Is the Enablement Standard Changing?
Written by Michael Boldt
I. Introduction to Amgen Inc. v. Sanofi
On November 4, 2022, the Supreme Court agreed to review Amgen Inc. v. Sanofi, No. 21-757, which questioned the proper enablement test. Amgen Inc. owns patents claiming antibodies that bind to specific proteins that effectually block these proteins from binding to low-density lipoprotein (LDL) receptors. [1] In effect, the antibodies help to lower LDL levels in a human, which can be useful for combating heart disease. [2] Amgen Inc. initiated this matter by claiming infringement of these patent claims by Sanofi; however, the validity of Amgen Inc.’s patents became a key issue, specifically the written description and enablement of their disclosures. [3]
The district court granted Sanofi’s Motion for Judgment as a Matter of Law, holding Amgen Inc.’s patents did not provide proper enablement or meet the written description requirement. [4] The Federal Circuit Court of Appeals noted that each “claim in this case is a composition claim defined, not by structure, but by meeting functional limitations . . . [and agreed] with the district court’s finding that the specification here did not enable preparation of the full scope of these double-function claims without undue experimentation.” [5] Both courts relied on the Wands factors in concluding that a person having ordinary skill in the art would not be able to practice the claimed invention without undue experimentation. [6]
On appeal, Amgen Inc. argued that the district court erred because “under a proper analysis of the Wands factors, the claims at issue were enabled because no undue experimentation is required to obtain antibodies fully within the scope of the claims.” [7] However, Sanofi maintained that the functionally defined claims cover a vast scope, and “there are millions of antibody candidates within the scope of the claims, the disclosures do not provide sufficient guidance, antibody generation is unpredictable, and practicing the full scope of the claims requires substantial trial and error.” [8]
The Supreme Court granted certiorari to answer Amgen Inc.’s second question presented, which is “whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial ‘time and effort’.” [9]
II. How We Got Here
The enablement requirement is set forth in 35 U.S.C. §112(a), requiring that the specification “contain 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 which it pertains, or with which it is most nearly connected, to make and use the same[.]” [10] The main purpose of the enablement requirement is to “ensure that the public is told how to carry out the invention, i.e., to make and use it.” [11] In other words, the public gains this useful knowledge of the invention in exchange for the inventor’s twenty-year monopoly on the invention.
The Supreme Court first addressed the enablement requirement in 1895 in Consol. Elec. Light Co. v. McKeesport Light Co. (“Incandescent Lamp Patent”), which is relied on by Sanofi. [12] In that case, an incandescent illumination system was claimed by Sawyer and Man, and Edison’s later discovered incandescent system allegedly infringed such patent. [13] An incandescent system generally involves “the passage of a current of electricity through a continuous strip or piece of refractory material. . . . It was discovered early in this century that various substances might be heated to a white heat by passing a sufficiently strong current of electricity through them.” [14] Sawyer and Man utilized a carbon paper conductor, but, rather than “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 or textile material.” [15] Edison, after trying a substantial number of exotic woods and growths, discovered bamboo to be a potential material. [16] Edison thereafter continued to experiment with different bamboo to arrive at his successful incandescent illumination system. [17] The Court ruled in favor of Edison, invalidating Sawyer and Man’s patent because if “the description be so vague and uncertain that no one can tell, except by independent experiments, how to construct the patented device, the patent is void.” [18] In sum, the Court found that Sawyer and Man claimed much too broad of a scope (“all fibrous and textile material”) while only disclosing and enabling a mere type of fibrous and textile material (“carbonized paper”).
In 1916, the Supreme Court provided more guidance to the enablement requirement in Minerals Separation, Ltd. v. Hyde, which is relied on by Amgen Inc. In that case, a patent containing “improvements in the concentration of ores by a process of oil flotation” was issued to an inventor and upheld as valid. [19] In upholding the patent’s validity, the Court surprisingly admitted that the “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.” [20] Yet, the Court goes on to state that “the process is one for dealing with a large class of substances and the range of treatment within the terms of the claims, while leaving something to the skill of persons applying the invention, is clearly sufficiently definite to guide those skilled in the art to its successful application.” [21]
III. Arguments, Genus Claims, and Policy
As noted above, the Federal Circuit Court of Appeals holds “‘substantial time and effort’ would be required to reach the full scope of claimed embodiments” in Amgen Inc.’s patent claims. [22] Amgen Inc. dubs this court’s holding as a new test for enablement, called the “reach-the-full-scope test.” [23] As Amgen Inc. points out, the Federal Circuit Court of Appeals stated that the “use of broad functional claim limitations raises the bar for enablement.” [24] Amgen Inc. argues that this new test, which is much stricter, is inconsistent with precedent, and the Supreme Court must rely on the plain language of 35 U.S.C. §112(a), which provides that one must only “enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” [25]
In general, “a genus can be sufficiently disclosed by ‘either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.’” [26] However, courts have previously noted how the “problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. . . .The functional claim may simply claim a desired result, and may do so without describing species that achieve that result.” [27] To combat this problem, “the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” [28]
As such, Sanofi, as mentioned above and with whom the Federal Circuit Court of Appeals agreed, argued that there are “millions of antibody candidates within the scope of the [Amgen] claims, the disclosures do not provide sufficient guidance, antibody generation is unpredictable, and practicing the full scope of the claims requires substantial trial and error.” [29] Sanofi’s arguments seem to align with an underlying policy in patent law, which is that the patentee gains such a monopoly for the invention in exchange for full and complete disclosure to enable society to make and use this innovative creation. The disclosure theory provides that enablement is directly linked to improvements, new innovations, and alternatives. In other words, without Amgen Inc.’s full disclosure of what is claimed, Sanofi believes Amgen Inc. should not have been granted the patent to such broad claims, and failure to deny the patent would stifle innovation.
