throbber

`(Slip Opinion)
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` OCTOBER TERM, 2022
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`Syllabus
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`1
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` NOTE: Where it is feasible, a syllabus (headnote) will be released, as is
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` being done in connection with this case, at the time the opinion is issued.
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` The syllabus constitutes no part of the opinion of the Court but has been
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` prepared by the Reporter of Decisions for the convenience of the reader.
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` See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.
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`SUPREME COURT OF THE UNITED STATES
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`
` Syllabus
`
` AMGEN INC. ET AL. v. SANOFI ET AL.
`
`
`
`CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR
`
`THE FEDERAL CIRCUIT
` No. 21–757. Argued March 27, 2023—Decided May 18, 2023
`
` This case concerns patents covering antibodies engineered by scientists
`
`that help reduce levels of low-density lipoprotein (LDL) cholesterol,
`
` sometimes called bad cholesterol because it can lead to cardiovascular
` disease, heart attacks, and strokes. To treat patients with high LDL
`
`
`cholesterol, scientists explored how antibodies might be used to inhibit
`PCSK9—a naturally occurring protein that binds to and degrades LDL
`receptors responsible for extracting LDL cholesterol from the blood-
` stream. Two pharmaceutical companies—Amgen and Sanofi—each
`
`developed a PCSK9-inhibiting drug. In 2011, Amgen obtained a pa-
` tent for the antibody employed in its drug, and Sanofi received one
`
`
` covering the antibody used in its drug. Each patent describes the rel-
`evant antibody by its unique amino acid sequence. The dispute in this
`
` case concerns two additional patents Amgen obtained in 2014 that re-
`
` late back to the company’s 2011 patent. These later-issued patents
`
` purport to claim for Amgen “the entire genus” of antibodies that
`(1) “bind to specific amino acid residues on PCSK9,” and (2) “block
`
` PCSK9 from binding to [LDL receptors].” 872 F. 3d 1367, 1372. As
`part of its submission to the patent office, Amgen identified the amino
`
`
`
`
` acid sequences of 26 antibodies that perform these two functions.
` Amgen then described two methods—one Amgen called “the roadmap”
`
`
` and a second it called “conservative substitution”—that scientists could
`
`
`
` use to make other antibodies that perform the binding-and-blocking
`
`
` functions described in the claims.
`After Amgen obtained the 2014 patents, it sued Sanofi for infringe-
`
`ment. Sanofi replied that it was not liable to Amgen for infringement
`because Amgen’s relevant claims were invalid under the Patent Act’s
`
`
`“enablement” requirement. That provision requires a patent applicant
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`to describe the invention “in such full, clear, concise, and exact terms
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`AMGEN INC. v. SANOFI
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`Syllabus
`as to enable any person skilled in the art . . . to make and use the [in-
`vention].” 35 U. S. C. §112(a). Sanofi characterized the methods
`Amgen outlined for generating additional antibodies as amounting to
`little more than a trial-and-error process of discovery, and thus con-
`tended that Amgen’s patents failed to meet the enablement require-
`ment because they sought to claim for Amgen’s exclusive use poten-
`tially millions more antibodies than the company had taught persons
`skilled in the art to make. Both the district court and the Federal Cir-
`cuit sided with Sanofi.
`
`Held: The courts below correctly concluded that Amgen failed “to enable
`
`any person skilled in the art . . . to make and use the [invention]” as
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`defined by the relevant claims. Pp. 7–19.
`
`(a) The patent “bargain” describes the exchange that takes place
`when an inventor receives a limited term of “protection from competi-
`
`tive exploitation” in exchange for bringing “new designs and technolo-
`
`gies into the public domain through disclosure” for the benefit of all.
`
`
`Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U. S. 141, 150.
`
`From the Patent Act’s beginnings, Congress has sought to ensure the
`
`benefit of this bargain for the public by requiring the patent applicant
`to deposit a “specification . . . so particular . . . as not only to distin-
`
`guish the invention or discovery from other things before known and
`used, but also to enable a workman or other person skilled in the art
`or manufacture . . . to make, construct, or use the same.” 1 Stat. 110.
