy of Finnegan Henderson Farabow Garrett & Dunner will guide patent counsel on the issues surrounding Risk Evaluation and Mitigation Strategy (REMS) patents and listing in the Orange Book, discuss REMS patents and what patent prosecutors need to know, address the current efforts of the USPTO and FDA to determine what policy or rules will govern the listing of REMS patents, discuss other issued patents relating to REMS, and offer best practices for obtaining and managing REMS patents.  The webinar will review the following issues:

• What are the considerations for patent counsel when deciding whether to list a REMS patent in the Orange Book?
• What is the significance of the FTC intervention in the Jazz case?
• What best practices should counsel employ when obtaining and managing REMS patents?

The registration fee for the webcast is $347.  Those interested in registering for the webinar, can do so here.