HATCH-WAXMAN ACT: OVERVIEW What You Really Need To Know and Then Some Richard T. Ruzich 1
Background of Hatch-Waxman “ Where Are The Cheap Drugs?” • Roche Products Inc. v. Bolar Pharmaceutical – 733 F.2d 858 (Fed. Cir. 1984) – Testing in connection with FDA approval is patent infringement – Massive delays in generic drugs into market • Hatch-Waxman Enacted (1984) – Provides for a safe harbor for FDA related submissions, 35 U.S.C. 271(e)(2) – Incentive to challenge patents with 180-day exclusivity period – Protects Brand Patents with automatic 30 month stay 2
The Notice Letter Dance • Paragraph IV certification — patents listed in Orange Book are invalid, unenforceable, and/or not infringed • Orange Book Listings — NDA holder required to list patents that cover its drug • Only compositions and MOT patents listable • Notice of Acceptance for Filing — must send NL within 20 days (355(j)(2)(B)(ii)); suit must be filed within 45 days of receipt by NDA holder • NL must contain detailed statement of facts/law 3
Exclusivity Forfeiture – “Little aa, Little bb” Dates & 75 days after: (aa) Final FDA approval of the ANDA or 30 months after the ANDA filing, whichever is earlier; AND (bb) (i) Final decision of patent invalidity or non-inf; (ii) court executed settlement or consent decree that enters final judgment of patent invalidity or non-inf; or (iii) FTF withdraws PIV certification or the NDA holder withdraws the patent information. 4
Reality Hits & Forfeiture Looms Apotex v. Daiichi (olmesartan) • Two patents listed – ‘599 & ‘703 patents • Mylan PIV’ed certified against both patents • After receiving NL, Daiichi disclaimed ‘703 patent • Mylan found to infringe ‘599 patent • Earliest entry date for Mylan is Oct. 25, 2016 • Enter Apotex two years later 5
The Olmesartan Conundrum & Apotex Gets Trigger Happy • Apotex PIII’ed the ‘703 patent (now disclaimed) and PIV’ed the ‘599 patent • Daiichi doesn’t sue Apotex, so Apotex files DJ • Initially dismissed by ND Illinois for lack of SMJ • Reversed on April 7, 2015 by Fed. Cir. holding “The stakes over which the parties are vigorously fighting are concrete and substantial.” 6
What Is Apotex’s Objective? Get To the Market On Time! • Mylan is FTF, but is now blocked by ‘599 patent, with entry date of Oct. 25, 2016 • If Apotex gets TA and is successful against the ‘703 patent, then Mylan will forfeit • Little (aa) & (bb) dates generated • Apotex can possibly capture entire market or at a minimum, enter the same time as Mylan 7
QUESTIONS 8
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