`Over time, Congress has left this “enablement” obligation largely in-
`tact.
`
`This Court has addressed the enablement requirement many times,
`
`and its decisions in O’Reilly v. Morse, 15 How. 62, The Incandescent
`
`
`
`Lamp Patent, 159 U. S. 465, and Holland Furniture Co. v. Perkins Glue
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`
`
`
`Co., 277 U. S. 245, reinforce the simple statutory command: If a patent
`claims an entire class of processes, machines, manufactures, or com-
`
`positions of matter, the patent’s specification must enable a person
`skilled in the art to make and use the entire class. In Morse, for ex-
`
`
`ample, the Court held that one of the claims in Morse’s patent for a
`telegraphic system was “too broad, and not warranted by law.” 15
`
`How., at 113. The problem was that the claim covered all means of
`achieving telegraphic communication, yet Morse’s specification did not
`
`describe how to make or use them all. See id., at 113–117. In Incan-
`
`descent Lamp, inventors of an “electric lamp” with an “incandescing
`
`conductor” made of “carbonized paper” claimed that a lamp created by
`Thomas Edison infringed their patent because it used bamboo as a
`conductor. The Court sided with Edison because the rival inventors,
`rather than confining their claim to carbonized paper, “made a broad
`
`claim for every fibrous and textile material.” 159 U. S., at 472. That
`broad claim “might” have been permissible, the Court allowed, if the
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`3
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`Cite as: 598 U. S. ____ (2023)
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`Syllabus
`inventors had disclosed “a quality common” to fibrous and textile sub-
`stances that made them “peculiarly” adapted to incandescent lighting,
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`but they did not. Ibid. Finally, in Holland Furniture, a company that
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`had developed a starch glue that was similar enough to animal glue to
`
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`be used for wood veneering included a claim in its patent covering all
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`“starch glue which, [when] combined with about three parts or less . . .
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`of water, will have substantially the same properties as animal glue.”
`277 U. S., at 251. The specification described the key input—the
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`“starch ingredient”—in terms of its “use or function” rather than its
`“physical characteristics or chemical properties.” Id., at 256. The
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`problem, as the Court put it, was that “[o]ne attempting to use or avoid
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`the use of [the] discovery as so claimed and described functionally
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`could do so only after elaborate experimentation” with different
`starches. Id., at 257.
`
`All this is not to say a specification always must describe with par-
`ticularity how to make and use every single embodiment within a
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`claimed class. It may suffice to give an example if the specification
`
`also discloses “some general quality . . . running through” the class
`
`that gives it “a peculiar fitness for the particular purpose.” Incandes-
`cent Lamp, 159 U. S., at 475. Nor is a specification necessarily inade-
`quate just because it leaves the skilled artist to engage in some meas-
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`ure of adaptation or testing. See, e.g., Wood v. Underhill, 5 How. 1, 4–
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`5. A specification may call for a reasonable amount of experimentation
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`to make and use a claimed invention, and reasonableness in any case
`will depend on the nature of the invention and the underlying art. See
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`Minerals Separation, Ltd. v. Hyde, 242 U. S. 261, 270–271. Pp. 7–15.
`
`
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`(b) Turning to the patent claims at issue in this case, Amgen’s claims
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`sweep much broader than the 26 exemplary antibodies it identifies by
`
`
`their amino acid sequences. Amgen has failed to enable all that it has
`
`
`claimed, even allowing for a reasonable degree of experimentation.
`Amgen’s claims bear more than a passing resemblance to the broadest
`claims in Morse, Incandescent Lamp, and Holland Furniture. While
`Amgen seeks to monopolize an entire class of things defined by their
`
`function—every antibody that both binds to particular areas of the
`sweet spot of PCSK9 and blocks PCSK9 from binding to LDL recep-
`tors—the record reflects that this class of antibodies does not include
`just the 26 that Amgen has described by their amino acid sequences,
`but a vast number of additional antibodies that it has not.
