1.

Product

Selection and Portfolio management support

- Identification of potential products with early launch chance 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

📌 Intellectual Property Manager (Chandigarh)
🏢 TalentXplore
📍 Chandigarh