HATCH-WAXMAN ACT: OVERVIEW What You Really Need To Know and Then - - PowerPoint PPT Presentation

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HATCH-WAXMAN ACT: OVERVIEW What You Really Need To Know and Then Some Richard T. Ruzich

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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

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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

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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.

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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

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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.”

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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

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QUESTIONS