The disclosure requirements that will meet the written description requirement of s. 112(1) had a fairly mundane priority policing role prior to the expansion of the importance of the requirement in the biotech cases leading up to the en banc Ariad decision in 2010. However, in the recent district court’s ruling in Biogen v. Mylan, Civil Action 1:17C116 (N. D. West Virginia, June 18, 2020), Mylan and the other defendants in this Hatch-Waxman litigation returned to the roots of the WDR to convince the judge that the originally filed specification of U. S. Pat. No. 8,399,514 did not provide an adequate description of Biogen’s later-presented claims to a method of treating multiple sclerosis (MS) with dimethyl fumarate and/or monomethyl fumarate in a daily dose of 480 mg. This has been reported as a big deal, since DMF is Biogen’s biggest selling drug, under the trade name Techfidera.
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This blog, Patents4Life, does not contain legal advice and is for informational purposes only. Its publication does not create an attorney-client relationship nor is it a solicitation for business. This is the personal blog of Warren Woessner and does not reflect the views of Schwegman Lundberg & Woessner, or any of its attorneys or staff. To the best of his ability, the Author provides current and accurate information at the time of each post, however, readers should check for current information and accuracy.