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

o 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