PTAB Invalidates Lucerne Biosciences' '813 Patent for the Treatment of Binge Eating Disorder with Lisdexamfetamine Dimesylate

WILMINGTON, Del., June 13, 2015 /PRNewswire/ -- Lucerne Biosciences, LLC announced today that the U.S. Patent Trial and Appeal Board (PTAB), on June 4, 2015, entered an adverse judgment against the company in the inter partes review of U.S. Patent 8,318,813 that cancelled all thirteen of the patent's claims involving the treatment of Binge Eating Disorder with lisdexamfetamine dimesylate (LDX).  LDX is an FDA-approved treatment for moderate to severe Binge Eating Disorder in adults and is marketed under the trade name "Vyvanse®" by Shire U.S. Inc.  The inter partes review of the '813 patent was based on a petition initiated by Shire Development LLC that alleged the patent would have been obvious at the time of its invention on September 13, 2007 and therefore was invalid.  Inter partes review is a provision of the American Invents Act (AIA) to challenge the validity of a patent before the Patent Trial and Appeal Board in the United States Patent and Trademark Office.

About Lucerne Biosciences, LLC

Lucerne Biosciences is a privately-held intellectual property development company that wholly owns the now invalidated '813 Patent.  The company also wholly owns U.S. Patent Application 14/464, 249 which also encompasses claims involving the use of LDX to treat BED.   

About BED 

BED is a serious eating disorder.  BED's DSM-V^® criteria include eating unusually large amounts of food in a discrete period of time (i.e., within a 2 hour period) and a sense of lack of control over eating during the episode with binge eating episodes associated with at least three (or more) of the following: eating much more rapidly than normal; eating until feeling uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed or very guilty after overeating.  Additionally, marked distress regarding the binge eating is present and the binge eating occurs, on average, at least once a week for 3 months; also, the binge eating does not occur exclusively during the course of bulimia nervosa or anorexia nervosa.

About Lisdexamfetamine Dimesylate

Lisdexamfetamine dimesylate (l-lysine-d-amphetamine) is an amphetamine prodrug approved by the FDA to treat moderate to severe BED in adults.  LDX is also FDA approved for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

Media Contact: 
Louis Sanfilippo, MD 
203-521-1143

U.S. Patent Application No. 14/464,249/ Method of Treating Binge Eating Disorder 
U.S. Patent No. 8,318,813/ Method of Treating Binge Eating Disorder

SOURCE Lucerne Biosciences, LLC

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