`
`Amgen insists that its claims are nevertheless enabled because sci-
`entists can make and use every functional antibody if they simply fol-
`low the “roadmap” or “conservative substitution.” These two ap-
`
`proaches, however, amount to little more than two research
`
`assignments. The “roadmap” merely describes step-by-step Amgen’s
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`own trial-and-error method for finding functional antibodies. Not
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`4
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`AMGEN INC. v. SANOFI
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`Syllabus
`much different, “conservative substitution” requires scientists to make
`substitutions to the amino acid sequences of antibodies known to work
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`and then test the resulting antibodies to see if they do too.
`
`Amgen’s alternative arguments lack merit. Amgen first suggests
`that the Federal Circuit erred by conflating the question whether an
`invention is enabled with the question how long may it take a person
`
`skilled in the art to make every embodiment within a broad claim. But
`the Federal Circuit made clear that it was not treating as dispositive
`the cumulative time and effort required to make the entire class of
`antibodies. Amgen next argues that the Patent Act supplies a single,
`
`universal enablement standard, while the Federal Circuit applied a
`
`
`higher standard to Amgen’s claims that encompass an entire genus of
`
`
`embodiments defined by their function. The Court agrees in principle
`that there is one statutory enablement standard, but the Federal Cir-
`cuit’s treatment in this case is entirely consistent with Congress’s di-
`rective and this Court’s precedents. Finally, while Amgen warns that
`a ruling against it risks destroying the incentives that lead to break-
`through inventions, since 1790 Congress has included an enablement
`
`mandate as one feature among many designed to achieve the balance
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`it wishes to strike between incentivizing inventors and ensuring the
`public receives the full benefit of their innovations. In this case, the
`Court’s duty is to enforce the statutory enablement requirement ac-
`
`cording to its terms. Pp. 15–19.
`10 F. 4th 1016, affirmed.
`GORSUCH, J., delivered the opinion for a unanimous Court.
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` Cite as: 598 U. S. ____ (2023)
`
`Opinion of the Court
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`1
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` NOTICE: This opinion is subject to formal revision before publication in the
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` United States Reports. Readers are requested to notify the Reporter of
` Decisions, Supreme Court of the United States, Washington, D. C. 20543,
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` pio@supremecourt.gov, of any typographical or other formal errors.
`
`SUPREME COURT OF THE UNITED STATES
`
`_________________
`
` No. 21–757
`_________________
` AMGEN INC., ET AL., PETITIONERS v. SANOFI, ET AL.
`
`
`ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF
`
`APPEALS FOR THE FEDERAL CIRCUIT
`[May 18, 2023]
`JUSTICE GORSUCH delivered the opinion of the Court.
`
`The development of antibody drugs has yielded life-
`
`changing therapies. Individuals across the world now rely
`on antibody drugs to treat conditions ranging from Crohn’s
`disease to cancer. This case concerns patents covering an-
`tibodies that help reduce levels of low-density lipoprotein
`cholesterol, sometimes called LDL cholesterol (for the obvi-
`ous reason) or bad cholesterol (because it can lead to cardi-
`ovascular disease, heart attacks, and strokes).
`
`The case comes to us this way. Several years ago, peti-
`
`tioners (Amgen) obtained two patents. Together, these pa-
`tents claim a monopoly over all antibodies that (1) bind to
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`specific amino acids on a naturally occurring protein known
`as PCSK9, and (2) block PCSK9 from impairing the body’s
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`mechanism for removing LDL cholesterol from the blood-
`stream. Soon after receiving these patents, Amgen sued re-
`spondents (Sanofi) for infringement. In response, Sanofi ar-
`gued that the patents were invalid under §112 of the Patent
`
`Act. That provision requires a patent applicant to describe
`its invention “in such full, clear, concise, and exact terms as
`to enable any person skilled in the art . . . to make and use
`the [invention].” 35 U. S. C. §112(a). Sanofi contended that
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`2
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`AMGEN INC. v. SANOFI
`
`Opinion of the Court
`Amgen’s patents failed to meet this standard because they
`sought to claim for Amgen’s exclusive use potentially mil-
`lions more antibodies than the company had taught scien-
`tists to make. In the end, both the district court and Fed-
`
`eral Circuit sided with Sanofi. The question we face is
`
`whether to disturb their judgment.
