KVK Tech Inc v. Shire LLC

1. Case Identification

• Case #: IPR2018-00290
• Patent #: 8,846,100
• Filed: December 11, 2017
• Petitioner(s): KVK-Tech, Inc.
• Patent Owner(s): Shire PLC
• Challenged Claims: 1-31

2. Patent Overview

• Title: Controlled Release Amphetamine Salt Compositions
• Brief Description: The ’100 patent discloses a pharmaceutical composition for treating ADHD comprising three types of amphetamine salt beads: an immediate release bead, a first delayed (pulsed) release bead, and a second delayed (sustained) release bead, designed to provide therapeutic effect over an extended period.

3. Grounds for Unpatentability

Ground 1: Anticipation - Claims 1-21 and 31 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, asserting that the experimental examples in the ’100 patent were virtually identical to those in Burnside. Burnside’s Example 1 was alleged to teach the immediate release bead; Examples 2 and 3 taught the first delayed pulsed-release bead; and Example 4 taught the second delayed sustained-release bead. The sustained release coating used in Burnside (SURELEASE®) was argued to be pH-independent, meeting a key limitation of claim 1.
  • Key Aspects: Petitioner contended that Burnside teaches the combination of these beads by disclosing a limited number of bead types for a multi-unit dosage form, making the claimed combination immediately apparent to a person of ordinary skill in the art (POSITA). The pharmacokinetic limitations of claims 5-12 and the "no food effect" limitation of claim 21 were argued to be inherent properties of the anticipated composition.

Ground 2: Obviousness over Burnside Alone - Claims 1-31 are obvious over Burnside

• Prior Art Relied Upon: Burnside (Patent 6,605,300).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that, at a minimum, the claimed composition would have been obvious from Burnside's own teachings. Burnside’s Example 5 explicitly teaches a two-bead system combining immediate release beads (from Example 1) and delayed pulsed release beads (from Examples 2 or 3). The missing element, the delayed sustained release bead, is taught in Burnside’s Example 4.
  • Motivation to Combine: The motivation to add the sustained release bead of Example 4 to the two-bead system of Example 5 arose from a well-documented clinical need to prolong the therapeutic effect of amphetamine formulations beyond what was offered by existing two-bead systems. A POSITA would have been motivated to combine Burnside's own disclosed components to create a longer-acting formulation.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because Burnside provided straightforward methods and in vitro release data for each bead type. Combining them was a predictable extension to achieve a known goal (prolonged efficacy).

Ground 3: Obviousness over Adderall XR® in view of Burnside - Claims 1-31 are obvious over Adderall XR® in view of Burnside

• Prior Art Relied Upon: Adderall XR® (as described in the 2004 PDR® or product label) and Burnside (Patent 6,605,300).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the commercial product Adderall XR® teaches a two-bead system comprising immediate release and delayed pulsed release beads containing the specific mixed amphetamine salts recited in the claims. Burnside teaches the only missing element: the third, delayed sustained release bead, as described in its Example 4.
  • Motivation to Combine: A POSITA would combine these references to address the known clinical need for a formulation with a longer duration of action than Adderall XR®. The ’100 patent itself acknowledges that a proportion of patients required additional treatment to extend the therapeutic effect. A POSITA would look to prior art like Burnside, which discloses amphetamine salt formulations, to find a suitable sustained-release component to add to the existing Adderall XR® platform.
  • Expectation of Success: Success was reasonably expected because adding a known sustained release bead to a known pulsed release system was a predictable way to extend drug release. Basic pharmacokinetic principles (e.g., the superposition principle) would lead a POSITA to expect that the effects would be additive, prolonging therapeutic plasma concentrations as desired.

4. Key Claim Construction Positions

• "no food effect": Petitioner argued this term should be construed according to its explicit definition in the ’100 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." This construction was central to the argument that the lack of a food effect was an inherent property of the claimed amphetamine salts.
• "about": Petitioner argued this term should be construed as meaning "a range of up to 20%... of a given value," as stated in the specification. This was relevant to the dosage strength limitations recited in dependent claims 22-30.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §325(d) would be inappropriate for two primary reasons:
  • The petition presented new prior art not before the Examiner that expressly taught the sustained release coating (SURELEASE®) is pH-independent. Petitioner argued the Examiner was unaware of this evidence and only allowed the claims after requiring an amendment to specify this exact feature.
  • The petition asserted that the Examiner withdrew rejections over Burnside based on false representations by the applicant, specifically that Burnside’s Example 4 did not teach a sustained release formulation. Petitioner noted that the Patent Owner itself later contradicted this position in related district court litigation.

6. Relief Requested

• Petitioner requested the institution of an inter partes review and cancellation of claims 1-31 of the ’100 patent as unpatentable.