The U.S. Supreme Court case, Amgen v. Sanofi, likely will have a significant impact on biotech innovation because of the Court’s ruling on the concept of enablement, or disclosure of the knowledge of how to make and use an invention. The Court invalidated Amgen’s claims to all antibodies which block a protein that decreases the body’s ability to remove low-density lipoprotein cholesterol. Amgen’s patents had identified only 26 specific antibodies, and there are potentially millions of other antibodies which have this function. The Supreme Court found that Amgen’s claims were not adequately enabled and therefore invalid because it would have required undue experimentation for a person of ordinary skill in the art to have identified these additional antibodies.

Panitch Schwarze attorneys Philip L. Hirschhorn and Travis W. Bliss, Ph.D. authored an article in MedTech Intelligence examining how this case may impact the enablement of similar claims going forward. They highlight the significance of Amgen claiming the antibodies by function rather than by structure and note the risks of making broad claims of this nature. They also examine how the Supreme Court approached the question of enablement in historical cases involving the telegraph and incandescent lamps.

Hirschhorn and Bliss urge caution when pursuing broad patent claims but emphasize that the Amgen opinion indicates it is not always necessary to describe every embodiment within a claim. They remind patent practitioners that the scope of disclosure defines what has been enabled and that purely functional claims may be problematic in certain circumstances.

Read the full article here: “The (Re-) Emergence of the Age of Enablement:  Amgen v. Sanofi”