(Slip Opinion) OCTOBER TERM, 2022 1
Syllabus
NOTE: Where it is feasible, a syllabus (headnote) will be released, as is being done in connection with this case, at the time the opinion is issued. The syllabus constitutes no part of the opinion of the Court but has been prepared by the Reporter of Decisions for the convenience of the reader. See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.
SUPREME COURT OF THE UNITED STATES
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 to describe the invention “in such full, clear, concise, and exact terms 2 AMGEN INC. v. SANOFI
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 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 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 Cite as: 598 U. S. ____ (2023) 3
inventors had disclosed “a quality common” to fibrous and textile sub- stances that made them “peculiarly” adapted to incandescent lighting, but they did not. Ibid. Finally, in Holland Furniture, a company that had developed a starch glue that was similar enough to animal glue to be used for wood veneering included a claim in its patent covering all “starch glue which, [when] combined with about three parts or less . . . of water, will have substantially the same properties as animal glue.” 277 U. S., at 251. The specification described the key input—the “starch ingredient”—in terms of its “use or function” rather than its “physical characteristics or chemical properties.” Id., at 256. The problem, as the Court put it, was that “[o]ne attempting to use or avoid the use of [the] discovery as so claimed and described functionally 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 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- ure of adaptation or testing. See, e.g., Wood v. Underhill, 5 How. 1, 4– 5. A specification may call for a reasonable amount of experimentation 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 Minerals Separation, Ltd. v. Hyde, 242 U. S. 261, 270–271. Pp. 7–15. (b) Turning to the patent claims at issue in this case, Amgen’s claims 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 own trial-and-error method for finding functional antibodies. Not 4 AMGEN INC. v. SANOFI
much different, “conservative substitution” requires scientists to make substitutions to the amino acid sequences of antibodies known to work 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 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. Cite as: 598 U. S. ____ (2023) 1
Opinion of the Court
NOTICE: This opinion is subject to formal revision before publication in the United States Reports. Readers are requested to notify the Reporter of Decisions, Supreme Court of the United States, Washington, D. C. 20543, 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 specific amino acids on a naturally occurring protein known as PCSK9, and (2) block PCSK9 from impairing the body’s 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 2 AMGEN INC. v. SANOFI
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 antibodies are not just linear chains of amino acids. As the Cite as: 598 U. S. ____ (2023) 3
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, 4 AMGEN INC. v. SANOFI
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 Cite as: 598 U. S. ____ (2023) 5
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 6 AMGEN INC. v. SANOFI
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 Cite as: 598 U. S. ____ (2023) 7
by their amino acid sequences. Ibid. In response to 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 8 AMGEN INC. v. SANOFI
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., Cite as: 598 U. S. ____ (2023) 9
at 68. “In the course of this discussion, it occurred to [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
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 Cite as: 598 U. S. ____ (2023) 11
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 material,’ ” which they claimed was an improvement over conductors made of “ ‘mineral or gas carbon.’ ” 159 U. S., at 466, 468. Sawyer and Man’s patent had not won them commercial success. They had designed a lamp with a conductor made of carbonized paper, but the lamp proved defective and quickly fell out of use. See id., at 471–472. Still, their failure did not stop them from seeking to share in some of Edison’s success. Sawyer and Man alleged that Edison’s lamp infringed their patent because it “made use of a fibrous or textile material, covered by the patent.” Id., at 471. What was that offending material? Bamboo. This Court sided with Edison. It held that Sawyer and Man’s patent claimed much but enabled little. “Sawyer and Man supposed they had discovered in carbonized paper the best material for an incandescent conductor.” Id., at 472. But “[i]nstead of confining themselves to carbonized paper, as they might properly have done, and in fact did in their third claim, they made a broad claim for every fibrous and 12 AMGEN INC. v. SANOFI
