Case 2:17-cv-09105-SRC-CLW Document 582 Filed 03/09/20 Page 1 of 76 PageID: 18209
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`NOT FOR PUBLICATION
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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`SANOFI-AVENTIS U.S. LLC et al.,
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`Plaintiffs,
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` Civil Action No. 17-9105 (SRC)
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` OPINION
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`____________________________________
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`Defendants.
`____________________________________:
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`CHESLER, U.S.D.J.
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`v.
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`MYLAN GMBH et al.,
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`INTRODUCTION
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`Plaintiffs Sanofi-Aventis U.S. LLC, Sanofi- Aventis Deutschland GmbH, and Sanofi
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`Winthrop Industrie (collectively, “Sanofi”) bring this action for patent infringement against
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`Defendants Mylan GmbH, Biocon Ltd., Biocon Research Ltd., Biocon Sdn. Bhd., and Biocon
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`S.A. (collectively, “Mylan.”) Plaintiffs own U.S. Patent No. 9,526,844 (“the ’844 patent”),
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`which is listed in the Orange Book as protecting Plaintiffs’ Lantus® SoloSTAR® insulin pen
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`product. Mylan GmbH has filed New Drug Application (“NDA”) No. 210605 seeking approval
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`to market an insulin pen product. Plaintiffs complain that, by filing this NDA with the United
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`States Food and Drug Administration, Defendants have infringed claims 21, 22, 25, and 30 of the
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`’844 patent. Mylan contends that the asserted patent claims are invalid, pursuant to 35 U.S.C. §
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`112 ¶ 1 and 35 U.S.C. § 103. A bench trial on patent infringement and patent validity was held
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`for 5 days, beginning on December 2, 2019, and ending on December 6, 2019. Upon hearing
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`the evidence presented at trial, this Court finds that Sanofi has failed to prove that claims 21, 22,
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`25, and 30 are infringed by Mylan’s NDA product, and Mylan has proven that the asserted
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`claims are invalid for failure to satisfy the written description requirement stated in 35 U.S.C. §
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`112 ¶ 1.
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`STIPULATED FACTS
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`The parties stipulated to the following facts in the Final Pretrial Order (“FPO”):
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`72. The following documents are prior art to the Device Patents under 35 U.S.C. §
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`102:
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`a. U.S. Patent No. 4,865,591 (“Sams”)
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`b. U.S. Patent No. 6,235,004 (“Steenfeldt-Jensen”)
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`c. U.S. Patent No. 5,674,204 (“Chanoch”)
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`d. U.S. Patent No. 6,221,046 (“Burroughs”)
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`e. U.S. Patent No. 7,241,278 (“Møller”)
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`f. U.S. Patent No. 6,248,095 (“Giambattista ’095”)
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`g. U.S. Patent No. 6,582,404
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`h. U.S. Patent App. Pub. No. 2002/0052578
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`i. EU Patent Specification EP 0 608 343
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`j. Erdman Arthur G & Sandor, George N., Mechanism Design: Analysis and
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`Synthesis, 110-20 (Prentice Hall 1984)
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`k. Sclater, Neil & Chironis, Nicholas P., Mechanisms & Mechanical Devices
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`Sourcebook, 191-95 (McGraw Hill, 3d ed. 2001)
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`l. European Standard EN ISO 11608-1 (Dec. 2000)
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`THE ISSUES FOR TRIAL
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`1.
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`Have Plaintiffs proven, by a preponderance of the evidence, that Defendants’ NDA
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`product infringes claims 21, 22, 25, or 30 of the ’844 patent?
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`2.
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`Have Defendants proven, by clear and convincing evidence, that claims 21, 22, 25, and
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`30 of the ’844 patent are invalid as obvious, pursuant to 35 U.S.C. § 103?
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`3.
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`Have Defendants proven, by clear and convincing evidence, that claims 21, 22, 25, and
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`30 of the ’844 patent are invalid for lack of adequate written description, pursuant to 35
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`U.S.C. § 112 ¶ 1?
