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