Knobbe/Martens: Intellectual Property Law

The Law and Human Cloning

By Raj D. Pai, PhD. and Jason J. Jardine June 11, 2018

Until the cloning of Dolly the sheep in 1996 by scientists at the Roslin Institute, the idea of cloning a mammal, let alone a human being, was an idea relegated to science fiction[1]. Dolly was created using a technique known as somatic cell nuclear transfer. This technique essentially used the cell nucleus from an adult cell that is transferred into an unfertilized oocyte that had its cell nucleus removed. After stimulating the cell to divide, the resulting blastocyte was transported into the surrogate mother.

At the time of Dolly's creation, the technology to clone mammals was highly inefficient. Dolly was the only lamb that survived to adulthood in over 277 attempts[2].  Questions quickly arose as to whether the technique could be used for humans.  Recently, in January 2018, two identical Macaque monkeys were created by researchers in China out of over 70 attempts[3].  By using techniques to undo chemical modifications in DNA that occur when embryonic cells turn into specialized cells, the researchers expanded upon the somatic cell nuclear transfer technology[4]

Soon after Dolly’s creation, many companies offered services to clone animals.  Given the inefficient nature of cloning, the expense to clone an animal can be quite high.  For instance, a dog may be cloned from anywhere between $50,000 to $100,000[5].  Larger animals, such as polo horses, have been cloned for over $120,000[6].  Interestingly, many executives at these companies admit to being approached by wealthy individuals inquiring about human cloning[7].     

Since Dolly's creation, a legal framework regarding the regulatory issues and patentability of human cloning has created an oddly patched quilt.  Within the United States, federal laws and regulations focus on addressing funding and only indirectly relate to cloning. On the state level, several states passed various laws regarding cloning. World-wide many countries banned human cloning altogether[8]

Within the United States, the first efforts to ban human cloning were introduced shortly after Dolly's creation[9]. Several bills were presented before the United States Congress. For instance, within the 114th Congress, a bill to ban human cloning was introduced[10]. The bill stated that it would be unlawful for any public or private entity to perform human cloning and included fines up to 1,000,000 dollars. However, despite numerous attempts, there have been no bills passed banning human cloning.

Despite the enactment of no legislation prohibiting cloning by the United Stated

Federal Government, the United States Food and Drug Administration (FDA), prepared a letter in 1998 preempting regulatory concerns[11]. The letter stated that under federal law, the FDA has jurisdiction over cloning-to-produce children. Further, the FDA asserted that in order to produce cloned children, permission must be granted due to safety issues. However, it is uncertain what penalty, if any, would be involved.

With regards to intellectual property, the United States Patent and Trademark Office (USPTO) is forbidden under congressional measures from issuing patents "directed to or encompassing" human organisms (including embryos)[12].  Nevertheless, human embryonic stem cell lines have been patented. Additionally, methods to clone humans are also potentially patentable.  A question arises to the patentability of cloned mammals.  In 2014, the Federal

Circuit held, that "Dolly's genetic identity to her donor parents renders her unpatentable"[13]. This is because the cloned sheep is not "markedly different" from a product of nature.

Interesting, while federal law does not directly prohibit human cloning, individual states have passed laws against cloning. As of 2014, state laws show significant variation[14],[15].  There are currently 8 states (Arizona, Arkansas, Indiana, Michigan, North Dakota, Oklahoma, South Dakota, Virginia) that prohibit cloning for any purpose.  There are 4 states (Arizona, Indiana, Louisiana, and Michigan) that expressly prohibit state funding of human cloning for any purpose.  There are 10 States (California, Connecticut, Illinois, Iowa, Maryland, Massachusetts, Missouri, Montana, New Jersey, and Rhode Island) with "clone and kill" laws. These laws prevent cloned embryo implantation for childbirth, but allow embryos to be destroyed.  Two states, Idaho and Louisiana expressly include "human cloning" as a practice that health professionals cannot be compelled to participate in under their healthcare rights of conscience laws.

 



[2] See http://time.com/438494 7 /dolly-sheep-cloning-history/

[9] See https://www.nytimes.com/l 997 /06/1 O/science/clinton-seeks-to-ban-human-cloning-but-not-allexperiments.html

[10] See https: //www.congress.gov/bill/l 14th-congress/house-bill/3498

[12] See Leahy-Smith America Invents Act Section 33

[13] See In Re Roslin Institute, 750 F.3d 1333 (Fed. Cir. 2014).

[14] See http://www.ncsl.org/research/health/ embryonic-and-fetal-research-laws .aspx

 

Meet the Knobbe Martens Attorneys

Raj D. Pai’s practice focuses on patent prosecution and litigation in the pharmaceutical, biotechnology, and the medical device sectors. Prior to joining the firm, Raj worked as a...
Appreciated for his strategic analysis and solutions that fit each client’s specific needs, Jason Jardine represents a diverse clientele in all aspects of intellectual property...
Attorney Finder