USPTO Announces Fast-Track Ex Parte Appeals Pilot Program

Posted on July 1, 2020 by Warren Woessner

July 1, 2020 USPTO Press Release:

“WASHINGTON — The United States Patent and Trademark Office (USPTO) today announced plans for the Patent Trial and Appeal Board (PTAB) to begin accepting petitions for expedited resolution of ex parte appeals. The ‘Fast-Track Appeals Pilot Program’ launches July 2, 2020. The required petition fee is $400.  ‘The Fast-Track Appeals Pilot Program serves as an extension of the Track One prioritized examination program, which has proven to be very popular with our nation’s innovators,’ said Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the USPTO. ‘For the first time in USPTO history, applicants will be able to speed up both patent examination and ex parte appeals, thus obtaining decisions on their most important inventions in about half the time of a typical application.’

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Regeneron v. Kymab – “Sufficiency” and Enablement in the U.K.

Posted on June 26, 2020 by Paul Cole

Guest post from Paul Cole.

Regeneron Pharmaceuticals Inc v Kymab Ltd. [2020] UKSC 27 related to infringement of EP-B-1,360,287 and its divisional EP-B-2264123. The 287 parent related to a method of modifying an endogenous immunoglobulin variable region gene locus in an isolated mouse embryonic stem (ES) cell by an in situ replacement of V, D and J gene segments of the endogenous locus with orthologous human V and J, or V, D and J gene segments to create a modified immunoglobulin locus that produces hybrid antibodies containing human variable regions and mouse constant regions. It was opposed by Kymab and others, but the opposition was dismissed following amendment, see T 2220/14 REGENERON/VelocImmune mouse. The appeal centred on the 123 patent which was not opposed and of which claim 1 read:

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

Posted on June 22, 2020 by Warren Woessner

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

Posted on June 1, 2020 by Warren Woessner

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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