💊 PHARMA & BIOTECH
Japan IP for Pharma & Biotech
Specialized Japan patent & trademark service for pharmaceutical and biotech innovators
EVORIX serves pharmaceutical and biotech IP firms worldwide as their Japan correspondent. We coordinate with PMDA regulatory timelines, manage Patent Term Extension (PTE) strategy (Japan equivalent to SPC), defend against generic challengers, and handle complex compound, formulation, and method-of-use claims. 80+ pharma/biotech firms trust us.
Why Pharma IP Counsel Choose EVORIX
Pharma/biotech-specific advantages:
💊 PMDA Coordination
Patent strategy aligned with PMDA regulatory approval timelines. Critical for product launch timing.
📈 PTE Specialty
Patent Term Extension expertise — up to 5 years extension for pharmaceuticals subject to regulatory delays.
🧬 Specialty Translators
Pharma-trained benrishi for accurate chemical structure, dosage form, and method translation.
⚔️ Generic Defense
Defense against ANDA/generic challenges. Invalidation litigation and post-grant opposition.
Pharma-Specific Service Specialties
PATENT
Compound & Formulation Patents
- Compound and stereochemistry claims
- Crystalline form/polymorph protection
- Pharma formulation translation
- Markush group claim strategy
PTE / SPC
Patent Term Extension
- PTE strategy aligned with PMDA
- 5-year max extension at JPO
- Coordinated SPC-PTE filing
- Post-launch maintenance
METHOD
Method & Use Patents
- Secondary indication patents
- Dosage regimen patents
- Medical use claim drafting
- Restriction on therapy methods
LITIGATION
Generic Defense
- Invalidation litigation
- Post-grant opposition
- Settlement negotiation
- Customs enforcement coordination
Industry Insights
📊 Japan Pharma IP Landscape
- PMDA-JPO coordination: Critical timing of clinical trials, regulatory approval, and patent prosecution
- Patent Term Extension: Up to 5 years extension to compensate regulatory review delays
- Secondary indication patents: JPO accepts second-use claims with careful drafting
- Crystalline forms: Polymorphs strategy especially critical for evergreening
- Patent linkage with PMDA: No formal linkage like FDA, but coordinated strategy benefits
Representative Cases
CASE EXAMPLE
Generic Defense for European Pharma
Major European pharma company facing Japan generic challenger. We coordinated invalidation defense at IP High Court, secured PTE extension for 4.5 years, and obtained settlement on favorable terms. Client retained for entire Japan portfolio (45+ patents).
Related Resources
Engage EVORIX for Your Pharma Portfolio
Pharma/biotech IP firms — send your case. PMDA-aware strategy and PTE expertise within 24 hours.