Definition
Patent Term Extension (PTE) is a provision under the Hatch-Waxman Act that restores patent time lost during FDA’s regulatory review process. It compensates patent holders for delays inherent in drug development and approval.
How PTE Works
Sponsors apply for PTE within 60 days of approval. The extension is calculated based on time spent in IND clinical testing and NDA review, minus any applicant delays.
PTE Calculation
PTE = (1/2 × IND Phase) + (NDA Review Phase) - (Applicant Delays)
Maximum: 5 years
Total post-approval patent life: ≤14 yearsPTE Eligibility Requirements
| Requirement | Description |
|---|---|
| Patented Product | Active ingredient, method of use, or formulation |
| First Approval | Never previously approved by FDA |
| Timely Application | Within 60 days of approval |
| Due Diligence | No unreasonable delays by applicant |
| Single Patent | One patent per product only |
Why BD Teams Track PTE
For business development professionals, PTE affects competitive timeline:
- Deal Implication: PTE can add significant value by extending protected market period
- Due Diligence Focus: Calculate potential or actual PTE and verify application status
- Opportunity Signal: Products with expiring patents may have PTE runway remaining