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Bioinformatics, the interface between biotechnology and information technology, is expected to revolutionize modern research in biology, and to usher in a new era of pharmaceutical innovation. The development of bioinformatics already has led to the dramatic expansion of genetic sequence information. As a result, new drugs are expected to be discovered more efficiently through computerized analysis of disease-related genes, proteins and biochemical pathways, and through comparative computer modeling of potential drug compounds and receptors. The biotechnology and pharmaceutical industries have invested a great deal of resources toward attaining that goal, and expect thorough protection for all of the resulting intellectual property. But as with any other software-related patent application, special consideration must be given to the enablement and best mode requirements. The inventor’s disclosure may range from all code with little comment to a simple description without codes, object charts or flow diagrams. The patent practitioner must determine the desired content of the bioinformatic patent application, as with any software patent application, in order to satisfy the enablement and best mode requirements. Different sections of any computer program may have different inventors, authors and/or copyright owners. Inventors may copy and paste parts of existing code into a software program. Where the patent application includes code, it is best for the patent practitioner to inquire about the actual source of the code. Code that has been copied from other sources is likely copyrighted to a third party. Although the technology involved in bioinformatics is predominantly software-oriented, patent practitioners must be conscious of additional hidden proprietary rights unrelated to the software disclosure. Examples of hidden proprietary rights include example calculations or figures depicting proprietary chemical structures, protein or genomic sequences, and screen shots including third party graphical interfaces. The structures and sequences may not yet be covered by a patent application, while trade dress or copyright protection may cover the graphical interface. Potential owners of the divergent intellectual property rights involved include federal, state and local government, industries, universities, individuals and combinations thereof. Agreements between different parties to the development of bioinformatic inventions must be examined to determine what may, or may not, be disclosed. In cases where the bioinformatic invention is a module in a prior art software program, the parent programmers may have some upstream intellectual property rights including copyrights to their programming code and upstream patent rights in the main program. Intellectual property rights such as trade secrets (in the code) and trade dress also may need to be addressed. Although prior art searches are especially challenging with software patents in general — and more so in the bioinformatics technology area — a thorough search may be desirable. There are Web sites dedicated to the destruction of patents, especially software patents. The BountyQuest Web site has awarded up to $10,000 for the submission of significant and highly relevant prior art to help invalidate a broad bioinformatic patent. CHECK WITH THE INVENTORS Completed bioinformatic patent applications must be carefully reviewed for hidden intellectual property not earlier discovered. Inventors are the best resource for avoiding these pitfalls, and should be asked about the source of each part of the initial disclosure when it is forwarded to the patent practitioner and again in the cover letter of the completed application. Examples containing nucleic acid or protein sequences, and small molecules must be carefully reviewed because inventors prefer to develop relevant data and may use example molecules of interest to other researchers in their lab. When software code is to be disclosed in the patent application, a copyright notice should be placed at the front of the application. The only code present in the application should be copyrightable solely to the owners and inventors of the patent application, if possible. Disclosing third party copyrighted material should be avoided. Obviously, trademarks should always be identified. Although many erroneous disclosures are obvious, some are decidedly not. While it is obvious to review examples and calculations containing genomic sequences, small molecules and computer code, it is not so obvious to review process steps disclosed in the body of the specification. In light of the investment placed in bioinformatic inventions, patent practitioners are advised to double check the disclosure for hidden pitfalls prior to filing the application. Mary-Jacq Holroyd is an associate at McCormick, Paulding & Huber, www.IP-lawyers.com, an intellectual property law firm with offices in Springfield, Mass., and Connecticut.

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