Five Things to Watch in US Supreme Court Oral Argument in Amgen v Sanofi

On 27 March, the US Supreme Court will hear oral arguments in Amgen v Sanofi, an important patent case involving the enablement requirement of 35 U.S.C. §112. Following a long-running patent dispute, the Supreme Court is set to determine what enablement requires.

There are two options identified in the question presented:

• Does it require that the specification “enable those skilled in the art to reach the full scope of claimed embodiments” without undue experimentation?
• Or does it require only that the specification teach those skilled in the art to “make and use” the claimed invention?
  Sufficient enablement has been the subject of much debate—particularly for patents in the life sciences—and the court’s decision will likely significantly impact the role enablement plays in promoting innovation going forward. Those responsible for managing intellectual property at companies large and small will be keeping a close eye on what happens in this case.

Here are five things to watch for when oral argument begins.

Statutory text versus Federal Circuit test

Enablement is part of the patent bargain: inventors are granted a monopoly to exclude others from practising their invention in exchange for public disclosure. Inherent in this bargain is that the inventor’s disclosure be sufficiently detailed to allow one to “make and use” the invention. That is the statutory language adopted by Congress. When interpreting the statute, however, the US Court of Appeals for the Federal Circuit has at times required that the “full scope” of the patent claims be taught so that they can be practised “without undue experimentation.” This is the heart of the dispute. In the past, the Supreme Court has waded into the patent law arena several times, striking down legal tests created by the Federal Circuit. Here, whether the justices view the Federal Circuit as creating obligations that exceed the statutory requirements will likely play a critical role in the outcome of the case.

Will justices focus on specific technology?

Technologically, the Amgen case involves antibodies used to reduce cholesterol that can lead to heart disease. The claims at issue cover a class of antibodies defined by their function, specifically the ability to bind certain epitopes on a protein called PCSK9 (Amgen also has claims directed to antibodies with specific structures, but those patents are not at issue). The fundamental question is whether Amgen’s patent description, which discloses examples of antibodies that bind PCKS9 and methods for generating such antibodies, entitles Amgen to patent claims covering all antibodies having that function (even if not expressly described).  

This issue often arises in the context of pharmaceutical patents, but the question presented is not limited to functional claims or the specific technology involved in this case. As a result, the Court might simply address the statutory text and the Federal Circuit’s recent cases and issue a decision applicable to a wide variety of technology areas. The extent to which the justices focus on the technology during oral argument may give some indication of how broadly applicable their decision will be.

Justices' perceptions of enablement requirements? 

Many of the briefs submitted by the parties and amici address why enablement is important for fostering innovation, but they also offer competing views concerning the best approach. For example, some argue that a lower standard that requires only enough explanation to “make and use” the invention encourages earlier disclosure of inventions and does not require inventors to attempt to first perform every experiment (which can be expensive and frustrate the purpose of the patent system). On the other hand, some have argued that more enabling disclosure ensures that patentees do not receive a monopoly beyond what has been disclosed, potentially blocking other companies from independent innovation. This is a delicate balance. Whether the justices appear more sympathetic to one perspective or the other could foreshadow how they decide the case.      

Is the written description requirement implicated?

The written description requirement is arguably related to enablement, as both originate from the same statute. Recently, several cert petitions have sought clarification of the written description requirement, but none have been granted. Interestingly, in Juno v Kite, the petitioner presented a similar question as the one presented here: should written description be measured by the statute or under the Federal Circuit’s test requiring possession of the full scope of the invention? The Supreme Court denied certiorari in that case, even after agreeing to hear the relatively similar issue presented here.

Impact of the Solicitor General at oral argument?

The US Solicitor General was granted permission to participate in oral argument and will be allotted 15 minutes to argue on behalf of the United States. The Solicitor General recommended that the Court deny certiorari and submitted an amicus brief arguing that the Federal Circuit’s decision should be upheld. Historically, the Supreme Court has often deferred to the Solicitor General when it comes to issues of patent law, but it has not done so yet in this case. Whether the justices appear inclined to listen to the Solicitor General’s recommendations could make for an interesting dynamic that has rarely played out on this stage before.

Conclusion

Every time the Supreme Court hears a patent case, significant and far-reaching outcomes are possible. The Court’s decisions in Alice and Mayo created a framework that significantly altered the patent subject matter eligibility requirements in ways that continue to be felt and debated among the patent law community. The Court’s decision in Amgen could similarly have effects on enablement reaching far beyond the specific issue of functional genus claims in the case. Not only could the decision impact many issued patents and pending cases—strengthening or weakening patents in the process—it could also dramatically alter patent prosecution strategies and best practices, especially in the life sciences. For that reason, many people in the patent world will be watching the oral argument closely, hoping to glean useful insights on what might be in store.