“What emerges from our case law is that the enablement inquiry for claims that include functional requirements can be particularly focused on the breadth of those requirements, especially where predictability and guidance fall short.” – CAFC
The U.S. Court of Appeals for the Federal Circuit (CAFC) on Thursday upheld the District of Delaware’s grant of judgment as a matter of law (JMOL) that Amgen’s patent claims covering its Repatha cholesterol treatment were invalid for lack of enablement. The court found that Amgen’s composition claims were defined by meeting functional limitations, rather than by structure, and that the patent specifications didn’t enable the preparation of the full scope of the claims without undue experimentation. Judge Lourie authored the opinion. Amgen v. Sanofi (CAFC, Feb. 11, 2020)
This is the second time Amgen’s U.S. Patents No. 8,829,165 (the “’165 patent”) and No. 8,859,741 (the “’741 patent”) have been on appeal to the CAFC. The patents describe antibodies that work to lower low-density lipoprotein (LDL) cholesterol levels. The CAFC explained:
The ’165 and ’741 patents share a common written description and the specification discloses amino acid sequences for twenty-six antibodies, including the antibody (designated as “21B12”) with the generic name of evolocumab, marketed by Amgen as Repatha®…. The claimed antibodies are defined by their function: binding to a combinations of sites (residues) on the PCSK9 protein, in a range from one residue to all of them; and blocking the PCSK9/LDLR interaction.
In the 2017 appeal, a jury determined that the patents were not invalid for lack of enablement and written description and Sanofi appealed. The CAFC found that the district court had erred in its evidentiary rulings and jury instructions and remanded for a new trial. On remand, the district court eventually granted JMOL for lack of enablement, and Amgen file the present appeal.
The Wands Factors
Amgen specifically asked the CAFC to reverse the district court’s decision holding ’165 patent claims 19 and 29 and ’741 patent claim 7 invalid for lack of enablement, arguing that the court’s analysis of the “Wands factors” was improper. In In re Wands the Federal Circuit said that “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” The factual considerations that have come to be known as the Wands factors are:
(1) the quantity of experimentation necessary,
(2) the amount of direction or guidance presented,
(3) the presence or absence of working examples,
(4) the nature of the invention,
(5) the state of the prior art,
(6) the relative skill of those in the art,
(7) the predictability or unpredictability of the art, and
(8) the breadth of the claims.
These factors are applied once it has been shown that some experimentation is necessary to practice the patented claim in order to determine “whether the amount of that experimentation is either ‘undue’ or sufficiently routine such that an ordinarily skilled artisan would reasonably be expected to carry it out.”
Amgen argued that “no undue experimentation is required to obtain antibodies fully within the scope of the claims” and pointed to expert testimony showing that “a person of skill in the art can make all antibodies within the scope of the claims by following a roadmap using anchor antibodies and well-known screening techniques as described in the specification or by making conservative amino acid substitutions in the twenty-six examples.” The court further summarized Amgen’s argument:
Amgen argues that the court erred by focusing on the effort required to discover and make every embodiment of the claims…while failing to recognize that Sanofi could not identify any antibody that cannot be made by following the specification’s teachings…. Amgen contends that the embodiments in the patent are structurally representative for the purpose of fulfilling the written description requirement, and such evidence is sufficient to indicate a structure/function correlation establishing enablement.
But Sanfoi said that “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,” explained the CAFC.
The Facts Control
In its discussion of the Wands case, in which the claims at issue were found to be fully enabled by the specification, the CAFC explained that, while it has become the “go-to” case for guidance on enablement and also involved antibody claims, it “did not proclaim that all broad claims to antibodies are necessarily enabled. Facts control and, in this court, so does the standard of review.” Instead, the CAFC agreed with the district court that Amgen’s claims were more analogous to the facts of cases like Wyeth & Cordis Corp. v. Abbott Laboratories; Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc.; and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., in which the CAFC found the claims at issue invalid for lack of enablement. The opinion added:
What emerges from our case law is that the enablement inquiry for claims that include functional requirements can be particularly focused on the breadth of those requirements, especially where predictability and guidance fall short. In particular, it is important to consider the quantity of experimentation that would be required to make and use, not only the limited number of embodiments that the patent discloses, but also the full scope of the claim.
Ultimately, said the court, the claims at issue are composition claims “defined, not by structure, but by meeting functional limitations” and the specification failed to enable the claims without undue experimentation. Furthermore, the invention “is in an unpredictable field of science with respect to satisfying the full scope of the functional limitations,” and lastly, as the opinion previously described, Amgen’s contention that affirming the district court would overrule Wands is incorrect, as “Wands was based on the facts of that case and the evidence presented there.”
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