Intellectual Property Impacts of In Vitro Gametogenesis
In vitro gametogenesis (IVG) is a recent development in reproductive technology, and has been used for creating mouse embryos in vitro. IVG includes obtaining cells from a donor (such as skin cells), and differentiating the cells in a laboratory culture dish into gametes (eggs and sperm). Differentiated eggs can be inseminated with differentiated sperm in the laboratory culture dish to generate embryos for implantation into a womb. Thus, IVG is similar to in vitro fertilization by the generation of an embryo in a culture dish. However, unlike in vitro fertilization, IVG generates gametes from stem cells. Numerous implications arise related to the use of IVG for generating human embryos. Among those implications are intellectual property considerations.
Setting ethical considerations aside, patents on products of IVG, including differentiated human gametes or IVG human embryos, are not likely to be issued in the U.S. under current patent law. The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33(a), 125 Stat. 284, expressly states: “Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.”(1) The question becomes whether human gametes and human embryos fall within the category of a “human organism.” By dictionary definition, an organism is an individual entity that exhibits properties of life, and a human organism would thus be an individual entity exhibiting properties of life and belonging to the species Homo sapiens. A human embryo would appear to fit within this definition, and in fact, during legislative considerations, Representative Weldon stated that the term human organism would “cover [all] human organisms (including human embryos).” (2)
Under the AIA it seems clear that IVG human embryos themselves would be construed as a “human organism.” On the other hand, it is not as clear whether a differentiated human gamete, technically not considered an organism, could possibly be construed as a human organism under the law. Gametes are unique cells with only half the total DNA of all of the other cells that make up a human organism. Accordingly, they cannot by themselves fully develop into a human embryo. However, two gametes (e.g., an egg and a sperm) have the potential, when joined, to form a human embryo with a full complement of DNA and fully develop into a human organism. Besides the AIA prohibition on patenting a human organism, the differentiated human gametes may be indistinguishable from natural human gametes, and thus, despite their artificial differentiation, might be considered a natural product, recognized as a judicial exception to patent eligibility. (3)
On the other hand, methods of performing IVG or methods of generating IVG products (such as methods of producing differentiated gametes or methods of producing IVG embryos) may still be subject to patent protection. One such example is U.S. Patent Publication No. 2017/0108499, filed on August 31, 2016, directed to methods of expanding stem cells and methods for in vitro gametogenesis, including differentiating stem cells into gametes. No claims have yet issued, but it will be interesting to observe the developments in the field. Creative patent draftsmanship may yet yield patent claims that cover aspects of IVG methods. Also, by filing international (PCT) applications, those developing IVG for commercial markets abroad may be able to secure patent rights in non-U.S. jurisdictions, and take advantage of up to 30 months deferred examination in the U.S. in hopes of a change in U.S. law.
(1) Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011), § 33(a), 125 Stat at 340.