NEW HAVEN, Conn., April 7, 2016 /PRNewswire/ -- Lucerne Biosciences, LLC announced today that its Manager Louis Sanfilippo, M.D., acting in a personal representative capacity, has communicated with Yale School of Medicine's Department of Psychiatry Chairman John H. Krystal regarding his observations on Shire Development LLC's Inter Partes Review of U.S. Patent No. 8,318,813 (the '813 Patent) that led to the patent's invalidation on June 4, 2015 by the U.S. Patent Trial & Appeal Board. The '813 Patent, which was invented by Sanfilippo and owned by the company at the time of its invalidation, claimed methods to treat Binge Eating Disorder (as defined in the DSM-IV-TR) with Shire's ADHD drug Vyvanse® (i.e., lisdexamfetamine dimesylate), an indication that was FDA approved on January 30, 2015 for adults with moderate to severe symptoms. The communications to Chairman Krystal, from April 1 and 4, 2016 and made electronically from Sanfilippo's gmail account as part of a rapidly unfolding multi-party collaboration to bring a final resolution to "The Patent '813 Story, Part II," also cc'd Yale School of Medicine Dean Robert Alpern, M.D. and University President Peter Salovey, Ph.D. This was done, according to the April 1 email, because of a "series of actions, which have been in planning for quite some time and are expected to take place imminently in different venues, are likely to bring extremely high publicity to Yale University and its School of Medicine, in particular the School of Medicine's Department of Psychiatry…."
In the April 1 communication, Sanfilippo -- a Yale-trained psychiatrist who taught many Psychiatry Residents within the Department for over a decade -- informed Chairman Krystal, a renowned leader in the field of Psychiatry, "Of course, it would not take long for a person of your background -- or for that matter any of the Department's competent psychiatry faculty or even its bright and talented residents -- to see the egregious distortions and misrepresentations Shire made in its IPR petition and that it continued to support throughout its IPR proceeding until the PTAB cancelled all thirteen of the '813 Patent's claims, thus bringing the IPR to a rather troubling close." Sanfilippo added, apparently to highlight the story's unique behavioral dimension to a fellow psychiatrist who might appreciate its implications, "Remarkably (from a behavioral perspective), Shire and its CEO Flemming Ornksov (himself an M.D.) seem to have been utterly indifferent [to it]…." Sanfilippo encouraged communication on the topic within Yale's Department of Psychiatry, a bastion of clinical education and research, in order to "generate substantial buzz," and concluded by telling Chairman Krystal that he effectively had an extraordinary opportunity at hand to advance the field publicly in view of the invalidated '813 Patent, "Really, what better way for Yale's Department of Psychiatry, under your leadership Dr. Krystal, to make a difference to the profession it has long served -- and also to make a difference to the public-at-large -- than to support the truth of the matter on important teachings involving the art of Psychiatry as this story goes increasingly public with Yale's Department of Psychiatry at its center."
Sanfilippo's April 4 electronic communication to Chairman Krystal, in response to Krystal's thanking him for the April 1 email, curiously expanded the email platform to include Shire's CEO Dr. Flemming Ornskov, M.D. and its outside counsel Ed Haug and Sandra Kuzmich of the law firm Frommer, Lawrence & Haug, LLP. That email provided several high-yield documents to quickly bring Chairman Krystal, and others in Yale's Department of Psychiatry, up to speed on Shire's extensive representational deception on eating disorders and their treatments. Sanfilippo offered Krystal words of encouragement on the matter, even in the unsettling face of the '813 Patent's invalidation driven by Shire's relentless anti-competitive efforts, stating that this "has uniquely served an unprecedented opportunity to teach on the diagnosis and treatment of DSM-defined eating disorders to the general public, including the one for which Shire earned an FDA-approval based on the claims featured in the '813 Patent." But Sanfilippo forewarned Krystal by offering him some behavioral insight before taking to the evidence with a critical eye, "the legalese in Shire's IPR petition and the Brewerton Declaration is nothing but an intentional, well-calculated smokescreen to disguise some extremely heavy deception in their rendition of the medical literature which, at times, represents things diametrically opposite its truthful reality."
Remarkably, Sanfilippo's April 4 communication brought Shire and Yale together in its concluding paragraph, signaling perhaps newly evolving dynamics behind a final resolution to "The Patent '813 Story, Part II," "What should be very obvious by now to Dr. Ornskov, which is another reason why he is cc'd on this email, is that this has all been designed to end in the truth of the matter on account of certain decisions that were made on October 1, 2014. But specifically how it ends in the truth of the matter is not up to me. In this regard, Yale's Department of Psychiatry is perfectly positioned to influence where things go and how quickly they go there, in a way that I think would really benefit a good many persons, businesses and institutions who are surely awaiting a meaningful final resolution to this matter. To my view, that's about the most obvious thing about this story at this point in time."
Additional, Related Information
LCS Therapeutics and Lucerne Biosciences to Commercialize '813 Patent for Lisdexamfetamine Dimesylate in the Treatment of Binge Eating Disorder (December 26, 2014) at: http://www.prnewswire.com/news-releases/lcs-therapeutics-and-lucerne-biosciences-to-commercialize-813-patent-for-lisdexamfetamine-dimesylate-in-the-treatment-of-binge-eating-disorder-300013986.html
Lucerne Biosciences Announces Publication of Claimed Methods for Treating Binge Eating Disorder with Lisdexamfetamine Dimesylate (March 6, 2015) at: http://www.prnewswire.com/news-releases/lucerne-biosciences-announces-publication-of-claimed-methods-for-treating-binge-eating-disorder-with-lisdexamfetamine-dimesylate-300046271.html
LCS Group Announces Exclusive License from Lucerne Biosciences to Commercialize '813 Patent and '249 Application through Shire's Marketing of Lisdexamfetamine Dimesylate for Binge Eating Disorder (May 13, 2015) at: http://www.prnewswire.com/news-releases/lcs-group-announces-exclusive-license-from-lucerne-biosciences-to-commercialize-813-patent-and-249-application-through-shires-marketing-of-lisdexamfetamine-dimesylate-for-binge-eating-disorder-300083124.html
PTAB Invalidates Lucerne Biosciences' '813 Patent for the Treatment of Binge Eating Disorder with Lisdexamfetamine Dimesylate (June 13, 2015) at: http://www.prnewswire.com/news-releases/ptab-invalidates-lucerne-biosciences-813-patent-for-the-treatment-of-binge-eating-disorder-with-lisdexamfetamine-dimesylate-300098752.html
Louis Sanfilippo, Public Manager
Lucerne Biosciences, LLC
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SOURCE Lucerne Biosciences, LLC