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Imagine receiving medicine that has been specifically prepared to match your genetic profile, so that, when taken, it treats “what ails you” without side effects of any kind. Or imagine a “smart bomb” cancer treatment that searches for, and attacks, only specific cancer cells bearing a specific protein expression profile, so that the cancer is cured without harm to normal cells. Sound like science fiction? It won’t, if one or more of the ongoing initiatives using bioinformatics becomes successful. Bioinformatics is one of the hottest and fastest growing “new” technology areas. One estimate calls for the global bioinformatics industry to grow from about $2 billion in 2000 to $60 billion by 2005. [FOOTNOTE 1]Although various definitions of bioinformatics abound, it can generally be described as the application of computer science and information technology to acquire, store, analyze and use biological data in order to solve various medical and biological problems. Given the three billion base pairs in the human genome, the amount of raw bioinformatics data generated and stored daily in just three of the related bioinformatics fields of genomics, proteomics and pharmacogenomics is enormous. Many of the new, exciting and valuable technological advances making news headlines result from the acquisition and analysis of these data. Due to the very large and lucrative market that is anticipated for bioinformatics technology, it is important for emerging and established companies alike to protect their investment in technology through acquisition of intellectual property rights. Since the intellectual property protection regimes (patents, trade secrets, copyrights and trademarks) afford different protections, and because each may be individually sold or licensed, it is important to carefully select and use one or more of these regimes to protect and maximize the value of the intellectual property protection for these new, emerging bioinformatics technologies. HOT AREAS Bioinformatics is used in numerous fields, the most significant being genomics, proteomics and pharmacogenomics. Genomics is the field of study that created the need for and most influenced the development of bioinformatics, as well as the other related “-ics” fields. Timothy A. McCaffrey, associate professor of biochemistry and molecular biology at The George Washington University Medical Center, offers a very good, top-level definition of genomics as: “the scientific methods directed toward discovering the relationship between genotype and phenotype, [where genotype refers to] the actual chromosomal, physical genetic elements that are transmissible and inheritable [and phenotype refers to] the expression of those genetic markers in terms of eye color, hair color or [a person's] propensity to a given disease.” [FOOTNOTE 2]The field of genomics has evolved to now include intellectual property covering technology in, at least, the following areas: comparative genomics (comparing genomes of different species), functional genomics (identifying and validating the functions of individual genes), and structural genomics (developing two-dimensional and three-dimensional models of genes and the proteins that they encode). Similar to genomics, proteomics is “the analysis of complete complements of proteins, including the identification and quantification of proteins, and the determination of their localization, modifications, interactions, activities, and, ultimately, their function.” [FOOTNOTE 3]Current, proteomic analyses involve the use of high-throughput mass spectrometry techniques to determine peptide mass fingerprints and protein sequence information. Additionally, expectations are high that advances in proteomics will extend the understanding the effects post-translational modifications have on protein function to aid in the design and development of more effective, targeted drug therapies. Though still in the early stages of development, proteomics has the potential to bring about significant technological advances and discoveries, since the number of expressed proteins in the human proteome is estimated to be roughly twice the predicted size based on the number of open reading frames in the human genome. This additional level of variability is due to the possibility of several different post-translational chemical modifications that cannot be predicted from the primary protein structure (i.e., amino acid sequence). Pharmacogenomics [FOOTNOTE 4]involves the “use of genetic information to predict the safety, toxicity and/or efficacy of drugs in individual patients or groups of patients.” [FOOTNOTE 5]The theory driving pharmacogenomics is the discovery and development of drugs tailored to a patient’s genetic make-up, thus eliminating adverse drug reactions and ensuring the most efficacious treatments for each patient. A phrase often associated with pharmacogenomics is “personalized medicine,” which describes the notion that clinicians will not only be able to determine a patient’s predisposition toward a disease and its early diagnosis, but also individualize a treatment regimen for the disease based on the patient’s genetic make-up. Significant intellectual property is being created in the development of the new methodologies to quantify and correlate the expression of genetic disease markers with clinical outcome with respect to various types of treatment to achieve the promise and goals of personalized medicine. Bioinformatics has also proven to be a key platform in numerous other fields, including biometrics, cheminformatics, and laboratory