When do drug patents expire and when can generic drugs launch?

1. WHEN DO DRUG PATENTS EXPIRE? DrugPatentWatch.com info@DrugPatentWatch.com

2. DrugPatentWatch.comDrugPatentWatch.com Contents • Slide 3: Patents and Drug Development • Slide 4: Patent Claim Types • Slide 8: Patent Extension • Slide 9: Non-Patent Protection • Slide 12: Patent and Regulatory Exclusivity Timeline • Slide 15: Summary: When can Generics Launch?

3. DrugPatentWatch.comDrugPatentWatch.com Types of Patent Claims The ‘claims’ define what a patent protects Product patents • Cover the active ingredient or compound in a drug Process patents • Cover a process for manufacturing a drug Method-of-use patents • Protect a particular method of using a drug (e.g. specific diseases) Formulation patents • Cover active and inactive ingredients in a drug (e.g. final dosage form, tablet, or capsule)

4. DrugPatentWatch.comDrugPatentWatch.com Patent Claims and Generic Entry Product claims • Generally impossible to work around. Patents containing these claims must all expire or be invalidated Process claims • It may be possible to develop alternative production methods Method-of-use claims • A generic may gain approval for unpatented uses, and hope that physicians will prescribe the drug off-label for the patented uses Formulation claims • Generics may be able to work around some formulation patents

5. DrugPatentWatch.comDrugPatentWatch.com DrugPatentWatch Shows Patent Claim Types

6. DrugPatentWatch.comDrugPatentWatch.com DrugPatentWatch Also Shows Patent Claims

7. DrugPatentWatch.comDrugPatentWatch.com When do Drug Patents Expire Short Answer:20 years from the date of filing But it is much, much, more complicated…

8. DrugPatentWatch.comDrugPatentWatch.com Patent Extensions and Regulatory Exclusivities Enable recovery of time spent waiting for regulatory approval US: Hatch-Waxman Patent Extensions • Listed as patent expiration date by DrugPatentWatch EU: Supplementary Protection Certificates • Ex-US patent information shows estimated expiration date. SPC expiry listed separately.

9. DrugPatentWatch.comDrugPatentWatch.com Non-Patent Regulatory Exclusivities New Chemical Entity: 5 years • A compound never before approved for any indication New Clinical Investigation: 3 years • A new formulation, new patient population, new dosage regimen, etc. Orphan Drug: 7 years • Treatments for rare diseases Conduct Pediatric Clinical Trials Following FDA Request: 6 months First Successful Patent Challenge: 6 months generic exclusivity

10. DrugPatentWatch.comDrugPatentWatch.com DrugPatentWatch has US Regulatory Exclusivity and EU SPCs

11. DrugPatentWatch.comDrugPatentWatch.com DrugPatentWatch Lists Exclusivity Expirations

12. DrugPatentWatch.comDrugPatentWatch.com Drug Patents are Generally Filed Years Before Approval Patent (20 years + extensions) Drugapproved Patentfiled Patentexpiration ←Clinical testing→

13. DrugPatentWatch.comDrugPatentWatch.com Most Regulatory Exclusivities Start From Drug Approval 5 years Patent (20 years + extensions) 3 years New Clinical Investigation New Chemical Entity 7 years Orphan Drug Exclusivity Drugapproved Patentfiled Patentexpiration ←Clinical testing→

14. DrugPatentWatch.comDrugPatentWatch.com Pediatric Exclusivity and SPCs (EU) Start When Patents Expire 5 years Patent (20 years + extensions) 3 years New Clinical Investigation New Chemical Entity Pediatric Exclusivity / SPC 7 years Orphan Drug Exclusivity Drugapproved Patentfiled Patentexpiration Possiblegenericentry ←Clinical testing→

15. DrugPatentWatch.comDrugPatentWatch.com Summary: When Can Generics Launch? All ‘blocking’ patents must be expired (or invalidated) • Composition of matter, core formulation, etc. • Some method of use or enhanced formulation patents may not fully block generics. All regulatory exclusivities must be expired • NCE, pediatric exclusivity, etc.