Manager - Intellectual Property

9 hours ago

Chandigarh, India TalentXplore Full time

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 support3. 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 interest4. 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 curation5. 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/ customers6: 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 (ref:iimjobs.com)

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