Insulin (Lantus Solostar) - USA

IPR decision: May 29, 2020

AIA Review #	Filing Date	Institution   Decision       Date	Petitioner	Patent	Respondent	Status
IPR2018-01675	09/10/2018	04/02/2019	Mylan	8,603,044	Sanofi-Aventis	All Challenged Claims Unpatentable
IPR2018-01676	09/10/2018	04/02/2019	Mylan	8,603,044	Sanofi-Aventis	All Challenged Claims Unpatentable
IPR2018-01678	09/10/2018	04/03/2019	Mylan	8,992,486	Sanofi-Aventis	All Challenged Claims Unpatentable
IPR2018-01679	09/10/2018	04/03/2019	Mylan	8,992,486	Sanofi-Aventis	All Challenged Claims Unpatentable
IPR2019-00122	10/29/2018	04/03/2019	Mylan	8,992,486	Sanofi-Aventis	All Challenged Claims Unpatentable
IPR2018-01680	09/10/2018	04/03/2019	Mylan	9,526,844	Sanofi-Aventis	All Challenged Claims Unpatentable
IPR2018-01682	09/10/2018	04/03/2019	Mylan	9,526,844	Sanofi-Aventis	All Challenged Claims Unpatentable
IPR2018-01684	09/10/2018	04/03/2019	Mylan	9,604,008	Sanofi-Aventis	Claims 1, 7, 8, and 17 are Unpatentable

US  8,603,044 (Sanofi-Aventis Deutschland GmbH.; Exp: 03/02/2024):

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, said helical groove provided along an outer surface of said dose dial sleeve; a dose dial grip 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 drive sleeve extending along a portion of said piston rod, said drive sleeve comprising an internal threading near a distal portion of said drive sleeve, said internal threading adapted to engage an external thread of said piston rod; a tubular clutch located adjacent a distal end of said dose dial grip, said tubular clutch operatively coupled to said dose dial grip, wherein said dose dial sleeve extends circumferentially around at least a portion of said tubular clutch; and a cartridge retaining part operatively coupled to said main housing, said cartridge retaining part comprising a fluid container, wherein said fluid container defines a medicament filled reservoir with a movable cartridge piston at a proximal end and an outlet at a distal end, said cartridge piston movable by said piston rod to be advanced toward an outlet of said fluid container when said piston rod is moved distally.

11. 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, said helical groove provided along an outer surface of said dose dial sleeve; a dose dial grip 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 drive sleeve extending along a portion of said piston rod, said drive sleeve comprising an internal threading near a distal portion of said drive sleeve, 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 dial grip, said tubular clutch operatively coupled to said dose dial grip, wherein said dose dial sleeve extends circumferentially around at least a portion of said tubular clutch, and wherein said helical groove of the dose dial sleeve has a first lead and said internal threading of said drive sleeve has a second lead, and wherein said first lead and said second lead are different.

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

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.

US  9,526,844 (Sanofi-Aventis Deutschland GmbH; Exp: 03/02/2024):

1. A drive mechanism for use in a drug delivery device comprising: a housing comprising an inner surface; a dose dial sleeve threadedly engaged with the inner surface of the housing through an outer thread having a first lead; an insert that is rotationally and axially fixed relative to the housing; a piston rod engaged with the insert, where the piston rod is threaded with a second lead and remains axially fixed relative to the housing during dose setting and moves axially relative to the insert during dose delivery; a clutch operatively engaged with the dose dial sleeve to allow rotation of the dose dial sleeve during dose setting and dose delivery; and a drive sleeve that extends about the piston rod and is operatively engaged with the clutch, where the clutch connects the drive sleeve and dose dial sleeve so they rotate together and disconnects the drive sleeve and dose dial sleeve so the dose dial sleeve can rotate relative to the drive sleeve, wherein during dose delivery the drive sleeve and the piston rod are configured to rotate relative to one another and the drive sleeve is configured to traverse axially towards the distal end.

21. A drug delivery device comprising: a housing comprising a dose dispensing end and a first thread; a dose indicator comprising a second thread that engages with the first thread; a driving member comprising a third thread; a sleeve that is (i) disposed between the dose indicator and the driving member and (ii) releasably connected to the dose indicator; a piston rod comprising either an internal or an external fourth thread that is engaged with the third thread; a piston rod holder that is rotatably fixed relative to the housing and configured to (i) prevent the piston rod from rotating during dose setting and (ii) permit the piston rod to traverse axially towards the distal end during dose dispensing; wherein: the housing is disposed at an outermost position of the drug delivery device; the dose indicator is disposed between the housing and the sleeve and is configured to (i) rotate and traverse axially away from the dose dispensing end during dose setting and (ii) rotate and traverse axially towards the dose dispensing end during dose dispensing; the driving member is configured to rotate relative to the piston rod; the sleeve is rotatably fixed relative to the driving member and configured to traverse axially with the dose indicator; and the piston rod and the driving member are configured to rotate relative to one another during dose dispensing; and the piston rod is configured to traverse axially towards the dose dispensing end during dose dispensing.

US  9,604,008 (Sanofi-Aventis Deutschland GmbH; Exp: 03/02/2024):

1. A drive mechanism for use in a drug delivery device comprising: a housing comprising a helical thread; a dose dial sleeve having a threaded surface that is engaged with the helical thread of the housing, an insert provided in the housing, where the insert has a threaded circular opening; a drive sleeve releasably connected to the dose dial sleeve and having an internal helical thread; a piston rod having a first thread and a second thread, wherein the first thread is engaged with the threaded circular opening of the insert and the second thread is engaged with the internal helical thread of the drive sleeve; and a clutch located between the dose dial sleeve and the drive sleeve, wherein the clutch is located (i) radially outward of the drive sleeve and (ii) radially inward of the dose dial sleeve.