when do drug patents expire and when can generic drugs launch?
TRANSCRIPT
WHEN DO DRUG PATENTS EXPIRE?DrugPatentWatch.com
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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?
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Types of Patent ClaimsThe ‘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)
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Patent Claims and Generic EntryProduct 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
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DrugPatentWatch Shows Patent Claim Types
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DrugPatentWatch Also Shows Patent Claims
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When do Drug Patents Expire
Short Answer: 20 years from the date of filing
But it is much, much, more complicated…
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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.
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Non-Patent Regulatory ExclusivitiesNew 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
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DrugPatentWatch has US Regulatory Exclusivity and EU SPCs
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DrugPatentWatch Lists Exclusivity Expirations
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Drug Patents are Generally Filed Years Before Approval
Patent (20 years + extensions)
Drug
app
rove
d
Pate
nt fi
led
Pate
nt e
xpira
tion
←Clinical testing→
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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 ExclusivityDr
ug a
ppro
ved
Pate
nt fi
led
Pate
nt e
xpira
tion
←Clinical testing→
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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 ExclusivityDr
ug a
ppro
ved
Pate
nt fi
led
Pate
nt e
xpira
tion
Poss
ible
gen
eric
ent
ry
←Clinical testing→
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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.