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PTAB Institutes Two Inter Partes Review (“IPR”) Petitions Filed by Axinn Against Shire’s Patents for ADHD Drug Mydayis®
July 6, 2018

On July 6, 2018, the Patent Trial and Appeal Board (PTAB) agreed to review two inter partes review petitions filed by a team of Axinn attorneys challenging the validity of Shire’s patents, U.S. Patent No. 8,846,100 ("the ‘100 patent") (Case IPR2018-00290) and U.S. Patent No. 9,173,857 ("the ‘857 patent") (Case IPR2018-00293).

On behalf of generic drug company KVK-Tech, Inc. ("KVK"), Axinn petitioned the patent office to invalidate two key patents held by Shire PLC for the Attention Deficit Hyperactivity Disorder "ADHD" drug – Mydayis® (a longer-acting form of Shire’s Adderall® drug), claiming that patents are invalid because they were obvious over a prior Shire patent alone or in combination with Adderall XR or anticipated by the prior Shire patent. On July 6, the PTAB found that the arguments raised in Axinn’s petitions were sufficiently strong for the Board to institute both IPRs.

The IPRs filed by Axinn could significantly shorten Shire’s patent exclusivity for Mydayis, thereby allowing earlier entry for a generic alternative.

Both Shire patents were previously asserted by Shire Development LLC against generics in Shire Development LLC et al v. Teva Pharmaceuticals USA, Inc. et al, 1:17-cv-01696-RGA (D. Del).  

Axinn’s team is led by IP partners Jonathan Harris and Chad Landmon and counsel James Evans and Thomas Hedemann.