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We recently commented on a welcome alignment of the EPO and UPC concerning (in part) the extent to which an antibody may be defined broadly in a medical use claim. This confirmed a long-established European practice of allowing relatively broad definitions of antibodies in claims, particularly where the invention primarily concerns the identification of the target and/or its role in disease.
We briefly contrasted this to the strict assessment of written description/enablement in the US courts, which post-Amgen v Sanofi have typically required narrow, structural definitions for most antibody claims. Many practitioners will therefore be pleased to hear that in Teva Pharmaceuticals International GmbH v. Eli Lilly & Co., the Federal Circuit has adopted an approach that appears much closer to that applied in Europe, at least with respect to claims to methods of treatment – the counterpart to European medical use claims.
In its decision, the Federal Circuit indicated that assessment of written description/enablement of a claim to a method of treatment should consider primarily the claimed use of the antibody, not the molecule itself. The following claim was therefore considered valid:
“A method for reducing incidence of or treating headache in a human, comprising administering to the human an effective amount of an anti-CGRP antagonist antibody, wherein said anti-CGRP antagonist antibody is a . . . humanized monoclonal antibody.”
The court did not consider it necessary in the context of this claim to recite any structural limitations (sequences) of a specific anti-CGRP antibody, although the functional limitation to “antagonistic” was relevant in the context of the condition “headache”. The court also acknowledged that the generation of such antibodies can be achieved via routine techniques. Notably, Teva’s patent disclosed only a single humanized antagonistic antibody, although there were also several murine antibodies.
Overall this decision confirms a welcome distinction between the (typically narrow) scope of antibody per se/antibody composition claims allowed in the USA, versus the (potentially broad) scope of claims now allowed for methods of treatment using antibodies. The effective alignment with European patent practice in this area is also a welcome development providing greater certainty for patent portfolios that typically exist on both sides of the Atlantic.
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