Lead Intellectual Property Counsel

Role Summary

Lead Intellectual Property Counsel responsible for designing and implementing IP strategies, managing patent litigations in North America, and guiding life-cycle development from selection to launch. Collaborates with Portfolio, R&D, Business Development, and Regulatory Affairs to advance affordable health care solutions.

Responsibilities

• Manage patent litigations in North America, including ANDA/ANDS, 505(b)(2) and biosimilar litigations, including post-grant patent office proceedings by developing and implementing claims and defenses
• Secure freedom-to-operate for Dr Reddy’s products, including clearance of Orange Book and unlisted patents for the bulk API, route of synthesis, finished dosage form and polymorphs
• Prepare ANDA patent certifications and the corresponding notice letters and detailed statements
• Examine patents, file histories, prior art, ongoing litigations, and citizen’s petitions for possible Paragraph IV and related strategies for ANDA/ANDS, 505(b)(2), and BPCIA products
• Conduct IP due diligence and provide IP support towards business development activities
• Manage drafting and prosecution of patent applications
• Advise internal stakeholders on all aspects of pharmaceutical patent and regulatory law, including exclusivity issues and launch scenarios

Qualifications

• Educational qualification: A Juris Doctor from a recognized, accredited law school and licensed to practice in New Jersey or in at least one other state with eligibility to apply for limited New Jersey in-house counsel legal license. Registered to practice before the U.S. Patent and Trademark Office preferred
• Minimum: Bachelor’s Degree in Science or Engineering; degree in Chemistry, Biochemistry, or similar preferred; advanced degree highly preferred
• Minimum work experience: 8+ years of patent litigation experience, including significant experience in Hatch-Waxman matters

Skills

• Patent litigation experience
• Significant experience in Hatch-Waxman matters
• Exhibit leadership by example, effort and attitude
• Ability to work independently

Education

• Juris Doctor and science/engineering background as above

Additional Requirements

• Must be a U.S. citizen or lawful permanent resident of the U.S. or otherwise authorized to work in the U.S. without visa transfer or sponsorship