Director, Intellectual Property
Position Duties:
Manage patent and other company litigations, including management of outside counsel litigation budgets. Perform patent clearance evaluations relating to the company’s products, with primary emphasis on the company’s generic products, but may include work on the company’s branded products. Responsible for patent clearance evaluations of active pharmaceutical ingredients used in the company’s products. Perform infringement and validity analyses of third party patents. Manage outside counsel with respect to patent clearance opinions and non-infringement advice. Analyze the patent landscape relating to new product proposals for generic products and, potentially, for some proposed new branded products. Manage P-IV litigations and other litigations as required. Work with in-house personnel and outside counsel in the discovery process and developing litigation strategies. Manage litigation budgets. Work closely with the drug formulation chemists in the company at an early stage to advise on patent avoidance strategies. Conduct prior art searches and evaluate patent validity issues. Review patent file histories to determine design-around strategies. Monitor ongoing third party litigations as they relate to patents of interest to the company. Advise the company regarding numerous patent validity and infringement issues. Monitor pending applications relating to company products. Update management and formulation chemists of changes as necessary. Manage outside patent counsel with regard to patent review and opinion work. Manage preparation of Paragraph IV certifications and detailed statements.
Degree Requirements:
J.D. degree from Top 20 U.S. law school. Master’s degree in Chemistry or related field.
Expierience Required:
5 years of progressively responsible post-baccalaureate work experience in the job offered or related field.
Other Special Requirements:
Experience must include ANDA litigation, opinion drafting including freedom to operate, non-infringement, and invalidity opinions, the Hatch-Waxman Act, ensuring regulatory compliance with FDA regulations, ITC experience, preparing patent applications for medical devices or the pharmaceutical field, and experience with trademarks. Must be admitted to the California Bar.