Posts Tagged: "enablement"

What I’ll Be Watching for in the Amgen Oral Arguments

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.

Amgen Reply Brief Addresses Mischaracterizations by Sanofi, U.S. Government on Proper Enablement Inquiry for Genus Claims

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.

Will the Supreme Court Save Biopharma from CAFC Enablement Insanity?

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.

Patently Strategic: SCOTUS in Focus – Amgen v. Sanofi and the Future of Pharma Patents

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?

Amici for Sanofi Add Their Two Cents as Amgen’s Day in High Court Approaches

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.