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`4.
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`Have Defendants proven, by clear and convincing evidence, that claims 21, 22, 25, and
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`30 of the ’844 patent are invalid for lack of enablement, pursuant to 35 U.S.C. § 112 ¶ 1?
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`THE EVIDENCE AT TRIAL
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`What follows are selected summaries of the testimony of the witnesses appearing in
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`Court at trial:
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`A.
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`Testimony of Robert Veasey
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`What follows is a summary of the witness’s testimony. Mr. Veasey is a co-inventor,
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`with Robert Perkins and David Plumptre, on the ’844 patent. (Tr. 33:25-34:2.) The
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`SoloSTAR® pen injector is a commercial product that came from this project. (Tr. 36:19-21.)
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`The project to develop SoloSTAR® was named “Alpha.” (Tr. 38:8-10.) When he began work
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`on the Alpha project, three disposable injector pens were available to consumers, Opti Set,
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`Humalog, and Novo’s FlexPen, which was considered better than the others. (Tr. 38:11-22.)
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`The Alpha team studied the FlexPen and measured aspects of it, including the coefficient of
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`friction. (Tr. 39:2-8.) The coefficient of friction is a measure of the resistance to sliding of two
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`components in contact with each other. (Tr. 40:10-13.) The team derived a coefficient of
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`friction of .15 for the FlexPen, based on the measured value of the most critical friction interface
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`in the device, which was between the dial, the dose dial and the body. (Tr. 40:15-20.) Mr.
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`Veasey told Dr. Slocum that .1 was the lowest realistic value that one could achieve for the
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`coefficient of friction in a high-volume product like SoloSTAR® or FlexPen, if one used
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`tribological grades of polymers, which have additives in them that make them slip particularly
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`well. (Tr. 41:1-10.)
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`The team studied the FlexPen and found shortcomings, and designed the SoloSTAR® to
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`improve on them. (Tr. 42:4-20.) In the real world, the coefficient of friction affects the amount
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`of force a user must use to depress the pen button. (Tr. 44:4-16.) One goal for the design
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`project was a pen with low injection force, because the elderly diabetes population has lower
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`hand strength. (Tr. 46:15-47:15.) Another goal was a pen that had a maximum insulin dose of
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`80 units or more. (48:10-16.) SoloSTAR® is about 40 percent lower injection force than
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`FlexPen. (Tr. 50:20-21.) The ’844 patent embodies the team’s design concept 12. (Tr. 56:25-
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`57:1.) A patent application for the SoloSTAR® design was filed in Great Britain in March of
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`2003, and it has essentially the same specification as the ’844 patent has. (Tr. 57:9-23.)
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`The OptiClik was a reusable pen injector from Sanofi with a very different mechanism
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`from SoloSTAR®. (Tr. 58:7-13.) To date, about 3 billion SoloSTAR® pens have been sold.
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`(Tr. 61:4-5.) The SoloSTAR® has been awarded a number of industry awards. (Tr. 61:6-23.)
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`On cross-examination, Mr. Veasey said that he held an actual FlexPen at the end of 2001.
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`(Tr. 64:1-11.)
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`B.
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`Testimony of Charles Reinholtz
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`What follows is a summary of the witness’s testimony. Dr. Reinholtz was qualified as
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`an expert in mechanical engineering mechanisms as it relates to the issues of infringement in this
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`case. (Tr. 89:15-20.) Dr. Reinholtz identified exhibit PTX-894 as the assembled Semglee1
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`pen. (Tr. 92:12-14.) Becton Dickinson is the company that designed the Semglee pen. (Tr.
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`93:16-20.) As to ’844 claim 21, the parties have agreed that only three elements are disputed as
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`to infringement; the first is 21e. (Tr. 97:4-25.)
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`Limitation 21e states: “A sleeve that is disposed between the dose indicator and the
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`driving member and releasably connected to the dose indicator.” (Tr. 97:25-98:2.) The parties’
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`dispute over 21e concerns the “releasably connected” limitation. (Tr. 98:3-6.) Defendants
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`have taken the position that this means connected when the device is in a resting state, but Dr.
