Nikhil Patil

WORK HISTORY

EDUCATION

ABOUT NIKHIL PATIL

I am having 12 years experience in Intellectual Property for pharmaceutical products. I am working for US ANDA products (Paragraph IV products- First to File, NCE-1 or subsequent to file products) as well as for other territory like Europe (Pipeline, In-licensing/Out-licensing), Australia, Canada and ROW.I am responsible for Managing Intellectual Property, Product Identification/ Portfolio Management/ Business Development Support, and Regulatory Support.Intellectual Property Management: Patent infringement analysis (US, Europe, Australia, Canada and ROW), Preparation of patent landscape and freedom to operate analysis, Co-ordinating with scientists to provide necessary inputs to design around patents, Prior art search, Preparation of invalidity and non-infringement note for attorney’s opinion, Review and analysis of attorney’s opinion and notice letter, Communication with Attorney from conflict check till dismissal of the case, US Litigation Support (Answers, Disclosures, Contentions, Protective Order, Interrogatory, RFP, Claim Construction, Document Production, Fact Depositions, Expert Discovery, Pre-Trial, Trial, Post-Trial, CAFC etc.), Review and analysis of settlement and licensing agreements, EU litigation support, filing of post grant oppositions and Third Party Observations at European Patent Office, Identifying opportunities like Inter Partes Review, SPC invalidation, Post grant oppositions, IP Due Diligence, Evaluation of in-licensed dossiers, Orange Book/ Drugs@FDA updates and Weekly updates for pipeline products, Patents drafting and prosecution, Patentability evaluation, Well acquainted with Patent Database like Scifinder, Thomson Innovation, IPD Analytics, USPTO, Espacenet, AUS-PAT, Canada patent database etc.Product Identification/ Portfolio Management/ Business Development Support: Product identification based on patents for US, Europe and Australia (Identification of products for US market as 505b2 strategy to design around patents, EU and AU market based on alternate salt strategy for early launch. Identifying potential SPC/ PTE invalidation strategy in EU and AU for early launch), Maintaining competitive intelligence for all pipeline products, Identifying new opportunities through clinical trials, providing potential entry dates, competitive intelligence updates, litigation updates, litigation budget, Communication with BD personnel of various territories for their requirements.Regulatory Support: Review of Paragraph (I, II, and IV) certifications, Patent Amendments, PIL review, Carve-outs, Exclusivity Statements.