textile material.” Ibid. Even that broad claim “might” have been permissible, the Court allowed, if Sawyer and Man had disclosed “a quality common” to fibrous and textile sub- stances that made them “peculiarly” adapted to incandes- cent lighting. Ibid. Had they done so, others would have known how to select among such materials to make an op- erable lamp. But the record showed that most fibrous and textile materials failed to work. Only through “painstaking experimentation” did Edison discover that bamboo “an- swered the required purpose.” Id., at 475–476. The Court summed up things this way: “[T]he fact that paper happens to belong to the fibrous kingdom did not invest [Sawyer and Man] with sovereignty over this entire kingdom.” Id., at 476. The Court returned to these principles in Holland Furni- ture. There, the evidence indicated that animal glue has properties that have long made it excellent for wood veneer- ing. See 277 U. S., at 247. Seeking a substitute, Perkins Glue Company had developed and patented a starch glue similar enough to animal glue that craftsmen could also use it for wood veneering. See ibid. Yet Perkins’s patent in- cluded a claim that went beyond the specific starch glue it manufactured. See id., at 250–251. This claim covered all “starch glue which, [when] combined with about three parts or less by weight of water, will have substantially the same properties as animal glue.” Id., at 251. Perkins’s specifica- tion instructed gluemakers to choose a “starch ingredient” with “such qualities” that it would yield a product “ ‘as good as animal glue’ ” for wood veneering “when combined with three parts of water and with alkali.” Id., at 256. The Court held this broad claim invalid for lack of ena- blement. Id., at 258. The specification described the key input—the “starch ingredient”—in terms of its “use or func- tion” rather than its “physical characteristics or chemical properties.” Id., 256. And that left gluemakers in a bind. As the Court put it: “One attempting to use or avoid the Cite as: 598 U. S. ____ (2023) 13
use of Perkins’ discovery as so claimed and described func- tionally could do so only after elaborate experimentation” with different starches. Id., at 257. To be sure, the Court held, Perkins was entitled to its patent on the specific starch glue it had invented. See id., at 255. The specifica- tion described that glue’s “characteristic ingredient” with “particularity.” Ibid. But just as Morse could not claim all means of telegraphic communication, and Sawyer and Man could not claim all fibrous and textile materials for incan- descence, Perkins could not claim all starch glues made from whatever starch happened to perform as well as ani- mal glue. To hold otherwise, the Court said, “would extend the monopoly beyond the invention.” Id., at 258. Our decisions in Morse, Incandescent Lamp, and Holland Furniture reinforce the simple statutory command. If a pa- tent claims an entire class of processes, machines, manu- factures, or compositions of matter, the patent’s specifica- tion must enable a person skilled in the art to make and use the entire class. In other words, the specification must en- able the full scope of the invention as defined by its claims. The more one claims, the more one must enable. See §112(a); see also Continental Paper Bag Co. v. Eastern Pa- per Bag Co., 210 U. S. 405, 419 (1908) (“[T]he claims meas- ure the invention.”). That is not to say a specification always must describe with particularity how to make and use every single embod- iment within a claimed class. For instance, it may suffice to give an example (or a few examples) if the specification also discloses “some general quality . . . running through” the class that gives it “a peculiar fitness for the particular purpose.” Incandescent Lamp, 159 U. S., at 475. In some cases, disclosing that general quality may reliably enable a person skilled in the art to make and use all of what is 14 AMGEN INC. v. SANOFI
claimed, not merely a subset. See id., at 475–476.1 Nor is a specification necessarily inadequate just because it leaves the skilled artist to engage in some measure of ad- aptation or testing. In Wood, a patent claimed a process for making bricks by mixing coal dust into clay. 5 How., at 4. The patent included “a general rule” about the proportion of dust and clay to use and offered two alternative propor- tions “where the clay has some peculiarity.” Id., at 5. The Court upheld the claim, recognizing that “some small dif- ference in the proportions must occasionally be required” given the varieties of clay. Ibid. Similarly, in Minerals Sep- aration, the Court dismissed a challenge to a claimed pro- cess for separating metal from mineral ores. 242 U. S., at 270. The record showed that “preliminary tests” were re- quired to adapt the process to any particular ore. Ibid. Once more, the Court explained that “the certainty which the law requires in patents is not greater than is reasona- ble.” Ibid. And because the “composition of ores varies in- finitely,” it was “impossible to specify in a patent the precise treatment which would be most successful and economical in each case.” Id., at 271.2