information management systems. PROTECTIONS Obtaining intellectual property protection for bioinformatics and bioinformatics-related technology is a vitally important process, since it can not only ultimately afford the owner of the intellectual property the right to exclude others from using the protected technology, but can also potentially provide the owner a monopoly position for the manufacture and sale of the technology. Obtaining protection for its intellectual property assets is usually absolutely essential for early stage companies that rely on a single technology (or even a few technologies) for its revenue stream. This revenue can be derived from the actual sale of manufactured product(s) and/or from royalties received from licensing intellectual property rights to others. Even in circumstances when a company’s success does not depend on an individual patent (e.g., a generic drug manufacturer without intellectual property, or a large pharmaceutical company with sufficient other patents), it must still be aware of the rights that may be held by potential competitors. Because of the potential liability, it is important to avoid infringing the rights of others. One way to help ensure that the company’s products and/or processes do not infringe the rights of others, or limit liability if infringement is found, is to conduct an analysis of potential patents that may cover the technology and obtain impartial non-infringement opinions. Each of the intellectual property protections can give rise to additional liabilities if not prudently acquired and used. Since the acquisition process can be a complex one, especially in the area of patents, the following information is provided to highlight some of the issues associated with each type of intellectual property protection. � Patents. Through patents, companies and entrepreneurs can obtain a legal monopoly to protect their technology from being manufactured and sold by competitors, thus making patents an important incentive for technology development and innovation. Patents can be obtained by filing an application in the U.S. Patent and Trademark Office; three types of patents exist: utility, plant and design. Of these, the utility patent is the type most commonly associated with bioinformatics inventions and can be obtained for a new, useful and non-obvious process, machine, manufacture or composition of matter, or a new and useful improvement of any of the aforementioned. A utility patent’s term, once granted, is for 20 years from the priority application filing date. Patents can be obtained for such bioinformatics areas as: the computational and analytical aspects of genomics and proteomics (including algorithms, sequence analysis techniques, mapping techniques, comparison techniques, primer design, phylogenetic analysis, molecular modeling, protein structure prediction, and protein function prediction), databases (for example, construction, querying and data mining), biological integrated circuits, micro arrays, and image analysis. To enhance the potential for obtaining valid, useful, enforceable and valuable bioinformatics patents, the applicant or practitioner should consider the following suggestions. First, identify the novelty and focus of the invention in light of the current state of the art, so that the novel aspects of the invention can be readily determined and described. Second, identify all of the potential uses and implementations of the invention to include all of the possible products and/or services that are planned or being considered. Third, provide a detailed written description of the invention to describe all of the embodiments in sufficient detail to enable one of skill in the applicable art(s) to practice the invention without undo experimentation. Fourth, draft a variety of claims that distinguish over the current state of the art, cover all aspects of the current and envisioned products and/or services, and minimize how many parties have to act to infringe each claim. Optionally, claims can be directed toward the acts and/or products of a single party, for example, a competitor or potential licensee. � Trade Secrets. Trade secret protection can be used to keep important company technologies and information secret from the company’s competitors. A trade secret protection program is a company-implemented program that does not require registration with any governmental agency. Although there is no time limit on the protection, provided the trade secret information stays secret, accidental and/or illegal disclosure of the trade secret information can effectively eliminate the trade secret protection. Trade secrets can be used to protect bioinformatics-related intellectual property such as software code, manuals, compilations of facts (databases), formulas and processes. A key difference between patent and trade secret protections is that patents can be enforced against both willful infringers, who knowingly use, and “innocent” infringers, who later independently develop, the patented technology; trade secrets, on the other hand, only protect against the misappropriation of the trade secret information. � Copyrights. Copyrights protect the expression of an idea, not the underlying idea, method or system, and copyright protection exists from the time the work is created in a fixed form, for example, paper, film or electronic medium. Copyrights can be registered in the U.S. Copyright Office and, although not required to obtain copyright protection, copyright registration is required to sue for infringement. Copyright protections can last for the author’s lifetime plus 70 years for