Recent court decisions have caused uncertainty about the rules for enabling claims to a genus of antibodies and categories of complex molecules, making excellent lawyering imperative. The case of Amgen v. Sanofi has brought the issue of enablement into focus, with the Supreme Court narrowly considering how to articulate the enablement test when the claim scope extends to variations or embodiments beyond what the specification exemplifies. Investors and inventors face challenges, as huge investments in complex drug discovery and development are made years in advance of any commercial return, let alone litigation. The enablement question is getting more acute as science makes breakthroughs in antibody and other large molecule therapies. The Supreme Court might focus on the narrow issue before it on the specific facts of the case and try to provide clarity on that alone. The court’s decision may have far-reaching implications, not only for the pharmaceutical industry but also for any art that uses functional or genus claiming.
Key Takeaways from Amgen v. Sanofi Oral Arguments
On March 27, the United States Supreme Court heard oral arguments in the case of Amgen v. Sanofi. The case involves the question of whether and how the court should interpret the requirement of enablement in patent law. The case has garnered the attention of 27 amici, including the US government.
One issue of interest is whether the court will provide a clear statement of the enablement test, which trial lawyers hope for. This would provide more predictability, but a clear statement may not guarantee certainty in particular cases. It is also unclear whether the court will focus narrowly on functional antibody claims or will attempt to increase predictability of outcomes when enablement is disputed.
The specific question that the court granted certiorari on is whether enablement is governed by the requirement that the specification teach those skilled in the art to “make and use” the claimed invention, or whether it must enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation. The latter approach requires identifying and making all or nearly all embodiments of the invention without substantial time and effort.
Depending on the court’s analysis, the opinion could have significant implications, not just for the pharmaceutical industry, but for any art that uses functional or genus claiming. Some 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.
Regardless of the outcome, it is expected that the need for excellent lawyering on the enablement question in future cases will not go away. The parties and amici involved in the case are eager to see the court’s decision and the potential impact it may have on patent law.
The Significance of the Amgen v. Sanofi Judgment
The judgment of invalidity in the case of Amgen v. Sanofi turned on a finding by the trial court that there was no 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 convinced the jury that the full scope of the claims was enabled, but the trial court disagreed and entered judgment of invalidity.
The Supreme Court has not addressed 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. The court appears to be narrowly focused on how to articulate the enablement test when the claim scope may extend to variations or embodiments beyond what the specification exemplifies, rather than how to allocate that issue between fact-finder and legal decision.
Recent court decisions have caused some uncertainty about the rules for enabling claims to a genus of antibodies and categories of complex molecules, creating a premium on excellent lawyering. Enablement issues tend to be highly fact-specific and depend on the particulars of the science and what the patent specification says. This has made it challenging for investors and inventors, as huge investments in complex drug discovery and development are made years in advance of any commercial return, let alone litigation. The enablement question is getting more acute as science makes breakthroughs in antibody and other large molecule therapies.
In the face of this uncertainty, the industry, investors, and the bar are hungry for clarity. Clarity and consistent application of the law over time may be more important to researchers and investors than anything else. However, there is an important policy decision 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.
Given the stakes involved, it is hoped that the Supreme Court is focused on clarity in its decision. The court’s decision may have far-reaching implications not only for the pharmaceutical industry but also for any art that uses functional or genus claiming. Investors and inventors will be eagerly awaiting the court’s decision and the potential impact it may have on patent law.
The Supreme Court’s Focus in Amgen v. Sanofi
The Supreme Court may be tempted 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. However, this may be a tall order to satisfy in the context of the question presented, which implicates complex science, prediction of specific facts that will arise in the future, and subtle policy. It might be wiser for the Court 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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