—————— 1 See also Béné v. Jeantet, 129 U. S. 683, 684–686 (1889) (rejecting
claim to method of shrinking coarse hair because the specification failed to give “one skilled in chemistry such an idea of the particular kinds and character of the chemicals, or combination of chemicals, with the relative proportions of each, as would enable him to use the invention without having to resort to experiments of his own to discover those ingredients”); Corona Cord Tire Co. v. Dovan Chemical Corp., 276 U. S. 358, 385 (1928) (rejecting claims to process of treating rubber with “ ‘a disubstituted guanidine’ ” because “between fifty and one hundred substances” fit that description and the specification did not disclose “any general quality common to disubstituted guanidines which makes them all effective”). 2 See also, e.g., Ives v. Hamilton, 92 U. S. 426, 429, 432 (1876) (uphold-
ing claim “for an improvement in sawmills” based on “curved guides at the upper end of the saw,” even though the specification did not “stat[e] the nature of the curve,” because a “good mechanic acquainted with the construction of sawmills, and having the patent and diagram before him, Cite as: 598 U. S. ____ (2023) 15
Decisions such as Wood and Minerals Separation estab- lish that a specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art. See Minerals Sepa- ration, 242 U. S., at 270–271; see also Mowry v. Whitney, 14 Wall. 620, 644 (1872) (“[T]he definiteness of a specification must vary with the nature of its subject. Addressed as it is to those skilled in the art, it may leave something to their skill in applying the invention.”). But in allowing that much tolerance, courts cannot detract from the basic statu- tory requirement that a patent’s specification describe the invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art” to “make and use” the invention. §112(a). Judges may no more subtract from the requirements for obtaining a patent that Congress has pre- scribed than they may add to them. See Bilski v. Kappos, 561 U. S. 593, 602–603, 612 (2010). III With these principles in mind, we return to claims 19 and 29 of the ’165 patent and claim 7 of the ’741 patent. In doing so, we do not doubt that Amgen’s specification enables the 26 exemplary antibodies it identifies by their amino acid se- quences. Even Sanofi concedes that description is enough to allow a person skilled in the art to make and use those embodiments. See Tr. of Oral Arg. 68. But the claims be- fore us sweep much broader than those 26 antibodies. And we agree with the lower courts that Amgen has failed to enable all that it has claimed, even allowing for a reasona- ble degree of experimentation. —————— would have no difficulty in adopting the improvement, and making suit- able curves”); Tilghman v. Proctor, 102 U. S. 707, 732–733 (1881) (up- holding claim for process of separating fats and oils even though the spec- ification “suggests a trial . . . with different degrees of heat so as to ascertain that which is best for each particular kind of fat”). 16 AMGEN INC. v. SANOFI
While the technology at the heart of this case is thor- oughly modern, from the law’s perspective Amgen’s claims bear more than a passing resemblance to those this Court faced long ago in Morse, Incandescent Lamp, and Holland Furniture. 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 receptors. The record reflects that this class of antibodies does not include just the 26 that Amgen has described by their amino acid se- quences, but a “vast” number of additional antibodies that it has not. 987 F. 3d, at 1085, 1088; see 2019 WL 4058927, *8 (“at least millions of candidates”); see also Tr. of Oral Arg. 52–53. Much as Morse sought to claim all telegraphic forms of communication, Sawyer and Man sought to claim all fibrous and textile materials for incandescence, and Per- kins sought to claim all starch glues that work as well as animal glue for wood veneering, Amgen seeks to claim “sov- ereignty over [an] entire kingdom” of antibodies. Incandes- cent Lamp, 159 U. S., at 476. That poses Amgen with a challenge. For if our cases teach anything, it is that the more a party claims, the broader the monopoly it demands, the more it must enable. That holds true whether the case involves telegraphs de- vised in the 19th century, glues invented in the 20th, or an- tibody treatments developed in the 21st. To be fair, Amgen does not dispute this much. It freely admits that it seeks to claim for itself an entire universe of antibodies. Still, it says, its broad claims are enabled because scientists can make and use every undisclosed but functional antibody if they simply follow the company’s “roadmap” or its proposal for “conservative substitution.” We cannot agree. These two approaches amount to little more than two research assignments. The first merely de- scribes step-by-step Amgen’s own trial-and-error method for finding functional antibodies—calling on scientists to Cite as: 598 U. S. ____ (2023) 17
