Biotechnology is a rapidly growing field that has pushed the limits of patent eligible subject matter. In response to the expansion of biotechnology, critics have emerged with both economic and moral concerns over the development and patenting of these technologies. On the economic front, critics are wary of the potential development of an“anticommons.” On the moral front, critics are concerned with the potential to erode human dignity and “play God.” Congress has responded to the moral concerns with section 33 of the America Invents Act. Section 33 states that“[n]otwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.” This provision was intended to ban the patenting of human beings at any stage of development, including embryos, fetuses, human/non-human chimeras, and clones. However, the vague wording of section 33 and the absence of definitions for “directed to” and “human organism,” give courts wide latitude when construing section 33, possibly leading to a construction that invalidates several biotechnology inventions.
Ava Caffarini, Directed To or Encompassing a Human Organism: How Section 33 of the America Invents Act May Threaten the Future of Biotechnology, 12 J. Marshall Rev. Intell. Prop. L. 768 (2013)