Mylan Pharmaceuticals Inc. et al. vs Horizon Pharma USA, Inc. et al.

Denying Petitioners Request for Rehearing of Denial of Refund 37 C.F.R. seC. 42.71

PANEL CHANGE ORDER Conduct of the Proceedings 37 C.F.R. ¿¿ 42.5

Request for Rehearing of Notice of Denial of Refund

Notice of Refund Denial

Mylan Refund Request

JUDGMENT Terminating the Proceeding Granting Request to Treat Settlement Agreement as Confidential Business Information 35 U.S.C. sec. 317(a); 37 C.F.R. sec. 42.72, 42.74(c)

Decision - Denying Dr. Reddy's Request for Rehearing - 37 CFR 42.71

Motion to Terminate

Exhibit 1059

Motion to Keep Confidential

Petitioners' Request for Rehearing Under ¿¿ 42.71

Denying Patent Owner's Motions to Terminate

Termination Decision Document

ORDER Adjusting One-Year Pendency Due to Joinder

Response to Motion to Terminate

Notice of Appeal (District Court)

Notice of Appeal (District Court)

Notice of Appeal (District Court)

Petitioners' Updated Exhibit List

Revising the Scheduling Order

PATENT OWNERS¿¿¿ MOTION TO TERMINATE

Ex. 2073 Markman Opinion

PATENT OWNERS¿¿¿ BRIEFING REGARDING CLICK-TO-CALL TECHS., L.P. v. INGENIO, INC.

Ex. 2072 2016-03-31 Plfs' Disclosure of Asserted Claims to Mylan

Patent Owners Exhibit List

Ex. 2074 Opening Brief

Ex/ 2075 MSJ Opinion

Ex. 2076 Mylan Judgment

Ex. 2077 DRL Judgment

Mylan Brief on Click-to-Call

Proposed Scheduling Order

Order - Granting Unopposed Motion to Withdraw Counsel - 37 CFR 42.10

EXPUNGED

ORDER - Conduct of the Proceeding 37 .C.F.R ¿¿ 42.5

PETITIONER¿¿¿S MOTION FOR WITHDRAWAL OF COUNSEL

Petitioners' Updated Mandatory Notices

Updated Mandatory Notices

Amended Power of Attorney

Patent Owner Horizon Power of Attorney

Sale Order

Stalking Horse Agreement

Updated Exhibit List

Patent Owner Pozen Inc. Exhibit 2072 - Bankruptcy Petition

Patent Owners Exhibit List

Order - Conduct of the Proceeding Suspending Deadlines Due to Suggestion of Bankruptcy

Ex. 3002

Patent Owner Pozen Inc.'s Suggestion of Bankruptcy

Order Granting Petitioner Mylan Pharmaceuticals Inc.'s Motion for Pro Hac Vice Admission of Autumn N. Nero

Petitioners' Notice of Deposition of David A. Johnson, M.D.

Trial Instituted Document Granting Petitioner's Motion for Joinder and Instituting Inter Partes Review

Petitioner's Notice of Deposition of David R. Taft, Ph.D.

Joint Notice of Stipulation to Adjust Schedule

EXPUNGED

EXPUNGED

Patent Owner's Exhibit List

Updated List of Petitioner's Exhibits

Declaration of Autumn N. Nero

Petitioner's Updated Mandatory Notices

Motion for pro hac vice admission of Autumn N. Nero

Granting Petitioner Mylan Pharmaceuticals Inc. Motion for Pro Hac Vice Admission of Bryan D. Beel and Robert D. Swanson 37 C.F.R. sec 42.10

Granting Patent Owner Horizon Pharma USA, Inc. Motion for Ellen Scordino to Appear Pro Hac Vice 37 C.F.R. sec 42.10

Petitioner's Objections to Patent Owners' Evidence

Patent Owner's Exhibit List

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Fries, J.F., et al., Nonsteroidal Anti-Inflammatory Drug-Associated Gastropathy: Incidence and Risk Factor Models, The American Journal of Medicine, Vol. 91, pp. 213-222 (1991) (with publication information)

Oct. 12, 2017 Deposition Testimony of Everardus Orlemans, Ph.D. in the Horizon Pharma, Inc. v. Dr. Reddy¿¿¿s Laboratories, Inc., Case No. 3:15-cv-03324 (D.N.J.)

Stollman, N. and Metz, D.C., Pathophysiology and prophylaxis of stress ulcer in intensive care unit patients, J. Critical Care, Vol. 20, pp. 35-45 (2005)

Cryer, B. and Feldman, M., Effects of Nonsteroidal Anti-inflammatory Drugs on Endogenous Gastrointestinal Prostaglandins and Therapeutic Strategies for Prevention etc., Vol. 152, pp. 1145-1155 (1992) (with publication information)

Jan. 12, 2017 Trial Testimony of John R. Plachetka in the Horizon Pharma, Inc. v. Dr. Reddy¿¿¿s Laboratories, Inc., Case No. 3:11-cv-02317 (D.N.J.)

