Download hatch-waxman act: overview

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