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Intellectual Property Formulation Specialist Resume Example

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INTELLECTUAL PROPERTY FORMULATION SPECIALIST
Professional Summary

Intellectual Property Technical Specialist with over 7 years of successful experience in dealing with generic and innovator drug products in the United States market. Expert in analyzing patent and patent applications from diverse perspectives. Recognized consistently for performance excellence and contributions to success in the pharmaceutical industry.

Skills
  • Carried patent searches patentability, freedom to operate, validity, patent landscape, PCT examination
  • Predominantly performed invalidity, patent clearance, and patentability searches in chemical, pharmaceutical, medical, packaging, and devices
  • Effectively utilized a variety of patent and scientific databases and open sources
  • Communicated with company leadership, other departments, and outside patent counsel to optimized the efficiency of the legal team
  • Delivered final reports and summaries to the company head and outside counsel
  • Received specialized training in Questel Orbit, Thomson innovation, STN, and IPD analytics
  • Lectured on searching techniques and US patent laws
  • Awarded High praise for invalidity and landscape projects on chemical, pharmaceutical, and medical device patents
  • Worked independently under minimal supervision
  • Analyzed patents under a broad range of technologies such as Nano Technology, medical devices, drug delivery technology, polymer technology, and childproof packaging
  • Thoroughly searched prior art including non-patent literature using various patent searching tools and databases
  • Assisted in the prosecution of the patent application at USPTO in a wide range of areas
  • Analyzed the office actions received and drafted amendments, drafted provisional patent application, and response for office actions
  • Well versed with generic drugs, ANDA filing, competitive intelligence, and drugs @FDA website
Work History
Intellectual Property Formulation Specialist | TOLMAR Inc. - Fort Collins, CO11/2015 - 09/2018
  • Prior art searches
  • Patentability searches
  • Patent landscape preparation and patent monitoring of drug products
  • Freedom to operate (FTO) analysis – Drug product-based, Technology-based, API based or packaging based
  • ANDA filing strategies preparation- Para I/ Para II/ Para III/ Para IV filings
  • Working knowledge of FDA and ICH regulatory guidance and regulations
  • Orange Book Patent Analysis - Critical non-infringement strategy preparation and patent invalidation for para IV filings
  • Patent clearances – API, Formulation, Process of preparing formulation, API Synthesis pathway, Packaging/Device, etc
  • Collaboration with formulation scientists, Analysts, process, or packaging engineers regarding patent matters
  • Patent Application drafting and preparing response to office actions
  • Handling outside patent counsel landscape budget
  • Drafting work instruction email to outside patent counsel
  • Enter patent application data and docket patent deadlines
  • Patent litigation support and monitoring
  • Analytical project management
  • Business development project opportunities evaluation
  • Providing required support to Senior Director IP and Patent Agent
Officer IPR (Formulation) | Mylan Laboratories Ltd. - Hyderabad, Telangana03/2014 - 03/2015
  • Patent landscape preparation and clearance analysis of drug products for various markets – US, Europe, Japan, Canada, and other emerging markets
  • Study of Antiretroviral product launch in emerging markets
  • Patent prosecution – preparing response for office actions
  • IP filing strategies preparation
  • Indian patent opposition and revocation
  • Critical non-infringement strategy preparation and patent invalidation for para IV filings
  • Prior art search
Officer - IPR (Formulation) | Sun Pharmaceuticals Industries Ltd. - Mumbai, Maharashtra03/2011 - 01/2014
  • Freedom to operate (FTO) analysis – Patent Screening – US and EP
  • ANDA Filing strategies preparation– Para I/ Para II/ Para III/ Para IV filings
  • Para IV filings – Non-infringing and Patent invalidation approaches-specifically for US market
  • Prior art searches
  • Experienced in handling patent searches through various databases (WIPO, USPTO, EPO, MICROPAT, LEXIS-NEXIS TOTAL PATENTS, LEXIS-NEXIS-COURTLINK, THOMSON REUTERS, ORBIT SEARCH ENGINE, and PIPELINE, etc.)
  • IP portfolio validity studies
  • Preparation of certifications for ANDA Filing
  • Clearance of ANDA product labels
  • Litigation study
  • Technology specific searches and studies
Education
Uttar Pradesh Technical University - India12/2010Master of Pharmacy: Pharmaceutics
  • Thesis: Formulation and evaluation of self-micro emulsifying drug delivery system (SMEDDS) of Atorvastatin
Uttar Pradesh Technical University - India2008Bachelor of Pharmacy
Additional Information

CONFERENCES/SEMINARS/WORKSHOPS

  • Got membership of AIPLA in 2018
  • Attended Practicing Law Institute' Patent Agent' live course in Chicago.
  • In house seminar for IPR in the pharmaceutical industry
  • E-seminar on Scifinder web version
  • Establishing FTO and avoiding infringement in Europe
  • Regulatory and IP aspects of generic entry in Canada
  • European laws and SPC's
  • Seyfarth Shaw LLP Webinar: 2012 IP and FDA law in review – significant developments for the brand and generic pharma companies
  • Pharma IPR 2013 conference
  • E-seminar on use of web version of Scifinder
  • Customized Finance and Accounting for Manufacturing
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Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.

Resume Overview

Companies Worked For:

  • TOLMAR Inc.
  • Mylan Laboratories Ltd.
  • Sun Pharmaceuticals Industries Ltd.

School Attended

  • Uttar Pradesh Technical University

Job Titles Held:

  • Intellectual Property Formulation Specialist
  • Officer IPR (Formulation)
  • Officer - IPR (Formulation)

Degrees

  • Master of Pharmacy : Pharmaceutics
    Bachelor of Pharmacy

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