Intellepharm, Inc. Licensing, Intellectual Property, Legal Expert    PATENT PREPARATION SERVICES In today's competitive environment, existing pharmaceutical patents are at risk from a number of pitfalls. In particular, "Designing Around" (i.e., developing a chemical entity, device, or method that avoids the claims of an existing patent)is a legal means for producing new products to compete with existing patented products. Moreover, would-be competitors have enhanced incentives to invalidate patents. Under the terms of paragraph 4 of the Hatch-Waxman legislation, invalidation of a US patent provides 180 days of regulatory exclusivity to a generic manufacturer. The value of 180 days of exclusivity for the generic version of a patented $500 million drug is such that a legal challenge to the patent is highly attractive financially. Crucial goals in patent preparation to minimize such pitfalls--both "design around" attacks and invalidation attacks--include strict attention to the question "what is the correct identification of the invention"; full disclosure of the invention; fully enabling the invention; correct listing of inventorship; clear understanding of the prior art; and the preparation of broad, carefully crafted claims that are fully supported by the disclosure. The utilization of patent professionals who have broad managerial experience in industrial pharmaceutical R&D--particularly when the inventors are relatively inexperienced regarding some of these pitfalls--markedly facilitates the attainment of these goals and is a highly effective means to produce bullet-proof patents. Intellepharm patent professionals have the experience and insight into these issues to make this possible. Although proprietary considerations limit the use of examples of our work, attention is called to US Patent 6,447,058, entitled "Seat Means for Preventing Shock." This valuable patent, which protects extensively used passenger aircraft seat constructions, provides examples of important claims that Manfred E. Wolff PhD was able to secure in a crowded field by correct identification of the actual invention, and by sophisticated disclosure and claim elaboration. STRATEGIC PLANNING SERVICES Strategic Planning is a process that may be likened to getting on a bus and asking the question "Where are we going and how do we get there?" The answers to these questions will depend on the desirability of a particular destination, the capabilities of the bus, the costs of the journey, the funds available, the roads, the weather, and a long list of many other factors. For a research organization, the issues are just as numerous. However, the questions can be reduced to: What shall we continue, what shall we do more of, what shall we do less of, what shall we start, and what shall we stop. Many of the factors that have been discussed under the evaluation of licensing opportunities, such as market size, competitive landscape, costs, timelines, etc., etc. come into play here as well. A strategic plan is crucial to the success of any research organization, but particularly in pharmaceuticals. The long timelines, complexity, and costs of pharmaceutical research mandate the preparation of a sophisticated strategic plan and regular updates. The alternative is fragmented efforts by otherwise talented individuals with only occasional completion of projects. Manfred E. Wolff has been involved in strategic planning for pharmaceutical research since 1988, first with a subsidiary of SmithKline Beckman, and later as Senior Vice-President for R&D at Immunopharmaceutics, Inc. Since founding Intellepharm, Inc., he has conducted planning sessions for a number of biotechnology start-ups.