Saritha Bommakanti

WORK HISTORY

EDUCATION

SKILLS

ABOUT SARITHA BOMMAKANTI

Handling end-to-end IP strategies of Generics & Proprietary/505(b)(2)/Differentiated products in US, EP, IN, & other Regulated/Emerging markets of interest.Key Profile:Identifying IP-based new product opportunities; Product selection with possible launch dates in various territories; Patent landscaping & assisting R&D with IP clearance/ freedom-to-operate with robust IP risk-free development strategies; Invalidation of bottle-neck patents & pending applications; Timely coordination with various cross-functional teams for IP & product-related findings including F&D, Strategy, Analytical, Clinical, Regulatory, and Business Development teams; Supporting Regulatory team for timely product filings by certifications & label carve outs; Supporting litigation team by working closely with in-house counsel and external attorneys worldwide on ongoing and foreseen litigation challenges with possible remedial measures, drafting notice letters & providing solutions to critical IP queries; Tracking Litigation updates and critical info; Monitoring Innovator Life-cycle management for potential new & early development First-to-file opportuntities; Patent Drafting, Filing & Prosecution; Analyzing Patentability and IP strength against close prior arts; Advising R&D on additional experiments & data requisition for strengthening IP; Prosecuting patent applications targeting to achieve Grants with minimum Office Actions.Peforming IP-Due Diligence for In-Licensing opportunities and collaborations with universities w.r.t their products & IP.Regularly monitoring new FDA approvals, OB listings, exclusivities, patent extensions, new FDA Para IV filings, citizen petitions, 180 day exclusivities updates, and FDA reviews.Competitive Intelligence analysis to identify competitors, product pipelines, technology platforms, development status, deals, licensing and aquisitions.Understanding and maintaining compliance with global statutory policies.Monitoring IP blogs and case laws to seek new learnings. Knowledge sharing within the team.Taking necessary initiatives for preventing high costs of external services of law firms.Ability to identify opportunities for 505(b)(2) and differentiated products.Mentoring and providing guidance to the team/independently working w.r.t all the above activities. Achievements: All India 183 GATE rank- 99.5%ile;Certification on successful completion of US Patent Law & Practice Online Course from George Washington University.Talent-based On-site Project Opportunity to UK. Multiple star performance awards for consistent quality and efficiency.