Protecting Trade Secrets Disclosed To The FDA

By Douglas Nemec, William Casey and Tara Melillo (February 13, 2018, 10:50 AM EST) -- While intellectual property is a key value driver for most every company, in the life sciences industry, intellectual property is paramount. It provides for periods of market exclusivity and allows companies to differentiate their offerings from those of competitors. Given regulatory approval time lines that can take more than a decade and development costs that can exceed one billion dollars, strong intellectual property protection is necessary to ensure business viability. See, e.g., Costs to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion, Tufts Center for the Study of Drug Dev. (Nov. 18, 2014), here....

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