The posting
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



