Intellectual Property Rights Manager

2 days ago

Chandigarh, Chandigarh, India Talentxplore Full time

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
• 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, ₹1,500,000.00 per year

Work Location: In person

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