Amicus Curiae Brief — Idenix Pharmaceuticals LLC, et al., Petitioners v. Gilead Sciences, Inc.
Supreme Court briefNov 16, 2020
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No. 20-380
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In The
Supreme Court of the United States
---------------------------------♦--------------------------------IDENIX PHARMACEUTICALS LLC AND
UNIVERSITA DEGLI STUDI DI CAGLIARI,
Petitioners,
v.
GILEAD SCIENCES, INC.,
Respondent.
---------------------------------♦--------------------------------On Petition For A Writ Of Certiorari
To The United States Court Of Appeals
For The Federal Circuit
---------------------------------♦--------------------------------BRIEF OF INTELLECTUAL PROPERTY
PROFESSORS AS AMICI CURIAE
IN SUPPORT OF PETITIONERS
---------------------------------♦--------------------------------PROFESSOR MARK A. LEMLEY
Counsel of Record
STANFORD LAW SCHOOL
559 Nathan Abbott Way
Stanford, CA 94305
650-723-4605
mlemley@law.stanford.edu
================================================================================================================
COCKLE LEGAL BRIEFS (800) 225-6964
WWW.COCKLELEGALBRIEFS.COM
i
TABLE OF CONTENTS
Page
Table of Contents .................................................
i
Table of Authorities .............................................
iii
Interest of Amici Curiae ......................................
1
Summary of Argument ........................................
1
Argument .............................................................
3
I.
II.
Genus Claims Have Traditionally Been
Understood to Be Critical for Meaningful
Patent Protection in the Chemical Industry ..............................................................
3
A. This Court’s Precedents Recognize the
Critical Role of Genus Claims .............
4
B. Decisions of Other Tribunals and Secondary Sources Confirm the Historical
Viability of Genus Claims ...................
7
C. Enablement is Not a Numbers Game....
9
The Federal Circuit Has Changed the Law
of Enablement............................................ 12
A. The Federal Circuit Has Made Enablement a Numbers Game ....................... 12
B. The Federal Circuit’s Approach to
§ 112(a) Frustrates Patenting and Innovation in the Chemical and Life Sciences .................................................... 14
III.
This Court Should Grant Certiorari to Restore
the Traditional Law of Genus Claims .......... 15
A. The Federal Circuit’s New Rule Ignores
the Knowledge of the PHOSITA ........... 16
ii
TABLE OF CONTENTS—Continued
Page
B. The Federal Circuit’s New Requirement of “Full Scope” Enablement Is
Not Consistent with the Purposes of
that Doctrine ....................................... 18
C. The Federal Circuit’s New Requirement
Makes Effective Patent Protection
Nearly Impossible in the Chemical Industry ................................................... 21
Conclusion............................................................ 25
APPENDIX
APPENDIX A—List of Signatories ..................... App. 1
iii
TABLE OF AUTHORITIES
Page
CASES
Atlas Powder Co. v. E.I. du Pont de Nemours &
Co., 750 F.2d 1569 (Fed. Cir. 1984) ....... 10, 11, 18, 19
Bonito Boats, Inc. v. Thunder Craft Boats, Inc.,
489 U.S. 141 (1989) .................................................10
Brenner v. Manson, 383 U.S. 519 (1966) ....................17
Carnegie Steel Co. v. Cambria Iron Co., 185 U.S.
403 (1902) .............................................................. 5, 6
Consol. Elec. Light Co. v. McKeesport Light Co.
(Incandescent Lamp Patent), 159 U.S. 465
(1895) ..................................................................... 6, 8
Corona Cord Tire Co. v. Dovan Chem. Corp., 276
U.S. 358 (1928) ..........................................................8
Cont’l Paper Bag Co. v. E. Paper Bag Co., 210
U.S. 405 (1908) ..........................................................5
Ex parte Sloane, 22 U.S.P.Q. 222, 1934 WL 25325
(Pat. Off. Bd. App. 1934) ............................................8
Fields v. Conover, 443 F.2d 1386 (C.C.P.A. 1976) .......11
Fullerton Walnut Growers’ Ass’n v. AndersonBarngrover Mfg. Co., 166 F. 443 (9th Cir.
1908) ..........................................................................7
Grasselli Chem. Co. v. Nat’l Aniline & Chem. Co.,
26 F.2d 305 (2d Cir. 1928) .........................................7
Graver Tank & Mfg. Co. v. Linde Air Prods. Co.,
339 U.S. 605 (1950) ...................................................3
Holland Furniture Co. v. Perkins Glue Co., 277
U.S. 245 (1928) ..........................................................7
iv
TABLE OF AUTHORITIES—Continued
Page
Hybritech Inc. v. Monoclonal Antibodies, Inc.,
802 F.2d 1367 (Fed. Cir. 1986) ................................19
In re Angstadt, 537 F.2d 498 (C.C.P.A.
