“I suspect that, no matter what the Court does, the need for excellent lawyering on the enablement question in future cases is not going away. A clear statement of the test is not going to provide certainty as to the outcome in particular cases.”
On Monday, March 27, the Supreme Court will hear oral argument in Amgen v. Sanofi, a case with the parties and 27 Amici, including the United States, weighing in on whether and how the Court should address the enablement requirement of Section 112 in the context of genus claims, and in particular, genus claims to antibodies in the pharmaceutical sciences.
Depending on how the court focuses its analysis, the opinion could be as narrow as how the jury instruction should read for pharmaceutical antibody claims written in the form of “a binding site plus a function.” But some of the briefs invite the court to loosen the constraints of Section 112 by eliminating the requirement of enablement of the “full scope” of the claimed embodiments in favor of a test focused on the “make and use the invention” language in the statute without the “full scope of the claimed embodiments” language the courts have used for years, with implications not just for pharma but for any art that uses functional or genus claiming.
Issues of Interest
As a trial lawyer, I hope that whatever the Court holds, it includes a plain and clear statement of the enablement test. The worst outcome might be a number of opinions with differing views on the proper statement of the test. But I suspect that, no matter what the Court does, the need for excellent lawyering on the enablement question in future cases is not going away. A clear statement of the test is not going to provide certainty as to the outcome in particular cases. I’ll also be paying attention to whether the court focuses narrowly on functional antibody claims, or whether the court seems inclined to try to increase the predictability of outcomes when enablement is disputed. More predictability could come at the expense of the proper balance of rewarding innovation while encouraging further development in an art.
The specific question on which the Court granted certiorari is “Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 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 Amgen v. Sanofi judgment of invalidity turned on a finding of the trial court that “there does not appear to be a genuine dispute between the parties” that “millions” of antibodies “would need to be tested to determine whether they fell within the claims.” Amgen’s counsel persuaded a jury that the full scope of the claims was nevertheless enabled, but the trial court disagreed and entered judgment of invalidity. The Supreme Court has declined to address whether the trial court appropriately took the factual predicate of the enablement decision out of the hands of the jury after letting them decide it in the first instance. It appears, therefore, that the Supreme Court is narrowly focused on how to articulate the enablement test when the claim scope may extend to variations or embodiments beyond what the specification exemplifies, and not how to allocate that issue between factfinder and the legal decision.
What’s at Stake
Recent court decisions have caused some uncertainty about the rules for enabling claims to a genus of antibodies, and more generally to categories of complex molecules. Industry, investors, and the bar are hungry for clarity. More and more new therapies are based on large, complex molecules that can have many variations. When competitors seek to commercialize a variation of a complex patented molecule, the question arises whether the variation is something that the original patent described and enables, or a new discovery in its own right.
These enablement issues tend to be highly fact-specific and depend on the particulars of the science and what exactly the patent specification says, so there is a premium on excellent lawyering to write a good specification, claim well, and make a good clear record and the right argument when it comes to trial. That answer may be unsatisfying to investors and inventors. Huge investments in complex drug discovery and development are made years in advance of any commercial return, let alone litigation, and it can be difficult for those making the huge investments when expectations about the scope and validity of patent rights are not clear until late in the game. The enablement question is getting more acute as science is making breakthroughs in antibody and other large molecule therapies. In some ways, clarity and consistent application of the law over time may be more important to researchers and investors than anything. That said, there is an important policy decision here about how best to motivate and reward drug discovery. The goal is to motivate and reward real discoveries without preempting further additional discoveries that flow from the initial discovery.
Let’s Hope the Court is Focused On Clarity
The Supreme Court could be tempted to try to wade into the larger policy issue of how best to foster and protect settled expectations and how best to articulate the difference between obvious variation and novel discovery within a genus. I think that is a tall order to satisfy in the context of the question presented, and one that implicates complex science, prediction of specific facts that will arise in the future, and subtle policy. The Court might be wise to focus on the narrow issue before it on the specific facts of the case and try to provide clarity on that alone.
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Author: artursz