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`Reinholtz disagreed with this. (Tr. 98:7-13.) He disagreed because the claim limitation does
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`not require it to be connected in any particular state. (Tr. 98:15-16.)
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`The language of limitation 21e does not require that the sleeve is connected to the dose
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`indicator during dose setting or injection. (Tr. 98:17-23.) The sleeve in the patent claims is
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`called the setback in the Semglee, and the dose indicator is called the dose set knob in the
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`Semglee. (Tr. 99:4-16.) In the Semglee, the setback is releasably connected, in rotation, to
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`the dose set knob. (Tr. 99:17-23.) The NDA for the Semglee says that, when the user dials
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`up a dose, there is no pressure on the button to lock the DSK and setback together so that the
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`DSK can rotate freely whilst the setback remains rotationally static. (Tr. 100:17-24.) Then, to
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`1 “Semglee” is one of the names used to refer to Mylan’s accused pen, which is also called
`“Vystra.” “Vystra” is the name that this Opinion will generally use for Mylan’s accused device.
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`deliver a dose, the user pushes a button and this locks those two components together so they’re
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`connected and they rotate together. (Tr. 100:25-101:2.) When the user releases the button, the
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`rotatable connection is released. (Tr. 101:7-10.) The Semglee pen practices limitation 21e.
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`(Tr. 102:8-10.)
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`As to limitation 21f, the parties dispute whether the piston rod must be solid or may be
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`hollow. (Tr. 102:22-25.) The Semglee has a hollow piston rod. (Tr. 103:1-2.) A hollow rod
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`is still a rod. (Tr. 103:5-6.) Nothing in the ’844 patent requires the piston rod to be solid, nor
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`precludes it from being hollow. (Tr. 103:7-12.) Limitation 21f says the rod can have an
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`internal thread, which requires a portion that is hollow. (Tr. 103:13-18.) Limitation 21f refers
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`to a third thread, which is on the driving member in claim 21, or the lead screw in the Semglee.
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`(Tr. 104:2-9.) The plunger rod in the Semglee has either an internal or an external fourth thread
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`that is engaged with the third thread of the lead screw. (Tr. 104:10-18.) The plunger rod in
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`the Semglee pen advances the piston. (Tr. 105:8-10.) The Semglee pen practices limitation
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`21f. (Tr. 106:8-11.)
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`As to limitation 21g, the piston rod holder of claim 21 is the component in the Semglee
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`called the tower core. (Tr. 106:22-25.) Defendants dispute that the tower core is the claimed
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`piston rod holder, and also whether it is configured to prevent the piston rod from rotating during
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`dose setting. (Tr. 107:1-7.) Defendants dispute whether the tower core holds the piston rod in
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`the Semglee, and also that the tower core is configured to prevent rotation during dose
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`dispensing. (Tr. 107:10-21.) “Hold” means to constrain, so as to remove degrees of freedom
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`from one part relative to another. (Tr. 108:1-3.) There is a slot in the tower core that engages
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`with a tab in the piston rod, and the engagement is like a keyed connection that only allows the
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`piston rod to slide axially relative to the tower core; it does not allow it to rotate relative to the
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`tower core or move side to side relative to the tower core. (Tr. 108:7-16.) The tower core
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`holds the plunger rod against rotation, and prevents it from moving side to side, so it is therefore
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`a piston rod holder. (Tr. 109:7-14.) In the Semglee, the tower core is configured to prevent the
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`plunger rod from rotating during dose setting because it’s configured to prevent it from rotating
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`at all times when the pen is assembled. (Tr. 109:18-21.) The Semglee NDA states that the
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`tower core is keyed to the plunger rod and prevents it from rotating when the lead screw rotates
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`during dose delivery, which confirms this. (Tr. 110:1-11.) If the keyed connection were not
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`present, the plunger rod could rotate during dose setting. (Tr. 110:22-25.) Dr. Reinholtz did
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`an experiment that confirmed this. (Tr. 111:16-114:15.) The tower core is a piston rod holder
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`that is configured to prevent the piston rod from rotating during dose setting. (Tr. 115:6-9.)
