According to Nutter’s Kathleen Williams, the Supreme Court “halfheartedly” engaged with the legal precedent in this area, which had previously been flexible and fact-dependent, and missed an opportunity to address the law on patent enablement.

On the basis of lack of enablement, a Federal Circuit 2021 decision that declared Amgen’s cholesterol inhibitor Repatha patent invalid was upheld by the US Supreme Court on May 18.

The tone of the questions asked during oral arguments was consistent with the decision to invalidate the broad Amgen patent. There was an unmistakable feeling of dissatisfaction among the judges all through contentions that they didn’t grasp neutralizer innovation.

Subsequently, they depended on excessively basic inquiries, for example, the number of antibodies that fall under the Amgen patent. When Sanofi asserts that the number of antibodies that can be produced by following the instructions in the Amgen patent is as high as “millions,” there is a fundamental problem with focusing on that number. It normally prompts a feeling that making and testing that numerous antibodies is unduly time-serious.

The legal precedent that recognizes the absurdity of needing to know the number of species included within the scope of a claim to determine its validity was not acknowledged in the justices’ questions or their decision. Those omitted legal precedents emphasize that the proper focus should be on whether a skilled scientist can follow the patent’s instructions for making and utilizing the invention.

The knowledge of a “person having ordinary skill in the art” is what determines enablement. which is covered by the patent. Here, that individual is a researcher who explores antibodies.

The criterion for enablement has always been fluid because it is based on the particulars of each case and has not been enforced as a strict rule that all possible species that fall under a claim must be enabled. This has changed recently.

The “full scope” enablement standard, which was applied by the US Court of Appeals for the Federal Circuit, was upheld by the Supreme Court in a unanimous decision. That standard is focused on determining which species are successful and whether the amount of time required to create and test nearly every species covered by the patent constitutes “undue experimentation.”

Generally, the law has permitted claims that require trial and error for however long it’s not “excessive,” and the “full extension” idea has connected with the broadness of a case, and not a norm to pass judgment on enablement.

The enablement inquiry’s fundamental purpose is misunderstood by the “full scope” standard. Although an antibody researcher may not be able to produce every viable antibody species in a short amount of time, the law does not mandate this, and there is no compelling reason to do so.

“[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,” as the Federal Circuit’s predecessor court stated in a related context.

The high court did not take into account that there is a lot of legal precedent for enabling cases that use a flexible, fact-dependent approach when it upheld the Federal Circuit’s approach. The Federal Circuit’s incorrect interpretation of enablement, which emphasizes knowing which species of a claimed genus will function, was basically accepted by the court. As a result, the court required the patentee to demonstrate that virtually all species of a genus are functional.

This approach is problematic since, in such a case that the objective of enablement as expressed by legal regulation is knowing “how to make and utilize a creation,” then, at that point, one need not know ahead of time which species (or the number of) species will work.

The High Court held that the Amgen patent neglected to empower all that it guaranteed, in any event, considering a healthy level of trial and error, and reasoned that the patent was invalid. All things being equal, the judges ignored the chance to inspect the issue with respect to whether the Government Circuit’s “full extension” standard is the appropriate norm to apply to sort claims.

Instead of fully performing its duties as principal interpreter of that law and thoroughly reviewing the legal precedent, the court addressed the law on enablement in a half-hearted manner.

Amgen Inc. vs. Sanofi, United States, No. 21-757, asserted 5/18/23.

Source – Bloomberglaw