Assistant Manager / Executive - Intellectual Property Management (API)

Job Title : Senior Officer / Executive - Intellectual Property Management (API) Location : Mahape, Navi Mumbai, Maharashtra

Experience Required : 5 - 10 Years

Position Summary :

We are seeking a proactive candidate with 5 to 10 years of experience in handling Active Pharmaceutical Ingredient (API) intellectual property activities. The primary focus is on ensuring IP clearance for APIs sourced from vendors for our in-house formulation products intended for regulated and non-regulated markets, specifically the US, Europe, India, and Emerging Markets (Brazil, Russia, Mexico).

Overall Job Responsibilities :

IP Search & Analysis : Conduct comprehensive literature searches (patent / non-patent) and prepare IP summary reports / landscapes for designated APIs for specified target markets, including analysis of patented polymorphs, salts, particle size distributions (PSDs), and impurities.

IP Evaluation & Clearance : Perform IP evaluation and clearance for APIs and Key Starting Materials (KSMs), analysing the associated route of synthesis (ROS), polymorphic status, salt forms, and required PSD ranges. Prepare risk assessments for review and action by the IP Manager.

Vendor Coordination & Approval : Coordinate with API Vendors to resolve IP-related queries and provide "go-ahead" recommendations to the Formulation R&D team for the use of specific vendors / sources.

Invalidation Strategies : Prepare invalidation / opposition strategies for Orange Book (OB) listed and other constraining patents related to APIs.

Opposition Filing Support : Prepare reports and documentation for filing Third-Party Observations (TPO), pre-grant, and post-grant oppositions as & when required.

Due Diligence : Conduct IP due diligence activity (landscape reports, dossier review, monitoring relevant patents / applications) for in-licensed selected products for specified markets.

Cross-Functional Liaison : Coordinate with Portfolio Management and Business Development (BD) teams to resolve API IP-related queries.

IP Monitoring : Periodically monitor new patent publications and changes in patent status within target markets, apprising the manager for required action.

Compliance & Legal Updates : Stay updated on industrial regulations and legal developments related to patents, including searching and reviewing relevant case laws and providing summaries to the team.

Preferred Qualification

Education : M.Sc. in Organic Chemistry OR M. Pharma in Pharmaceutical / Medicinal Chemistry.

Post Graduate Diploma in IPR, or registration as an Indian Patent Agent will be an added advantage.

Knowledge & Skills (Functional / Technical)

Database Proficiency : Well-trained in using IP databases (paid and free) such as SciFinder, Reaxys, Orbit, Espacenet, WIPO, EPO, USPTO, and various RoW national databases.

Solid State Chemistry Interpretation : Excellent understanding and experience with the interpretation of analytical data, specifically XRPD, DSC, and TGA, and their correlation to patent claims covering specific polymorphs and PSD.

Chemistry Fundamentals : Thorough understanding of organic reactions, spectroscopy, stereochemistry, impurity profiling, and applied polymorph evaluation based on patent scenarios.

Search Expertise : Excellent understanding and experience in conducting substance and reaction searches using Sci-Finder / Reaxys databases.

Formulation Awareness : Preliminary knowledge and understanding of various formulations (solid oral, oral liquid, injectable, inhalable products) which is essential in carrying out API IP assessment, including how PSD and salt forms impact drug delivery and IP status.

Legal Expertise : Thorough knowledge about Data Exclusivity Laws and regulations, and basic patent law for US, Europe, India, and Emerging Markets.