`I
`A
`The immune system produces antibodies as a defense to
`
`foreign agents called antigens. When a particular anti-
`gen—a virus, for example—enters the body, the immune
`system generates antibodies to attack it. In a successful
`
`attack, the antibodies target and bind to the antigen, stop-
`ping it from causing harm to the body. See Brief for Sir
`Gregory Paul Winter et al. as Amici Curiae 8 (Winter
`Brief ); M. Lemley & J. Sherkow, The Antibody Patent Par-
`
`adox, 132 Yale L. J. 994, 1001–1002 (2023).
`Antibodies are incredibly diverse. Some scientists esti-
`
`mate that there may be as many unique antibodies as there
`are stars in the galaxy. See id., at 1003; see also B. Briney,
`
`A. Inderbitzin, C. Joyce, & D. Burton, Commonality Despite
`Exceptional Diversity in the Baseline Human Antibody
`Repertoire, 566 Nature 393, 397 (No. 7744, Feb. 2019) (es-
`timating that the immune system could potentially gener-
`ate up to a quintillion unique antibodies). This diversity
`shows up in both structure and function.
`Start with structure. “When scientists refer to an anti-
`
`
`
`body’s ‘structure,’” they may have in mind “several related
`concepts,” each of which describes “what an antibody is.”
`
`Winter Brief 10. Antibodies are made up of amino acids,
`and scientists commonly identify a particular antibody ac-
`
`cording to its specific sequence of amino acids—what they
`
`call an antibody’s “‘primary structure.’” Id., at 9–10. But
`
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`antibodies are not just linear chains of amino acids. As the
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`Opinion of the Court
`atoms of the amino acids interact with each other, they cre-
`
`ate folds that result in complex three-dimensional shapes.
`
`Ibid. Scientists refer to an antibody’s intricate topography
`as its “tertiary structure.” Id., at 10.
`
`An antibody’s structure does much to dictate its func-
`tion—its ability to bind to an antigen and, in some in-
`
`stances, to block other molecules in the body from doing the
`same. “For an antibody to bind to an antigen, the two sur-
`faces have to fit together and contact each other at multiple
`
`points.” Id., at 11. But just because an antibody can bind
`
`to an antigen does not mean that it can also block. To bind
`and block, the antibody must establish a sufficiently broad,
`strong, and stable bond to the antigen. See ibid. Different
`
`antibodies have different binding and blocking capacities
`based on the amino acids that compose them and their
`three-dimensional shapes. See id., at 11–12.
`
`Despite recent advances, aspects of antibody science re-
`main unpredictable. For example, scientists understand
`that changing even one amino acid in the sequence can alter
`an antibody’s structure and function. See id., at 14. But
`scientists cannot always accurately predict exactly how
`
`trading one amino acid for another will affect an antibody’s
`structure and function. Ibid. As Amgen’s expert testified
`
`at trial: “ ‘[T]he way in which you get from sequence to
`
`that three-dimensional structure isn’t fully understood to-
`
`day. It’s going to get a Nobel Prize for somebody at some
`point, but translating that sequence into a known three-di-
`mensional structure is still not possible.’” Id., at 14–15.
`B
`
`While the immune system naturally produces an army of
`antibodies to protect us from various harms, scientists are
`now able to engineer antibodies to assist in treating dis-
`eases. Some of these lab-made antibodies target not foreign
`
`agents but the body’s own proteins, receptors, and ligands.
`“While naturally occurring in our bodies, these [proteins,
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`4
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`AMGEN INC. v. SANOFI
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`Opinion of the Court
`receptors, and ligands] can also be involved in inflamma-
`tory disorders, uncontrolled cell growth, or other biological
`
`pathways that may be associated with disease.” Id., at 8.
