Intellectual Property Rights Manager

Job Description

1. Product Selection and Portfolio management support

• Identification of potential products with early launch opportunity with Invalidation/NI strategy.
• Identification and evaluation of key patents of Innovator for compound of interest and their expiry with possible extensions in country of interest.
• Identification of data exclusivity/ market exclusivities of reference products.
• Determining possible generic entry in country of interest.
• Defining polymorph selection and NI formulation requirement for earliest entry.

2. Development support/ Freedom to operate opinion

• Literature search and patent search of selected molecule in various free or paid databases.
• Identification of relevant reference and landscaping.
• Patent report preparation with claimed subject matter of relevant references, family members in countries of interest, expiry and current legal status.
• Raising request for ADL/ F&D support for data generation to evaluate IP
• Non-infringement analysis of strategies/polymorphs- literally and under DoE for all identified patents/ applications
• Patentability analysis of pending applications of concern
• Preparation of basis of clearance for development strategies
• IP clearance/ Freedom to operate opinion for polymorph and formulation strategies.
• Regular monitoring of legal status critical patents/ application
• Reply to customer queries
• Patent challenge and litigation support

3. API due diligence

• Patent search for process of preparation of molecules of interest and intermediates used in RoS from scifinder/ orbit molecule search.
• Report preparation with patent family equivalents, expiry, claimed subject matter and current legal status.
• IP evaluation of RoS of Vendor in country of interest and country of manufacturing and IP evaluation of intermediates used in RoS in country of manufacturing
• Raising queries to vendors for specific patents of concern, requesting characterization data from vendor, and regular follow ups
• IP evaluation of response, requested data, and providing IP clearance to purchase team/ formulation team for API procurement for country of interest

4. Patent filing and Prosecution• Identifying inventions during development

• Patent drafting and filing support in various countries
• Timely preparation of response to examination report issued by patent offices
• Managing patent renewals/ Patent curation

5. Regulatory support

• Identifying and reporting patents relevant for Method of use, dosage form, drug interactions.
• Support in label/indication carve outs, if any relevant patent exists in country of interest
• Patent/ exclusivity certification
• Handling IP queries from Regulatory authorities/ customers

6: Miscellaneous

• IP trainings to cross functional team/ subordinate development
• Monitoring and reporting of Litigation update/ IP law changes in country of interest
• SoP preparation for IP functioning
• CDA/ Legal contracts review from IP perspective

Job Types: Full-time, Permanent

Pay: ₹900,000.00 - ₹1,500,000.00 per year

Work Location: In person