On
Amgen's patents at issue claim a class of monoclonal antibodies that can lower low-density lipoprotein ("LDL") cholesterol levels.2 The claimed genus of antibodies bind to a particular region or "sweet spot" on a particular protein, PCSK9, involved in regulating the levels of LDL receptors.3 Because PCSK9 can degrade LDL receptors responsible for extracting LDL cholesterol from blood-stream, it can contribute to high cholesterol levels. By binding to PCSK9 and blocking it from contributing to high cholesterol levels, members of Amgen's claimed genus of antibodies were shown to be therapeutically effective at maintaining healthy cholesterol levels. While the Amgen's patents describe 26 exemplary antibodies, the claimed genus would encompass millions of antibodies—including those unknown at the time.
After obtaining the '165 Patent and the '741 Patent, Amgen sued
In 2021, Amgen appealed to the
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."
The
The Court also revisited its prior decisions addressing the enablement requirement, including O'Reilly v. Morse, 15 How. 62 (1854), The Incandescent Lamp Patent, 159 U. S. 465 (1895), and
[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent's specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims. The more one claims, the more one must enable.14
The Court was clear to point out that their analysis "is not to say a specification always must describe with particularity how to make and use every single embodiment within a claimed class;" "[n]or is a specification necessarily inadequate just because it leaves the skilled artist to engage in some measure of adaptation or testing."15 In support of these points, the Court pointed specifically to Wood and Minerals Separation,16 where claims were upheld because "a specification may call for a reasonable amount of experimentation to make and use a patented invention."17
Regarding Amgen's patents at issue, the Court did "not doubt that Amgen's specification enables the 26 exemplary antibodies it identifies by their amino acid sequences."18 Yet, the Court decided that "Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation."19 The Court reasoned that (1) "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;" (2) Amgen's roadmap to make the claimed antibodies in the specification "merely described step-by-step Amgen's own trial-and-error method;" and (3) Amgen's proposal for conservative substitution, which requires scientists to make substitution to the known amino sequences, was "an uncertain prospect given the state of art."20
While Amgen raised three alternative arguments that (1) enablement requirement should not be analyzed by how long a person skilled in the art to make every embodiment within a broad claim; (2) the Federal Circuit raised the bar for enablement—reach the full scope of claimed embodiments without undue experimentation; and (3) finding otherwise can "destroy incentives for breakthrough inventions,21 the Court found these positions lacked merit. While the Court agreed with Amgen that enablement is not measured against the cumulative time and effort it takes to make every embodiment within a claim, the Court found that "Amgen offers persons skilled in the art little more than advice to engage in 'trial and error.'"22 Further, the Court disagreed with Amgen that the Federal Circuit had raised the bar for enablement. Instead, the Court affirmed that the Federal Circuit's decision was consistent with the enablement standard, specifically, "the more a party claims for itself the more it must enable."23 Finally, the Court noted that the policy judgment for ensuring incentives for inventions belongs to
*
Footnotes
1 Amgen v.
2 The patent claims at issue in this case are claims 19 and 29 of
3
4 See Amgen v.
5 See Amgen v.
6 See Amgen, 2019 WL 4058927.
7 Id.
8 See Amgen v.
9 See Amgen v.
10 Amgen, 598 U.S. ____, at 8 (citing
11 Id. at 10 (citing O'Reilly v. Morse, 15 How. 62, 113-117 (1854)
12 Id. at 11-12 (citing The Incandescent Lamp Patent, 159 U. S. 465, 472 (1895)).
13 Id. at 12 (citing
14 Id. at 13.
15 Id. at 13-14.
16 Wood v. Underhill, 5 How. 1 (1846);
17 Amgen, 598 U.S. ____, at 15 (emphasis added).
18 Id.
19 Id.
20 Id. at 15-16.
21 See id. 18-19.
22 Id. at 18.
23 Id.
24 Id. at 19.
25 Id. at 18.
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