1. Hatch-Waxman Overview

2. Innovator Company Identifies Patents to FDA
Orange Book Listing
Innovator Company Identifies Patents to FDA
Patents Generally Cover the Brand Product
Must be Listed within 60 days of FDA Approval or 30 Days From Issuance
Exclusivity Bearing vs. “Pop-Up”
Most Common Types of Patents Listed:
Compound
Formulation
Method of Use
Polymorph
Pharmacokinetic Profile
Process Patents Cannot be Listed
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3. ANDA Filer Certifies to FDA
Patent Certification
ANDA Filer Certifies to FDA
Four Types of Certification
Paragraph I – There is no patent information in the Orange Book
Paragraph II – The patent(s) have all expired
Paragraph III – The planned marketing will not occur until the expiry of the patent(s)
Paragraph IV – That listed patents are invalid, unenforceable or not infringed
21 U.S.C. § 355(j)(2)(A)(vii)
Can have “mixed” certifications if more than 1 patent in the Orange Book
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4. ANDA Filer Must Provide Notice to Innovator
Notice Letters
ANDA Filer Must Provide Notice to Innovator
Within 20 Days From FDA Acceptance of ANDA
Immediately for Patent Amendments on “Pop-Up” Patents
Notice Letters Contain:
Detailed Bases for Allegations of Invalidity, Unenforceability, and/or Non-Infringement
Need not be all bases that may later be alleged
Offer for Confidential Access
Sent to Patentee and NDA Holder
Patentee/NDA Holder Has 45 Days from Receipt to Sue
Can still sue after 45 Days, but no 30-month Stay
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5. Patentee/NDA Holder Can Sue
Lawsuit
Patentee/NDA Holder Can Sue
If filed within 45 Days of Receipt of Notice Letter – 30 Month Stay of FDA Approval
No 30-Month Stay for:
Suits filed after 45-Days
Later-Listed “Pop-Up” Patents
Additional 30-Month Stays For:
New Strengths
New Uses*
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6. Unique Provisions of Hatch-Waxman
Safe Harbor to File ANDA
Work Reasonable Related to FDA Submission Exempted. 35 U.S.C. §271(e)(1)
Artificial Act of Infringement
No Marketing of Accused Product Has Occurred 35 U.S.C. § 271(e)(2)
30-Month Stay of Approval
180-Day Exclusivity for First PIV ANDA Filer
Can be Forfeited in Certain Circumstances. 21 U.S.C. § 355(j)(5)(iv)(D)
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7. Unique Provisions of Hatch-Waxman
New Chemical Entities
5 Years of Regulatory/Data Exclusivity
No ANDAs filed until 4 Years after NDA Approval
Gets 7.5 Years from Approval Instead of 30-Month Stay
New Uses/Dosage Forms
Eligible for Other Regulatory Exclusivities
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8. Unique Provisions of Hatch-Waxman
Bench Trials
Usually No Damages
Unless ANDA Product is Launched
Often Many Defendants Joined
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9. Additional Considerations
IPR
In the Patent Office
More Limited Defenses
Shorter Timeline
Different Evidentiary Standards
Can Be Filed Any Time
Have Caused Stays
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