Further, as mentioned, Sanofi relies on the Incandescent Lamp Patent, analogizing how the broad Sawyer and Man patent for “all fibrous material” was invalidated when Edison brought his invention, which used a bamboo material for incandescent lights. [30] However, Amgen Inc. makes a distinguishing point: Edison examined over 6,000 vegetable growths, provided actual embodiments within the claims that required undue experimentation, and provided evidence of independent discovery after months of experimentation. [31] In that case, Sanofi has failed to provide and “could not identify any antibody that cannot be made by following the specification’s teachings.” [32] As such, Sanofi’s claim seems to be patently different than the case of Edison coming to court with actual evidence of undue experimentation and lack of enablement.
The Supreme Court can further look to the fact that the Federal Circuit has previously concluded that no “bright-line rules gov[ern], for example, the number of species that must be disclosed to describe a genus claim, as this number necessarily changes with each invention, and it changes with progress in a field.” [33] The courts have proved to be flexible, looking at the specific invention and progress in the field. In addition, the Wands factors provide similar flexibility for undue experimentation analysis, looking at “(4) the nature of the invention, [and] (5) the state of the prior art.” [34]
In sum, the Supreme Court in this case can seemingly knock Amgen Inc.’s notion of any new enablement test and provide clarity on the case-by-case basis and flexibility of the undue experimentation analysis. At the time of the Incandescent Lamp Patent, the progress in the field had not reached the use of specific, foreign bamboo plants as a replacement for carbonized paper, which presumably led to the original patent to Sawyer and Man being granted in the first place. As a result, the Court can allow Amgen Inc. to retain its patent claims because the state of the prior art and progress in the field has not shown the claims to be so broad, and if and when any individual, like Edison, finds a valid antibody candidate not disclosed in the scope of the patent, a court can make a proper ruling then.
References
[1] Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080, 1083 (Fed. Cir. 2021).
[2] Id.
[3] Id. at 1084.
[4] Id.
[5] Id. at 1087.
[6] Sanofi, 987 F.3d at 1084.
[7] Id. at 1085.
[8] Id. at 1085.
[9] Amgen Inc. v. Sanofi, SCOTUSBLOG, https://www.scotusblog.com/case-files/cases/amgen-inc-v-sanofi-2/ [https://perma.cc/Q44X-PUS6].
[10] 35 U.S.C. § 112(a).
[11] Sanofi, 987 F.3d at 1084.
[12] Consolidated Electric Light Co. v. McKeesport Light Co., 159 U.S. 465 (1895) [hereinafter Incandescent Lamp Patent].
[13] Id.
[14] Incandescent Lamp Patent, 159 U.S. at 470.
[15] Id. at 472.
[16] Id. at 473.
[17] Id.
[18] Id. at 474.
[19] Minerals Separation v. Hyde, 242 U.S. 261, 263 (1916).
[20] Id. at 271.
[21] Id.
[22] Sanofi, 987 F.3d at 1088.
[23] Reply Br. for Pet’rs at 4, Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021) (No. 21-757) [hereinafter Br. for Pet’rs].
[24] Sanofi, 987 F.3d at 1087.
[25] Br. for Pet’rs at 20.
[26] Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1335 (Fed. Cir. 2021).
[27] Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349 (Fed. Cir. 2010).
[28] Id.
[29] Sanofi, 987 F.3d at 1085.
[30] Incandescent Lamp Patent, 159 U.S. at 472.
[31] Br. for Pet’rs at 4.
[32] Sanofi, 987 F.3d at 1085.
[33] Ariad Pharm., Inc., 598 F.3d at 1351.
[34] In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).