known authors or 95 years from publication or 120 years from creation, whichever is shorter, for works by unknown authors or works made for hire. Once registered, the copyright can be recorded with the U.S. Customs Service to prevent the importation of infringing copies. Copyright can be used to protect bioinformatics-related materials such as scientific articles, books, software code, manuals, Web pages, graphic artwork, multi-media works, compilations of facts (databases), online works, and maskworks. [FOOTNOTE 6] � Trademarks. Trademarks are used to represent and/or indicate the source and/or origin of a product or service, and trademark protections can be used to prevent a trademark from being used by others. Trademark protection is available via federal registration or common law, and both protections can last forever, provided use of the mark continues. Although it does provide some procedural advantages during litigation, registration is not a prerequisite for an infringement lawsuit. Once registered, trademarks can be recorded with the U.S. Customs Service to keep out infringing goods bearing the mark. Federal trademark registrations have a 10-year term that can be renewed in 10-year term increments, provided the mark is still in use. Trademarks can be used to protect trade names, product names, domain names, and service marks/slogans for bioinformatics companies. LICENSING The time, effort and cost associated with acquiring and protecting intellectual property assets may be recovered, at least to some degree, through licensing. However, a host of issues can arise when licensing intellectual property assets that, if not properly addressed, can be very costly to the owner of it. Specifically, these issues include, but by no means are limited to, product liability, warranties, indemnification, scope and duration, geographic limitations, basis for and royalty rates, payment schedules, march-in rights, accountability requirements, quality control, and responsibilities in the enforcement of the licensed intellectual property rights. In general, the key questions to be answered when licensing bioinformatics intellectual property include: � Who are the parties and what roles will each play? � What is the type of license desired (exclusive, non-exclusive or combination)? � What is being licensed (patents, trademarks, copyrights and trade secrets)? � Who will own related newly developed intellectual property? � How will payments be made (lump sum, royalties or both)? � Is confidentiality required? � What are the responsibilities for dealing with infringement? � What is the term of the license? � What are the reasons for termination? � Can the license be sublicensed and/or assigned? � Is there any limitation of liability? � Will one party be indemnifying the other party? � What warranties are provided by the licensor? � Does the licensor need to exercise quality control over the licensee? The above list is illustrative of some, but certainly not all, of the questions that can and should be answered when preparing to license bioinformatics intellectual property. Of course, it should be understood that since this is a conglomeration of licensing questions for different types of intellectual property, the actual questions that should be answered for each type of license and in different situations will vary. CONCLUSION While it is clear that intellectual property protection of bioinformatics technology is very important, it is equally clear that how the protections are acquired and used is vitally important in determining the value of the intellectual property. It is recommended that competent legal counsel be consulted and retained to assist the acquisition and licensing of strong and enforceable intellectual property protections for the new, emerging bioinformatics technologies. Likewise, counsel should be consulted to help understand the intellectual property rights claimed by others and to advise on strategies for handling such claims. Brian S. Mudge is a partner with Kenyon & Kenyon ( www.kenyon.com), and David R. Schaffer and Adam M. Treiber are associates in the Washington, D.C. office of the firm. If you are interested in submitting an article to law.com, please click herefor our submission guidelines. ::::FOOTNOTES:::: FN 1Dr. Sandya Tiwari, “Bioinformatics and Genomics,” paper published in “BUSINESS OPPORTUNITIES IN BIOTECHNOLOGY”, Confederation of Indian Industry (CII), March 8, 2001 (available at http://www.ciionline.org/NEWS/pressrel/ 2001/March/8March01.htm). FN 2Timothy A. McCaffrey, Ph.D., “Fundamentals Of Genomics And Bioinformatics,” Presentation at George Washington University Medical Center for a new Master’s degree program in Genomics and Bioinformatics (Sept. 3, 2002) (available at http://www.astutetechnology.com/gwuppts/ mccaffrey/Introduction, %20Basic%20Methodology%20 and%20Terminology%20Part%20I.ppt). FN 3Adapted from the Proteomics Glossary, last revised Dec. 18, 2002, (available at http://www.genomicglossaries.com/ content/ printpage.asp? REF=/content/proteomics.asp). FN 4Pharmacogenetics is another commonly used term that, although it may have a slightly different definition, is frequently used synonymously with pharmacogenomics. FN 5 The Biospace Glossary, Pharmacogenomics definition, (available at http://www.biospace.com/ gls_detail.cfm?t_id=1728). FN 6Maskworks protect original semiconductor chip design layouts, and may be applicable to lab and Nanotechnology chips that satisfy the definition of a semiconductor chip product, but is not applicable to pure DNA micro arrays.

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