Expert Declaration

Subscribe to Expert Declaration via RSS

Red boxing gloves with the glow of flashes in the background.

On March 21, 2017, the PTAB refused to cancel claims of a Biogen MA Inc. (Biogen) patent covering multiple sclerosis drug Tecfidera® during IPR2015-01993, which was instituted in response to a petition filed by the Coalition for Affordable Drugs V LLC (CFAD), a group started by hedge fund manager Kyle Bass.

Biogen’s U.S. Pat. No. 8,399,514 claims methods of treating patients for multiple sclerosis (MS). Each claim requires the administration of a dose of about 480 milligrams (mg) per day of dimethyl fumarate (DMF), monomethyl fumarate (MMF), or their combination. CFAD argued that a combination of several prior art references renders obvious all claims of Biogen’s patent. Generally, this combination of prior art describes results from administering 120, 360 and 720 mg/day of DMF to MS patients, but do not disclose the claimed dose. The 720 mg/day dose was reported to reduce brain lesions in a dose-dependent manner, while the 120 and 360 mg/day dose did not show statistically significant results versus placebo. CFAD nevertheless argued that a person of ordinary skill in the art would have been motivated to conduct routine experiments to optimize the effective dose and ultimately arrive at the dose recited in the claims.Continue Reading Coalition for Affordable Drugs Fails to Knock Out Biogen’s Tecfidera® Patent

This Blog previously highlighted the risks involved when a petitioner does not submit an expert declaration with their petition.  This risk may be lessened where the “the invention and prior art references are directed to relatively straightforward and easily understandable technology.” [Paper No. 41 at 17 n.6 of IPR2014-00169] (ruling in favor of petitioner despite its failure to present expert declaration until its Reply brief).  However, a petitioner should strongly consider submitting an expert declaration to support their arguments in technology areas that are considered complex. 
Continue Reading It’s Complicated: PTAB Reinforces Notion That Petitioners Should Consider Expert Testimony in Complex Technology Areas

AppleRemember when the PTAB denied institution of two IPR petitions filed by Kyle Bass’s Coalition for Affordable Drugs V LLC’s (CFAD) against Acorda Therapeutics, Inc. (Acorda)?  Well, if at first you don’t succeed, try citing different prior art! 
Continue Reading A Second Bite at the Apple? Kyle Bass’s CFAD is Awarded IPR Institution of Follow-on Petitions

Woman hands connecting two jigsaw puzzle pieces against sunset sky.

On January 19, 2016, the PTAB denied Coalition for Affordable Drugs V LLC’s (CFAD) request for rehearing following the Board’s decision denying institution of IPR.  In IPR2015-01086, CFAD filed a petition requesting an IPR of claims 1–13 in Biogen International GmbH’s (Biogen) U.S. Patent No. 8,759,393.  The Board denied the petition and CFAD filed a request for rehearing on the (same) grounds of anticipation and obviousness.  As discussed below, the denial of the rehearing highlights the importance of supporting all conclusions in an expert declaration with reasoned explanations.
Continue Reading PTAB Reminds Petitioners That Conclusions in Expert Declarations Must be Supported by Explanations

Resources & Info

Arthrex and the Supreme Court Resource Center

In United States v. Arthrex, Inc., the Supreme Court has heard whether 125+ PTAB decisions rendered through October 2019 must be remanded for new decisions. Read about how that issue developed through our post.

Learn more

Our Team

PTABWatch, provided by Marshall, Gerstein & Borun LLP, analyzes and reports recent developments concerning Post-Grant Proceedings at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), including Inter Partes Review (IPR), Post Grant Review (PGR), and Covered Business Method (CBM) proceedings.