1976) ........................................................ 9, 11, 14, 22
In re Dillon, 919 F.2d 688 (Fed. Cir. 1990) .................17
In re Grimme, 274 F.2d 949 (C.C.P.A. 1960) ................9
In re Kalm, 378 F.2d 959 (C.C.P.A. 1967) ................. 3, 4
In re Wands, 858 F.2d 731 (Fed. Cir. 1988) .......... 10, 11
Intelligent Bio-Sys., Inc. v. Illumina Cambridge
Ltd., 821 F.3d 1359 (Fed. Cir. 2016) ........................16
Malignani v. Hill-Wright Elec. Co., 177 F. 430
(C.C.S.D.N.Y. 1910)....................................................8
Minerals Separation, Ltd. v. Hyde, 242 U.S. 261
(1916) ......................................................... 6, 9, 11, 22
Takeda Chem. Indus., Ltd. v. Alphapharm Pty.,
Ltd., 492 F.3d 1350 (Fed. Cir. 2007) ........................17
The Telephone Cases, 126 U.S. 1 (1888) ................... 4, 5
Tilghman v. Proctor, 102 U.S. 707 (1880).....................5
Tyler v. Boston, 74 U.S. (7 Wall.) 327 (1868) ................7
Wood v. Underhill, 46 U.S. (5 How.) 1 (1846) ...............7
Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d
1380 (Fed. Cir. 2013) ................................... 12, 13, 19
v
TABLE OF AUTHORITIES—Continued
Page
STATUTES
35 U.S.C. § 103 ............................................................16
35 U.S.C. § 112 .................................................... passim
TREATISES
GEORGE TICKNOR CURTIS, A TREATISE ON THE
LAW OF PATENTS FOR USEFUL INVENTIONS
(Boston, Little, Brown & Co., 4th ed. 1873) .............9
WILLIAM CALLYHAN ROBINSON, THE LAW OF
PATENTS FOR USEFUL INVENTIONS (Boston, Little, Brown & Co. 1890) .................................... 5, 9, 11
OTHER AUTHORITIES
JAMES BESSEN & MICHAEL J. MEURER, PATENT
FAILURE: HOW JUDGES, BUREAUCRATS, AND
LAWYERS PUT INNOVATION AT RISK (2008)................24
DAN L. BURK & MARK A. LEMLEY, THE PATENT
CRISIS AND HOW THE COURTS CAN SOLVE IT
(2009) .......................................................................23
Kristina Caggiano Kelly & Paul A. Calvo, The
Scope of a Sextillion – How Courts Misapply
Law of Enablement to Life Sciences, BNA IP
LAW NEWS, May 1, 2020 ..........................................21
ROBERT C. FABER, LANDIS ON MECHANICS OF
PATENT CLAIM DRAFTING (5th ed. 2003 & Supp.
July 2008) ..................................................................9
vi
TABLE OF AUTHORITIES—Continued
Page
Dmitry Karshtedt, Mark A. Lemley & Sean B.
Seymore, The Death of the Genus Claim, 35
HARV. J.L. & TECH. (forthcoming 2021) ...... 3, 4, 6, 15
CHRIS P. MILLER & MARK J. EVANS, THE
CHEMIST’S COMPANION TO PATENT LAW (2010) ...........9
WENDY H. SCHACHT, CONG. RES. SERV., RL33367,
PATENT REFORM: ISSUES IN BIOMEDICAL AND
SOFTWARE INDUSTRIES (2006) ...................................23
Sean B. Seymore, Patenting Around Failure, 166
U. PA. L. REV. 1139 (2018) ......................................19
JOHN R. THOMAS, CONG. RES. SERV., R43264, TAILORING THE PATENT SYSTEM FOR SPECIFIC INDUSTRIES (2015)........................................................23
1
INTEREST OF AMICI CURIAE
Amici curiae are intellectual property law professors throughout the United States.1 We have considerable experience with both patent practice and patent
doctrine. Amici have no personal interest in the outcome of this litigation, but we share a professional
interest in seeing that the patent laws are applied in
such a way as to provide adequate incentives for innovation.2 All parties have consented to the filing of this
brief.
---------------------------------♦---------------------------------
SUMMARY OF ARGUMENT
The central feature of patent law in the chemical,
biotechnology, and pharmaceutical industries is the genus claim—a patent that covers not just one specific
chemical but a group of related chemicals. Genus
claims are everywhere, and any patent lawyer will tell
you they are critical to effective patent protection. This
Court has long recognized the legality and desirability
of genus claims. Without them, a competitor could
make a minor change to the chemical the patentee
1
Appendix A includes a list of the amici.
Amici certify that no party or party’s counsel authored this
brief in whole or in part, no party or party’s counsel contributed
money that was intended to fund the preparation or submission
of this brief, and no person or entity—other than amici or their
counsel—authored the brief or made a monetary contribution to
its preparation or submission.
2
2
invented and avoid liability while capturing the heart
of the invention.
This Court, the Patent and Trademark Office
(“PTO”), and the regional circuit courts have long upheld genus claims, finding that they were compliant
with the enablement requirement of 35 U.S.C. § 112(a)
provided they taught the person having ordinary skill
in the art (“PHOSITA”) enough that the PHOSITA
could make and use a chemical within the genus without undue experimentation. Early cases from the
Court of Appeals for the Federal Circuit and one of its
predecessor courts, the Court of Customs and Patent
Appeals (“CCPA”), were also in accord.