`
`One part of this effort has focused on the creation of an-
`tibodies to treat patients with high LDL cholesterol. A si-
`lent killer, LDL cholesterol can contribute to the formation
`of plaque in the arteries that may lead to cardiovascular
`
`disease, heart attacks, and strokes. For many people with
`high LDL cholesterol, drugs called statins offer an effective
`treatment. For others, statins do not work well or come
`
`with unwelcome side effects. In those cases, a relatively
`new antibody-based treatment known as a PCSK9 inhibitor
`
`may be appropriate. See Amgen Inc. v. Sanofi, 872 F. 3d
`1367, 1371 (CA Fed. 2017).
`
`PCSK9 is a naturally occurring protein that binds to and
`
`degrades LDL receptors. That can pose a problem because
`
`the body produces LDL receptors to perform the beneficial
`function of extracting LDL cholesterol from the blood-
`stream. See ibid. Scientists have understood this much for
`
`some time. But it wasn’t until fairly recently that they be-
`gan exploring how antibodies might be used to inhibit
`
`PCSK9 from binding to and degrading LDL receptors as a
`way to treat patients with high LDL cholesterol.
`
`
`In the mid-2000s, a number of pharmaceutical companies
`
`began looking into the possibility of making antibodies to
`target PCSK9. See Brief for Respondents 7; Brief for Ar-
`
`
`nold Ventures et al. as Amici Curiae 17–20. More precisely,
`they sought to create antibodies that could bind to a partic-
`ular region of PCSK9 called the “sweet spot.” See Brief for
`Petitioners 10–11. The sweet spot is a sequence of 15 amino
`acids out of PCSK9’s 692 total amino acids. Id., at 11. By
`binding to the sweet spot, scientists found, an antibody
`could prevent PCSK9 from binding to and degrading LDL
`receptors. See id., at 10–11; Amgen, 872 F. 3d, at 1371.
`
`Eventually, Amgen developed a PCSK9-inhibiting drug
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`Opinion of the Court
`that it marketed under the name Repatha, and Sanofi pro-
`duced one it labeled Praluent. Each drug employs a distinct
`
`antibody with its own unique amino acid sequence. See id.,
`
`at 1371–1372; Brief for Respondents 8–10. In 2011, Amgen
`obtained a patent for the antibody employed in Repatha,
`
`and Sanofi received one covering the antibody used in
`Praluent. See id., at 8, 9. Each patent describes the rele-
`vant antibody by its amino acid sequence. See ibid. Nei-
`ther of these patents is at issue in this case.
`
`Instead, our dispute focuses on two additional patents
`
`Amgen obtained in 2014 that relate back to the company’s
`2011 patent. See U. S. Patent No. 8,829,165 (Sept. 9, 2014);
`
`U. S. Patent No. 8,859,741 (Oct. 14, 2014). We refer to them
`as the ’165 and ’741 patents. In particular, this case re-
`
`volves around claims 19 and 29 of the ’165 patent and claim
`
`7 of the ’741 patent. See 987 F. 3d 1080, 1082 (CA Fed.
`2021). In these claims, Amgen did not seek protection for
`
`any particular antibody described by amino acid sequence.
`Instead, Amgen purported to claim for itself “the entire ge-
`nus” of antibodies that (1) “bind to specific amino acid resi-
`
`dues on PCSK9,” and (2) “block PCSK9 from binding to
`
`[LDL receptors].” Amgen, 872 F. 3d, at 1372.
`
`As part of its submission to the patent office, Amgen iden-
`tified the amino acid sequences of 26 antibodies that perform
`
`these two functions, and it depicted the three-dimensional
`
`
`structures of two of these 26 antibodies. 987 F. 3d, at 1083.
`But beyond that, Amgen only offered scientists two meth-
`ods to make other antibodies that perform the binding and
`
`blocking functions it described. The first method is what
`Amgen calls the “roadmap.” Brief for Petitioners 13. At a
`
`high level, the roadmap directs scientists to: (1) generate a
`
`
`range of antibodies in the lab; (2) test those antibodies to
`determine whether any bind to PCSK9; (3) test those anti-
`
`bodies that bind to PCSK9 to determine whether any bind
`to the sweet spot as described in the claims; and (4) test
`those antibodies that bind to the sweet spot as described in
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`6
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`AMGEN INC. v. SANOFI
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`Opinion of the Court
`the claims to determine whether any block PCSK9 from
`
`
` binding to LDL receptors. See id., at 13–14. The second
`
` method is what Amgen calls “conservative substitution.”