Norman, A. and Hawkey, C.J., What you need to know when you prescribe a proton pump inhibitor, Frontline Gastroenterology, Vol. 2, pp. 199-205 (2011)

Declaration of Michael Mayersohn, Ph.D. in Support of Defendants¿¿¿ Claim Construction Brief filed on April 24, 2014 in Par Pharm., Inc. v. Takeda Pharm. Co., Case No. 5:13-CV-1927 LHK (PSG)

IPR2017-01995, May 24, 2018 Deposition Transcript of Dr. Michael Mayersohn

Email string from Tore Lind to Richard Leff, Doug Levine, David Magner, and Mark Sostek, dated May 27, 2006 to May 31, 2006

Tolman et al., The Effects of Oral Doses of Lansoprazole and Omeprazole on Gastric pH, J. CLIN. GASTROENTEROL., 24(2):65-70 (1997)

Leucuta et al., Pharmcokinetics and Metabolic Drug Interactions, CURRENT CLINICAL PHARMACOLOGY, 1:5-20 (2006)

Vanderhoff et al., Proton Pump Inhibitors: An Update, AMERICAN FAMILY PHYSICIAN, 66:273-280 (2002)

Arnold, Safety of proton pump inhibitors-an overview, Aliment Pharmacol. Ther., 8(Suppl. 1):65-70 (1994)

M.M. Wolfe et al., Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs, N. Engl. J. Med., 340(24):1888-1899 (1999)

L. Laine, Nonsteroidal anti-inflammatory drug gastropathy, Gastrointest. Endosc. Clin. North Am., 6(3):489¿¿¿504 (1996)

F.E. Silverstein et al., Gastrointestinal toxicity with celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A randomized controlled trial, JAMA, 284(10):1247¿¿¿1255 (2000)

C. Bombardier et al., Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis, N. Engl. J. Med., 343(21):1520¿¿¿1528 (2000)

G. Singh, Gastrointestinal complications of prescription and over-the-counter nonsteroidal anti-inflammatory drugs: a view from the ARAMIS database, Am. J. Ther., 7:115¿¿¿121 (2000)

N. Hudson et al., Famotidine for healing and maintenance in nonsteroidal anti-inflammatory drug-associated gastroduodenal ulceration, Gastroenterology, 112:1817-1822 (1997)

L. Olbe et al., Reviews: A Proton-pump inhibitor expedition: The case histories of omeprazole and esomeprazole, Nature 2:132-139 (2003)

C.W. Howden, Clinical pharmacology of omeprazole, Clin. Pharmacokinet 20(1):38-49 (1991)).

J.Q. Huang & R.H. Hunt, Pharmacological and pharmacodynamic essentials of H2-receptor antagonists and proton pump inhibitors for the practising physician, Best Prac. & Res. Clin. Gastroenterol. 15(3):355-370 (2001)

January 30, 2013 Amendment C and Response to Final Office Action, Application No. 12/553,107

IPR2017-01995, May 25, 2018 Deposition Transcript of David C. Metz

Redacted Amended Memorandum Opinion (D.I. 498), Case 3:11-cv-02317-MLC-DEA (D.N.J. July 12, 2017)

Andersson et al., Pharmacokinetic Studies with Esomeprazole, the (S)-Isomer of Omeprazole, CLIN. PHARMACOKINET., 40(6):411-426 (2001)

Hartmann et al., Twenty-four-hour intragastric pH profiles and pharmacokinetics following single and repeated oral administration of the proton pump inhibitor pantoprazole in comparison to omeprazole, ALIMENT PHARMACOL. THER., 10:359-366 (1996)

Meyer, Interaction of Proton Pump Inhibitors with Cytochromes P450: Consequences for Drug Interactions, YALE J. BIOL. MED., 69:203-209 (1996)

Prilosec Label

VIMOVO Prescribing Information

NIH, National Institute of Diabetes and Digestive and Kidney Diseases, Bleeding in the Digestive Tract, etc. (last accessed March 23, 2015)

K.S. Jain, et al., Recent advances in proton pump inhibitors and management of acid-peptic disorders, Bioorganic & Medicinal Chemistry 15:1181-1205 (2007)

Nexium label

S.H. Roth, NSAID gastropathy: A new understanding, Arch. Intern. Med. 156:1623¿¿¿1628 (1996)

W. Bensen & A. Zizzo, Newer, safer nonsteroidal anti-inflammatory drugs. Rational NSAID selection for arthritis, Can. Fam. Physician 44:101-102, 105-107 (1998)

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Wolfe et al., Gastroprotective therapy and risk of gastrointestinal ulcers: risk reduction by COX-2 therapy, J. Rheumatol. 29(3):467-473 (2002)

