On
Conceptual Background
LDL, or low-density lipoprotein, cholesterol is often termed "bad" cholesterol. Excessive amounts can lead to buildup of plaque in the arteries and increase the risk of developing cardiovascular disease, heart attack and stroke. The body produces LDL receptors to facilitate the removal of LDL from the bloodstream. One particular protein of interest, PCSK9, is known to bind to LDL receptors and inhibit removal of LDL. It is beneficial to target PCSK9 and inhibit its ability to interfere with LDL receptors, thereby lowering LDL levels in the body and reducing the risk of developing further disease. There are numerous drugs that target PCSK9, for example, Repatha, marketed by Amgen, and Praluent, marketed by
Patents at Issue
Amgen owns
Case History
Amgen sued
The
While
Amgen argued that in teaching the "road map" and "conservative substitution" methods of making and uncovering new antibodies having the same claimed functions in the specification, the claims are sufficiently enabled. The Court disagreed, indicating that the methods described result in "trial-and-error method[s] for finding functional antibodies" that do not help to "identif[y] a quality common to every functional embodiment," leaving scientists "to engage in 'painstaking experimentation' to see what works." Such activity would be outside of enablement and amounts to "a hunting license." Amgen, No. 21-757 slip op. at 16-17 (quoting Brenner v. Manson, 383 U. S. 519, 536 (1966)).
The Court, in a unanimous decision affirming the Federal Circuit's holding, focused on whether the specification enabled the full scope of the invention to be practiced. In other words, in claiming a class of process, machine, manufacture or composition of matter, the specification must enable the full scope of the claimed class. In upholding the quid pro quo bargain, the more that is claimed in a patent, the more that needs to be enabled. Based on the disputed claims in the '165 and '741 patents, the Court noted that claiming an entire genus of antibodies by their function would be an attempt 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." Id. at 16. This would include the 26 antibodies defined by sequence, of which there is no dispute about their enablement, and those antibodies are not disclosed in the patent and have not yet been discovered. The Court analogized its holding to prior decisions in O'Reilly v. Morse,
In its decision, the Court clarified and reiterated that a patent specification does not need to disclose each and every embodiment in a claimed class, indicating that "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.'" Id. (quoting Incandescent Lamp, 159 U.S. at 475). This general quality "may reliably enable a person skilled in the art to make and use all of what is claimed, not merely a subset." Id. (citing Incandescent Lamp, 159 U.S. at 475-76). Furthermore, the Court clarified that a specification is not inadequate just because some experimentation is required. For example, preliminary tests would be required to characterize a claimed process to a particular ore of varying composition. See id. at 14 (citing
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