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EN
Clinical Efficacy a Functionally Unrelated Limitation That Creates No Patentability, CAFC Finds
['Steve Brachmann']
IPWatchdog.com | Patents & Intellectual Property Law
Bayer argued that the PTAB erred in finding that the claim term “clinically proven effective” was non-limiting and inherently anticipated.
On appeal, the Federal Circuit evaded Bayer’s argument, finding that even if the claim term were limiting, it is functionally unrelated and fails to make Bayer’s challenged claims patentable.
Functionally unrelated limitations do not contribute to patentability so as to prevent the indefinite patenting of known products and methods by including novel, unrelated limitations.
The Federal Circuit distinguished Allergan Sales v. Sandoz (2019), which according to Bayer required the appellate court to treat “clinically proven effective” as material to patentability.
Finally, Bayer’s offered secondary characteristics of unexpected clinical efficacy had no nexus with the merits of the claimed invention due to the functionally unrelated nature of the limitation.
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