But the Federal Circuit has changed the law dramatically in recent years, to the point where it is no
longer possible to have a valid genus claim in the
chemical and biotechnology industries. Federal Circuit
opinions confronting those claims almost always hold
them invalid. They do so because the Federal Circuit
has, without acknowledging it, fundamentally changed
this important area of law. Under that new interpretation, it no longer suffices that the patent gives enough
information that the PHOSITA can “make and use” the
invention, as § 112(a) requires. Rather, the Federal Circuit now rejects claims as invalid because the genus
contains thousands or millions of possible chemicals,
unless the patent itself identifies exactly which of
those myriad species will work. That is an impossible
burden, and it is not one the law imposed until recently.
3
This case presents a strong vehicle for reviewing
the Federal Circuit’s new rule and returning the law to
its traditional moorings. The Federal Circuit’s decision
“cemented . . . a categorical shift in thinking away from
teaching the PHOSITA and towards a precise delineation of the boundaries of the claim.” Dmitry Karshtedt,
Mark A. Lemley & Sean B. Seymore, The Death of the
Genus Claim, 35 HARV. J.L. & TECH. (forthcoming 2021),
at 43 (“KLS”), available at https://ssrn.com/abstract=
3668014. As the authors note, the Federal Circuit opinion in this case “turns the law of genus claims on its
head.” Id. at 66.
---------------------------------♦---------------------------------
ARGUMENT
I.
Genus Claims Have Traditionally Been Understood to Be Critical for Meaningful Patent Protection in the Chemical Industry
This Court has long recognized that, in order to
achieve meaningful patent protection, the patentee
must be allowed to claim more than merely a specific
embodiment in the invention. See Graver Tank & Mfg.
Co. v. Linde Air Prods. Co., 339 U.S. 605, 607 (1950)
(warning that failure to prohibit minor variants on an
invention would turn a patent into a “hollow and useless thing”).
In the chemical and biochemical sciences, patent
claims that capture a group, or “genus,” of related molecular structures that may be used for a particular
purpose achieve these aims. See In re Kalm, 378 F.2d
4
959, 963 (C.C.P.A. 1967) (“When one speaks of a ‘genus’
in the chemical arts, one ordinarily speaks of a group
of compounds closely related both in structure and
properties.”). Until recently, genus claims have routinely been held to comply with the Patent Act’s enablement requirement. The traditional patentability of
such claims is reflected not only in a long line of decisions of this Court and other courts, but also in the numerous patent treatises and handbooks reflecting the
assumption that such claims are available. This Court
should change the law “back to the way it was” before
the Federal Circuit’s departure from precedent, KLS,
supra, at 4, to restore adequate patent protection for
chemical, pharmaceutical, and biotechnological inventions.
A. This Court’s Precedents Recognize the
Critical Role of Genus Claims
This Court has repeatedly held that patentees are
entitled to claim their inventions generically if they
demonstrate, in the patent’s specification, some feasible way of making and using the invention. Upholding
the claims to Alexander Graham Bell’s patent on the
telephone, this Court observed that “a patent for such
a discovery is not to be confined to the mere means
he improvised to prove the reality of his conception.”
The Telephone Cases, 126 U.S. 1, 539 (1888). The Court
held that “[i]t is enough if [the patentee] describes his
method with sufficient clearness and precision to enable those skilled in the matter to understand what the
process is, and if he points out some practicable way of
5
putting it into operation.” Id. at 536 (emphasis added).
Quoting from a leading patent law treatise, this Court
explained in another opinion that “the principle of the
invention is a unit, and invariably the modes of its embodiment in a concrete invention may be numerous
and in appearance very different from each other.”
Cont’l Paper Bag Co. v. E. Paper Bag Co., 210 U.S. 405,
419-20 (1908) (quoting 2 WILLIAM CALLYHAN ROBINSON,
THE LAW OF PATENTS FOR USEFUL INVENTIONS § 485
(Boston, Little, Brown & Co. 1890)). This rule has a
venerable pedigree, and this Court expounded upon it
in the seminal case of Tilghman v. Proctor:
Perhaps the process is susceptible of being applied in many modes and by the use of many
forms of apparatus. The inventor is not bound
to describe them all in order to secure to himself the exclusive right to the process, if he is
really its inventor of discoverer. But he must
describe some particular mode, or some apparatus, by which the process can be applied
with at least some beneficial result, in order
to show that it is capable of being exhibited
and performed in actual experience.
102 U.S. 707, 728-29 (1880).
This Court’s approach to enablement is critical for
meaningful patent protection. As this Court put it in
Continental Paper Bag, “[i]f this were not so most patents would be of little worth.” 210 U.S. at 418. Indeed,
a contrary rule creates “the risk of an infringement being avoided” by a minor modification of the particular
embodiments disclosed in the patent’s specification.
6
Carnegie Steel Co. v. Cambria Iron Co., 185 U.S. 403,
437 (1902). Applying these principles to a patent on a
process of concentrating crushed or powdered ores containing various “metal and metallic compounds,” this
Court held that the claims at issue “satisf[y] the law”
even though “the process is one for dealing with a large
class of substances and the range of treatment within
the terms of the claims.” Minerals Separation, Ltd. v.
