Intellectual Property > IP Newsflash > Method-of-Treatment Claims That Did Not Require a Specific Level of Efficacy Held Unpatentable as Obvious in Light Of References Describing Clinical Trials
07 Jul '17

The Patent Trial and Appeal Board (the “Board”) issued a final written decision in an inter partes review determining Claims 1-5 of U.S. Patent No. 8,889,135 owned by Abbvie Biotechnology Ltd. unpatentable as obvious. Those claims cover methods of treating rheumatoid arthritis by administering—once every 13-15 days (i.e., biweekly) for a time period sufficient to treat the rheumatoid arthritis—40 mg of an antibody having certain sequences. The antibody D2E7, the active ingredient in Humira, is an antibody used in such a dosing regimen. The Board concluded that the challenged claims would have been obvious in light of two prior art references – van de Putte 2000 and Rau 2000 – which each described the results of clinical trials using D2E7.

Critical to its conclusion, the Board had construed “for a time period sufficient to treat rheumatoid arthritis” under the broadest reasonable interpretation standard as “for a time period sufficient to reduce the signs, symptoms, and/or progression of RA.” Boehringer Ingelheim Int’l GMBH et al. v. Abbvie Biotechnology, Ltd., IPR2016-00408, Paper No. 46 at 11 (PTAB July 6, 2017). The Board stressed that its construction did not require any particular level of efficacy.

The petitioner argued that biweekly dosing is the only claim element that is not expressly disclosed in van de Putte 2000, which teaches weekly dosing at a variety of doses (including 20 mg). Biweekly dosing is, however, expressly taught by Rau 2000, and it would have been obvious to try such dosing with a reasonable expectation of success based on the antibody’s half-life and the results of the three fixed doses in van de Putte. Abbvie did not challenge that all claim elements are present in the combination of van de Putte 2000 and Rau 2000, but alleged that one of skill in the art would not have been motivated to combine the references, and the art actually taught away from such a combination. According to Abbvie, Rau shows that biweekly dosing with 0.5 mg/kg (equivalent to a fixed dose of 40 mg in the average patient of 80 kg) was inter alia insufficient across the entire population. The Board noted that Abbvie’s arguments that related to lower efficacy had some merit, but found that Rau 2000 did not indicate that the 0.5 mg/kg does was “ineffective.” The Board again stressed that its construction of the term “for a period of time sufficient to treat rheumatoid arthritis” did not require any particular level of efficacy.

Turning to the objective evidence of nonobviousness, there was no dispute that Humira has been commercially successful. The petitioner successfully argued, however, that it is unclear whether such success is due to the claimed dosing regimen in the challenged claims or due to the prior art attributes, such as the fully humanized antibody itself. Accordingly, the petitioner rebutted any presumption that the commercial success of Humira was due to the claimed dosing regimen. The Board found that Abbvie’s evidence of long-felt need was insufficient because the dosing regimen was available in the prior art, and Abbvie failed to tie its evidence to the 40 mg dose recited in the claims. Finally, the Board rejected Abbvie’s arguments that the claimed dosing regimen would have been unexpected for the same reasons it rejected Abbvie’s teaching-away arguments related to the efficacy of the dosage. Having considered all of the evidence, the Board rendered its final conclusion that the challenged claims would have been obvious.

Boehringer Ingelheim Int’l GMBH et al. v. Abbvie Biotechnology, Ltd., IPR2016-00408, Paper No. 46 (PTAB July 6, 2017).