Posts Tagged: "written description"

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.

CAFC Says University of Minnesota Patent Fails Written Description Test

In a precedential decision published Monday, the United States Court of Appeals for the Federal Circuit (CAFC) affirmed the Patent Trial and Appeal Board’s (PTAB) decision to invalidate a pharmaceutical patent owned by the University of Minnesota. Gilead Sciences filed an inter partes review (IPR) in 2017 challenging the claims of the university’s  U.S. Patent 8,815,830 as unpatentable. The ‘830 patent covers chemical compounds that prevent the reproduction of viruses or the growth of cancerous tumors. The PTAB found that the University of Minnesota failed to provide a sufficient written description that supported the patent’s priority claim. The Board thus concluded that the patent would not guide a skilled artisan to the patent’s claims. The CAFC agreed with the PTAB’s decision and with the ruling that a 2010 patent application publication filed by Gilead was “prior art” over the university’s patent.

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 Urge Justices to Grant Novartis’ Petition on CAFC’s Approach to Reconstituting Panels

A number of amici weighed in this week on Novartis Pharmaceuticals’ petition to the U.S. Supreme Court asking the Justices to consider whether the U.S. Court of Appeals for the Federal Circuit (CAFC) should have been allowed to vacate the decision of a previous three-judge panel composed of different judges, thus invalidating Novartis’ patent for a dosing regimen for its multiple sclerosis drug, Gilenya. In January of this year, Novartis followed through on its September 2022 promise that it would appeal the CAFC’s June 2022 decision invalidating its U.S. Patent No. 9,187,405 to the Supreme Court, after the CAFC denied its request to rehear the case.

SCOTUS Sustains Blow to Patent Prosecution Practice in Denying Juno v. Kite Rehearing

The Federal Circuit’s decision in Juno v. Kite undermines effective prosecution practice and ultimately patent enforcement. The Juno panel held that to satisfy the written description requirement, a patent needs to demonstrate to a skilled artisan that the inventors possessed and disclosed in their filing the full scope of every genus being claimed. By denying rehearing to the Federal Circuit’s 2021 decision on the scope of the written description requirement, Juno v. Kite demonstrates how once again, the courts never consider anything from a prosecutor’s point of view. Here’s why Juno v. Kite is bad for patent prosecution practice.