Between the roadmap and the examples, “Amgen contends that the embodiments in the patent are structurally representative for the purpose” of enablement.ĭespite a jury verdict in Amgen’s favor, the Federal Circuit rejected Amgen’s position and affirmed the JMOL of non-enablement. On appeal, Amgen contended that its functional claims were enabled for two reasons: (1) the specification discloses “a roadmap using anchor antibodies and well-known screening techniques” that would easily identify working antibodies and (2) a person of ordinary skill could make “conservative amino acid substitutions in the twenty-six examples” disclosed in the specification to find many other working antibodies. Following the trial, the district court granted Sanofi’s motion for judgment as a matter of law (JMOL) that Amgen’s asserted patent claims were not enabled.
The patents claim any antibodies that meet these two functional requirements, whether or not the structure of these antibodies is similar to the antibodies disclosed in the patents’ specifications.Īfter a stipulation of infringement from Sanofi, a jury in the District of Delaware found Amgen’s patents to be valid over obviousness and enablement challenges. Amgen’s patents claimed any antibodies that bind PCSK9, meeting two functional requirements: (1) binding at least one of fifteen specific amino acid residues of the PCSK9 protein and (2) blocking PCSK9 from binding to the LDL receptors. Certain receptors – called LDL receptors – “remove LDL cholesterol from the bloodstream.” However, a protein called PCSK9 can interfere with the action of LDL receptors by binding to and blocking their ability to regulate LDL cholesterol. In the District of Delaware, Amgen asserted that certain Sanofi antibodies infringed several Amgen patents directed to antibodies used to treat elevated levels of “bad” LDL cholesterol in the bloodstream. While the Amgen opinion may render functional claiming more difficult, functional claims that follow its guidance may still have an important role to play in pharmaceutical patents.Īfter outlining the Federal Circuit’s decision in Amgen, this brief article identifies practical implications – as well as pitfalls to avoid – to obtain valid and enabled functional claims. After several recent decisions clarifying and perhaps heightening the requirements for enablement of functional claims, the Federal Circuit is continuing its trend of invalidating broad pharmaceutical claims containing very large numbers of species, drafted with functional elements. The opinion, issued on February 11, 2021, is likely to raise some questions about the viability of functional claiming.
Sanofi, a case which addressed the enablement of antibody claims containing very large numbers of embodiments that rely upon functional claiming. The Federal Circuit has issued its opinion in Amgen v.
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