Written by Linda Xu and Kerry S. Taylor, Ph.D.

The PTAB issued a Final Written Decision finding that Biogen’s patent on treating Multiple Sclerosis (“MS”) with a certain dose amount was not obvious because the clinical efficacy exhibited by administering this dose amount was unexpected. Coalition for Affordable Drugs V LLC v. Biogen MA Inc., IPR 2015-01993, Paper 63 (P.T.A.B., March 21, 2017).

Kyle Bass’s patent challenging entity, Coalition for Affordable Drugs (“Coalition”), filed an inter partes review (“IPR”) petition against Biogen’s U.S. patent 8,399,514 directed to treating MS with Biogen’s product Tecfidera® (dimethyl fumarate). The challenged claims recite administering about 480 miligrams (mg) per day of a genus of compounds that include dimethyl fumarate (DMF). Coalition challenged the claims with four references. One reference, Kappos 2006, describes treating MS patients with DMF doses of 120, 360, and 720 mg/day. Kappos 2006 found no statistically significant efficacy in administering 120 and 360 mg/day. Kappos 2006 further noted adverse side-effects and concluded that the effectiveness of DMF in treating MS is dose-dependent.

In response, Biogen submitted testimony of various experts that one skilled in the art would not have expected the 480 and 720 mg/day doses to have the same effect, and 480 mg/day would have been expected to be closer to that of 360 mg/day rather than to 720 mg/day. Biogen also relied on results of Phase III trials treating MS patients with both 480 and 720 mg/day of DMF. Biogen argued that the results of the trials surprisingly showed that a 480 mg/day and 720 mg/day doses had similar efficacy.

The PTAB found that Coalition’s prior art established a motivation to optimize DMF treatment. The PTAB held, however, that “obviousness is not established when the results of optimization are shown to result in a property or benefit that a person of ordinary skill in the relevant art would have found to be unexpected.” The PTAB agreed with Biogen that the efficacy of the 480 mg/day dose of DMF would have been unexpected.

This case illustrates another example of a patent owner successfully overcoming a prima facie case of obviousness by presenting evidence of unexpected results. Previously, the PTAB found unexpected results supported a conclusion of non-obviousness in a case involving reducing ulcers in patients taking aspirin. This trend may signal that the Board is increasingly open to evidence of secondary considerations to support a finding of non-obviousness..