On November 4, the United States Supreme Court granted a petition for writ of certiorari to review the Federal Circuit’s decision in Amgen Inc., v. Sanofi. Certiorari was limited to the question of whether the enablement requirement of 35 U.S.C. § 112 requires patent specifications to enable the “full scope” of the claims, or rather whether it is sufficient that the specification teach those skilled in the art to “make and use” the claimed invention. The Supreme Court will review the Federal Circuit’s holding that Amgen’s patent claims fail to satisfy the enablement requirement of § 112. This “full scope” enablement question has come up in several Federal Circuit cases before Amgen, but this is the first time the Supreme Court has addressed the issue.
Amgen’s patents are directed to antibodies that reduce low-density lipoprotein (“LDL”) cholesterol, which is linked to heart disease. LDL receptors in cells remove LDL cholesterol from the blood stream. The proprotein convertase subtilisin/kexin type 9 (“PCSK9”) enzyme facilitates LDL receptor degradation by binding to the LDL receptors, thus decreasing the number of LDL receptors available in cells to remove LDL cholesterol from the blood stream. Certain antibodies may bind to and block PCSK9 to prevent this degradation of LDL receptors, allowing LDL receptors to continue removing LDL cholesterol.
The antibodies claimed in Amgen’s patents are defined by their function, which is to bind to a combination of sites on the PCSK9 protein, thus blocking the PCSK9 protein from binding to LDL receptors. The claims are “genus”-type claims that are defined by their function, and broader in functional diversity than the examples disclosed in the patent specification.
In the district court proceeding, a jury found that Sanofi had failed to prove that Amgen’s patent claims are invalid for lack of written description and enablement. However, the district court granted Sanofi’s motion for Judgment as a Matter of Law, finding the claims invalid for failing to meet the requirement of 35 U.S.C. § 112 that a patent’s specification must enable a person skilled in the art to make and use the claimed invention. The purpose of the enablement requirement is to ensure that the public is told how to carry out the invention. To prove that a claim is invalid for lack of enablement, a challenger must show by clear and convincing evidence that a person of ordinary skill in the art would not be able to practice the claimed invention without undue experimentation.
Amgen appealed the trial judge’s ruling to the Federal Circuit, arguing that its patent claims are enabled because no undue experimentation is required to obtain antibodies within the scope of the claims. Sanofi responded that the claims are not enabled because there are millions of antibody candidates within the scope of the claims, the disclosures do not provide sufficient guidance, antibody generation is unpredictable, and practicing the full scope of the claims requires substantial trial and error.
The Federal Circuit agreed with Sanofi. The court found that while the “full scope” of the genus claims was broad, the examples disclosed in the specification were narrow. The court held that under those facts, and given the broad “full scope” of the claims, the trial judge did not err by concluding that undue experimentation would be required to practice the full scope of the claims.
This is not the first time the Federal Circuit has held that the enablement requirement applies to the full scope of the claims, and it has done so most often in biopharma cases. For example, in Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc., a case on which we have previously provided commentary, the Federal Circuit upheld a jury verdict of invalidity for lack of enablement after determining there was sufficient evidence to support a finding that the full scope of claims directed to methods for sequencing a nucleic acid using nanopore technology had not been enabled. In our analysis, we noted that patent applicants should take care in how broadly they draft their claims in view of the disclosure and advised that, depending on the circumstances, applicants may want to take steps to include claims of different scope or consider whether a slight delay in filing is warranted to conduct more testing and provide additional disclosure in the application.
Amgen petitioned the Supreme Court for review of the Federal Circuit’s decision, and the Supreme Court granted certiorari on Amgen’s question of:
Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to make and use the claimed invention, 35 U.S.C. §112, 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.
Amgen and others in the industry do not want to delay patent filings so that they can clear the “high hurdle” of showing full-scope enablement of a genus claim. They believe that having to enable the “full scope” of a claim will allow competitors to leapfrog the original innovator by focusing on minor changes that avoid infringement without having to invest in the same R&D. They argue that innovators faced with the elevated enablement standard that the Federal Circuit applied in Amgen and earlier cases will divert resources away from making new discoveries or advancing discoveries to market, devoting them instead to making and testing additional embodiments of their invention to satisfy the “full scope” enablement requirement, slowing the pace of research and development and hindering innovation to the detriment of the public.
Sanofi and its supporters argue that the Federal Circuit has it correct, and that genus claims, when properly supported, are alive and well. Broad, unsupported genus claims, they argue, would have an even more chilling impact on innovation. For example, other companies would have less incentive to develop new therapeutics within the scope of such broad functional claims, even if those therapeutics might prove more effective for patients.
Until now, the Supreme Court has repeatedly denied petitions raising this question, so it is interesting that the Court is now taking on the issue. Indeed, the United States Solicitor General argued in an amicus curiae brief that Amgen’s challenge to the Federal Circuit’s enablement holding did not warrant further review. Perhaps the Court simply seeks to end the debate by reinforcing the Federal Circuit’s interpretation of the enablement requirement for functional genus claims. On the other hand, the Supreme Court’s decision to review the Amgen case may signal a shift in favor of functional genus claims without the requirement of enabling the “full-scope” of the claims in the specification. It is also intriguing that the Supreme Court did not follow the recommendation of the Solicitor General. In any event, patent owners, inventors, and patent practitioners now await briefing, oral argument, and the Supreme Court’s decision.
