Mylan Pharmaceuticals Inc. et al. vs Sanofi-Aventis Deutschland GmbH et al.

Notice of Refund

Petitioner's Refund Request

Trial Instituted Document

Petitioner's Mandatory Change-Of-Information Notices

Petitioner's Power of Attorney

Patent Owner's Sur-reply in Support of Patent Owner Preliminary Response

Amended Schedule, Sanofi-Aventis U.S. LLC v. Mylan, N.V., et al., Civil Action No. 17-9105-SRC-CLW (D.N.J. Mar. 18, 2019), Dkt. No. 285

Order - 37 C.F.R. 42.10

Mylan¿¿¿s Reply to Patent Owner¿¿¿s Preliminary Response

Graph showing PTAB Days to Docketing for Review Proceedings filed between 2016-201

Mylan Pharmaceuticals Inc. Unopposed Motion for Pro Hac Vice Recognition

Declaration of Elham F. Steiner ISO Unopposed Motion for Pro Hac Vice Recognition

Elham F. Steiner, Attorney Biography

Patent Owner's Preliminary Response

Press Release, Mylan Commences Phase III Clinical Trials for its Generic Version of Advair Diskus and Insulin Analog to Lantus, Sept. 16, 2014 (PR Newswire)

Mylan GMBH¿¿¿s Exhibit F to Invalidity Contentions, dated Jan. 25, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)

Excerpts from Mylan GMBH¿¿¿s Amended Invalidity Contentions, dated April 25, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW

Patent Owner's Updated Mandatory Notices

Press Release, Mylan Enhances Partnership with Biocon through Strategic Collaboration for Insulin Products, Feb. 13, 2013 (PR Newswire)

Press Release, Mylan and Biocon Present Clinical Data on Insulin Glargine at the American Diabetes Association¿¿¿s 77th Scientific Sessions, June 10, 2017 (PR Newswire)

First Amended and Supplemental Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, and Sanofi Winthrop Industrie v. Merck Sharp & Dohme Corp., C.A. No. 1-16-cv-00812-RGA (D. Del. Apr. 5, 2017)

Stipulation and Proposed Order, Sanofi-Aventis U.S. LLC v. Mylan, N.V., Civil Action No. 17-9105-SRC-SLW (D.N.J. Feb 5, 2018)

Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J. Oct. 24, 2017)

Excerpts from Defendants¿¿¿ Invalidity Contentions, dated Jan. 25, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)

Aug. 13, 2018 Service of Sanofi¿¿¿s Responses to Mylan¿¿¿s Amended Contentions, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)

MP4 file of Sanofi¿¿¿s Patented Pen animation

Animation depicting M¿¿ller¿¿¿s first embodiment

Animation depicting M¿¿ller¿¿¿s second embodiment

International Patent WO 99/38554

Defendants¿¿¿ Opposition to Plaintiffs¿¿¿ Motion to Stay dated Nov. 22, 2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 1:17-cv-00181-IMK (N.D. W. Va.)

Joint Proposed Discovery Plan dated Dec. 14, 2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105- SRCCLW (D.N.J.)

Initial Planning Meeting Report and Discovery Proposals dated Dec. 22, 2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 1:17-cv-00181-IMK (N.D. W. Va.),

Transcript of Motion / Scheduling Conference dated Jan. 3, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 1:17- cv-00181-IMK (N.D. W. Va.)

Transcript, Conference Call for Case IPR2018-01675, -01676, - 01678, -01680 (P.T.A.B. Feb. 5, 2019)

Mylan GMBH¿¿¿s Exhibit F to Amended Invalidity Contentions, dated April 25, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)

Excerpts from Transcript, Conference Call dated Aug. 2, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17- cv-09105-SRC-CLW (D.N.J.)

Report of the Local Patent Rules Committee, Explanatory Notes for 2016 Amendments

Letter from A. Calmann to Judge Waldor dated Apr. 24, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17- cv-09105-SRC-CLW (D.N.J.)

Motion to Expedite Defendants¿¿¿ Motion Requesting an Expedited Scheduling Conference dated Nov. 22, 2017 , Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 1:17-cv-00181-IMK (N.D. W. Va.)

Authorizing Reply and Sur-Reply 37 C.F.R. § 42.108(c); 37 C.F.R. § 42.5

Transcript of Call 02.13.2019

Petitioners Updated Exhibit List

Notice of Accord Filing Date

Updated Mandatory Notices

Petitioner's Mandatory Change-of-Information Notices

Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GMBH

Patent Owner's Mandatory Notices Pursuant to 37 C.F.R. 42.8

Petitioner¿¿¿s Mandatory Change-of-Information Notices Under 37 C.F.R. ¿¿42.8(A)(3)

U.S. Patent 8,679,069, Pen-Type Injector (issued Mar. 25, 2014)

U.S. Patent 9,526,844, Pen-Type Injector (issued Dec. 27, 2016)

File History for U.S. Patent 8,679,069

File History for U.S. Patent 8,603,044

File History for U.S. Patent 8,992,486

File History for U.S. Patent 9,526,844

File History for U.S. Patent. 9,604,008

U.S. Patent 6,221,046 - A. Burroughs et al., ¿¿¿Recyclable Medication Dispensing Device¿¿¿ (issued Apr. 24, 2001)

