Posts Tagged: "Amgen v. Sanofi"

Last term, the U.S. Supreme Court did something strange: the Court unanimously affirmed a circuit decision, which had unanimously affirmed a trial court decision. Little about the law seemed ripe for dispute or change, nevertheless, in Amgen v. Sanofi the Supreme Court spoke. Seven months later, innovators and patent practitioners are still scratching their heads. What impact, if any, does Amgen have? Is there a sign lower courts are interpreting Amgen as signaling a change in American patent law or did it merely ratify what already existed?

Although the proceedings before federal district courts may not garner as much attention as those of the U.S. Court of appeals for the Federal Circuit or the Supreme Court, they can be an important proving ground for the decisions rendered by those courts. And 2023 was no exception to that rule. As discussed below, the Zogenix v. Apotex and Teva v. Eli Lilly decisions provide a glimpse into what litigants can expect in the aftermath of the GSK v. Teva and Amgen v. Sanofi decisions, respectively. These cases will have an especially significant impact on the life sciences industry, and watching how these decisions are applied by the district courts should be a priority for practitioners in this space.

It seems likely that Amgen Inc. v. Sanofi 598 U.S. 594 (2023) will be one of the most significant, if not the most significant Supreme Court patent decision of 2023. Its holding that a claim to a genus of antibodies must be enabled to the full scope of species within that genus was emphatic and—coming from our highest court—about as final as stare decisis can guarantee. Forty years ago, I was knee deep in U.S. Patent and Trademark Office (USPTO) and court proceedings on behalf of laser pioneer, Gordon Gould. A 1983 decision in Gould’s favor by an appellate court effectively shut down efforts by the USPTO and laser manufacturers to derail Gould’s patent portfolio, ultimately leading to widespread licensing of Gould’s patents. But there was one point in that 1983 decision that might be viewed as inconsistent with Amgen’s holding.

The Supreme Court’s decision in Amgen Inc. v. Sanofi, 143 S. Ct. 1243, 1248 (2023), found that antibody claims defined by their binding and blocking function lacked enablement…. The Supreme Court’s decision relied highly on the unpredictability of the art—scientists cannot always predict how substitutions of even single amino acids will affect the binding and/or blocking function of an antibody. The disclosed methods of identifying species within the scope of the claim were little more than “trial and error.”… The consensus seems to be that Amgen generally forecloses broad genus claims in the biotechnology field. The remaining questions are: Are patent applicants limited to claiming species (e., sequence listings)? What steps may a patent applicant take to obtain broader coverage?

Earlier today, the United States Supreme Court issued its decision in Amgen, Inc. v. Sanofi et al. The Court held, as many feared they would, that the 26 antibody examples and detailed instructions for generating additional antibodies within the genus—which covered some 400 pages and included a CD Rom of the x-ray crystallography coordinates of Amgen’s “anchor” (or lead) antibodies 21B12 (Repatha) and 31H4—was insufficient to satisfy the enablement requirement. Unfortunately, the Supreme Court did not explain what level of detail would have been sufficient, nor did the Court provide direction to the industry on what more is expected to satisfy the enablement requirement. So, we simply learned today that the extraordinary disclosure and detail provided by Amgen was not enough.

Yesterday’s oral argument in Amgen v. Sanofi was long-awaited and closely watched by many in the patent community. The Justices seemed skeptical that the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) decision was a significant departure from existing law, and they repeatedly questioned whether this particular case can be resolved on the facts and by employing current legal tests. During oral argument, Sanofi’s counsel, Paul Clement, admitted that the Court’s affirmance of the CAFC decision could result in the inability to functionally claim a genus in this particular area of antibody science, but said that’s ok because “functional genus claims are terrible. I think they retard the science.”

The U.S. Supreme Court heard three separate arguments today in Amgen v. Sanofi, a case that even Sanofi’s counsel agreed could effectively wipe out patents involving genus claims if the Court sides with Sanofi, or—as counsel for Sanofi and the Solicitor General’s Office suggested the Court could do—if it were to dismiss the case as improvidently granted.