`
` Id., at 14, 17. This technique requires scientists to:
`(1) start with an antibody known to perform the described
`functions; (2) replace select amino acids in the antibody
`with other amino acids known to have similar properties;
`and (3) test the resulting antibody to see if it also performs
`
`the described functions. See id., at 14–15.
`C
`Soon after receiving the ’165 and ’741 patents, Amgen
`
`
`sued Sanofi for infringing them. Sanofi replied that it was
`not liable to Amgen because the relevant claims were inva-
`lid as a matter of law. Invalid, Sanofi said, because Amgen
`
`had not enabled a person skilled in the art to make and use
`
`all of the antibodies that perform the two functions Amgen
`described in its claims. See 987 F. 3d, at 1083–1085. While
`Amgen had identified the amino acid sequences of 26 anti-
`bodies that bind to PCSK9 and block it from binding to LDL
`receptors, Sanofi observed that Amgen’s claims cover poten-
`tially millions more undisclosed antibodies that perform
`these same functions. And, Sanofi argued, neither of the
`
`two methods Amgen had outlined for generating additional
`antibodies with the same functions enable a person skilled
`in the art to do so reliably. Instead, Sanofi submitted, those
`methods require scientists to engage in little more than a
`trial-and-error process of discovery. See id., at 1085.
`
`
`After lengthy proceedings, the district court granted
`Sanofi judgment as a matter of law, concluding that the
`
`claims at issue “are not enabled.” 2019 WL 4058927, *13
`(Del., Aug. 28, 2019). The Federal Circuit affirmed. 987
`F. 3d, at 1088. It determined that “no reasonable factfinder
`could conclude” that Amgen had provided “adequate guid-
`
`ance” to make and use the claimed antibodies “beyond the
`narrow scope of the [26] working examples” it had identified
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`

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`7
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`
`Opinion of the Court
`In response to
`
`by their amino acid sequences.
`Ibid.
`
`
` Amgen’s petition for certiorari, we agreed to take up the
`case. 598 U. S. ___ (2022).
`
` II
`
`The Constitution vests Congress with the power to “pro-
`
`mote the Progress of Science and useful Arts, by securing
`for limited Times to Authors and Inventors the exclusive
`Right to their respective Writings and Discoveries.” Art. I,
`§8, cl. 8. Right there in the text, one finds the outline of
`what this Court has called the patent “bargain.” Bonito
`
`Boats, Inc. v. Thunder Craft Boats, Inc., 489 U. S. 141, 150
`
`(1989). In exchange for bringing “new designs and technol-
`ogies into the public domain through disclosure,” so they
`may benefit all, an inventor receives a limited term of “pro-
`tection from competitive exploitation.” Id., at 151; see also
`
`The Federalist No. 43, p. 272 (C. Rossiter ed. 1961) (J. Mad-
`ison) (explaining that in such cases “[t]he public good fully
`coincides . . . with the claims of individuals”).
`
`
`Congress has exercised this authority from the start. The
`Patent Act of 1790 promised up to a 14-year monopoly to
`any applicant who “invented or discovered any useful art,
`manufacture, . . . or device, or any improvement therein not
`
`
`before known or used.” Act of Apr. 10, 1790, §1, 1 Stat. 110.
`Reflecting the quid-pro-quo premise of patent law, the stat-
`ute required the applicant to deposit with the Secretary of
`State a “specification . . . so particular . . . as not only to dis-
`
`tinguish the invention or discovery from other things before
`known and used, but also to enable a workman or other per-
`son skilled in the art or manufacture . . . to make, construct,
`
`or use the same.” §2, ibid. The statute made clear that this
`disclosure would ensure “the public may have the full ben-
`efit [of the invention or discovery], after the expiration of
`
`the patent term.” Ibid.
