Intellectual Property Manager

• 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.

• 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

• 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

• 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

• 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

• 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