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WHEN DO DRUG
PATENTS EXPIRE?
DrugPatentWatch.com
info@DrugPatentWatch.com
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?
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)
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
DrugPatentWatch.comDrugPatentWatch.com
DrugPatentWatch Shows Patent Claim Types
DrugPatentWatch.comDrugPatentWatch.com
DrugPatentWatch Also Shows Patent Claims
DrugPatentWatch.comDrugPatentWatch.com
When do Drug Patents Expire
Short Answer:20 years from the date of filing
But it is much, much, more complicated…
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.
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
DrugPatentWatch.comDrugPatentWatch.com
DrugPatentWatch has US Regulatory Exclusivity
and EU SPCs
DrugPatentWatch.comDrugPatentWatch.com
DrugPatentWatch Lists Exclusivity Expirations
DrugPatentWatch.comDrugPatentWatch.com
Drug Patents are Generally Filed Years Before Approval
Patent (20 years + extensions)
Drugapproved
Patentfiled
Patentexpiration
←Clinical testing→
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→
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→
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.

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