PTAB
IPR2018-00293
KVK-Tech, Inc. v. Shire, LLC
1. Case Identification
- Patent #: 9,173,857
- Filed: December 11, 2017
- Petitioner(s): KVK-Tech, Inc.
- Patent Owner(s): Shire PLC
- Challenged Claims: 1-29
2. Patent Overview
- Title: Controlled-Release Amphetamine Formulations for ADHD Treatment
- Brief Description: The ’857 patent discloses a method for treating Attention Deficit Hyperactivity Disorder (ADHD). The method involves administering a pharmaceutical composition comprising three distinct populations of beads containing mixed amphetamine salts: an immediate release bead, a delayed pulsed release bead, and a delayed sustained release bead.
3. Grounds for Unpatentability
Ground 1: Anticipation of Claims 1-19 and 29
- Prior Art Relied Upon: Burnside (Patent 6,605,300).
- Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Burnside teaches every element of the challenged claims. It asserted that the experimental examples in Burnside are virtually identical to those forming the basis of the ’857 patent. Specifically, Burnside’s Example 1 teaches the immediate release bead, Examples 2 and 3 teach the delayed pulsed release bead, and Example 4 teaches the delayed sustained release bead (a core coated with an enteric layer, then a sustained release layer using SURELEASE®). Burnside further teaches combining these bead types into a single dosage form for treating ADHD.
- Key Aspects: Petitioner contended that the Patent Office withdrew its anticipation rejection during prosecution only after the applicant made inaccurate representations that Burnside did not teach the claimed delayed sustained release bead structure. Petitioner highlighted that the Patent Owner itself later contradicted these representations in federal court litigation, admitting that the relevant Burnside example shows a sustained release profile.
Ground 2: Obviousness of Claims 1-29 over Burnside Alone
- Prior Art Relied Upon: Burnside (Patent 6,605,300).
- Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that even if not anticipating, Burnside renders the claims obvious. Burnside’s Example 5 explicitly discloses combining immediate release beads (from its Example 1) with delayed pulsed release beads (from its Examples 2 or 3). A person of ordinary skill in the art (POSITA) would have found it obvious to add the delayed sustained release beads, also taught by Burnside in its Example 4, to this known two-bead system. Dependent claims reciting pharmacokinetic properties and dosage strengths were argued to be inherent results or the product of routine optimization.
- Motivation to Combine: A POSITA would combine the beads taught in Burnside to create a longer-acting, once-daily ADHD treatment, which was a well-recognized clinical need at the time. Burnside itself motivates this combination by describing its invention as a "multiple unit" dosage form and providing the distinct bead types as building blocks.
- Expectation of Success: A POSITA would have a high expectation of success. Burnside provides clear methods for making each bead type and includes in vitro release data demonstrating their predictable function. Combining known pharmaceutical components to achieve a predictable, extended-release profile was a routine and well-understood practice.
Ground 3: Obviousness of Claims 1-29 over Adderall XR® in view of Burnside
- Prior Art Relied Upon: Adderall XR® (as described in the 2004 PDR® and 2004 Label), Burnside (Patent 6,605,300), Couch (Application # US2004/0059002), and Mehta (Patent 4,728,512).
- Core Argument for this Ground:
- Prior Art Mapping: Petitioner asserted that the commercial product Adderall XR® teaches a two-bead system for treating ADHD comprising immediate and delayed pulsed release beads of mixed amphetamine salts, thus providing the first two components of claim 1. Burnside’s Example 4 teaches the missing third component: a delayed sustained release bead formulated with the same active ingredients.
- Motivation to Combine: A POSITA would be motivated to combine these references to address the known clinical need for an ADHD treatment with a longer duration of efficacy than that provided by Adderall XR®. The ’857 patent’s own specification admits this deficiency in the prior art. A POSITA would therefore logically add a sustained-release component, like the one disclosed in Burnside, to the existing Adderall XR® formulation. Other prior art, such as Mehta and Couch, further established that combining immediate, pulsed, and sustained release components was a known strategy for achieving full-day therapeutic efficacy.
- Expectation of Success: A POSITA would have a reasonable expectation of success in combining the well-characterized components from Adderall XR® and Burnside to achieve the predictable outcome of an extended therapeutic effect.
4. Key Claim Construction Positions
- The petition argued that for the purposes of the IPR, the terms “no food effect” and “about” should be construed based on their explicit definitions in the ’857 patent’s specification.
- “No food effect” is defined as “no significant difference in the bioavailability of a drug... when administered in a fasted state compared to a fed state.”
- “About” is defined to mean a range of up to 20% of a given value.
5. Key Technical Contentions (Beyond Claim Construction)
- Petitioner contended that the pharmacokinetic parameters recited in claims 5-12 are inherent properties of the obvious composition of claim 1. It argued that an obvious formulation cannot be rendered non-obvious simply by claiming the resulting, predictable serum concentrations.
- Petitioner also argued that the various dosage strengths recited in claims 20-28 are result-effective variables subject to routine optimization by a POSITA, not an inventive step, as FDA-approved ranges for similar drugs were well known in the art.
6. Arguments Regarding Discretionary Denial
- Petitioner argued that discretionary denial under 35 U.S.C. §325(d) would be inappropriate because the petition raises new issues and arguments not considered by the Examiner during the original prosecution.
- First, the Examiner was unaware of prior art presented in the petition that expressly teaches that the SURELEASE® coating is pH-independent, a key limitation that was added to the claims to secure allowance.
- Second, the Examiner withdrew rejections over Burnside in reliance on the applicant's representations that Burnside did not teach a sustained release coating over an enteric coating. Petitioner argued these representations were false and were contradicted by the Patent Owner's own statements in later litigation.
- Third, the petition presented a more robust and extended case for the motivation to combine prior art references, including a detailed analysis of Couch and Mehta, which was not substantively considered by the Examiner.
7. Relief Requested
- Petitioner requested the institution of an inter partes review and the cancellation of claims 1-29 of Patent 9,173,857 as unpatentable.