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`Limitation 21g also requires that the piston rod holder is rotatably fixed relative to the
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`housing. (Tr. 115:13-16.) In the Semglee, it is labeled the upper body housing, and the tower
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`core is rotatably fixed relative to it. (Tr. 115:17-24.) The tower core snaps into the brake
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`tower, and the brake tower stays fixed with respect to the housing. (Tr. 115:25-116:2.) Once
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`assembled, these three pieces are locked together. (Tr. 116:3-4.) The Semglee NDA confirms
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`that the housing retains the brake tower, which retains the tower core; the three components
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`cannot move relative to one another. (Tr. 116:8-22.)
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`Limitation 21g also requires that the piston rod holder be configured to permit the piston
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`rod to traverse axially toward the distal end during dose dispensing, and it isn’t disputed that the
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`Semglee practices this. (Tr. 117:6-12.) The Semglee NDA confirms that the plunger rod
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`traverses axially toward the distal end during dose dispensing. (Tr. 117:17-118:1.) The
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`Semglee tower core is a piston rod holder configured to permit the piston rod to traverse axially
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`toward the distal end during dose dispensing. (Tr. 118:4-7.) The Semglee practices the
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`limitation in 21g and claim 21 is infringed by the accused device. (Tr. 118:10-21.)
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`Dependent claim 22 requires the device of claim 21 where the piston rod has a circular
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`cross-section, and the Semglee plunger rod does, as the picture shows. (Tr. 119:14-20.) It is a
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`cylinder along its length. (Tr. 119:24.) A wide feature at its distal end is a pressure foot, and it
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`is an integral, molded part of the plunger rod. (Tr. 120:3-13.) Claim 22 is infringed by the
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`Semglee. (Tr. 120:18.)
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`Claim 23 recites the device of claim 21 further comprising a clutch, which is the setback
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`in the Semglee. (Tr. 120:24-121:8.) When the user presses the button, the dose set knob and
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`the setback are locked in rotation; the setback is both the sleeve of claim 21 and the clutch of
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`claim 23. (Tr. 121:13-21.)
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`Claim 24 recites the device of claim 23 where the clutch provides audible and tactile
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`feedback indicative of unit doses of medicament; the setback has teeth, and those teeth interact
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`with a pair of arms that have teeth on them, part of the double clicker. (Tr. 122:6-123:6.) The
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`relative rotation of these components causes a clicking sound and tactile feedback. (Tr. 123:7-
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`9.) Each click corresponds to one unit dose of medication, so each is indicative of unit doses of
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`medicament. (Tr. 123:13-17.)
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`Claim 25 recites the device of claim 24 where the clutch provides audible clicks during
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`dose canceling, where each click is equal to a unit dose of medicament, and the setback does that
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`during dose cancelling. (Tr. 124:14-21.) Claim 25 is infringed by the Semglee. (Tr. 125:8.)
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`Claim 30 recites the device of claim 21 further comprising a nut that tracks each set dose
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`of medicament delivered; in the Semglee, this nut is called the dose stop. (Tr. 125:13-19.) The
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`parties dispute whether the dose stop is a nut in part because it has external threads. (Tr.
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`125:21-24.) Defendants contend that the nut must have internal threads, but some nuts have
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`external threads -- flare nuts, as well as lug nuts in automobiles have only external threads. (Tr.
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`125:25-126:7.) Defendants also question whether the dose stop is a nut because it does not
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`wrap around in a full circle. (Tr. 126:15-18.) A nut that wraps around in a full circle is a full
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`nut, while a nut that wraps around halfway would be a half nut or partial nut. (Tr. 126:19-24.)
