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Advances in Large-Scale Biopharmaceutical Manufacturing
and Scale-Up Production*, 2nd Edition

    Intellectual Property Considerations in Scale-Up of Biomanufacturing Processes


    One purpose of intellectual property law is to provide direction and bright line rules that individuals and organizations can use when conducting business and making business plans. Unfortunately, the present state of intellectual property laws around the world has created an environment that imposes timing issues and ambiguities that are vexing to decision makers in every industry, including the biomanufacturing industry. In the United States, courts have defined a “super” enablement standard that patent applications must meet in order to mature into valid, issued patents. European and Japanese courts appear to be following the lead of the United States, by embracing the “super” enablement standard. The timing of intellectual property protection and public notice frequently act as impediments to developing global strategy and in making changes in the strategy. This chapter describes basic considerations in intellectual property law when scaling up biomanufacturing processes, including barriers imposed by the law. The chapter also describes intellectual property law tools and strategies for protecting assets of a biomanufacturer engaged in a scale-up operation.

    About the Author

    Janal Kalis, Shareholder, Schwegman Lundberg Woessner & Kluth in Minneapolis, Minnesota
    Ms. Kalis has over 30 years of experience in medical research, engineering, and law. Early in her career, she co-authored many articles in the area of virology. Her scientific work led to the development of more effective immunosuppressive regimen for transplant patients. Ms. Kalis has drafted and procured hundreds of patents for companies around the world. She counsels on both defensive and offensive intellectual property strategies for her clients. In her legal practice, Ms. Kalis’ firm has represented biopharmaceutical clients, including Atrix Laboratories, Cornell University, Gilead Sciences, MGI Pharma, Dekalb corn patent, The National Institutes of Health, NeoRx, Pfizer, Rutgers University, The Scripps Research Institute, University of California, and others. She is presently working on developing software for mapping patent portfolios so that her clients have the best possible understanding of what their patent portfolios cover and what their competitors’ portfolios cover. Ms. Kalis is also founder of a software company, FoundationIP.

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