`
`Even as Congress has revised the patent laws over time,
`
`it has left this “enablement” obligation largely intact. See
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`8
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`AMGEN INC. v. SANOFI
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`Opinion of the Court
`35 U. S. C. §§111, 112. Section 111 of the current Patent
`
`Act provides that a patent application “shall include . . . a
`
`specification as prescribed by section 112.” §111(a)(2)(A).
`Section 112, in turn, requires a specification to include “a
`written description of the invention, and of the manner and
`process of making and using it, in such full, clear, concise,
`and exact terms as to enable any person skilled in the
`art . . . to make and use the same.” §112(a). So today, just
`as in 1790, the law secures for the public its benefit of the
`patent bargain by ensuring that, “upon the expiration of
`[the patent], the knowledge of the invention [i]nures to the
`
`people, who are thus enabled without restriction to practice
`it.” United States v. Dubilier Condenser Corp., 289 U. S.
`
`178, 187 (1933); see also Grant v. Raymond, 6 Pet. 218, 247
`(1832) (Marshall, C. J.) (“This is necessary in order to give
`
`the public, after the privilege shall expire, the advantage
`for which the privilege is allowed, and is the foundation of
`the power to issue a patent.”); Whittemore v. Cutter, 29
`
`F. Cas. 1120, 1122 (No. 17,600) (CC Mass. 1813) (Story, J.)
`(“If therefore [the disclosure] be so obscure, loose, and im-
`perfect, that this cannot be done, it is defrauding the public
`of all the consideration, upon which the monopoly is
`
`granted.”).
`
`This Court has addressed the enablement requirement
`
`on many prior occasions. See, e.g., Wood v. Underhill, 5
`
`How. 1 (1846); O’Reilly v. Morse, 15 How. 62 (1854); The
`
`Incandescent Lamp Patent, 159 U. S. 465 (1895); Minerals
`
`Separation, Ltd. v. Hyde, 242 U. S. 261 (1916); Holland
`
`Furniture Co. v. Perkins Glue Co., 277 U. S. 245 (1928).
`While the technologies in these older cases may seem a
`world away from the antibody treatments of today, the de-
`cisions are no less instructive for it.
` Begin with Morse. While crossing the Atlantic Ocean in
`1832 aboard a ship named Sully, Samuel Morse found him-
`self in conversation with other passengers about “experi-
`ments and discoveries” around electromagnetism. 15 How.,
`
`
`
`
`
`
`
`

`

`9
`
`
`
`
`
` Cite as: 598 U. S. ____ (2023)
`
`Opinion of the Court
` “In the course of this discussion, it occurred to
`at 68.
`
`[Morse] that, by means of electricity, signs representing fig-
`ures, letters, or words, might be legibly written down at any
`distance.” Id., at 69. So clear was the idea in Morse’s mind
`
`that, “[b]efore he landed in the United States, he had . . .
`drawn out in his sketch book . . . the form of an instrument
`
`for an electro-magnetic telegraph.” Ibid.
`
`
`Immediately upon his arrival in New York, Morse showed
`
`his brothers his sketches. See id., at 69–70. He spent the
`
`next few years refining his invention. See id., at 70–76.
`
`The “great difficulty” he faced was that “the galvanic cur-
`rent, however strong in the beginning, became gradually
`weaker as it advanced on the wire[,] and was not strong
`enough to produce a mechanical effect, after a certain dis-
`tance.” Id., at 107. By 1837, Morse had a solution: “com-
`bining two or more electric or galvanic circuits, with inde-
`pendent batteries for the purpose of overcoming the
`diminished force of electro-magnetism in long circuits.” Id.,
`
`at 109. Morse demonstrated his telegraph the following
`year at the Franklin Institute in Philadelphia, and he dis-
`played it soon after in Congress. See id., at 76. He received
`a patent in 1840, which reissued in 1848. See id., at 81–83.
`
`The litigation that brought Morse before this Court con-
`cerned a telegraphic system that Henry O’Reilly had in-
`stalled between Louisville and Nashville. See id., at 65.
