U.S. Pat. No. 8,399,514 B2
March 22, 2016
Brief Summary: IPR for US 8,399,514 B2 relating to Biogen’s multiple sclerosis (MS) drug Tecifedra (dimethyl fumarate) instituted because prior art encompassed range including the claimed 480 mg/day dosage.
Summary: This is the second petition filed with respect to patents relating to Biogen’s multiple sclerosis (MS) drug Tecifedra (dimethyl fumarate). The first Petition (IPR2015-01136) was based on different prior art than the second and was denied. This second petition relies upon obviousness arguments including three combinations of six prior art references. The first issue addressed but not resolved was whether Biogen could properly claim the benefit of its provisional application for the “about 480 mg” dosage in the ‘514 claims. But the Board pointed out that the ‘514 patent discloses administration of “from about 480 mg to about 720 mg per day” and that Atofina (FC 2006) “states that a disclosure of a range of 150 to 350o C does not constitute a specific disclosure of the endpoints of that range, i.e., 150oC and 350oC; the disclosure is only that of a range, not a specific temperature in that range” and “[s]ince the description of 480 mg in the ‘514 patent is an enpoint, in the event Patent Owner elects to seek benefit of its Provisional Application, it should address why benefit should be accorded in light of Atofina.” Claims 1, 11, 15 and 20 encompass methods for treating MS with a “therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof [of] about 480 mg per day”. The Board concluded Petitioner made out a sufficient case to establish a reasonable likelihood of success in proving the obviousness of the independent claims due to “[t]he combined ‘effective’ ranges” disclosed by the prior art and “[t]he ICH Guideline provides convincing evidence of how a person of ordinary skill in the art likely would go about determining an appropriate dosage”. Biogen argued the prior art and arguments were already presented in the first IPR but the Board disagreed because “the prior art cited and relied upon in this IPR [is] considerably more persuasive” (“institution or non-institution decisions in other IPRs based on different facts are of little help in resolving whether to institute in the IPR before us”). On the merits, the Board pointed to KSR’s guidance that “[o]ften, it will be necessary…to look to interrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art, all in order to determine whether there was a specific reason to combine the known elements in the fashion claimed by the patent at issue” and In re O’Farrell’s (FC, 1998) instruction that “obviousness does not require absolute predicitability” but only a “reasonable expectation of success”. The Board concluded it was not “apparent why dosages between 300 mg/day and 720 mg/day reasonable would not…have been expected to be effective” and that “there was ample reason for one skilled in the art to have looked into dosages below 720 mg/day.” Biogen unsuccessfully argued that CAD had not “attempt[ed] to rebut the claimed invention’s unexpected results established during prosecution” because those results were presented in an ex parte reexamination which is “not binding on Petitioner” (Keystone Bridge, US 1877) and CAD did not have a chance to cross-examine Biogen’s experts. Thus, the IPR was instituted.