As we previously reported, the PTAB instituted IPR on U.S. Patent 8,889,135, which is drawn to a method of treating rheumatoid arthritis (“RA”) with Humira®, a TNFα-inhibitor.
Claim 1 is directed to “A method for treating rheumatoid arthritis in a human subject, comprising administering subcutaneously to a human subject having rheumatoid arthritis a total body dose of 40 mg of a human anti-TNFα antibody once every 13-15 days for a time period sufficient to treat the rheumatoid arthritis….”
The institution decision considered the degree of efficacy required by the claims. Petitioner Coherus had argued that the term “a method for treating” should not require a particular level of efficacy, so long as the treatment reduces the signs, symptoms, and/or progression of RA to some extent. Patent Owner Abbvie had argued that the term “for a period sufficient to treat the rheumatoid arthritis” is limiting and that the specification supports a construction of that phrase that requires meaningful therapeutic efficacy.
While the Board did not construe the preamble as advocated by Coherus, the Board essentially adopted Coherus’ argument that the claims do not require a specific level of efficacy. The Board explained that the preamble was not necessary to give meaning to the claims and therefore is not limiting, and also found that the term “for a period sufficient to treat the rheumatoid arthritis” does not limit the claim. Further, the Board concluded that Abbvie’s proposed construction would have introduced ambiguity into the claims as the specification did not set forth a standard for measuring a level of efficacy.
The Board found a reasonable likelihood that Coherus will prevail in its argument that the subject matter of the claims would have been obvious over two pieces of prior art, both of which had been before the examiner during prosecution. The prior art Kempeni reference disclosed three studies in which patients had been dosed with either TNFα-inhibitor or placebo. In the first study, the results were described as “encouraging,” and in a follow on study, patients were continuously dosed until a “good” response was achieved. Kempeni disclosed both subcutaneous and intravenous administration in the second study, and found that the safety profile of the treatment was similar to placebo in the third study.
The prior art van de Putte study compared three dose levels of the inhibitor and placebo over three months. van de Putte concluded that the inhibitor was statistically significantly superior to placebo for all dose levels.
Coherus had argued that a person of ordinary skill would have arrived at the claimed dosage amounts of 40 mg every 13-15 days because the lowest dose level described in the van de Putte study was 20 mg per week and Kempeni described administration every other week. Abbvie had argued that one would not have arrived at the claimed dosage amounts because the data in van de Putte showed that higher dosages were clinically superior and the goal of a person of ordinary skill in the art “was to provide the highest level of efficacy possible while maintaining patient safety.” The Board rejected this argument, having previously rejected Abbvie’s argument that the claims required a specific level of efficacy. The Board also noted that “all that is required to show obviousness is a reasonable expectation of success, not conclusive proof of superior efficacy.”
As to secondary considerations that might weigh in favor of non-obviousness, the Board stated that any the commercial success of Humira® is not commensurate with the scope of the claims.
Keep reading Big Molecule Watch for updates on this now-instituted IPR.