Hyde, 242 U.S. 261, 271 (1916). This Court explained
that a contrary result would lead to a patentability
standard that cannot be met for any chemical patent
claim covering a significant number of species: “[T]he
composition of ores varies infinitely, each one presenting its special problem, and it is obviously impossible
to specify in a patent the precise treatment which
would be most successful and economical in each case.”
Id.
To be sure, this Court has found patent claims
nonenabled when the characteristic around which the
genus was organized was irrelevant or even harmful
for the invention’s purpose. See, e.g., Consol. Elec. Light
Co. v. McKeesport Light Co. (Incandescent Lamp Patent), 159 U.S. 465, 468 (1895) (invalidating a claim for
a light bulb filament made of fibrous or textile materials because these materials were generally bad as filaments); cf. KLS, supra, at 86-87 (explaining that claims
are correctly invalidated for this kind of “improper
generalization”). In addition, this Court has rightly
frowned upon claims drafted in purely functional
terms, since such claims tend to have immense breadth
and, as a result, require an impermissible amount of
7
experimentation to practice. See, e.g., Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245, 256-58 (1928).
Finally, this Court has invalidated claims if the patentee failed to provide any guidance on how to practice the claimed invention. Tyler v. Boston, 74 U.S. (7
Wall.) 327, 330 (1868); Wood v. Underhill, 46 U.S. (5
How.) 1, 4-5 (1846); see also Grasselli Chem. Co. v. Nat’l
Aniline & Chem. Co., 26 F.2d 305, 308 (2d Cir. 1928) (L.
Hand, J.) (invalidating claim where patent “furnishes
no guidance to the art”). But this Court has never endorsed a rule, relied upon by the Court of Appeals in
this case, that a structurally well-defined genus is not
enabled unless the patent’s specification provides a
way for rapidly making and testing numerous species
that potentially fall into that genus.
B. Decisions of Other Tribunals and Secondary Sources Confirm the Historical
Viability of Genus Claims
Until the Federal Circuit’s jurisprudence took its
recent turn, the decisions of other tribunals were consistent with this Court’s case law. For example, upholding a claim requiring a particular use of a genus of
acids against an overbreadth challenge, the Ninth Circuit observed that “[o]bviously [the patentee] was not
required to experiment with all kinds of acids, and to
state in his specifications what acids would and what
would not be suitable for the purpose.” Fullerton Walnut Growers’ Ass’n v. Anderson-Barngrover Mfg. Co.,
166 F. 443, 450 (9th Cir. 1908). It was enough that some
acids “may . . . be successfully used in the process.” Id.;
8
see also, e.g., Malignani v. Hill-Wright Elec. Co., 177 F.
430, 433 (C.C.S.D.N.Y. 1910) (“The specification referring [sic] to the use of substances adapted under certain conditions to generate gases or vapors mentions
arsenic, sulphuric, or iodine. The patentee, however,
did not limit himself to the use only of such substances,
and he was not required to specify all the known substances which might be advantageously used in the
process.”). These precedents confirm that it was permissible for a patentee to validly claim a class of chemicals so long as the specification made a showing that
there was some way to put the invention into practice.
To a similar effect are the decisions of the PTO and
the CCPA. Applying this Court’s precedents, the Patent Office Board of Appeals explained in Ex parte
Sloane that
While the number of specific substances mentioned is doubtless important, especially in a
case where the generic nature of a case must
be inferred from the mention of specific substances, we do not think that a proper determination of the breadth of disclosure can be
made solely from a consideration of the specific examples given. If the disclosure, taken
as a whole, is generic, an applicant is entitled
to generic claims if they are otherwise allowable.
22 U.S.P.Q. 222, 1934 WL 25325, at *2 (1934) (citing
Corona Cord Tire Co. v. Dovan Chem. Corp., 276 U.S.
358 (1928) and Incandescent Lamp Patent, 159 U.S.
465).
9
The CCPA’s decisions are in accord. See, e.g., In re
Angstadt, 537 F.2d 498, 503-04 (C.C.P.A. 1976) (citing
Minerals Separation, 242 U.S. at 270-71) (relying on
this Court’s reasoning to uphold a broad chemical genus claim); In re Grimme, 274 F.2d 949, 952 (C.C.P.A.
1960) (“It is manifestly impracticable for an applicant
who discloses a generic invention to give an example of
every species falling within it, or even to name every
such species. It is sufficient if the disclosure teaches
those skilled in the art what the invention is and how
to practice it.”).
Finally, secondary sources routinely assume that
chemical genus claims can be patented without the inventor’s having to test all or most of the species to
see if they work. See, e.g., CHRIS P. MILLER & MARK J.
EVANS, THE CHEMIST’S COMPANION TO PATENT LAW 7-8
(2010); ROBERT C. FABER, LANDIS ON MECHANICS OF PATENT CLAIM DRAFTING § 6.9 (5th ed. 2003 & Supp. July
2008); see also 2 ROBINSON, THE LAW OF PATENTS, supra,
at § 535; cf. GEORGE TICKNOR CURTIS, A TREATISE ON
THE LAW OF PATENTS FOR USEFUL INVENTIONS § 224
(Boston, Little, Brown & Co., 4th ed. 1873) (explaining
that “[t]he rule of our law [is] that the specification
may control the generality of the terms of the patent”
provided there is adequate teaching of a general invention).