`Morse sued O’Reilly for infringement, alleging that
`
`O’Reilly’s system was “identical with” Morse’s own. Id., at
`66. O’Reilly mounted a number of defenses, including that
`Morse’s patent was void because it lacked an adequate spec-
`ification. See id., at 99–101, 112.
`
`
`Morse’s patent included eight claims, and this Court had
`no trouble upholding seven of them—those limited to the
`
`telegraphic structures and systems he had designed. See
`
`id., at 85–86, 112, 117. But the Court paused on the eighth.
`
`That claim covered “the essence” of the invention, which
`
`
`
`
`
`

`

`
`
`
`
`10
`
`
`AMGEN INC. v. SANOFI
`
`Opinion of the Court
`Morse described as “the use of the motive power of the elec-
`tric or galvanic current . . . however developed for marking
`or printing intelligible characters, signs, or letters, at any
`distances.” Id., at 112 (internal quotation marks omitted).
`
`Leaving no doubt about this claim’s scope, Morse stated
`
`plainly: “‘I do not propose to limit myself to the specific
`
`machinery or parts of machinery described in the foregoing
`
`specification and claims.’” Ibid.
`
`The Court held the eighth claim “too broad, and not war-
`
`ranted by law.” Id., at 113. The problem was that it covered
`all means of achieving telegraphic communication, yet
`Morse had not described how to make and use them all. See
`id., at 113–117; see also 3 Chisum on Patents §7.03[1],
`pp. 7–18 to 7–19 (2021). “[I]f the eighth claim . . . can be
`
`maintained,” the Court concluded, “there was no necessity
`for any specification, further than to say that he had discov-
`
`ered that, by using the motive power of electro-magnetism,
`he could print intelligible characters at any distance.” 15
`How., at 119. “[I]t will be admitted on all hands, that no
`
`patent could have issued on such a specification.” Ibid.
`
` Consider, too, Incandescent Lamp. For much of the 19th
`century, gas lamps helped illuminate streets and supple-
`mented candles inside homes, factories, offices, and thea-
`ters. But gas lighting had drawbacks. It took effort to ig-
`
`nite lamps each night and extinguish them each morning.
`
`
`Then there were the problems of soot and fumes. See R.
`Stross, The Wizard of Menlo Park 84–85 (2007) (Stross). By
`the 1870s, many had experimented with other forms of
`
`lighting, including incandescence and the arc light. 159
`
`U. S., at 470. But these alternatives burned unreliably or
`with unbearable brightness. See id., at 470–471. The latter
`
`problem in particular led one observer to lament this “new
`sort of urban star,” which shines “horrible, unearthly, ob-
`noxious” light. R. L. Stevenson, A Plea for Gas Lamps, in
`Virginibus Puerisque and Other Papers 295 (1881).
`
`Enter Thomas Edison. From his laboratory in Menlo
`
`
`
`

`

`
`
` 11
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Cite as: 598 U. S. ____ (2023)
`
`Opinion of the Court
`Park, Edison and a team toiled to improve upon the prevail-
`ing method of incandescent lighting, which tended to em-
`
`
`ploy carbon filaments. 159 U. S., at 471–473. The problem
`
`with carbon filaments was that they disintegrated rapidly.
`In a sense, “carbon contained in itself the elements of its
`own destruction.” Id., at 471. Seeking an alternative, Edi-
`
`son tinkered for a time with platinum, but it was expensive
`and difficult to bring to the point of incandescence without
`melting. Stross 78, 82. Eventually, Edison dispatched men
`
`across the globe to collect specimens of bamboo. Id., at 109–
`
`110. One sample from Japan worked brilliantly because
`
`“[its] fibres [ran] more nearly parallel than in other species
`of wood.” 159 U. S., at 473. Satisfied, Edison arranged to
`have a Japanese farmer supply all of the bamboo he would
`ever need. Stross 110.
`
`
`But there was a catch. William Sawyer and Albon Man
`had obtained a patent for an “‘electric lamp’” with an “‘in-
`candescing conductor’” made of “‘carbonized fibrous or tex-
`tile mater

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