Counsel and advise Sandoz in designing, developing and launching generic drugs under the Hatch-Waxman amendments to the Food & Drug Cosmetic Act. Attorney will be responsible for the entire life-cycle of the project from target to launch, requiring extensive interaction with Portfolio, Research & Development, Regulatory Affairs, and Sales & Marketing. Primary job duties include:

 Counseling Sandoz on Hatch-Waxman and related regulatory, exclusivity and forfeiture issues;

 Defining and reviewing patent landscapes for targeted products;

 Examining patents, file histories and relevant litigations for possible Paragraph IV strategies;

 Actively manage opinion and litigation counsel, including controlling budgets and explicitly directing litigation activities;

 Designing and supervising prior art searches for targeted products;

 Assisting in formulation development in view of patents and regulations;

 Securing freedom to operate for products, including clearance of Orange Book and unlisted patents for the raw API, route of synthesis, finished dosage form, and polymorphs;

 Drafting and prosecuting patent applications and securing patent rights;

 Preparing ANDA patent certifications and the corresponding notice letter;

 Tracking pending applications that may issue and become Orange-Book listed;

 Designing, arguing and defending Paragraph IV proposals to Executive Management;

 Evaluating competitors' litigations and advising accordingly;

 Mentoring junior attorneys, paralegals and support staff, including developing and delegating assignments to same;

 Sharing knowledge through presentations to the IP group and others;

 Synergizing overall company operations, including improving efficiency, productivity and profitability; and

 Exhibiting leadership by example, effort and attitude.EDUCATION/EXPERIENCE:

Requires significant Hatch-Waxman experience, J.D./L.L.M., B.S. or M.S., preferably Ph.D. and 8+ years related work experience.