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`The ’844 patent specification states that the nut 40 in figure 5 is a half-nut. (Tr. 127:3-10.) The
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`Semglee dose stop is a nut, even though it is not a full nut. (Tr. 127:16-18.)
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`Claim 30 also requires that the nut tracks each set dose of medicament delivered, and the
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`dose stop does this. (Tr. 127:19-23.) The nut threads along the axis of the pen as the user
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`dials a dose and ultimately prevents the user from dialing a dose that exceeds what is available.
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`(Tr. 128:4-11.) The nut moves along the pen to track each set dose of medicament delivered.
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`(Tr. 128:16-20.) Exhibit PTX-394 confirms that the dose stop rides along with the dose set
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`knob to track doses. (Tr. 129:1-8.) Claim 30 is infringed by Semglee. (Tr. 129:11-15.)
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`On cross-examination, Dr. Reinholtz stated that he had not published any paper that
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`talked about injector pens, nor had he ever done research (prior to this case) on them, nor
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`designed any. (Tr. 130:11-131:1.) When the Semglee is at rest, the sleeve and dose set knob,
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`or dose indicator, are not connected. (Tr. 132:5-11.) In the ’844 patent figures showing the
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`embodiment, the sleeve and dose indicator are coupled when the device is at rest; when the user
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`depresses the button, those two components become uncoupled. (Tr. 133:14-24.) Thus, in the
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`’844 embodiment, at rest, the sleeve is connected to the dose indicator; in the Semglee, the
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`setback and dose set knob become coupled only upon pressing the button. (Tr. 133:25-134:12.)
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`As to the hollow rod, the Semglee has a hollow piston rod, which could be called a tube,
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`a cylinder, or a sleeve. (Tr. 137:12-21.) The ’844 patent does not disclose an embodiment with
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`a hollow tube as a rod. (Tr. 137:22-25.)
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`The term “holder” does not appear in the ’844 patent except in the claim. (Tr. 138:21-
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`139:2.) When Dr. Reinholtz did his experiment on the tower core, he used a knife to cut off the
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`part of the tower core that is the slotted portion that resides inside the piston rod tube. (Tr.
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`139:9-24.) After he did the cut, he reassembled the pen without the dose stop nut. (Tr. 141:5-
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`7.) The Semglee’s setback serves the functions of both the sleeve and the clutch in the patent.
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`(Tr. 150:1-20.)
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`Most of the nuts we’re familiar with day to day are internally threaded. (Tr. 152:10-13.)
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`The nut shown in the ’844 patent is internally threaded. (Tr. 153:9-11.) A pipe nipple,
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`depending on how it’s used, could be considered a nut, but Dr. Reinholtz would not generally
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`describe it as a nut. (Tr. 154:7-21.)
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`On redirect examination, Dr. Reinholtz said that limitation 21f allows for a hollow piston
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`rod. (Tr. 155:17-22.)
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`C.
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`Testimony of Robin Goland
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`What follows is a summary of the witness’s testimony. Dr. Goland was admitted as an
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`expert in endocrinology and treatment of patients with diabetes. (Tr. 159:25-160:4.) Taking
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`injections is hard for everybody, and the need to use your hands and complicated self-care
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`techniques makes it harder, so it is important to have an easy-to-use pen to administer insulin.
