For clients in the biopharma industry, Li-Hsien (Lily) Rin-Laures, M.D. is a strategic partner in using intellectual property to achieve her clients' business goals. With two decades of experience in building and assessing patent portfolios in the biopharma industry, as well as in negotiating licenses and strategic alliances, she anticipates issues and opportunities. She brings to her practice a unique insider's perspective gained as former General Counsel of a publicly held biotechnology company, and insight acquired from managing patent portfolios for a number of FDA-approved drugs. A substantial part of her work involves the interface of patents with clinical product development, FDA regulations and regulatory exclusivity. Recent Client Work: Worked creatively and closely with company attorneys and scientists to obtain patent protection for FDA-approved drugs. Able to utilize proactive techniques including in-person interviews and accelerated examination. Successfully argued an appeal before the U.S. Patent Office's Board of Patent Appeals and Interferences on claims relating to new methods of using an FDA-approved drug. Persistently pursued patent applications relating to an FDA-approved drug through appeals, interference and an appeal to the Court of Appeals for the Federal Circuit. Partnered with a company's management team to craft worldwide IP strategy, and led IP interactions with collaborators. Negotiated the IP aspects of a collaboration alliance agreement with a large pharmaceutical company, and drafted and helped negotiate many licenses and other agreements. Advised on due diligence, valuation of patent portfolios and freedom-to-operate issues. Provided IP opinions to support securities offerings. Representative Experience Dr. Rin-Laures' extensive patent work for clients with biotechnology, pharmaceutical and medical technologies includes: Antibodies Antisense and RNAi Recombinant biological drug products, including hemopoietic factors, growth factors, chemokines, neurotrophic factors, cellular adhesion molecules, enzymes, macrophage and neutrophil products, and bacterial antigens Small peptides and chemically modified derivatives Vaccines and immune therapies Chemical pharmaceutical products Pharmaceutical formulations, including aqueous compositions, lyophilized compositions, hydrogels and transdermal delivery Therapeutic methods using traditional pharmaceuticals or biologicals Processes and vectors for recombinant protein production in bacteria, cell lines and plants Diagnostic methods, e.g., for cancer, infection and autoimmune diseases GMO plants Background and Credentials: Dr. Rin-Laures' capabilities in managing global patent portfolios for the biopharma industry are backed by her extensive experience in patent prosecution and contested proceedings, both in the U.S. and abroad, her familiarity with negotiating licenses and other transactions and her prior in-house role as General Counsel. She has protected clients' interests in securing patents on a number of important commercially-marketed products, providing advice on freedom-to-operate searches, validity and infringement opinions, patent opposition proceedings, reexaminations, protests, and interferences, as well as appeals to the Federal Circuit, where she clerked after law school. Dr. Rin-Laures regularly counsels clients - from startups to Fortune 500 companies - on patent strategy relating to new pharmaceutical/biotechnology product development, product life cycle management, as well as the interface with FDA regulations and related exclusivity provisions. She also advises clients in a variety of transactions from due diligence to term sheet negotiations and drafting complex agreements. Her experience includes agreements dealing with licenses, collaborations and other strategic alliances, sponsored research, technology and material transfer. Dr. Rin-Laures served as General Counsel of Hyseq Pharmaceuticals, Inc. (later known as Nuvelo, Inc.) in 2001-2002, while on leave of absence from Marshall, Gerstein & Borun. As General Counsel, she was responsible for settling litigation and negotiating numerous strategic alliance and license agreements. Dr. Rin-Laures was named one of "Forty Illinois Attorneys Under 40 to Watch," a list of the state's most talented and well-regarded young lawyers published by the Law Bulletin Publishing Company. She has also been voted an "Illinois Super Lawyer" for a number of years, a list which identifies the top five percent of the lawyers in Illinois based on a survey and research conducted by Law & Politics. Recently, she was recommended by her peers and selected as a "Leading Lawyer" by Leading Lawyers Network, a division of Law Bulletin Publishing Company. She graduated in 1992 from Harvard Law School, cum laude, where she was Executive Editor and Managing Editor of Harvard Journal of Law and Technology and Editor-in-Chief of "Recent Developments in Health Law" in Law, Medicine & Health Care. In 1992-93, after graduation, she served a clerkship with the Hon. S. Jay Plager at the Court of Appeals for the Federal Circuit. Dr. Rin-Laures completed her medical school studies in 1988 when she received her M.D. from Northwestern University Medical School. She was the youngest woman graduate at Johns Hopkins University where she received her B.A. in Chemistry, with honors, in 1984. Community and Professional Involvement: Delegate to the Coalition of Women's Initiatives in Law Firms; member of PR Committee Member, Intellectual Property Owner's organization; member, Pharmaceutical Issues Committee Former mentor for Menttium.