J.L. Wallace et al., Gastrointestinal-sparing anti-inflammatory drugs: the development of nitric oxide-releasing NSAIDs, Drug Dev Res 42:144-149 (1997)

M. Hassan-Alin et al., Pharmacokinetics of esomeprazole after oral and intravenous administration of single and repeated doses to healthy subjects, Eur. J. Clin. Pharmacol., 56:665-670 (2000)

H. Koop, Review article: metabolic consequences of long-term inhibition of acid secretion by omeprazole, Aliment. Pharmacol. Ther. 6:399¿¿¿406 (1992)

Donnellan C., Preston C., Moayyedi P., Sharma N., Medical treatments for the maintenance therapy of reflux oesophagitis and endoscopic negative reflux disease (Review), The Cochrane Library, Issue 4, at 14 (2004)

D.A. Johnson, Review of esomeprazole in the treatment of acid disorders, Expert Opin. Pharmacother. 4(2):253-264 (2003)

FDA Public Health Advisory, April 7, 2005, available at http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm150314.htm (last accessed March 23, 2015)).

F.L. Lanza, A guideline for the treatment and prevention of NSAID-induced Ulcers, Am. J. Gastroenterol., 93(11):2037¿¿¿2046 (1998)

J.L. Goldstein et al., Impact of adherence to concomitant gastroprotective therapy on nonsteroidal-related gastroduodenal ulcer complications, Clin. Gastroenterol. & Hepatology, 4:1337-1345 (2006)

J.L. Goldstein et al., Clinical trial: the incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN 400 (naproxen plus esomeprazole magnesium) vs. enteric-coated naproxen alone, Aliment Pharmacol. Ther., 32:401-413 (2010)

IPR2017-01995 Corrected Declaration of Bryan D. Beel in Support of Petitioner¿¿¿s Evidence, June 1, 2018

Declaration of David A. Johnson. M.D. In Support of Patent Owner Response to Petition for Inter Partes Review of U.S. Patent No. 9,220,698

Jan. 24, 2018 Deposition Testimony of Dr. John R. Plachetka in the Horizon Pharma, Inc. v. Dr. Reddy¿¿¿s Laboratories, Inc., Case No. 3:15-cv-03324 (D.N.J.) PROTECTIVE ORDER MATERIAL

Oct. 27, 2017 Deposition Testimony of Mark Sostek, MD in the Horizon Pharma, Inc. v. Dr. Reddy¿¿¿s Laboratories, Inc., Case No. 3:15-cv-03324 (D.N.J.) PROTECTIVE ORDER MATERIAL

Oct. 16, 2014 Deposition Testimony of Brian Ault, Ph.D. in the Horizon Pharma, Inc. v. Dr. Reddy¿¿¿s Laboratories, Inc., Case No. 3:11-cv-02317 (D.N.J.) PROTECTIVE ORDER MATERIAL

Oct. 10, 2014 Deposition Testimony of Dr. Mark Sostek in the Horizon Pharma, Inc. v. Dr. Reddy¿¿¿s Laboratories, Inc., Case No. 3:11-cv-02317 (D.N.J.) PROTECTIVE ORDER MATERIAL

PN400-104 Clinical Study Report PROTECTIVE ORDER MATERIAL

Oct. 27, 2017 Deposition Testimony of Mark Sostek, MD in the Horizon Pharma, Inc. v. Dr. Reddy¿¿¿s Laboratories, Inc., Case No. 3:15-cv-03324 (D.N.J.) PROTECTIVE ORDER MATERIAL

Oct. 16, 2014 Deposition Testimony of Brian Ault, Ph.D. in the Horizon Pharma, Inc. v. Dr. Reddy¿¿¿s Laboratories, Inc., Case No. 3:11-cv-02317 (D.N.J.) PROTECTIVE ORDER MATERIAL

AstraZeneca/Pozen Collaboration and License Agreement (August 1, 2006) PROTECTIVE ORDER MATERIAL

Declaration of David R. Taft PH.D. In Support of Patent Owner Response to Petition for Inter Partes Review of U.S. Patent No. 9,220,698

PN400-104 Clinical Study Report PROTECTIVE ORDER MATERIAL

Oct. 25, 2017 Deposition Testimony of Brian Ault, Ph.D. in the Horizon Pharma, Inc. v. Dr. Reddy¿¿¿s Laboratories, Inc., Case No. 3:15-cv-03324 (D.N.J.) PROTECTIVE ORDER MATERIAL

AstraZeneca/Pozen Collaboration and License Agreement (August 1, 2006) PROTECTIVE ORDER MATERIAL

