The US Supreme Court May 18 upheld a Federal Circuit 2021 decision that invalidated Amgen’s patent on its cholesterol inhibitor Repatha on the basis of lack of enablement.
The decision to invalidate the broad Amgen patent was consistent with the tenor of the questions posed during oral arguments. There was a clear sense of frustration among the justices throughout arguments that they didn’t understand antibody technology.
As a result, they resorted to overly simple questions such as how many antibodies fall under the Amgen patent. There’s a fundamental problem with focusing on the number of antibodies that may be made by following the teachings of the Amgen patent, when that number is as high as “millions,” as Sanofi asserted. It naturally leads to an impression that making and testing that many antibodies is unduly time-intensive.
The justices’ questions as well as their decision failed to acknowledge the legal precedent recognizing the absurdity of needing to know the number of species included within the scope of a claim to determine its validity. Those overlooked legal precedents emphasize that the proper focus is whether a skilled scientist may follow the patent’s teachings of how to make and use the invention.
Enablement turns on the knowledge of a “person having ordinary skill in the art ’. . . to which [the patent] pertains.” Here, that person is a scientist who researches antibodies.
Until recently, the standard for enablement has always been flexible because it depends on the facts of each case, and has not been applied as a rigid rule that all possible species falling under a claim must be enabled.
The Supreme Court’s unanimous decision upheld the US Court of Appeals for the Federal Circuit’s application of its rigid interpretation, called the “full scope” enablement standard. That standard focuses on knowing which species work, and whether the time it takes to make and test nearly every species that falls under the patent amounts to “undue experimentation.”
Traditionally, the law has allowed claims that require experimentation as long as it’s not “undue,” and the “full scope” concept has related to the breadth of a claim, and not a standard to judge enablement.
The “full scope” standard misunderstands the basic purpose of the enablement inquiry. While an antibody scientist may not be able to make every working antibody species in a short period of time, the law does not require that---and there is no reason to want to do it.
As the Federal Circuit’s predecessor court said in a related context, “[r]equiring specific testing of the thousands of [chemical] analogs encompassed by the present claim in order to satisfy the how-to-use requirement of §112 would delay disclosure and frustrate, rather than further, the interests of the public.”
By affirming the Federal Circuit’s approach, the high court failed to recognize that there exists abundant legal precedent on enablement applying a flexible, fact-dependent approach. The court essentially bought into the Federal Circuit’s erroneous interpretation of enablement that focuses on knowing which species of a claimed genus will work, thus requiring that a patentee demonstrate that virtually all species of a genus are operative.
This approach is troublesome because if the goal of enablement as articulated by statutory law is knowing “how to make and use an invention,” then one need not know in advance which species (or how many) species will work.
The Supreme Court held that the Amgen patent failed to enable all that it claimed, even allowing for a reasonable degree of experimentation, and concluded that the patent was invalid. Even so, the justices disregarded the opportunity to examine the issue as to whether the Federal Circuit’s “full scope” standard is the proper standard to apply to genus claims.
The court halfheartedly addressed the law on enablement instead of fulfilling its role as chief interpreter of that law and reviewing the legal precedent in depth.
The case is Amgen Inc. vs. Sanofi, U.S., No. 21-757, affirmed 5/18/23.
This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners.
Kathleen M. Williams, Ph.D., is a partner in Nutter’s Intellectual Property Department and the chair of the firm’s Life Sciences practice group.
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