Biogen v. Mylan: When Does a Specification Fail to Describe a Newly-Presented Claim?

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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Illumina v. Ariosa – Fed. Cir. Splits a Fine s. 101 Hair

Until I read that another commentator wrote that the split panel decision in Illumina v. Ariosa Diagnostics, Appeal No. 2019-1419 (Fed. Cir., March 17, 2020) struck a hopeful note in the patent eligibility wars, I confess that I had missed this decision altogether. I can only blame this on the general chaos that the pandemic has brought to all of our affairs.

But this decision is entitled to some analysis, a fact that becomes abundantly clear when you read it with a copy of Ariosa Diagnostics v. Sequenom, Appeal no. 2014-1139, 2014-1144 (Fed. Cir., June 12, 2015) at hand. Here is claim 1 of the Ariosa decision:

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G S Cleantech Petitions Fed. Cir. for Rehearing En Banc

Before you read this post, please read or re-read my post of March 9, 2020, that summarized the panel decision in some detail. The case involves the district court’s finding of inequitable conduct by both CleanTech and their attorneys via a bench trial, following its summary judgment ruling that the patents-in-suit were invalid because they were offered for sale prior to the one year grace period of s. 102(b). The patents were directed to a process for recovering oil from “thin silage”, that is a by-product of ethanol production, by evaporating the silage to yield a “syrup” and centrifuging the syrup. Here are the last two paragraphs of my earlier post:

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Patenting Vaccines – A Look Back and the Road Ahead

On May 21 at 11 a.m. Central, four senior members of Schwegman Lundberg & Woessner’s Chem/Biotech Group will present a new webinar. Drs. Warren D. Woessner, Janet E. Embretson, Monique Perdok and Robin A. Chadwick will review patenting opportunities and obstacles presented by the massive research effort to develop a vaccine against deadly viruses such as MERS, SARS and COVID-19.

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