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Patent Challenges Post-MMA
Third Annual FDA Regulatory and
Compliance Symposium
Presented by
Richard J. Berman,
Partner
Arent Fox LLP
Washington, DC
August 23, 2007
Topics To Be Discussed
• Hatch-Waxman Summary
• Pre-MMA Law On Generic Exclusivity
• MMA Changes to Exclusivity
• Hypotheticals & Conclusions
Patent Challenges Post-MMA
Hatch-Waxman Summary
• Pioneer drug manufacturer seeking to market new drug files
New Drug Application (NDA) with FDA.
• NDA must include data on safety and efficacy of drug.
• If NDA is approved and pioneer holds patents in approved drug,
pioneer must also disclose those patents to FDA.
• FDA lists patents of approved drugs in the Approved Drug
Products With Therapeutic Equivalence Evaluations, a.k.a. the
“Orange Book.”
Patent Challenges Post-MMA
Hatch-Waxman Summary (cont’d)
• When filing ANDA, generic required to make one of
four certifications as to status of any patents.
(I) no such patent information has been submitted to FDA (no patents
in Orange Book).
(II) patents in Orange Book have expired.
(III) patent(s) in Orange Book set to expire on a certain date, and
generic will not market until patent expiration.
(IV) patent(s) in Orange Book is/are invalid or will not be infringed by
manufacture, use, or sale of generic drug.
Patent Challenges Post-MMA
Hatch-Waxman Summary (cont’d)
• If Paragraph I or II certification is made, ANDA may
be approved immediately by FDA, assuming
product is “approvable.”
• If Paragraph III certification is made, approvable
ANDA may be approved as of expiration date of the
patent(s).
• If Paragraph IV certification is made, such
certification is deemed act of patent infringement.
Patent Challenges Post-MMA
Hatch-Waxman Summary (cont’d)
• Pioneer given right to notice of ANDA filing if P.IV
certification made: generic must send notice
within 20 days after FDA accepts ANDA for filing.
• Pioneer given 45 days after notice was received to
sue generic.
• If suit is not filed within 45 days of notification,
approvable ANDA will be approved.
• If suit is filed within 45 days, automatic 30 month
stay of approval for ANDA, unless resolution of
litigation occurs before that time.
Patent Challenges Post-MMA
Hatch-Waxman Summary (cont’d)
Why go “Paragraph IV”?
• First ANDA applicant with a P. IV Certification
granted 180 days of marketing exclusivity.
• Generic can charge approximately 2/3 price of
pioneer if first on market.
• Large incentive to be first applicant.
Patent Challenges Post-MMA
Pre-MMA Law On Generic Exclusivity
(at least the gist of it)
• First generic applicant to file an ANDA containing a P. IV
certification is awarded 180 days of marketing exclusivity.
• During exclusivity period, FDA cannot approve a
subsequent ANDA with a P. IV certification for the same
drug product.
• Exclusivity period calculated from either the date of the first
commercial marketing of the generic drug product or the
date of a court decision declaring the patent invalid or not
infringed, whichever is sooner.
• Shared Exclusivity (Agency interpretation) – patent-bypatent approach.
Patent Challenges Post-MMA
MMA – Forfeiture Concept Introduced
•
Shared exclusivity – product-by-product approach
•
Exclusivity begins only upon commercial marketing (no
court decision trigger).
•
Exclusivity forfeited if the “first applicant” generic fails to
market drug within 75 days after certain events, including:
appellate court’s decision in the generic’s favor;
settlement finding the patent invalid or not infringed; or
patent withdrawal.
Patent Challenges Post-MMA
Which patents to challenge?
• Typical case: compound patent, method of
treatment patent, formulation patent
• compound patent: most difficult to challenge (validity only)
• method of treatment patent: next most difficult to challenge
(typically validity)
• formulation patent: easiest to challenge (non-infringement or
validity)
• Challenges to newer “blockbuster” drugs
frequently occur on “NCE minus 1” date (4th year
of FDA-granted New Chemical Entity exclusivity)
Patent Challenges Post-MMA
Which patents to challenge (cont’d)
• Hypo #1:
• one compound patent (May 2009)
• two formulation patents (Jun. 2016 and Jan. 2018)
• “NCE minus 1” date May 2007
• “7 ½ year” rule – stay until ~ Jan. 2010
• easy call – likely P.III the compound patent, P.IV formulation
patents
Patent Challenges Post-MMA
Which patents to challenge (cont’d)
• Hypo #2:
• one compound patent (May 2011)
• two formulation patents (Jun. 2016 and Jan. 2018)
• “NCE minus 1” date May 2007
• “7 ½ year” rule – stay until ~ Jan. 2010
• tougher call – P.III or P.IV compound patent?
Patent Challenges Post-MMA
Which patents to challenge (cont’d)
• Hypo #3:
• one compound patent (May 2014)
• two formulation patents (Jun. 2016 and Jan. 2018)
• “NCE minus 1” date May 2007
• “7 ½ year” rule – stay until ~ Jan. 2010
• toughest call – “forced” to challenge compound patent due to
almost certain forfeiture of exclusivity
Patent Challenges Post-MMA
Real-World Implications
• Pioglitazone (ACTOS®) litigation
• One compound patent (Jan. 2011)
• Several composition patents (2016)
• “NCE minus 1” date Jul. 2003 – four generics file P.IV on
composition patents and win
• Two generics (Alphapharm and Mylan) P.IV compound
patent and lose in district court and on appeal
• No generic exclusivity if forfeiture provision was in force
• “Win” on composition patents is really a “loss”
Patent Challenges Post-MMA
Problems To Confront
• At least one generic will file on “NCE minus 1”
date.
• Cannot be “in the game” with a P. III certification
on late-expiring compound patent.
• Because no “passed” exclusivity, one generic can
ruin exclusivity for all others.
Patent Challenges Post-MMA
Thank you!
Any questions, please contact:
Richard J. Berman
Arent Fox LLP
direct dial: 202.857.6232
e-mail: [email protected]
Patent Challenges Post-MMA