create a wide range of candidate antibodies and then screen each to see which happen to bind to PCSK9 in the right place and block it from binding to LDL receptors. See Part I–B, supra; 987 F. 3d, at 1088; 2019 WL 4058927, *10–*13. The second isn’t much different. It requires scientists to make substitutions to the amino acid sequences of antibod- ies known to work and then test the resulting antibodies to see if they do too—an uncertain prospect given the state of the art. See Parts I–A, I–B, supra; 987 F. 3d, at 1088; 2019 WL 4058927, *10–*13. Whether methods like a “roadmap” or “conservative substitution” might suffice to enable other claims in other patents—perhaps because, as this Court suggested in Incandescent Lamp, the inventor identifies a quality common to every functional embodiment, supra, at 13—they do not here. They leave a scientist about where Sawyer and Man left Edison: forced to engage in “painstak- ing experimentation” to see what works. 159 U. S., at 475. That is not enablement. More nearly, it is “a hunting li- cense.” Brenner v. Manson, 383 U. S. 519, 536 (1966). Think about it this way. “Imagine a combination lock with 100 tumblers, each of which can be set to 20 different positions.” Brief for Intellectual Property Law Professors and Scholars as Amici Curiae 20. “Through trial and error, imagine that an inventor finds and discloses 26 different successful lock combinations.” Ibid. But imagine, too, “that the inventor tries to claim much more, namely all successful combinations,” while instructing others “to randomly try a large set of combinations and then record the successful ones.” Id., at 21. Sure enough, that kind of “roadmap” would produce functional combinations. Ibid. But it would not enable others to make and use functional combinations; it would instead leave them to “random trial-and-error dis- covery.” Ibid. Like many analogies, this one may oversim- plify a bit, but it captures the gist of the problem. Failing in its primary argument that it has enabled all of the antibodies it claims, Amgen tries a few alternative lines 18 AMGEN INC. v. SANOFI
of attack. First, it suggests that the Federal Circuit erred by applying an enablement test unmoored from the statu- tory text. As Amgen sees it, that court conflated the ques- tion 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. See Brief for Petitioners 24–29; see also id., at 2, 19–20, 30–36. We do not see it that way. While we agree with Amgen that enablement is not measured against the cumulative time and effort it takes to make every embodiment within a claim, we are not so sure the Federal Circuit thought otherwise. That court went out of its way to say that it “do[es] not hold that the effort re- quired to exhaust a genus is dispositive.” 987 F. 3d, at 1088 (emphasis deleted). Instead, the court stressed, the prob- lem it saw is the same problem we see: Amgen offers per- sons skilled in the art little more than advice to engage in “trial and error.” Ibid. (internal quotation marks omitted). In any event, we review judgments of the lower courts, not statements in their opinions. See Black v. Cutter Laborato- ries, 351 U. S. 292, 297 (1956). Taking a similar tack, Amgen next argues that the Fed- eral Circuit erroneously “raise[d] the bar” for enablement of claims that, like Amgen’s, encompass an entire “genus” of embodiments defined by their function. Brief for Petition- ers 25 (internal quotation marks omitted). This is imper- missible, Amgen argues, because the Patent Act “provides a single, universal enablement standard for all inven- tion[s].” Ibid. (internal quotation marks omitted). Here, too, we agree with Amgen in principle: There is one statu- tory enablement standard. But, once more, we do not un- derstand the Federal Circuit to have thought differently. Instead, we understand that court to have recognized only that the more a party claims for itself the more it must en- able. As we have seen, that much is entirely consistent with Congress’s directive and this Court’s precedents. Cite as: 598 U. S. ____ (2023) 19
Finally, Amgen warns that an affirmance risks “de- stroy[ing] incentives for breakthrough inventions.” Id., at 38. But striking the proper balance between incentivizing inventors and ensuring the public receives the full benefit of their innovations is a policy judgment that belongs to Congress. Since 1790, Congress has included an enable- ment mandate as one feature among many designed to achieve the balance it wishes. Our only duty in this case lies in applying that mandate faithfully. * Section 112 of the Patent Act reflects Congress’s judg- ment that if an inventor claims a lot, but enables only a lit- tle, the public does not receive its benefit of the bargain. For more than 150 years, this Court has enforced the stat- utory enablement requirement according to its terms. If the Court had not done so in Incandescent Lamp, it might have been writing decisions like Holland Furniture in the dark. Today’s case may involve a new technology, but the legal principle is the same. The judgment is Affirmed.