When do drug patents expire and when can generic drugs launch?
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From DrugPatentWatch.com - When do drug patents expire, and when can generic drugs launch? An overview of patents, non-patent regulatory exclusivities, and specific US and EU factors influencing generic drug launch.
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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
- 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
- 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.