Aligning A Product's Marketing, Regulatory And IP Plans

Law360, New York (September 8, 2017, 12:05 PM EDT) -- Patent protection can be critical for health care products, including medical devices, prescription drugs, dietary supplements and software as a medical device (SaMD). Although a precise regulatory pathway is not always clear, innovators’ initial development choices may influence how the product is regulated and protected. Innovators must decide whether to spend the tremendous time and money required to bring a drug or device to the market as a regulated product — as opposed to a dietary supplement, cosmetic or unregulated consumer product. The product’s marketing plan...
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