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`(Tr. 162:10-18.) Prior to the launch of the SoloSTAR® pen, Lantus was administered to
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`patients with the OptiClik pen, and Levemir with the FlexPen. (Tr. 163:5-17.) These pens
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`were not easy to use. (Tr. 163:18-19.) The OptiClik was not easy to use because it was big,
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`not disposable, people struggled to replace the cartridge and see the numbers, and they had
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`trouble pressing the button. (Tr. 163:23-164:5.) The FlexPen was not easy to use because the
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`dose stop didn’t work properly, and it was a lot harder to push. (Tr. 164:8-16.) Because of the
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`problems with OptiClik and FlexPen, there was a need for an easy-to-use pen with a low
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`injection force in 2007, and SoloSTAR® met that need. (Tr. 164:23-165:3.) The improvement
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`from the OptiClik to the SoloSTAR® was dramatic. (Tr. 165:4-6.) Prior to the launch of the
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`SoloSTAR®, patients would look at the vial and syringe and say it was too scary. (Tr. 165:14-
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`18.) The SoloSTAR® is discreet, can be carried in the pocket, is disposable, very easy to push,
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`the numbers are easy to read, and you can hear the dose as you dial it up. (Tr. 166:5-14.) The
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`low injection force of the SoloSTAR® helped patients with limited dexterity, and Dr. Goland
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`switched patients to SoloSTAR® because of its low injection force and ease of use. (Tr. 167:7-
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`12.) The SoloSTAR® can administer up to 80 units in an injection, whereas previous pens had
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`a maximum of 60 units. (Tr. 167:13-20.) Dr. Goland never encountered a patient who had
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`difficulty using the SoloSTAR®. (Tr. 168:5-8.) None of her patients switched to SoloSTAR®
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`based on her handing out marketing samples. (Tr. 170:5-8.)
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`On cross-examination, Dr. Goland said that the OptiClik had many issues, was actually
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`defective, a very bad pen, did not deliver accurately, was big, and the numbers were hard to read.
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`(Tr. 171:7-21.) The SoloSTAR® satisfied a long-felt need. (Tr. 172:7-10.) Dr. Goland did
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`not review the ’844 patent and does not know what it says. (Tr. 172:17-173:10.) When insulin
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`glargine was launched, it met a long-felt and unmet need. (Tr. 173:11-18.) Sanofi also sells
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`Apidra, a short-acting insulin, in the SoloSTAR® pen. (Tr. 174:5-10.) The only available
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`Lantus pen product is the SoloSTAR®. (Tr. 176:3-6.) Patients all notice the injection force of
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`the SoloSTAR®, and they’re very happy that it’s so much easier than expected. (Tr. 177:2-6.)
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`On redirect examination, Dr. Goland agreed that, were Apidra offered in the OptiClik
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`pen, the SoloSTAR® pen with Apidra would be an improvement over it. (Tr. 178:14-16.)
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`D.
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`Testimony of Henry Grabowski
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`What follows is a summary of the witness’s testimony. Dr. Grabowski was admitted as
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`an expert in the field of economics, including pharmaceutical and health economics. (Tr. 189:8-
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`13.) Dr. Grabowski said that his assignment in this case was to determine using economic data
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`whether SoloSTAR® was a commercial success and also whether there was a nexus to the patent
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`at issue, and he concluded that SoloSTAR® is a commercial success and there is a nexus to the
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`patent at issue. (Tr. 189:18-25.)
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`When Lantus SoloSTAR® was introduced in 2007, it immediately became the market
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`leader and, by its second full year on the market, it had more than 60% market share among
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`long-acting pens. (Tr. 191:3-10.) The FlexPen flatlined at about 30% share after SoloSTAR®
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`was introduced. (Tr. 191:11-15.) After SoloSTAR® was introduced, the number of
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`prescriptions written rapidly grew much faster than the other long-acting pens in the market, and
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`it is the most-prescribed long-acting insulin pen product since 2008. (Tr. 191:23-192:7.) By
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`2013, it became the market leader among all insulin injectable products. (Tr. 192:18-19.) Over
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`all the years, it has had gross sales of more than $40 billion. (Tr. 194:21.) Lantus SoloSTAR®
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`has been successful not only in terms of insulin injectable products, but it has been one of the
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`most successful introductions in the last 15 years. (Tr. 193:22-194:2.)
