Hatch-Waxman Overview

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 | CONFIDENTIAL

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 | CONFIDENTIAL

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 | CONFIDENTIAL

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* | CONFIDENTIAL

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) | CONFIDENTIAL

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 | CONFIDENTIAL

Unique Provisions of Hatch-Waxman Bench Trials Usually No Damages Unless ANDA Product is Launched Often Many Defendants Joined | CONFIDENTIAL

Additional Considerations IPR In the Patent Office More Limited Defenses Shorter Timeline Different Evidentiary Standards Can Be Filed Any Time Have Caused Stays | CONFIDENTIAL