Role Summary
The API IP Evaluation & Patent Strategy Specialist will be responsible for comprehensive patent evaluation, freedomtooperate (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.
- 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.
- 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, pregrant/postgrant opposition strategies.
- Conduct priorart 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.
- Conduct competitor tracking: filings, litigations, DMF/CEP updates.
- Identify whitespace opportunities for R&D and business teams.
- 5. CrossFunctional Collaboration
- Work with chemistry, process R&D, regulatory, and legal teams.
- Advise teams during route scouting and scale-up to ensure IPsafe processes.
- Support global regulatory submissions (DMF, ANDA, CEP, NDS, etc.).
Technical Skills
Required Skills & Competencies
Expertise In
- FTO & patentability analysis
- Patent drafting
- Pregrant & postgrant oppositions
- Patent litigation support
- Sound understanding of organic chemistry and API process development.
Soft Skills
- Good analytical and problemsolving 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.
