1. “On the patent front, more time and energy seem to be spent on nuisance and defensive patenting of the obvious than on innovation”, Boldrin, M., & Levine, D. (2002). The case against intellectual property. The American Economic Review, 92(2), 210.
2. IMDRF/SaMD WG/N10FINAL:2013.
3. According to section 210(h):
4. “The term “device” (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is –
5. 5 recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,