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ARTICLE · 26 SEPTEMBER 2023

The Federal Circuit's First Enablement Decision Since Amgen

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Federal Circuit applied Amgen v. Sanofi, 598 U.S. 594 (2013)in deciding that claims 1-4, 19 and 20 of Baxalta's hemophilia patent, U.S. Patent 7,033,590 (‘590)...

United StatesIntellectual Property
Richard D. Kelly
Richard D. Kelly
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Federal Circuit applied Amgen v. Sanofi, 598 U.S. 594 (2013)in deciding that claims 1-4, 19 and 20 of Baxalta's hemophilia patent, U.S. Patent 7,033,590 ('590), were invalid as lacking an enabling disclosure.

Hemophilia A is a blood clotting disorder where the activity of Factor VIII is functionally absent, thereby impeding the coagulation cascade and the body's ability to effectively form blood clots. Historically, Hemophilia A has been treated by intravenously administering Factor VIII. However, approximately 20–30% of Hemophilia A patients do not benefit from this treatment because their bodies develop Factor VIII inhibitors (i.e., antibodies against Factor VIII). The '590 patent sought to treat hemophilia with antibodies which increase the procoagulant activity of Factor IXa by binding to Factor IX/IXa. The court identified Claim 1 as representative of the claims on appeal and recites:

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