Sayali Kulkarni

Assistant Manager-IPR at Ami Lifesciences Pvt. Ltd.
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Contact Information
us****@****om
(386) 825-5501
Location
Vadodara, Gujarat, India, IN

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Credentials

  • Registered Patent Agent
    Government of India

Experience

    • India
    • Pharmaceutical Manufacturing
    • 200 - 300 Employee
    • Assistant Manager-IPR
      • Apr 2023 - Present

      Job Responsibilities  Preparing API Landscape Report and Freedom to Operate (FTO) Report for US, EP and ROW market  Preparing Patentability Report and Polymorph/ Salt Report for in-house PI.  Patent drafting and prosecution  Addressing and responding marketing queries from customers Job Responsibilities  Preparing API Landscape Report and Freedom to Operate (FTO) Report for US, EP and ROW market  Preparing Patentability Report and Polymorph/ Salt Report for in-house PI.  Patent drafting and prosecution  Addressing and responding marketing queries from customers

    • Assistant Manager-IPR
      • Feb 2021 - Apr 2023

      Job Responsibilities: Infringement analysis for US, EP and ROW market  Patent drafting and claim construction  Addressing and responding marketing queries from customers  Supporting business development for product selection  Patent office correspondence  Supporting prosecution and office action response  Identifying and monitoring competitors patent prosecution  Filing third party oppositions in EP and India  Identifying P-IV opportunity in US and early launch opportunity for EP and India  Polymorphism FTO analysis Show less

    • India
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Executive
      • Oct 2016 - Feb 2021

       Searching for Patent and Non-Patent Literature for different in-house projects Preparing IP Landscape Reports- Project Initiation Report and Polymorph Report Preparing Project Clearance Reports Patent drafting and prosecuting in India Monitoring Patent Portfolio Carrying out Infringement Analysis, Freedom to Operate search Respond to IP related query from Marketing, Regulatory and R&D teamPatiinformatics skill: Database:• Paid Patent Database: Proficient in using Orbit.com, Sci-Finder and knowledge of various databases such as Patseer and CAPLUS, MARPAT, CASREACT, REGISTRY etc. accessible through CAS products like Sci-Finder, Classic STN and New STN.• Free Patent Database: Espacenet, Google Patent, Patentscope, USPTO, PAIRS, IPAIRS (India), INPASS, KIPRIS, SIPO, PAJ and other country specific patent databases• Pharma/Drug Database: Drugs@FDA, Orange book, Pharmacodia, Pharmacompass, Molbase, DMF search, DrugBank, Pubchem etc. Patent Law: • Having knowledge of Indian Patent System: Indian Patent Act, Indian Patent Rules, Filling, Office Action, Prosecution etc. • Having Basic knowledge of US and Europe patent system • Having Basic Knowledge of Hatch-Waxman Act, AIA and related litigation process • Knowledge of various route of Patent Fillings – Domestic Filling, PCT Filling, Paris Convention etc. • Knowledge of Drug Approval process in US: IND, NDA (21 U.S.C. § 355(b)), ANDA (21 U.S.C. § 355(j) - Para I-IV, Sec viii), 505(b)(2) and BLA etc. Show less

    • Senior Executive
      • Oct 2016 - Feb 2021

      Job Responsibilities: Searching for Patent and Non-Patent Literature for different in-house projects Preparing IP Landscape Reports- Patent Evaluation Report and Polymorph Report Preparing Project Clearance Reports Patent drafting and prosecuting in India Monitoring Patent Portfolio Carrying out Infringement Analysis, Freedom to Operate search Respond to IP related query from Marketing, Regulatory and R&D team

    • Analyst-Chemistry Information
      • Dec 2011 - Oct 2016

      My work profile is to code Chemistry Information from patents. So, I have reviewed at least thousands of patents from Chemistry background ( API as well as formulation) which has boosted my knowledge about patents and Chemistry. My work profile is to code Chemistry Information from patents. So, I have reviewed at least thousands of patents from Chemistry background ( API as well as formulation) which has boosted my knowledge about patents and Chemistry.

Education

  • Nalsar University of Law
    P G Diploma in Patents Law, IPR
    2018 - 2019
  • MAEER'S Maharashtra Institute of Pharmacy, Pune
    M.Pharm, Pharmaceutical Chemistry
    2009 - 2011
  • Sinhgad Institute of Pharmacy, Pune
    B. Pharm, Pharmacy
    2005 - 2009
  • Sir Parshurambhau College
    Higher Secondary Education, First Class with Distinction
    2003 - 2005
  • Ahilyadevi High School for girls
    High School, First Class With Distinction
    1998 - 2003

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