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`As to the nexus between the commercial success of SoloSTAR® and the three claims of
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`the ’844 patent, Dr. Grabowski compared Lantus SoloSTAR® to Lantus OptiClik, and the
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`SoloSTAR® practices the ’844 patent while the OptiClik does not. (Tr. 195:1-21.) While the
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`two products have the same insulin, SoloSTAR® dramatically outperformed OptiClik, which
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`was eventually discontinued in 2012. (Tr. 196:8-15.) Dr. Grabwski also compared Apidra in
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`OptiClik with Apidra in SoloSTAR®, and SoloSTAR® was prescribed several multiples more
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`than the OptiClik version. (Tr. 196:23-197:8.) This confirms the view that the features enabled
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`by the ’844 patent were a driving factor in the performance of SoloSTAR®. (Tr. 197:12-15.)
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`These comparisons show that the performance of SoloSTAR® was not due to the insulin it
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`delivered. (Tr. 197:16-24.) Dr. Grabowski did not, however, attempt to apportion the
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`commercial success among the various factors that have contributed to it. (Tr. 199:8-11.) A
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`study by Clarke and Spollett showed that the injection force of SoloSTAR® was 30% lower than
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`that of FlexPen. (Tr. 201:13-18.) Two award press releases mention low injection force.
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`(202:23-204:3.)
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`Dr. Grabowski disagrees with Dr. McDuff’s positions about blocking patents because the
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`blocking patents cover insulin glargine, not pens. (Tr. 205:2-5.) And the blocking patents
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`expired in 2014-2015, so they have not been in effect for the past several years. (Tr. 205:20-
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`23.) Dr. Grabowski also disagreed with Dr. McDuff about the role of marketing efforts and
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`conversion strategy: there’s no evidence that Sanofi did excessive marketing for this product.
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`(Tr. 205:24-206:11.)
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`On cross-examination, Dr. Grabowski agreed that, by 2004, Lantus could be considered a
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`blockbuster drug. (Tr. 207:14-19.) The DCA press release does not constitute industry praise.
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`(Tr. 211:16-19.) The article Dr. Grabowski cited about superior injection force was authored by
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`Sanofi. (Tr. 214:11-14.) In 2007, there were 30 pages of winners of the Good Design Award,
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`with 16 other recipients in the medical category. (Tr. 217:14-23.)
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`E.
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`Testimony of Michael Quinn
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`What follows is a summary of the witness’s testimony. Mr. Quinn is a mechanical
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`engineer who designed the BD Vystra2 pen, which is Mylan’s proposed product. (Tr. 222:12-
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`25.) Mr. Quinn was admitted as an expert in the field of mechanical engineering, mechanisms,
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`and mechanical systems, including medical devices, medical injector pen, and medical device
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`design, development, and manufacturing. (Tr. 226:1-6.)
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`
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`In the ’844 pen, the clutch and dial sleeve are connected to each other, and during dialing
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`the clutch and drive sleeve rotate. (Tr. 228:20-22.) In Mylan’s pen, the dose set knob and the
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`setback are not connected, and as a user would dial or dial back, the setback and lead screw don't
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`rotate relative to the rest of the pen. (Tr. 228:23-229:1.) The opposite are the case during dose
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`administration. (Tr. 229:2-10.)
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`
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`As to the “releasably connected” limitation in claim 21, the word “connected” implies
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`that the components in a nominal state are joined to each other; the word is not “connectable,”
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`but “connected.” (Tr. 235:20-236:2.) The ’844 patent specification discloses that the clutch
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`and the dial sleeve are spring-loaded to be connected in a nominal state as well as dialing and
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`dial back. (Tr. 236:6-9.) The Vystra pen does not meet the “releasably connected” limitation
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`in claim 1. (Tr. 238:7-11.)
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`2 It appears that “Semglee” and “Vystra” are different names for the same thing, Mylan’s
`accused pen product. (See Tr. 249:3-9.)
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`As to the limitation in claim 21 that requires a piston rod holder configured to prevent
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`rotation during dose setting, the Vystra pen does not have this element. (Tr. 238:16-20.) Dr.
