Our PatientsOur PeopleOur BusinessOur Community © 2008 Endo Pharmaceuticals. All Rights Reserved. Strategies to Maximize Patent Term Balancing Scope and Term Pam Politis AIPLA Spring Meeting 2009 May 14, 2009

2 Pharmaceutical Patent Protection Timeline New Drug Approved First ANDA Filers NCE Expires “ API” Patent Expires w/out PTR “API” Patent Expires W/ 2 years PTR Secondary Patent s Expire Methods of Use Primary Polymorph Formulations Label Information Other Patents Expire Additional Polymorphs Process of Making “API” Patent may include more than one patent, with claims of varying scope

3 Pharmaceutical Protection Priorities PROTECT AGAINST GENERIC COMPETITION! BRANDED COMPETITON (505 (a) or 505 (b)(2)) does not eliminate market for product. – Branded NCE’s in same class or therapeutic area can serve to grow overall market –Prescriber’s gain familiarity and comfort with class and mechanism of action –DTC and disease state advertising develop market GENERALLY, patent portfolio development should focus on protecting against generic competition.

4 New Molecule Patents-Claim scope Molecular Scaffold Patent Claim Scope Patent Term Start Date (Priority Date) Functional Group Patent Molecule Patent

5 Less May Mean More Limit First in Class Patent Application Disclosure –Avoid Unnecessary Disclosure Application publication may be prior art to eventual drug candidate compound Limit prophetic examples: functional groups, salt, excipient, solvents, and formulation.| –Reduce Number of Claims Less claims=less time in prosecution –Streamline Prosecution Narrower claims that issue without appeal, RCE, or continuations may provide greater PTR/PTA

6 Less May Mean More Lead Compound Patent Application Disclosure –Disclose and claim known compounds KSR standard information –Specific Compound Patents narrow claims directed to specific molecule Avoid filing CIP applications –Streamline Prosecution Narrow claims that cover molecule/product are most valuable