Role Summary
The API IP Evaluation & Patent Strategy Specialist will be responsible for comprehensive patent evaluation, freedom-to-operate (FTO) analysis, patent drafting, oppositions, and litigation support for global markets. The role requires deep expertise in patent law, synthetic chemistry, and API development across key jurisdictions including US, EU, Canada, India, Australia, Latam, Asia and other Emerging Markets.
Key Responsibilities
- 1. Patent Evaluation & FTO for Global Markets
- Conduct FTO assessments for APIs, intermediates, and processes for US, EU, CA, India, AU, and Asia EM markets.
- Conduct FTO assessments for APIs, intermediates, and processes for US, EU, CA, India, AU, and Asia EM markets.
- Interpret and analyze global patents, SPCs, and regulatory exclusivities.
- Identify infringement risks and recommend non-infringing synthetic routes.
- Review competitor DMFs, ANDAs, CEPs for IP implications.
- 2. Patent Drafting & Prosecution
- Draft process patents, intermediate patents, and chemistry-related applications.
- Draft process patents, intermediate patents, and chemistry-related applications.
- Coordinate with external counsel for patent filings across jurisdictions.
- Prepare responses for office actions, FERs, and examination reports.
- Ensure alignment of drafting strategy with commercial and R&D goals.
- 3. Patent Litigation & Oppositions
- Support patent invalidation, pre-grant/post-grant opposition strategies.
- Support patent invalidation, pre-grant/post-grant opposition strategies.
- Conduct prior-art searches and prepare invalidity contentions.
- Collaborate with legal teams on:
- Paragraph IV / Hatch-Waxman cases (US)
- EPO opposition
- India IPO opposition hearings
- Patent revocation petitions in AU, CA, and Asia EM
- Monitor litigation outcomes and assess implications for product pipeline.
- 4. Patent Landscaping & Competitive Intelligence
- Develop detailed patent landscapes for current and future API targets.
- Develop detailed patent landscapes for current and future API targets.
- Conduct competitor tracking: filings, litigations, DMF/CEP updates.
- Identify white-space opportunities for R&D and business teams.
- 5. Cross-Functional Collaboration
- Work with chemistry, process R&D, regulatory, and legal teams.
- Work with chemistry, process R&D, regulatory, and legal teams.
- Advise teams during route scouting and scale-up to ensure IP-safe processes.
- Support global regulatory submissions (DMF, ANDA, CEP, NDS, etc.).
Required Skills & Competencies
Technical Skills
Expertise In
- FTO & patentability analysis
- Patent drafting
- Pre-grant & post-grant oppositions
- Patent litigation support
- Sound understanding of organic chemistry and API process development.
Soft Skills
- Good analytical and problem-solving capability.
- Strong communication, reporting, and presentation skills.
- Stakeholder collaboration with R&D, legal, regulatory, and business leaders.
Qualifications
- Master's or PhD in Chemistry/Organic Chemistry/Pharmaceutical Sciences.
- Certification in Intellectual Property / Patent Law preferred.
- Minimum 7 years relevant experience in API IP evaluation, drafting, opposition, and litigation support.
Preferred Experience In Pharma Industry
- Working knowledge of global IP systems: USPTO, EPO, CIPO (Canada), IP Australia, India IPO, ASEAN jurisdictions.
- Experience in Hatch-Waxman/Paragraph IV litigation support.
- Exposure to process-chemistry-driven patent drafting.
- Experience in managing external IP counsel and global filings.
