Patenting and regulation of methods for creating three-parent babies

A new infertility technique, mitochondrial replacement therapy (MRT), has been used to create so called “three-parent” babies. MRT is used in cases when mothers carry genes for mitochondrial diseases. Similar to in vitro fertilization (IVF), MRT involves removing an egg from a woman (mother), removing sperm from a man (father), fertilizing the egg with the sperm, allowing the fertilized egg to form a blastocyst, and then implanting the blastocyst into the mother’s womb. MRT, however, also involves an additional egg from another woman (donor egg).  The donor egg is used to provide mitochondria to the recipient egg before fertilization. Thus, the vast majority of the baby’s DNA came from the father and mother, and a small amount of mitochondrial DNA comes from another woman, and thus, the baby receives some of the genetic inheritance from each of the three parents.

Human genetic engineering such as MRT has transformed reproductive medicine and made gene modification of next generation no longer a science fiction. In February 2015, both the House of Commons and the House of Lords in the United Kingdom overwhelmingly approved the use of MRT in humans, making it the first country in the world to allow MRT. The United States, however, currently does not have federal law or regulations directly addressing the genetic modification of early embryos in humans. Both the National Institute of Health (NIH) and the Food and Drug Administration (FDA) provide some federal oversight for reproductive genetic technologies. In 2017, after a U.S. doctor performed MRT to create a three-parent baby, the FDA sent a warning letter asking him to stop marketing and performing the technique. The FDA’s warning letter may suggest that the federal government will also oppose use or development of other technologies that make genetically altered babies.

Patents on three-parent babies are not likely to be issued in the US for the foreseeable future. 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.” Further, the current stance of the USPTO that patents on human cloning violate the Thirteenth Amendment coupled with voluntary moratorium appear to end the patent debate on specific patents directed to the three-parent babies created using the MRT or other similar techniques. In addition, the Federal Circuit’s ruling that Dolly the cloned sheep, and any other genetic clones, are patent ineligible also weighs against the patent eligibility of a three-parent baby. In re Roslin Institute (Fed. Cir. May 8, 2014) However, technology leading up to a three-parent baby (the “methods” or “techniques for producing”) can still be subject to patent protection. For example, the USPTO granted patents on a method of making hybrid oocytes through MRT. (US 9434921).  Creative patent draftmanship may yet yield patent claims that would cover aspects of future reproductive technologies. Also, by filing international (PCT) applications, those developing MRT for commercial markets abroad may be able to secure patent rights in non-US jurisdictions, and take advantage of up to 30 months deferred examination in the US in hopes of a change in US law.