C. Enablement is Not a Numbers Game
The basic “bargain” or “quid pro quo” of patent law
is that in exchange for the limited period of exclusivity,
the patentee must “reveal to the public the substance
10
of his discovery” so that, once exclusivity expires, the
public is “enabled without restriction to practice it and
profit by its use.” Bonito Boats, Inc. v. Thunder Craft
Boats, Inc., 489 U.S. 141, 150-51 (1989). Section 112(a)
ensures that the public gets its end of the bargain by
requiring that the patent’s description of the invention
“enable any person skilled in the art to which it pertains . . . to make and use the same.”
An invention is enabled if the PHOSITA, armed
with the patent’s specification, can practice the invention without “undue experimentation.” In re Wands,
858 F.2d 731, 737 (Fed. Cir. 1988). What constitutes
undue experimentation is a case-specific, fact-intensive inquiry that depends on the breadth of the claims;
the nature of the underlying technological field; the
amount of guidance provided in the specification, including the presence or absence of working examples;
the quantity of experimentation required to practice
the invention; and the PHOSITA’s knowledge, abilities,
routine activities, and tools. Id.
The basic premise and practical advantage of genus claims in the chemical and life sciences is that
providing a detailed teaching about several covered
compounds in the form of examples can sufficiently
enable the entire claimed genus. This means that the
PHOSITA is permitted to engage in a reasonable
amount of routine experimentation to figure out compounds that can achieve the claimed result. See id. at
736-37. Experimentation is a common part of the
PHOSITA’s work and “does not preclude enablement.”
Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750
11
F.2d 1569, 1576-77 (Fed. Cir. 1984). So as long as the
specification provides some working examples, that
disclosure can give the PHOSITA sufficient guidance
to enable the full scope of a genus claim. This is what
the law has generally required. See 2 ROBINSON, THE
LAW OF PATENTS, supra, at § 485 (“The applicant is not
required to describe all possible forms” of his invention; “[t]hese belong to the skill of the mechanic, not
the inventor; and having one embodiment before them,
the public are presumed to be able to construct such
others as they desire.”).
Enablement has not traditionally turned on
whether there are a lot of compounds in the claimed
genus or whether routine screening takes considerable
time. Wands, 858 F.2d at 736-37. An enabled patent
may “deal[ ] with a large class of substances” and
“leav[e] something to the skill of persons applying the
invention.” Minerals Separation, 242 U.S. at 271; see
also id. (upholding patent with “infinite[ ]” embodiments as “clearly sufficiently definite to guide those
skilled in the art to its successful application”); In re
Angstadt, 537 F.2d at 502-03 (rejecting an enablement
challenge despite “thousands” of possible embodiments
within the scope of the genus because the needed experimentation “to determine which catalysts will produce hydroperoxides would not be undue and certainly
would not ‘require ingenuity beyond that to be expected of one of ordinary skill in the art’ ” (quoting
Fields v. Conover, 443 F.2d 1386, 1390-91 (C.C.P.A.
1971))).
12
II.
The Federal Circuit Has Changed the Law
of Enablement
A. The Federal Circuit Has Made Enablement a Numbers Game
Despite the case-specific, fact-intensive nature of
the enablement inquiry, the Federal Circuit has more
recently adopted a numbers-based standard to evaluate enablement. This standard gauges enablement not
by whether the experimentation needed to make and
test particular species is undue, but by how long it
would take the PHOSITA to make and screen every
species within the claimed genus—even if that work
would be routine. This heightened enablement standard
is inconsistent with the purposes of the enablement
doctrine, is impossible to meet for large genus claims,
and threatens patent protection for many inventions
in the chemical and life sciences where large genus
claims are ubiquitous. Unfortunately, that new standard has become the norm in Federal Circuit enablement cases.
In Wyeth & Cordis Corp. v. Abbott Laboratories, for
example, the claims were directed to methods of treating or preventing restenosis, a re-narrowing of an artery following procedures such as balloon angioplasty,
by treatment with a therapeutically effective amount
of a chemical belonging to the class of compounds
called “rapamycin.” 720 F.3d 1380, 1382 (Fed. Cir.
2013). The specification demonstrated that at least
one of the species within the rapamycin genus was
effective in treating restenosis, and it taught how to
determine through routine experimentation if other
13
rapamycin compounds have the requisite therapeutic
property. See id. at 1385. But this was not enough for
the Federal Circuit. The court concluded that the need
to synthesize “tens of thousands of candidate[ ]” compounds doomed the claims. Id. By focusing on the size
of the genus, Wyeth found a claim nonenabled even
though the PHOSITA could make and test each
claimed compound with routine experimentation.