Jan. 24, 2018 Deposition Testimony of Dr. John R. Plachetka in the Horizon Pharma, Inc. v. Dr. Reddy¿¿¿s Laboratories, Inc., Case No. 3:15-cv-03324 (D.N.J.) PROTECTIVE ORDER MATERIAL

Oct. 25, 2017 Deposition Testimony of Brian Ault, Ph.D. in the Horizon Pharma, Inc. v. Dr. Reddy¿¿¿s Laboratories, Inc., Case No. 3:15-cv-03324 (D.N.J.) PROTECTIVE ORDER MATERIAL

Oct. 10, 2014 Deposition Testimony of Dr. Mark Sostek in the Horizon Pharma, Inc. v. Dr. Reddy¿¿¿s Laboratories, Inc., Case No. 3:11-cv-02317 (D.N.J.) PROTECTIVE ORDER MATERIAL

PATENT OWNERS POZEN INC. AND HORIZON PHARMA USA, INC.¿¿¿S MOTION TO SEAL

PATENT OWNERS POZEN INC. AND HORIZON PHARMA USA, INC.¿¿¿S RESPONSE

Denying Patent Owners Request for Rehearing 37 C.F.R. sec 42.71

Patent Owners' Updated Mandatory Notices

Motion for Ellen Scordino To Appear Pro Hac Vice On Behalf Of Patent Owner Horizon Pharma USA, Inc.

Declaration Of Ellen Scordino In Support Of Motion To Appear Pro Hac Vice On Behalf Of Patent Owner Horizon Pharma USA, Inc.

Joint Notice of Stipulation to Adjust Schedule

Motion for Pro Hac Vice Admission of Bryan Beel

Declaration of Bryan Beel

Motion for Pro Hac Vice Admission of Robert Swanson

Swanson Declaration

Petitioners' Updated Exhibit List

Petitioner's Objections to Patent Owner Evidence

Patent Owners' Objections to Petitioner's Evidence Pursuant to 37 CFR section 42.64(b)(1)

Petitioner's Objections to Patent Owner Evidence

Patent Owners' Exhibit List

Patent Owners' Request for Rehearing of the Decision to Institute Pursuant to 37 CFR section 42.71(c) ,d)

Email string from Mylan's counsel, Robert D. Swanson from February 6, 2017 to February 15, 2017

Trial Instituted Document

Order - Granting Patent Owner Horizon Pharma USA, Inc.'s Motion for Pro Hac Vice Admission of Susan Krumplitsch - 37 CFR 42.10

Ex. 3001

Scheduling Order

Order - Granting Patent Owner Horizon Pharma USA, Inc.'s Motion for Pro Hac Vice Admission of Jonathan G. Graves - 37 CFR 42.10

Stipulation and Order

Petitioners' Updated Exhibit List

Reply to Patent Owner's Preliminary Response

Order Granting Petitioner Request to File a Reply

Motion for Jonathan G. Graves to Appear Pro Hac Vice on Behalf of Patent Owner Horizon Pharma USA, Inc.

Declaration of Jonathan G.Graves in Support of Motion to Appear Pro Hac Vice on Behalf of Patent Owner Horizon Pharma USA, Inc.

Motion for Susan Krumplitsch to Appear Pro Hac Vice on Behalf of Patent Owner Horizon Pharma USA, Inc.

Declaration of Susan Krumplitsch in Support of Motion to Appear Pro Hac Vice on Behalf of Patent Owner Horizon Pharma USA, Inc.

Patent Owner's Exhibit List

Patent Owner Preliminary Response

Exhibit 2001

Exhibit 2002

Exhibit 2003

Exhibit 2006

Exhibit 2007

Patent Owner's Exhibit List

Exhibit 2004

Exhibit 2005

Patent Owner's Mandatory Notices

Power of Attorney

Notice of Accord Filing Date

Power of Attorney

U.S. Patent No. 9,220,698

Metz Declaration

'907 Patent

'285 Patent

Howden 2005

'192 Patent

EC Naprosyn Approval

2007 EC Naprosyn Label

Zegerid 2004 Label

Goldstein 2008

Hochberg EULAR 2008

2013-01-30 Response to Office Action

Wolfe 2000

Bell

Hassan-Alin

Khosravan

Jung

Davies 1997

2017 Naprosyn Label

Harrison's 2005

Rowland and Tozer 1995

Clissold

'070 Patent

'504 Patent

Mayersohn, Modern Pharmaceutics

Howden 1991

Lind 2000

Regardh

Vimovo 2014 Label

Websters Dictionary (Target)

American Heritage Dictionary (Target)

Merriam Webster Dictionary (Target)

2012-01-05 Office Action

2012-07-30 Office Action

2014-06-16 Office Action

2015-03-26 Office Action

2012-05-08 Response

2014-12-16 Response

2015-09-25 Response

2012-10-09 Advisory Action

Goldlust 2004

Mayersohn Declaration

Petition for Inter Partes Review