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Craig J. Arnold protects, prosecutes and evaluates biotechnology, pharmaceutical, chemical and medical arts patents in the United States and overseas. His clients are pharmaceutical manufacturers, new and smaller ventures, universities, research centers and Wall Street analysts and investors with positions affected by the strength and validity of patents and claims of infringement. He works extensively with clients who are bringing a new drug, biologic product or device to market in the United States and other countries to develop strategy, obtain patents, assess freedom-to-operate and patentability, identify and evaluate potential third party patents and anticipate and plan defenses for challenges to validity and enforceability.
Developing a patent portfolio that maximizes the level of patent protection is complex. He counsels clients on prosecution strategies for achieving the highest level of protection through filings on fomulation, uses and manufacturing processes. His goal is to help commercial, academic and research entities structure and restructure their patent portfolios to maximize monetary value.
As a key member of a trial team during or in anticipation of litigation, Mr. Arnold develops strategies for defense and enforcement in courts and before the U.S. Patent and Trademark office. Clients also call on him to develop strategies for the acquisition of patents and to conduct due diligence in the context of an acquisition, financing or investment where the intellectual property is a significant element of enterprise value.
A particular area of focus is the interplay between branded and generic pharmaceuticals. The potential loss of market share of a branded product concerns owners and manufacturers as well as the analysts, hedge funds and investors who make decisions based on the security of a particular earnings stream. Mr. Arnold advises manufacturers as to the strength and durability of a patent in relation to competition from generics. He advises Wall Street investors to help them forecast earnings. When an actual litigation is started, financial institutions have retained him to evaluate the potential defenses and, in real time, follow the proceedings to provide early insight as to the likely outcome.