KVK Tech Inc v. Shire LLC

1. Case Identification

• Case #: IPR2018-00293
• 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: Method of Treating ADHD
• Brief Description: The ’857 discloses a method for treating Attention Deficit Hyperactivity Disorder (ADHD) by administering a pharmaceutical composition containing mixed amphetamine salts. The composition comprises a single dosage form with three distinct types of drug-releasing beads: an immediate release bead, a delayed pulsed release bead, and a delayed sustained release bead.

3. Grounds for Unpatentability

Ground 1: Claims 1-19 and 29 are anticipated by Burnside

• Prior Art Relied Upon: Burnside (Patent 6,605,300).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Burnside teaches every limitation of the challenged claims. The experimental examples in the ’857 patent, which form the basis of the claims, are virtually identical to those disclosed in Burnside. Specifically, Burnside’s Example 1 discloses the claimed immediate release bead; Examples 2 and 3 disclose the first delayed (pulsed) release bead; and Example 4 discloses the second delayed (sustained) release bead. Petitioner emphasized that Burnside’s Example 4 teaches a bead with an amphetamine core, a delayed-release enteric coating, and a sustained-release coating (SURELEASE®) layered over the enteric coating, directly corresponding to the structure recited in independent claim 1.
  • Key Aspects: Petitioner contended that Burnside also teaches the combination of these bead types into a single dosage form for treating ADHD, thereby anticipating the claimed method. The argument asserted that the Patent Office was misled during prosecution by inaccurate statements that Burnside did not teach the claimed sustained release bead structure.

Ground 2: Claims 1-29 are obvious over Burnside

• Prior Art Relied Upon: Burnside (Patent 6,605,300).
• Core Argument for this Ground:
  • Prior Art Mapping: As an alternative to anticipation, Petitioner asserted that Burnside renders the claims obvious. Burnside’s Example 5 explicitly teaches a two-bead system for treating ADHD by combining the immediate release beads of its Example 1 with the delayed pulsed release beads of its Examples 2 or 3. Burnside’s Example 4 separately teaches a delayed sustained release bead using the same amphetamine salts.
  • Motivation to Combine: A POSITA would be motivated to combine the sustained release bead of Burnside’s Example 4 with the two-bead system of Burnside’s Example 5. The motivation arose from the well-known clinical need to prolong the therapeutic effect of amphetamine treatments beyond what a simple two-bead (immediate and pulsed) system could provide. Burnside itself suggests combining its various bead types into a single dosage form, making the three-bead composition a predictable and obvious improvement.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because combining different bead types was a standard and well-understood formulation technique. Burnside provided in vitro release data for each bead type, demonstrating their functionality and making their combined effect predictable.

Ground 3: Claims 1-29 are obvious over Adderall XR® in view of Burnside

• Prior Art Relied Upon: Adderall XR® (2004 Physicians' Desk Reference and FDA Label) and Burnside (Patent 6,605,300).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the commercial product Adderall XR® was well-known prior art and constituted a two-bead system for treating ADHD, comprising immediate release and delayed pulsed release beads of mixed amphetamine salts. This corresponds to the first two bead components of claim 1. Burnside’s Example 4 teaches the third missing component: a delayed sustained release bead suitable for use with the same active ingredients.
  • Motivation to Combine: The motivation was exceptionally strong, as the ’857 patent’s own specification (as admitted prior art) and other clinical sources (e.g., Kratochvil) identified a known deficiency in Adderall XR®—that a proportion of patients required additional treatment to extend its therapeutic effect. A POSITA would combine the known Adderall XR® two-bead system with the sustained release bead taught in Burnside to solve this precise problem. This modification represented the use of a known technology (sustained release beads) to solve a known problem (insufficient duration of efficacy).
  • Expectation of Success: Success was reasonably expected because the combination involved well-characterized components and predictable formulation principles. A POSITA would expect that adding a sustained release component would, by its nature, extend the drug’s plasma concentration and therapeutic effect, directly addressing the identified clinical need.

4. Key Claim Construction Positions

• "no food effect": Petitioner argued this term should be construed according to its explicit definition in the ’857 patent specification as "no significant difference in the bioavailability of a drug in a patient when the drug is administered in a fasted state compared to a fed state."
• "about": Petitioner argued this term should be construed based on the specification’s statement that it can mean a range of up to 20% of a given value.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §325(d) was inappropriate for three primary reasons:
  • The petition presented new prior art not before the Examiner that expressly taught the sustained release coating (SURELEASE®) was pH-independent, a key limitation added to secure allowance.
  • The Examiner previously withdrew rejections over Burnside based on false representations made by the applicant regarding the teachings of Burnside's Example 4, which the Patent Owner itself later contradicted in district court litigation.
  • The petition provided a more detailed and compelling motivation-to-combine argument, based on additional prior art references, than what the Examiner had previously considered.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-29 of Patent 9,173,857 as unpatentable.