On the same day that the PTAB instituted review of an AbbVie Biotechnology Ltd. (“AbbVie”) patent covering a method of using adalimumab to treat psoriatic arthritis, it also instituted review of a second AbbVie patent directed to the use of adalimumab to treat chronic plaque psoriasis. More specifically, and once again at the urging of Sandoz Inc. (“Sandoz”), the PTAB instituted review of claims 1, 4, 7, 10, 13, 16, and 19 of U.S. Patent No. 9,090,689 (“the ʼ689 patent”), which is entitled “Use of TNFα Inhibitor for Treatment of Psoriasis.”
The challenged claims of the ʼ689 patent are directed to methods of administering adalimumab for the treatment of moderate to severe chronic plaque psoriasis. The claims require filling adalimumab into vessels (syringes) and subcutaneously administering 40 mg of adalimumab to a patient every other week. Certain dependent claims also recite various efficacy limitations, e.g., achieving a score reduction for a particular psoriasis severity measurement.
The only claim construction dispute at issue in the Petition was whether the preambles of the independent claims (1 and 7) are statements of intended use. If so, then Sandoz argued they are non-limiting. AbbVie did not respond to that position in its Preliminary Response, but reserved the right to do so if trial was instituted. However, the PTAB determined that it was unnecessary to determine if the preambles are limiting at this stage.
Sandoz proposed two Grounds of unpatentability in its Petition, although both Grounds are substantively similar. AbbVie did not contest that the cited references collectively disclose the claim limitations. Instead, AbbVie disputed that a person of ordinary skill would have had a reasonable expectation of success in using adalimumab to treat chronic plaque psoriasis, or a reasonable expectation of success in using the claimed dosing regimen, i.e., 40 mg adalimumab administered every other week.
AbbVie’s arguments in this IPR were very similar to those it made in arguing that trial should not be instituted in the companion ʼ992 patent. Briefly, Sandoz asserted there was a reasonable expectation of success in using adalimumab (a TNF-α inhibitor) to treat chronic plaque psoriasis because the disease was known to be mediated by TNF-α, and other TNF-α inhibitors had been successfully used to treat it. Because of this known link, Sandoz alleged a prior art disclosure in which adalimumab had been successfully used to treat rheumatoid arthritis (another TNF-α related disease) would have led a person of ordinary skill to believe it would also be effective to treat chronic plaque psoriasis. AbbVie countered that none of the cited references actually disclose using adalimumab to treat chronic plaque psoriasis, and a disclosure that adalimumab can treat rheumatoid arthritis is not predictive of its ability to treat psoriasis. However, much like in the ʼ992 IPR, the PTAB was not persuaded by this argument based on the record currently before it.
AbbVie also asserted that two of the relied upon references do not teach treating chronic plaque psoriasis at all; rather, they teach treating “psoriasis.” AbbVie contended that Sandoz did not establish that a disclosure of “psoriasis” teaches or suggests chronic plaque psoriasis. These arguments are part of a larger argument that AbbVie made regarding Sandoz’s failure to set forth an express construction of the term “moderate to severe chronic plaque psoriasis.” However, the PTAB was once again not persuaded by this argument, and pointed out that Sandoz’s experts offered uncontested testimony that the term “psoriasis” is most commonly associated with chronic plaque psoriasis. Regardless, the PTAB pointed out that another reference that is common to both Grounds does teach treating chronic plaque psoriasis.
With respect to the claimed dosage regimen, Sandoz argued that numerous prior art references demonstrate the same dosage of a TNF-α inhibitor was successful in treating both rheumatoid arthritis and psoriasis. Thus, Sandoz alleged that the prior art disclosure of dosing adalimumab at 40 mg every other week to successfully treat rheumatoid arthritis would have provided a person of ordinary skill a reasonable expectation of success in using the same dosage to treat psoriasis. AbbVie responded by arguing that Sandoz’s cited prior art references used higher doses than those approved for rheumatoid arthritis to treat chronic plaque psoriasis. Thus, AbbVie contended that the prior art would have led a person of ordinary skill to use a higher dosage of adalimumab than what is claimed. The PTAB disagreed, and pointed out that AbbVie assumed the FDA approved dosage is the only dosage relevant to the obviousness inquiry. The PTAB also found that Sandoz had submitted sufficient evidence showing that the same dose of adalimumab would have been effective to treat both rheumatoid arthritis and chronic plaque psoriasis.
With respect to the dependent claims, AbbVie contested only Sandoz’s allegations that the claimed efficacy requirements are the inherent result of administering the treatment. The PTAB noted that AbbVie’s contentions implicate a claim interpretation for the clinical endpoints that neither party addressed in its papers to date. Consequently, the PTAB determined the best course was to institute and let the parties resolve the dispute during trial.