Amphetamine mix salts (MYDAYIS) - USA

IPR decision: Jul 03, 2019

AIA Review	Filing Date	Institution Date	Petitioner	US Patent	Respondent	Final Written Decision
IPR2018-00290	12/11/2017	07/06/2018	KVK-Tech, Inc.	8,846,100	Shire, LLC	Claims are patentable
IPR2018-00293	12/11/2017	07/06/2018	KVK-Tech, Inc.	9,173,857	Shire, LLC	Claims are patentable

Note: On US’100 patent, Amerigen previously filed IPR (IPR2017-00665) on 01/13/2017 which was terminated by PTAB.

US 8,846,100 (Shire; Exp: 08/24/2029) –

1. A pharmaceutical composition comprising: (a) an immediate release bead comprising at least one amphetamine salt; (b) a first delayed release bead comprising at least one amphetamine salt; and (c) a second delayed release bead comprising at least one amphetamine salt; wherein the first delayed release bead provides pulsed release of the at least one amphetamine salt and the second delayed release bead provides sustained release of the at least one amphetamine salt; wherein the second delayed release bead comprises at least one amphetamine salt layered onto or incorporated into a core; a delayed release coating layered onto the amphetamine core; and a sustained release coating layered onto the delayed release coating, wherein the sustained release coating is pH-independent; and wherein the first delayed release bead and the second delayed release bead comprise an enteric coating.

US 9,173,857 (Shire; Exp: 05/12/2026) –

1. A method for treating attention deficit hyperactivity disorder (ADHD) which comprises: administering to a patient in need thereof, a pharmaceutical composition comprising: (a) an immediate release bead comprising at least one amphetamine salt; (b) a first delayed release bead comprising at least one amphetamine salt; and (c) a second delayed release bead comprising at least one amphetamine salt; wherein the first delayed release bead provides pulsed release of the at least one amphetamine salt and the second delayed release bead provides sustained release of the at least one amphetamine salt; wherein the second delayed release bead comprises at least one amphetamine salt layered onto or incorporated into a core; a delayed release coating layered onto the amphetamine core; and a sustained release coating layered onto the delayed release coating, wherein the sustained release coating is pH-independent; and wherein the first delayed release bead and the second delayed release bead comprise an enteric coating.

CONCLUSION:

PTAB concluded that petitioner has not shown that a skilled artisan would have been motivated to add Burnside’s Example 4 sustained release beads to Adderall XR (two-bead system) to arrive at the composition recited in claim 1 and would have had a reasonable expectation of success in doing so. Because Burnside only provides in-vitro results & lacks any in-vivo or IVIVC data, it was not predictable to add sustained release beads to Adderall XR which is two-bead system. The lack of in vivo data would have been a significant obstacle to a reasonable expectation of success given a skilled artisan would have been aware that GI barriers to drug absorption introduced variability and unpredictability. Furthermore, the record contains ample evidence that a skilled artisan would not have had a reasonable expectation of success because she would have been aware of the possibility that a patient might develop acute tolerance to amphetamine delivered in a sustained release dose, as opposed to a pulsed delivery.