Synergy Pharmaceuticals Inc. vs Ironwood Pharmaceuticals, Inc.

Notice of Refund

Petitioner's Request for Refund of Post-Institution Fees

Granting Amended Joint Motion to Terminate Proceeding Due to Settlement before Institution and Granting Amended Joint Request to File Settlement Agreement as Business Confidential Information 37 C.F.R. § 42.74

Settlement Agreement ("First Amended to the Binding Term Sheet") [Amended Motion 11.5.2018]

Binding Term Sheet

Amended Joint Motion to Terminate Proceedings

Amended Joint Request to File Settlement Agreement as Business Confidential Information

Order - Denying Without Prejudice Joint Motion to Terminate Proceeding Due to Settlement before Institution and Denying Without Prejudice Joint Request to File Settlement Agreement as Business Confidential Information - 35 USC 317; 37 CFR 42.71

Joint Motion to Terminate Proceeding Pursuant to 35 USC section 317 and 37 CFR section 42.74

Joint Request to File Settlement Agreement as Business Confidential Information Under 35 U.S.C. section 317 and 37 CFR section 42.74

SEALED Confidential Settlement Agreement

Mandatory Notice of Patent Owner Under 37 C.F.R. 42.8(a)(2)

Patent Owner's Power of Attorney

Notice of Accord Filing Date

Shailubhai, K., Therapeutic Applications of Guanylate Cyclase-C Receptor Agonists, Current Opinion in Drug Discovery & Development, March 2002 5(2)

Stroh, M., New Hormone may Lift Montezuma's Vendetta, Science News, July 4, 1992

Petitioner's Power of Attorney

Petitioner's Petition for Inter Partes Review of U.S. Patent No. 8,101,579 B2

U.S. Patent No. 8,101,579 B2

Declaration of Philip Miner, M.D.

Declaration of Andrea Brancale Ph.D.

U.S. Provisional Patent Appl. No. 60/478,492 (filed June 13, 2003)

U.S. Provisional Patent Appl. No. 60/532,361 (filed Dec. 23, 2003)

PCT Publication WO 02/078683 to Shailubhai et al. "Guanylate Cyclase Receptor Agonist for the Treatment of Tissue Inflammation and Carcinogenesis" filed March 28, 2002 and published October 10, 2002

9/24/2007 Reply to Office Action, File History of U.S. Patent Appl. No. 10/868,744

U.S. Patent No. 5,489,670

U.S. Patent No. 5,969,097

Beltowski, J., Guanylin and Related Peptides, Physiology and Pharmacology 52(3):351-375 (2001)

U.S. Patent No. 5,272,147

U.S. Patent No. 5,482,941

U.S. Patent No. 6,100,270

U.S. Patent No. 6,153,630

Letter from Peter David Rands to European Patent Office re European Patent Appl. No. 02721604.3 (EP Patent No. 1379224) (Oct. 25, 2011)

Letter from Harvey Vaughan John Adams to European Patent Office re European Patent No. 1379224 (Oct. 14, 2011)

Anthony J. Viera and Joseph Shaughnessy, Management of Irritable Bowel Syndrome, American Family Physician, Vol. 66(10):1867-74 (2002)

Dorothy B. Doughty, When Fiber Is Not Enough: Current Thinking on Constipation Management, Ostomy Wound Management, Vol. 48(12):30-41 (Dec. 2002)

Arnold Wald, Is Chronic Use of Stimulant Laxatives Harmful to the Colon?, J. Clin. Gastroenterol., Vol. 36(5):386-89 (2003)

Mark B. Cleveland, et al., New Polyethylene Glycol Laxative for Treatment of Constipation in Adults: A Randomized, Double-Blind, Placebo-Controlled Study, Southern Medical Journal, Vol. 94(5):478-81 (2001)

Jan Tack and Maura Corsetti, Tegaserod: a new 5-HT4 agonist in the treatment of irritable bowel syndrome, Expert Opin. Pharmacother., Vol. 3(8):1211-18 (2002)

G.E. Boeckxstaens, et al., Treatment of GI Dysmotility in Scleroderma with the New Enterokinetic Agent Prucalopride, Am. J. Gastroenterol., Vol. 97(1):194-97 (2002)

Kris A. Steinbrecher, et al., Increases in Guanylin and Uroguanylin in a Mouse Model of Osmotic Diarrhea Are Guanylate Cyclase C-Independent, Gastroenterology, 121:1191-1202 (2001)

Annotated Package Insert for Zelnorm (July 24, 2002)

Christopher M. Booth, et al., Gastrointestinal promotility drugs in the critical care setting: A systematic review of the evidence, Crit. Care Med., 30(7):1429-35 (2002)

Rachel Hutchins Thomas, PharmD, MS and Kyle Allmond, Linaclotide (Linzess) for Irritable Bowel Syndrome with Constipation and For Chronic Idiopathic Constipation, Drug Forecast, Vol. 38(3) at Table 1 (March 2013)

Food and Drug Administration Approval Letter for NDA 21-200 (July 24, 2002)

Michael Kamm, et al., Tegaserod for the Treatment of Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled Multinational Study, Am.J. of Gastroenterol. 100:362-72 (2005)

J. Novick, et al., A randomized, double-blind, placebo-controlled trial of tegaserod in female patients suffering from irritable bowel syndrome with constipation, Aliment Pharmacol. Ther. 16:1877-1888 (2002)