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Adcirca® Label | Oct 1, 2025 | EXHIBIT | PATENT OWNER |
Jacobs, M., Mechanism of Action of Hydralzaine on Vascular Smooth Muscle, BIOCHEM. PHARMACOL. | Oct 1, 2025 | EXHIBIT | PATENT OWNER |
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Stassi, D.L. et al., Ethyl-substituted erythromycin derivatives produced by directed metabolic engineering | Oct 1, 2025 | EXHIBIT | PATENT OWNER |
Humbert, M. et al., Treatment of Pulmonary Arterial Hypertension | Oct 1, 2025 | EXHIBIT | PATENT OWNER |
Schneider, M.P. et al., Contrasting Actions of Endothelin ETA and ETB Receptors in Cardiovascular Disease | Oct 1, 2025 | EXHIBIT | PATENT OWNER |
Lee, S.H. & Channick, R.N., Endothelin Antagonism in Pulmonary Arterial Hypertension | Oct 1, 2025 | EXHIBIT | PATENT OWNER |
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Paul, G.A., Bosentan decreases the plasma concentration of sildenafil when coprescribed in pulmonary hypertension | Oct 1, 2025 | EXHIBIT | PATENT OWNER |
Petitioner's Updated Mandatory Notices | Oct 1, 2025 | PAPER | PETITIONER |
EX 1051 - Complaint 1:25-cv-15227-RMB-SAK | Oct 1, 2025 | EXHIBIT | PETITIONER |
EX 1052 - Ravi Declaration | Oct 1, 2025 | EXHIBIT | PETITIONER |
EX 1053 - Baylor Declaration | Oct 1, 2025 | EXHIBIT | PETITIONER |
EX 1050 - Actelion Pending Litigation | Oct 1, 2025 | EXHIBIT | PETITIONER |
Petitioner's Response to PO's Request for Discretionary Denial | Oct 1, 2025 | PAPER | PETITIONER |
Patent Owner's Request For Discretionary Denial Of Institution | Sep 2, 2025 | PAPER | PATENT OWNER |
United Therapeutics Form 10K Annual Report for 2013 | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
United Therapeutics, Our History Timeline | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH) (Mar. 22, 2024) | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
FDA approves Opsumit to treat pulmonary arterial hypertension (Oct. 18, 2013) | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
Orange Book Entry for OPSUMIT® | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
Orange Book Entry for OPSYNVI® | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
Clinicaltrials.gov entry for the SERAPHIN study re: OPSUMIT® (macitentan) | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
Clinicaltrials.gov entry to the A DUE study re: OPSYNVI® (macitentan/tadalafil in one dose) | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
Canadian Pat. No. 2,659,770 | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
Decision of Canadian Court in Janssen, Inc. et al. v. Sandoz Canada Inc. (Court File No. T-549-20), 2022 FC 715 (Fed. Ct. May 31, 2022), appeal dismissed, Sandoz Canada Inc. v. Janssen Inc. (No. A-128-22), 2023 FCA 221 (Fed. Ct. App. Nov. 9, 2023) | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
Claim 1 of the ’847 patent compared to CA ’770 patent | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
A. Sertkaya et al., Costs of Drug Development and Research and Development Intensity in the US, 2000-2018, JAMA Network Open. 2024;7(6):e2415445 (June 8, 2024) | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
Research and Development in the Pharmaceutical Industry, Congressional Budget Office (April 2021) | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
OPSYNVI® (macitentan and tadalafil) Becomes the First and Only Health Canada-Approved Once Daily Fixed Dose Combination Treatment for Patients with Pulmonary Arterial Hypertension (PAH) (Oct. 15, 2021) | Sep 2, 2025 | EXHIBIT | PATENT OWNER |
Notice: Notice filing date accorded | Jul 1, 2025 | PAPER | BOARD |
Patent Owner Actelion Pharmaceuticals Ltd.'s Power of Attorney | Jun 27, 2025 | PAPER | PATENT OWNER |
Patent Owner's Mandatory Notice | Jun 27, 2025 | PAPER | PATENT OWNER |
Petition: as filed | Jun 10, 2025 | PAPER | PETITIONER |
Notice: Power of Attorney | Jun 10, 2025 | PAPER | PETITIONER |
EX 1001 - U.S. Patent No. 8,268,847 | Jun 10, 2025 | EXHIBIT | PETITIONER |
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EX 1015 - EP1097711A2 | Jun 10, 2025 | EXHIBIT | PETITIONER |
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EX 1043 - US 5,250,534 | Jun 10, 2025 | EXHIBIT | PETITIONER |
EX 1044 - Galie 2004 | Jun 10, 2025 | EXHIBIT | PETITIONER |
EX 1045 - Approval Letter | Jun 10, 2025 | EXHIBIT | PETITIONER |
EX 1046 - Ringbom 1998 | Jun 10, 2025 | EXHIBIT | PETITIONER |
EX 1047 - Hoeper | Jun 10, 2025 | EXHIBIT | PETITIONER |
EX 1048 - Morice | Jun 10, 2025 | EXHIBIT | PETITIONER |
EX 1049 - Declaration of Brennen P. Baylor | Jun 10, 2025 | EXHIBIT | PETITIONER |