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Attorney Intellectual Property The candidate will manage ANDA, 505(b)(2) and biosimilar patent litigations, including post-grant patent office proceedings by developing and implementing claims and defenses. Secure freedom to operate for 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 patients, file histories, prior art, ongoing litigations, and citizen's petitions for possible Paragraph IV and related strategies for ANDA,505(b)(2), and BPCIA products. Conduct IP due diligence and provide IP support for business development activities. Draft and prosecute patent applications and secure patent rights. Advise internal stakeholders on all aspects of pharmaceutical patent and regulatory law, including exclusivity issues and launch scenarios. 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 a limited New Jersey in-house counsel legal license. Registered to practice before the U.S. Patent and Trademark Office preferred. A Bachelors Degree in Chemistry, Biochemistry, or similar discipline. Advanced degree preferred. Should have 8 years of pharmaceutical patent litigation experience, preferably a combination of private and corporate practices, and including significant experience in Hatch-Waxman matters. Exhibit leadership by example, effort and attitude, including the ability to work independently. Ability to travel internationally, occasionally once or twice a year.
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