The Federal Circuit cemented its heightened enablement standard in the case under review. The inventors discovered that a certain group of compounds
sharing the same basic chemical structure are effective
against the Hepatitis C Virus (“HCV”). Pet. App. 7a–
9a. They then obtained a patent for a method of treating HCV, claiming a genus of compounds with a core
cyclic ring structure with a certain methyl group in a
2’-up position with multiple independent options for
other chemical moieties on the ring. While members of
the claimed genus numbered in the thousands, PHOSITAs could rely on their knowledge to exclude some
species that were unlikely to work. Id. at 16a. Some
candidate species could be bought commercially, id. at
18a, while others could be synthesized using routine
methodologies, id. at 18a–19a. Finally, the patent disclosed several working examples. Id. at 19a–21a.
Nevertheless, applying Wyeth, the panel held that
the PHOSITA would have too many compounds to obtain and screen because it was not possible to tell in
advance for many candidates whether their structures
would have the desired HCV efficacy. As the panel
framed it, “[t]he key enablement question is whether a
14
[PHOSITA] would know, without undue experimentation, which 2’-methyl-up nucleosides would be effective
for treating HCV,” and the answer was “no.” Pet. App.
10a. (emphasis added). Even accepting that the disclosed screening process allowed for straightforward
identification of compounds that worked, the panel determined the work involved to be excessive for enablement purposes. While any particular compound falling
within the scope of the genus and is effective against
HCV might be readily found, the overall sorting process was held to require undue experimentation. It is
effectively impossible for a genus claim of any non-trivial size to comply with this enablement standard.
B. The Federal Circuit’s Approach to § 112(a)
Frustrates Patenting and Innovation in
the Chemical and Life Sciences
The Federal Circuit’s approach is problematic because it focuses on knowing exactly which species of a
claimed genus will work instead of knowing how to
make and use the invention, which is what the text of
§ 112(a) actually requires. This Court and the Federal
Circuit’s predecessors have never required “reasonable
certainty” that a particular chemical structure would
work for its intended purpose. In re Angstadt, 537 F.2d
498, 503 (C.C.P.A. 1976) (emphasis omitted). As the
CCPA astutely noted, if this were so “then all ‘experimentation’ is ‘undue,’ since the term ‘experimentation’
implies that the success of the particular activity is
uncertain.” Id. (emphases in original).
15
The decision below confirms the massive shift in
the Federal Circuit’s enablement doctrine. Asking the
PHOSITA to sort operative from inoperative species,
whether routine or not, is emerging as a critical challenge for patentees facing enablement attacks. When
the number of operative species in a chemical genus
seems too time-consuming to identify, this proves fatal
to enablement. Under this new regime, “[a] chemical
genus with any decently large number of species will
never be able to satisfy” the Federal Circuit’s new enablement standard. KLS, supra, at 1. Worse yet, the
“routine but undue” theory makes it much easier for
defendants in patent infringement suits to argue that
genus claims are overbroad on their face. Any genus
claim covering a significant number of species in the
chemical and life sciences fields, which typically come
with built-in unpredictability even if the claimed technology is mature, is now in question. Accordingly, few
patent claims in this industry survive enablement
challenges today. See id. at 31.
III. This Court Should Grant Certiorari to Restore the Traditional Law of Genus Claims
The Federal Circuit’s move to invalidate large genus claims on enablement grounds reflects a puzzling
and troubling doctrinal shift. The Federal Circuit has
changed what it means to “enable the full scope of the
claim” in ways that make many genus claims unsustainable. In doing so, it has conflated different legal
theories and justifications for restricting the scope of
genus claims. And it has broken the symmetry that has
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traditionally existed between nonobviousness analysis
under 35 U.S.C. § 103 and the disclosure rules of § 112.
A. The Federal Circuit’s New Rule Ignores
the Knowledge of the PHOSITA
Both sections 103 and 112 set standards based on
the knowledge and experience of the PHOSITA. The
PHOSITA is rather like the “reasonable expert” in patent law. When we test whether a patentee has done
something obvious under § 103, we ask whether the
PHOSITA would have been motivated to make the new
invention and had a reasonable expectation of success.
Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd.,
821 F.3d 1359, 1366-69 (Fed. Cir. 2016). And when we
decide how much information the patentee must disclose, we turn again to the PHOSITA, making sure the
patent discloses enough that the PHOSITA can make
and use the invention without undue experimentation.
The enablement and obviousness PHOSITAs are not
always exactly the same, but in general, there is symmetry between obviousness and disclosure that turns
on the level of skill in the art. If PHOSITAs in a field
know a lot, they are more likely to find an invention
obvious, but they also do not need as much detail to
educate them about how to make and use that invention. If they know very little, by contrast, it is easier to
show nonobviousness (because they were less likely to
figure it out), but the patentee must teach more to
make sure the PHOSITAs understand the invention
for enablement purposes.
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That symmetry held for decades in the chemical
arts. Courts have regularly told us that chemistry is an
unpredictable art, so the PHOSITA cannot know what
effects a small change in chemical structure would
have. Brenner v. Manson, 383 U.S. 519, 532 (1966) (recognizing the unpredictability of chemical compounds).