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`Reinholtz testified that the brake tower was the piston rod element, but his report said that it was
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`the tower core alone or in conjunction with the brake tower. (Tr. 238:21-239:5.) Mr. Quinn
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`disagreed with Dr. Reinholtz, because the plunger rod has no torque applied to it from the pen
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`during dose dialing, so nothing is needed to prevent its rotation. (Tr. 239:6-11.) The plunger
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`rod doesn’t receive any torque because the setback absorbs it all and prevents any further motion
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`during dialing. (Tr. 239:13-15.) Because the setback isn't rotating during dose setting, nothing
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`inside of it is rotating during dose setting, including the lead screw and including the plunger rod.
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`(Tr. 240:5-7.) The tower core in Vystra is not configured to prevent rotation, but instead has
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`two main functions. (Tr. 240:8-10.) The first is to hold the lead screw and keep it from
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`popping out the back of the pen. (Tr. 240:11-13.) The second is to prevent the plunger rod
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`from rotating during dose injection because it’s during dose injection that the lead screw is
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`turning, and that’s when torque is applied to the plunger rod. (Tr. 240:17-20.) The components
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`in the Vystra are not configured as the claim language requires. (Tr. 241:4-14.)
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`
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`Dr. Reinholtz’ experiment on the Vystra did not accurately represent the pen. (Tr.
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`241:20-24.) In addition to removing the tower core, Dr. Reinholtz also removed the dose stop,
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`and he also pre-advanced the stopper in the cartridge. (Tr. 242:1-3.) He loosened up the
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`setback, which allows the lead screw to have more play, and he removed the tower core, which
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`supports the shaft of the lead screw, allowing the lead screw more freedom to move around.
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`(Tr. 242:6-11.) Most importantly, he pre-advanced the stopper away from the pressure foot of
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`the plunger rod; all these changes made a very loose system of parts. (Tr. 242:12-14.) The
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`experiment does not prove that the tower core is configured to prevent rotation during dialing.
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`(Tr. 242:19-20.) Dr. Reinholtz removed constraints in the pen with the effect of allowing more
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`vibration. (Tr. 242:22-23.) He eliminated a key constraint on the plunger rod, its contact with
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`the rubber stopper in the cartridge holder. (Tr. 242:23-25.) By aiming the pen upward and
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`using dialing to create vibration, he got the plunger rod to rotate itself back down on the lead
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`screw. (Tr. 243:1-5.) He also admitted that, if he points the needle end down and the pressure
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`foot of the plunger rod touches the stopper, if dialed, the plunger rod does not rotate. (Tr.
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`243:5-8.) The experiment is not something a person of ordinary skill in the art (hereinafter,
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`“POSA”) would consider in evaluating a pen injector. (Tr. 243:12-17.) Vystra does not meet
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`the limitations of claim 21. (Tr. 243:21-22.)
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`
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`Vystra does not meet the limitations of claim 25 because claim 25 depends on claim 23,
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`which requires a clutch, which Vystra does not have. (Tr. 244:4-9.) According to Dr.
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`Reinholtz, the sleeve of claim 21 is the setback of the Vystra, so there’s no component left to be
`
`the clutch. (Tr. 244:12-245:2.) If one allows one component to have two functions, the setback
`
`could have a clutch function: a series of four nubs interact with the dose set knob on
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`injection, and those are the clutch elements. (Tr. 245:16-21.) The setback has a lot of
`
`functions besides the clutching function; there are internally facing click teeth, but these have
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`nothing to do with clutching. (Tr. 245:24-246:5.) The audible clicks do not come from the
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`clutching aspect of the setback. (Tr. 246:8-9.) Vystra does not meet the limitations of claim
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`25. (Tr. 246:10-13.)
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`
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`As to the nut limitation in claim 30, a POSA would understand a nut as a mechanical
`
`component containing internal threads and some form of features on the outside for fixation or
`
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`connection using tools. (Tr. 246:21-25.) The ’844 specification, at col.4 ll.26-35, describes the
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`nut as having internal threads and external teeth, which interact with the housing to prevent
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`rotation. (Tr. 247:1-7.) Dr. Reinholtz contends that the Vystra dose stop is a nut;