PTAB

IPR2014-00739

Shire Development LLC v. LCS Group LLC

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Method of Treating Binge Eating Disorder
  • Brief Description: The ’813 patent is directed to methods of treating binge eating disorder (BED) by administering lisdexamfetamine dimesylate (LDX dimesylate), either alone or in combination with other active agents.

3. Grounds for Unpatentability

Ground 1: Obviousness over Appolinario and Mickle - Claims 1-5, 8-10, 12, and 13 are obvious over Appolinario in view of Mickle.

  • Prior Art Relied Upon: Appolinario (a 2004 journal article on pharmacological approaches for BED) and Mickle (Application # 2007/0042955).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Appolinario taught the treatment of BED with centrally acting anti-obesity agents, such as d-fenfluramine and sibutramine. It also taught diagnosing BED according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), which are identical to the DSM-IV-TR criteria recited in the claims. Mickle disclosed LDX dimesylate as a preferred abuse-resistant amphetamine prodrug for treating obesity, which releases d-amphetamine.
    • Motivation to Combine: Appolinario disclosed that the anti-obesity agents it studied for BED treatment had significant limitations, such as cardiopulmonary risks leading to market withdrawal. Petitioner contended a person of ordinary skill in the art (POSITA) would be motivated to find an alternative centrally acting anti-obesity agent with a better safety profile. Mickle provided such an alternative, teaching that LDX dimesylate was a centrally acting agent for obesity with reduced abuse potential.
    • Expectation of Success: A POSITA would have a reasonable expectation of success in using LDX dimesylate to treat BED, as it acts on the central nervous system similarly to the agents discussed in Appolinario and was known to be a safer alternative.

Ground 2: Obviousness over Ong, DSM-IV-TR, and Mickle - Claims 1-5, 8-10, 12, and 13 are obvious over Ong in view of DSM-IV-TR and Mickle.

  • Prior Art Relied Upon: Ong (a 1983 journal article on suppressing bulimic symptoms), DSM-IV-TR (the 2000 Diagnostic and Statistical Manual of Mental Disorders), and Mickle (Application # 2007/0042955).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Ong taught the successful suppression of "bulimia" (defined as overeating with a loss of control) using the stimulant methylamphetamine. DSM-IV-TR, the standard for diagnosing eating disorders, taught that the essential features of binge eating in both bulimia nervosa (BN) and BED are nearly identical. Mickle disclosed LDX dimesylate, a prodrug of d-amphetamine, which shares a similar neurobiological mechanism with methylamphetamine.
    • Motivation to Combine: Ong explicitly cautioned that stimulants carry dangers of dependence and drug-induced psychosis. Petitioner argued this warning would directly motivate a POSITA to search for an improved stimulant with the same therapeutic benefits but without the associated abuse liability. Mickle provided the solution by disclosing LDX dimesylate as an amphetamine prodrug specifically designed to have a lower potential for abuse.
    • Expectation of Success: Given that d-amphetamine (released by LDX dimesylate) and methylamphetamine are both stimulants with common psychopharmacological effects, a POSITA would reasonably expect LDX dimesylate to be effective in treating the binge eating symptoms taught by Ong, which DSM-IV-TR showed were analogous to BED symptoms.

Ground 3: Obviousness over Dukarm, DSM-IV-TR, and Mickle - Claims 1-5, 8-10, 12, and 13 are obvious over Dukarm in view of DSM-IV-TR and Mickle.

  • Prior Art Relied Upon: Dukarm (a 2005 journal article on stimulant medication for eating disorders), DSM-IV-TR, and Mickle (Application # 2007/0042955).

  • Core Argument for this Ground:

    • Prior Art Mapping: Dukarm reported that the stimulant d-amphetamine resulted in complete abstinence from binge eating in patients with BN. As established by DSM-IV-TR, the binge eating characteristics in BN and BED are essentially the same. Mickle disclosed LDX dimesylate as a prodrug that releases the exact same active agent, d-amphetamine.
    • Motivation to Combine: Dukarm raised concerns about the risk of abuse of stimulants in a patient population already susceptible to substance abuse. This created a recognized problem in the art. Petitioner argued a POSITA would be motivated to replace the standard d-amphetamine used in Dukarm with a formulation having reduced abuse potential. Mickle solved this problem by teaching that LDX dimesylate was a prodrug of d-amphetamine with reduced euphoric effects and abuse potential.
    • Expectation of Success: A POSITA would have an extremely high expectation of success, as the proposed modification involved substituting d-amphetamine with a prodrug (LDX dimesylate) that releases the very same active ingredient to treat the same underlying symptom (binge eating).

  • Additional Grounds: Petitioner asserted additional obviousness challenges for dependent claims 6, 7, and 11 based on the primary combinations above further combined with Marrazzi (for teaching naltrexone as a known BED agent) and Grilo (for teaching a methodology for assessing binge eating episodes over a month).

4. Key Claim Construction Positions

  • Petitioner proposed a construction for the term "therapeutically effective amount," which appears in independent claims 1, 8, and 13.
  • Based on the patent’s specification, Petitioner argued the term should be construed as "an amount effective to decrease the symptoms of BED or an amount sufficient to significantly reduce the frequency and severity of binge eating behavior." This construction was critical to mapping the dosage and efficacy data from the prior art to the claim limitations.

5. Relief Requested

  • Petitioner requests institution of an inter partes review (IPR) and cancellation of claims 1-13 of the ’813 patent as unpatentable.