But chemical compounds have a regular and wellunderstood structure, so courts confronting obviousness challenges have long held that variants on a
known chemical are likely obvious unless they embody
unexpected results. In re Dillon, 919 F.2d 688, 692
(Fed. Cir. 1990) (en banc); see also Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1364
(Fed. Cir. 2007) (Dyk, J., concurring) (noting the validity of subject matter involving unexpected results relative to a known compound was “not in question” on
obviousness grounds).
But a parallel assumption is strikingly absent
from the Federal Circuit’s recent enablement cases. To
the contrary, the recent cases generally start from the
premise that the chemical arts are unpredictable and
then apply the opposite of the Dillon-type analysis.
They assume that PHOSITAs would not be able to figure out what works in a genus unless the patent specification teaches them which variants of the chemical
compounds disclosed in the specification will have the
same effects and which ones will not. The result for
chemical patentees is the worst of both worlds—the
Federal Circuit will presume the new species you claim
is not patentable because PHOSITAs could figure out
how to make it if it is just a variant on an existing one,
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but it will not presume they understand the very same
thing when they try to practice your genus claim.
B. The Federal Circuit’s New Requirement
of “Full Scope” Enablement Is Not Consistent with the Purposes of that Doctrine
There is a second, and more fundamental, shift in
the Federal Circuit’s § 112 case law. The Federal Circuit has changed the focus of the § 112(a) inquiry from
“what information would be required to permit the
PHOSITA to make and use species that make up the
invention” to “what information is required to teach
the PHOSITA which species in the genus work and
which ones do not.” Put another way, before the Federal
Circuit’s recent approach took hold, § 112(a) was about
use and practice of the invention, while today it is primarily about understanding the boundaries of the invention. That shift has profound implications for large
genus claims. It is frequently impossible to test all or
even a significant fraction of the species of a genus that
may contain millions of different species. Even a patentee who tests a considerable number of species may
be unable to predict which species will work. The question is whether that inability should matter, and why.
If the goal is to enable the PHOSITA to make and
use the invention, the inability to predict in advance
which species will work does not matter much except
at the extremes. The patentee in Atlas Powder Co. v.
E.I. du Pont de Nemours & Co., mentioned in Part I.C,
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did not know which of its claimed dynamite compounds
would work and which would not, but with a 40% failure rate, a user would likely only have to try two or
maybe three compounds to find one that would work.
750 F.2d 1569, 1577 (Fed. Cir. 1984). That required
some experimentation, but the law has traditionally
allowed claims that require experimentation as long as
it is not “undue.” Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986); see also
Sean B. Seymore, Patenting Around Failure, 166 U. PA.
L. REV. 1139, 1165-73 (2018) (explaining that longstanding law has allowed claims to encompass inoperative species without defeating patentability). There
may be some genus claims that give so little information that trying to find a species that works takes
too much effort, but that is likely to be rare if the genus
is proper and well-defined.
The case under review and its immediate antecedents, like Wyeth, ignore this focus on how much experimentation is required. Rather, those cases reflect the
Federal Circuit’s new and different goal for § 112(a)—
explaining to the PHOSITA what subset of the genus
claims will work. The goal of those cases seems to be
knowledge of the precise boundaries of the genus. That
may be desirable in some cases (e.g., for purely functional claims). But it is not normally required for the
PHOSITA to make and use the invention without undue experimentation. And it has proven in practice to
be an impossible burden.
We think that this move, from undue experimentation to a search for a clear definition of which species
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work and which do not, misunderstands the basic purpose of the § 112(a) inquiry. If the patentee defines a
clear genus, so people will know whether or not the
chemicals they make fall within that genus, PHOSITAs will be able to make and use the full scope of that
genus so long as they can figure out how to make chemicals within it and determine whether they work for
the intended purpose without having to engage in undue experimentation. True, they will not be able to
make every working species. But why would they want
to? And true, they might have to experiment to figure
out whether the species they made works for the intended purpose, but that has never been a problem so
long as they do not have to do too much experimentation.
To be sure, there will be cases where the patent
does not give enough information to allow the PHOSITA to do even that much without undue experimentation, as discussed in Part I.A. And those claims are
properly invalid under the enablement doctrine. But
that problem is not limited to broad genus claims. The
claims may well be narrow, even directed to one species, but they are invalid if the patent’s specification
fails to give enough information and the PHOSITA
would not be able to figure out how to make the invention work at all.
If the PHOSITA can figure out how to make a
working embodiment without too much effort, there
is no reason to require more in most cases. Cases like
Wyeth and Idenix, which focus on the breadth of the
genus claim as the reason to reject it, miss the point.
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The genus is very large and it would take an impossible effort to identify all the species within its scope that
work. But there is no reason anyone needs to do that.
