The Associate General Counsel, Intellectual Property is responsible for the protection of and maximization of Daiichi Sankyo's US IP portfolio and foreign counterparts. This position will handle all aspects of U.S. patent litigation, U.S. Patent Office proceedings, IP counseling, manage prosecution of a portfolio of patents and patent applications in the U.S. and globally, and provide legal support for licensing, co-promotion, co-development, clinical trial collaboration, co-marketing and acquisition agreements (among other types of agreements) in the pharmaceutical and companion diagnostic fields, including drafting, negotiating and reviewing such agreements for U.S., global and ex-U.S. territories.
- Carries out pre-litigation investigations, assists in selection of outside litigation counsel, directs strategy for, and manages patent litigations and patent office proceedings (IPRs and PGRs) involving marketed and pipeline products; counsels senior management (U.S. and Tokyo) on settlement options, and negotiates directly with third parties for strategic settlements of such IP related matters.
- Manages prosecution of a portfolio of patents and patent applications in the U.S. and globally, including patent term extensions, and SPCs.
- Provides legal support, as needed in negotiating, drafting and reviewing licensing, co-promotion, co-development, co-marketing, clinical trial collaboration, companion diagnostic, and acquisition agreements.
- Works closely with development teams to monitor results, new uses, etc. arising during research and development of products and to manage disclosures and publications of such findings with Tokyo to ensure that all appropriate patentable matter is protected in a timely manner by the filing and prosecution of patent application(s) in the U.S. and worldwide (in coordination with Daiichi Sankyo Tokyo Intellectual Property Department). Collaborates with Daiichi Sankyo Tokyo Intellectual Property Department in obtaining and interpreting infringement/validity opinions authored by outside U.S. patent attorneys regarding early research and development compounds.
- Conducts patent due diligence for local licensing-in product candidates for Daiichi Sankyo Inc. (U.S.) and global licensing-in product candidates.
- Works closely with teams for pipeline and marketed products, in order to manage/process patent term extensions, Orange Book listings, claims for regulatory exclusivity, as well as ensure that any new patent protections available are obtained for new uses, different results, etc.; counsels development teams for pipeline products on IP, regulatory, and contractual issues arising during the course of product development.
- Monitors current developments in several key legal areas and provides the Tokyo Intellectual Property Department and DSI's V.P., IP Business Development with updates regarding same. Recommends strategic policies and procedures in the U.S. and in Japan to maximize IP protection in view of new legal and regulatory developments.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Bachelor's Degree Bachelor's degree in Chemistry or Biology sciences required
- JD from Law School of recognized standing, and Bar Admission in NJ (direct admission or eligible for limited in-house licensing in NJ.) required
- 10 or More Years post-law school experience in patent litigation and/or patent prosecution required
- 4 or More Years pharmaceutical industry experience preferred
Ability to travel up to 10% Travel includes approximately 2 week-long trips to Japan each year