Biogen’s Tecfidera-related ‘514 patent not obvious in IPR final written decision due to unexpected results of claimed dosage amount

Mylan Pharmaceuticals Inc. v. Biogen MA Inc.
IPR2018-01403 (PTAB Final Written Decision)
February 5, 2020

Brief Summary: Biogen’s Tecfidera-related US 8,399,514 B2 (“method of treating…multiple sclerosis” not obvious due in part to unexpected results (IPR final written decision).

Summary: Mylan challenged Biogen’s Tecfidera-related US 8,399,514 B2 (“method of treating…multiple sclerosis” with “dimethyl fumarate, monomethyl fumarate, or a combination thereof”) as obvious (§ 103) in view of four combinations of references (four grounds). The final written decision (FWD) indicates that the ‘514 patent has been involved in two other IPRs (IPR2015-01993, IPR2015–01136, Coalition for Affordable Drugs v LLC) and one interference proceeding (106,023, v. Forward Pharma A/S). The claims require administration of a “therapeutically effective amount” of DMF, MEF, or a combination thereof “wherein” that amount “is about 480 mg per day”. Biogen’s definition of a person of skill in the art (POSA) was accepted by the Board (“a medical degree with at least three years of training in neurology and at least three years of clinical experience treating MS”). No claim terms were specifically construed, and were reviewed “[u]nder the broadest reasonable construction standard…presumed to have their ordinary meaning, as would be understood by” a POSA (In re Translogic, FC 2007; Vivid Techs., FC 1999). The Board explained that on the first ground of obviousness “[t]he question before” them was “whether discovery of the 480 mg/day dose of DMF…was the result of DMF dose optimization within an established effective range (i.e., doses between 360 mg/day and 720 mg/day)” (citing, e.g., Pfizer, FC 2007 (“discovery of an optimum value of a variable in a known process is usually obvious”)), a range that “the asserted prior art must teach…was known.” And it found the first combination of references “does not support a finding that any such range was known” (e.g., “the Biogen Press Release…does not indicate which of the tested dosages…showed efficacy”, combination of fumarates “does not teach or suggest anything about the effectiveness of any individual fumarate”). Regarding the second ground of obviousness, the Board relied on its finding regarding the combination of fumarates, and also found the prior art did not “teach efficacy in treating MS with a 360 mg/day dose of DMF” based in large part on expert testimony. On the third ground of obviousness, the Board considered whether the 480 mg/day dose is a “result-effective variable” (In re Antoine, CCPA 1977; In re Boesch), and concluded the prior art would have motivated a POSA “to optimize the daily dose of DMF with a reasonable expectation of success”. But Biogen’s evidence of unexpected results (“unexpected magnitude of efficacy as compared to a much higher 720 mg/day dose”) was found to overcome a conclusion of obviousness on these grounds (In re Antoine (“rebutted… ‘where the results of optimizing a variable…[are] unexpectedly good’”)). In arguing the fourth ground, Mylan relied on the Board’s findings in IPR2015-01993 (also overcome by unexpected results), but this Board found this reference not to be enough, recognizing “the possibility for a different outcome based on the record” of this proceeding (Novartis AG, FC 2017; § 312(a)(3); Harmonic, FC 2016), and found Biogen’s unexpected results to overcome an obviousness finding.

This entry was posted in Inter Parties Review (IPR), IPR, Obviousness, Obviousness (Secondary Considerations), Uncategorized. Bookmark the permalink.

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