Petitioner Mylan Pharmaceuticals Inc. Power of Attorney

U.S. Patent 8,603,044, Pen-Type Injector (issued Dec. 10, 2013)

U.S. Patent 8,992,486, Pen-Type Injector (issued Mar. 31, 2015)

U.S. Patent 9,604,008, Drive Mechanisms Suitable for Use in Drug Delivery Devices (issued Mar. 28, 2017)

Curriculum Vitae of Karl Leinsing MSME,PE

File History for U.S. Patent 6,582,404

U.S. Patent 6,248,095 B1 ¿¿¿ L. Giambattista et al., ¿¿¿Low-cost Medication Delivery Pen¿¿¿ (issued June 19, 2001)

U.S. Patent 6,921,995 B1 ¿¿¿ A.A. Bendek et al., ¿¿¿Medication Delivery Pen Having An Improved Clutch Assembly¿¿¿ (issued July 13, 1999)

U.S. Patent 5,226,895 ¿¿¿ D.C. Harris, ¿¿¿Multiple Dose Injection Pen¿¿¿ (issued July 13, 1993)

Application as filed: U.S. Patent App. 14/946,203 ¿¿¿ R.F. Veasey, ¿¿¿Relating to a Pen-Type Injector¿¿¿ (filed Nov. 19, 2015)

WO 99/38554 ¿¿¿ S.Steenfeldt-Jensen & S.Hansen, ¿¿¿An Injection Syringe¿¿¿ (pub¿¿¿d Aug. 5, 1999) (Steenfeldt-Jensen PCT)

N. Sclater & N.P. Chironis, Mechanisms & Mechanical Devices Sourcebook 191-95, ¿¿¿Twenty Screw Devices¿¿¿ (3d ed., July 2, 2001)

EP 0 608 343 B1 ¿¿¿ L. Petersen & N.-A. Hansen, ¿¿¿Large Dose Pen¿¿¿ (pub¿¿¿d Oct. 18, 1991)

WO 01/83008 ¿¿¿ S. Hansen & T.D. Miller., ¿¿¿An Injection Device, A Preassembled Dose Setting And Injection Mechanism For An Injection Device, And A Method Of Assembling An Injection Device¿¿¿ (pub¿¿¿d Nov. 8, 2001)

K.J. Lipska et al., Association of Initiation of Basal Insulin Analogs vs Neutral Protamine Hagedorn Insulin With Hypoglycemia-Related Emergency Department Visits ... 320 J. Am. Med. Ass¿¿¿n 53-62 (2018).

U.S. Patent 6,235,004 ¿¿¿ S. Steenfeldt-Jensen & S. Hansen, ¿¿¿Injection Syringe¿¿¿ (issued May 22, 2001)

U.S. Patent Application US 2002/0053578 A1 ¿¿¿ C.S. M¿¿ller, ¿¿¿Injection Device¿¿¿ (pub¿¿¿d May 2, 2002)

U.S. Patent 6,932,794 B2 ¿¿¿ L. Giambattista & A. Bendek, ¿¿¿Medication Delivery Pen¿¿¿ (issued Aug. 23, 2005)

U.S. Patent 6,582,404 B1 ¿¿¿ P.C. Klitgaard et al., ¿¿¿Dose Setting Limiter¿¿¿ (issued June 24, 2003)

U.S. Patent 4,865,591 ¿¿¿ B. Sams, ¿¿¿Measured Dose Dispensing Device¿¿¿ (issued Sep. 12, 1989)

U.S. Patent 5,851,079 ¿¿¿ R.L. Horstman et al., ¿¿¿Simplified Unidirectional Twist-Up Dispensing Device With Incremental Dosing¿¿¿ (issued Dec. 22, 1998)

GB 0304822.0 ¿¿¿ ¿¿¿Improvements in and relating to a pen-type injector¿¿¿ (filed Mar. 3, 2003) (¿¿¿844 Priority Doc.)

Mylan GmbH and Biocon¿¿¿s Preliminary Claim Constructions and Supporting Evidence Pursuant to L. Pat. R. 4.2, Sanofi-Aventis U.S., LLC v. Mylan N.V., C.A. No. 17-cv-09105 (filed Sep. 5, 2018)

Memorandum Opinion, Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., No. 16-cv-812 (filed Jan. 12, 2018)

Memorandum Opinion, Sanofi -Aventis U.S. LLC v. Eli Lilly and Co., No. 14-cv-113 (filed Jan. 20, 2015)

A.G. Erdman &G.N. Sandor, ¿¿¿ Mechanical Advantage¿¿¿, ¿¿3.7 in 1 Mechanism Design: Analysis and Synthesis (1984)

Plaintiffs¿¿¿ Preliminary Claim Constructions and Preliminary Identification of Supporting Intrinsic and Extrinsic Evidence, Sanofi-Aventis U.S. LLC v. Mylan GmbH, No. 2:17-cv-09105 (D.N.J.) (filed Sep. 5 2018)

Expert Declaration of Karl Leinsing MSME, PE in Support of Petition for Inter Partes Review of U.S. Patent Nos. 8,679,069; 8,603,044; 8,992,486; 9,526,844 and 9,604,008

Petition for Inter Partes Review of USP 9,526,844