Following all of the latest IP developments in life sciences.

(Co-authored by Gabe McCool)

On February 11, 2021 the Federal Circuit upheld a United States District Court for the District of Delaware decision finding that Amgen’s function-only anti-PCSK9 monoclonal antibody claims were not enabled under 35 U.S.C. § 112. This highly anticipated decision involved a suit between the makers of the LDL-cholesterol-lowering drugs, Repatha® (Amgen) and Praluent® (Sanofi/Regeneron), filed nearly seven years ago by Amgen. Amgen had argued that patents for its cholesterol drug, RepathaⓇ, which cover a genus of antibodies that bind to a protein known as PCSK9, were sufficiently specific to allow one “skilled in the art” to “make and use” the patented invention without “undue experimentation” under the Wands factors.

Overview

On August 27, 2020, the Federal Circuit vacated the district court’s determination that Genentech’s Hemlibra® (emicizumab-kxwh) product for treating hemophilia did not infringe Baxalta’s US Patent No. 7,033,590 (the ‘590 patent) because it found the lower court had erred in its claim construction of “antibody” and “antibody fragment.”

Background and Issue Presented

Hemophilia is a rare blood clotting disorder characterized by an underlying malfunction in the coagulation cascade. A critical step in the cascade is the formation of a complex between activated factor IX (FIXa) and activated factor VIII (FVIIIa) which then goes on to activate factor X (FX). Hemophilia develops when this complex is unable to form, due in many cases to the development of self-antibodies that inhibit FVIIIa, thereby blocking the activation of FX. The disclosed and claimed invention in the ‘590 patent relates to antibodies against FIXa that take the place of FVIIIa and result in the activation of factor X by FIXa even in the absence of FVIIIa. Thus, rapid blood coagulation may be achieved in hemophiliacs with FVIIIa inhibitors by administering the claimed anti-FIXa antibodies.