With over 25 years in patent law, including 5 years in private practice at IP-focused boutique firms, and more than 20 years as in-house patent and transactional counsel at Rigel Pharmaceuticals, a publicly-traded biopharma company in South San Francisco, Jim brings to clients a pragmatic business development perspective that comes with his “seen it all” experience. Jim has handled everything from patent prosecution to complex license transactions—all with a focus of tying intellectual property needs to the advancement of a company’s business goals.

While at Rigel, Jim managed all aspects of the company’s IP procurement and monetization. Jim managed the development of an impressive and complex patent portfolio, guided the successful defense of the company’s patent rights in European oppositions, and set the stage for the company’s defense of a paragraph IV ANDA filing.

Jim also led Rigel’s IP licensing strategy—including out-licensing of major research and development programs to large pharmaceutical companies, including Lilly, AstraZeneca, and BMS; licenses for Rigel’s first commercial product to Grifols, Kissei, Medison and Knight Therapeutics; and in-licensing of Rigel’s second commercial product from Forma Therapeutics.

“I’ve seen the drug discovery, development, approval, and commercialization process unfold multiple times, and I had primary responsibility within the company for building a robust IP strategy—a strategy that takes into account offense and defense, third party risks, licensing opportunities, and the impact on the business and its investors—at every step along the way. I understand that at the outset, it is unclear which program will yield a promising candidate, and even after that which drug candidate will be a winner in the clinic. As the program progresses toward a potentially successful outcome, the costs and the risks increase in parallel. On the other hand, providing the best protection for the company’s IP assets requires capturing inventions as they arise and locking in rights, while maintaining as much flexibility as possible without breaking the bank. Communication with the client’s development team and timing are everything.“

Jim brings this experience to bear when counseling clients on all aspects of patent portfolio development and risk management—including patent drafting and prosecution (US and foreign), post-grant challenges (ex parte reexamination, inter partes reexamination, oppositions, ANDA litigation), freedom to operate analyses, patentability and validity opinions, and product life cycle management. Jim also has experience in due diligence relating to intellectual property rights in licensing transactions.

“In addition to building a patent portfolio for a client’s inventions, it is also critical to identify third party IP that may pose risks or provide added value to a program – and when that IP is available for license, give its tires a hard kick in due diligence and, if it passes muster, get an option or license in place with reasonable terms. Again, the goal is to maintain flexibility, as well as mitigate risks, so that a program is both attractive to investors and is poised for commercial success should the clinical trials deliver the hoped-for results.”

Prior to law school, Jim gained extensive, hands-on research experience which has proven invaluable both in having excellent communication skills with scientists, as well as an understanding of the challenges in drug development in life sciences.