Anyone who wants to know if their chemical is within
the scope of the claim can figure that out: the boundaries of the chemical genus are well-specified, and it
does not take much effort to determine whether or not
any particular chemical works for its intended purpose.3
C. The Federal Circuit’s New Requirement
Makes Effective Patent Protection Nearly
Impossible in the Chemical Industry
The Federal Circuit’s heightened enablement
standard frustrates patenting and innovation. It
“force[s] an inventor seeking adequate patent protection to carry out a prohibitive number of actual experiments” and ultimately “discourage[s] inventors from
filing patent applications in an unpredictable area
since the patent claims would have to be limited to
3
Kristina Caggiano Kelly and Paul Calvo offer an excellent
illustration of this. They point to an artist named Martin Silfen
who uses a combination of just sixteen geometric tiles to create
paintings. Because the tiles can be rotated and can each be used
in a different order, there are 89 sextillion different possible tile
combinations. But no one needs to try all or even very many of
those combinations to make the invention work; they just need to
know to lay out 16 tiles in a 4x4 grid. Kristina Caggiano Kelly &
Paul A. Calvo, The Scope of a Sextillion—How Courts Misapply
Law of Enablement to Life Sciences, BNA IP LAW NEWS, May 1,
2020, available at https://news.bloomberglaw.com/ip-law/insightthe-scope-of-a-sextillion-how-courts-misapply-law-of-enablementto-life-sciences.
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those [working] embodiments which are expressly disclosed.” In re Angstadt, 537 F.2d 498, 502-03 (C.C.P.A.
1976). Nothing in § 112(a) or this Court’s precedent
suggests that genus claims should be subject to any
numerical threshold. Minerals Separation, Ltd. v.
Hyde, 242 U.S. 261, 271 (1916) (explaining that while
“[t]he composition of ores varied infinitely” and that
“it is obviously impossible to specify in a patent the
precise treatment which would be most effective and
economical in each case,” the patent’s description sufficiently “guide[d] those skilled in the art to its successful application” in spite of covering “a very large class
of substances”).
The Federal Circuit has converted the enablement
inquiry from this sensible approach into one that
seems to ask the patentee to determine in advance
which species work and which ones do not. In other
words, instead of “did I teach you enough that you can
make use of the full scope of the invention?” (which
allows a genus to include some inoperative species as
long as the PHOSITA can figure out whether a particular species works without too much effort), the question now is, “did I give you enough information to figure
out the full list of what works and what doesn’t?”
The latter is an impossible requirement to meet,
and it does not serve the purposes of § 112. This category error is at the heart of the demise of genus claims
in the chemical arts today. And it is not something patentees can simply draft around. A chemical genus
with any decently large number of species will never
be able to satisfy the Federal Circuit’s Idenix standard.
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No matter how much testing the patentee does, there
will always be untested species, and because those species are not tested we do not know whether they are
properly included in the genus, so the claim will be invalid under the enablement and written description
doctrines. Under traditional law, all we cared about
was whether the PHOSITA could make a species and
figure out whether it worked without undue experimentation. But the Federal Circuit’s shift in that law
is fatal to genus claims.
That change endangers innovation. Patent protection is important in the pharmaceutical and biotechnology industries, perhaps more than anywhere else.
Certainly, the industries themselves seem to think so.
Policy disputes in courts and Congress over the past
two decades have time and again seen the chemical
and biomedical industries line up behind strong protection, with the information technology industries on
the opposite side. See generally DAN L. BURK & MARK
A. LEMLEY, THE PATENT CRISIS AND HOW THE COURTS
CAN SOLVE IT (2009); JOHN R. THOMAS, CONG. RES.
SERV., R43264, TAILORING THE PATENT SYSTEM FOR
SPECIFIC INDUSTRIES (2015); WENDY H. SCHACHT, CONG.
RES. SERV., RL33367, PATENT REFORM: ISSUES IN BIOMEDICAL AND SOFTWARE INDUSTRIES (2006). As Dan
Burk and Mark Lemley explain, those political differences reflect very real differences in how the industries
use and experience the patent system. Patents really
are more important to those industries than to others.
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Further, the patent system seems to function more
like it was designed in the chemical industries. The
scope of claims is clearer, independent invention is
rarer, “stacking” of multiple patents is less common,
and the slower pace of change means that a company
thinking of making a product could search for and find
the relevant patents, something that is not true in
many other industries. James Bessen and Michael
Meurer have gone so far as to suggest that the patent
system works well only in the biomedical and chemical
industries. JAMES BESSEN & MICHAEL J. MEURER, PATENT FAILURE: HOW JUDGES, BUREAUCRATS, AND LAWYERS PUT INNOVATION AT RISK 89-93 (2008). But at a
minimum, it has been working there.
Given the importance of strong patent protection
in these industries, the unwillingness of courts to permit chemical genus claims seems quite troubling as
a policy as well as a doctrinal matter. The Federal
Circuit’s new rule will not eliminate all patents or all
innovation in the chemical arts. Pharmaceutical companies can enforce claims to a single species against
competitors who want to make a generic version of that
very drug. But the Federal Circuit’s rule in this case
makes it unreasonably difficult for a pharmaceutical
company that comes up with an innovative new class
of drugs to protect that class against imitation. That
result threatens innovation.
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CONCLUSION
This Court should grant the petition for writ of
certiorari on the first question presented.4
Respectfully submitted,
PROFESSOR MARK A. LEMLEY
Counsel of Record
STANFORD LAW SCHOOL
559 Nathan Abbott Way
Stanford, CA 94305
650-723-4605
mlemley@law.stanford.edu
4
Amici take no position on the second question presented.
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.