As the field of nanotechnology advances, the classical distinctions between what the FDA considers a “drug,” “device,” or “biologic” begin to blend together. Envision, for example, a molecular machine programmed to seek and destroy cancer cells. These machines would combine into one therapeutic product – a nanoscale device for delivering a payload of drugs, together with a biologic component that self-assembles into a protective capsule around the delivery site, focusing the drugs on the cancer site within this capsule.
Just as a nanotech combination product unites these three physical components – drug, device, biologic – the regulatory, intellectual property, and business law issues are intertwined as well. To succeed in the marketplace, innovators developing combination products must be armed with an integrated legal strategy.