Insulin product(s) - USA

Decision on IPR: Nov 19, 2018

AIA Review	Filing Date	Institution Date	Petitioner	US Patent	Respondent	Status
IPR2018-01677	09/10/2018	--	Mylan Pharmaceuticals Inc.	8,992,486	Sanofi-Aventis US LLC	Terminated-Dismissed

On US’486 patent, Mylan previously filed IPRs (IPR2018-01678, IPR2018-01679 & IPR2019-00122) which are pending as on date.

US 8,992,486 (Sanofi-Aventis Deutschland GmbH; Exp: 06/05/2024): OB listed

1. A housing part for a medication dispensing apparatus, said housing part comprising: a main housing, said main housing extending from a distal end to a proximal end; a dose dial sleeve positioned within said housing, said dose dial sleeve comprising a helical groove configured to engage a threading provided by said main housing; a dose knob disposed near a proximal end of said dose dial sleeve; a piston rod provided within said housing, said piston rod is non-rotatable during a dose setting step relative to said main housing; a driver extending along a portion of said piston rod, said driver comprising an internal threading near a distal portion of said driver, said internal threading adapted to engage an external thread of said piston rod; and, a tubular clutch located adjacent a distal end of said dose knob, said tubular clutch operatively coupled to said dose knob, wherein said dose dial sleeve extends circumferentially around at least a portion of said tubular clutch.

43. A pen type drug delivery device, said device comprising: an external housing comprising a threading along a portion of an inner surface of said external housing, said external housing extending from a distal end to a proximal end; a dialing element positioned within said housing, said dialing element comprising an outer surface extending from a distal end to a proximal end of said dialing element, wherein said outer surface comprises a helical threading that defines a groove configured to engage said threading provided on said inner surface of said external housing; an actuator disposed about an outer surface of an end of said dialing element near said proximal end of said main housing; a driver extending along at least a portion of a piston rod, said driver comprising a thread adapted to threadingly engage an external thread of a piston rod; and, a clutch positioned at least partially within an open proximal end of said dialing element and located adjacent a distal end of said actuator and operatively coupled to said actuator, wherein said dialing element extends circumferentially around at least a portion of said clutch; a tubular barrel retainer operatively coupled to said external housing, said tubular barrel retainer comprising a cartridge containing a medicament, said cartridge comprising a reservoir, a piston, a septum, and a cap; said piston movable by said piston rod to be advanced toward an outlet of said cartridge when said piston rod is moved distally.

51. A clutch for use within a pen type drug delivery device, said clutch comprising a tubular body, said tubular body extending from a distal end to a proximal end; and said distal end of said tubular body having a diameter sized such that said distal end of said tubular body may be positioned within a proximal end of a dial member.