On March 6, biotechnology developer Amgen filed a reply brief  with the U.S. Supreme Court in its appeal of the invalidation of its patent claims covering antibodies effective at blocking low-density lipoprotein (LDL) cholesterol receptors. The brief responds to arguments raised both by rival pharmaceutical firm Sanofi and the U.S. federal government in Amgen’s appeal of the invalidation of its patent claims as a matter of law under 35 U.S.C. § 112, which the district court entered on judgment as a matter of law (JMOL) after a jury verdict upheld the validity of Amgen’s patent claims.

The United States Supreme Court is soon poised to decide the fate of the enablement requirement, and the patent community is collectively holding its breath, wondering if the Court will strike a deathblow to the biopharmaceutical industry—simultaneously making all patents harder to get and even easier to challenge than they already are. The Supreme Court does not have a strong track record of objectively getting patent issues correct, at least not from a pro-innovation standpoint, although the Justices and their supporters likely would disagree. The undeniable truth, however, is that since the Supreme Court issued its decision in eBay v. MercExchange, virtually every decision of consequence to the patent system has made patent rights weaker and patents themselves easier to successfully challenge.

The United States Supreme Court is set to hear opening arguments in Amgen Inc. v. Sanofi on March 27. This is a case that could have profound impacts both on the invention enablement issues that have been plaguing life science patenting, but also more broadly on defining the contemporary role that the patent system will play in our innovation economy going forward. Specifically at issue will be the question of what genus claims require from an enablement perspective. Will the enablement standard be governed by the black and white, codified Section 112 statutory requirement that the specification must only teach those skilled in the art how to “make and use” the claimed invention? Or will the Supreme Court lean on lower court-based additions to the standard that the specification must enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation?

Late last week, a slew of additional amicus briefs were filed with the U.S. Supreme Court in Amgen v. Sanofi, a closely-watched case that will consider the scope of the enablement inquiry under 35 U.S.C. § 112. More than 30 amici in total have now weighed in on the case. The Court granted certiorari in November 2022 over the U.S. Solicitor General’s recommendation to deny the petition. The justices granted cert on one of the two questions presented.

On January 3, a total of 14 amicus briefs and one motion for leave to participate in oral argument were filed with the U.S. Supreme Court on the question presented by Amgen Inc. v. Sanofi, on which the Supreme Court granted certiorari this past November. While organizations representing the most powerful interests in the technology industry supported the Federal Circuit’s holding that Amgen’s patent claims were invalid for lack of enablement, a wide swath of patent stakeholders are urging the Supreme Court to correct the enablement standard to continue the encouragement of genus patent claims. Below is a collection of arguments raised by several of the recent amicus filings from earlier this week.

Following the denial of Juno Therapeutics’ petition to the U.S. Supreme Court earlier this month, Juno last week petitioned the High Court for rehearing, arguing that the grant of certiorari in Amgen v. Sanofi warrants reconsideration. Juno explained that the issues presented in the Amgen case “are tightly related, and the outcome in Amgen is likely to at least affect, if not be outcome-determinative of, this case.” Juno is asking that the Court grant the petition for rehearing, vacate the denial of certiorari, and hold the case pending the outcome in Amgen.

On November 4, the U.S. Supreme Court granted Amgen’s petition for certiorari against the advice of the U.S. government – taking up Amgen’s challenge to the Federal Circuit’s enablement review of its PCSK9 antibody patents covering evolocumab (Repatha®). In its petition, Amgen asserts that the Federal Circuit has gone too far in invalidating its PCSK9 antibody patents by imposing a disclosure burden beyond the requirements of 35 U.S.C. § 112. Notably, the Supreme Court, albeit with a different composition, recently declined to hear several other similar cases raising issues with the Federal Circuit’s enablement precedent.