Updates to the Law on Cloning

Knobbe Martens
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Knobbe Martens

It was recently reported that China had successfully cloned a 12-year old schnauzer — the most recent of over 20 dog breeds successfully cloned by the nation so far. [1].  "Doudou" the schnauzer was cloned through somatic cell transfer, a technique in which the genetic material of a donor egg is replaced with the genetic material from the animal to be cloned.  The modified egg is stimulated to initiate cell division, and the egg is implanted in a surrogate mother.  Despite the number of breeds successfully cloned, China has only recently applied this technology to the cloning of  dogs.  In May of 2017, China first implemented the technique to produce a cloned beagle that had been genetically engineered to develop atherosclerosis in order to study possible treatments for the disease.  [2].   

China is not alone in its endeavors, and cloning has quickly transitioned from science fiction to commercial reality.  For instance, U.S. based biotechnology company ViaGen Pets offers to preserve a pet’s genetic material and produce a clone for about $25,000 for cats; $50,000 for dogs; and $85,000 for horses.  [3].  Indeed, there would appear to be a market for such commercial cloning operations among the wealthy.  It was recently reported that two of Barbra Streisand’s three Coton de Tulear dogs were clones of her late dog Samantha, which had been produced from mouth and stomach cells of Streisand’s deceased pet. [4].  Although cloning remains inefficient and expensive, the field of bioengineering and cloning continue to advance at a steady pace.  The commercial availability of cloning technology, and the pace at which biotechnology continues to advance, raise important ethical and regulatory concerns.   

Nevertheless, the regulatory framework surrounding cloning remains uncertain.  As previously reported on this blog, federal oversight is largely lacking, and although there have been no outright bans on human cloning at the federal level, states have taken widely variable positions ranging from prohibition of cloning for any purpose, to allowing the production of cloned embryos while disallowing their implantation for birth.  [5]. 

Moreover, patentability questions abound. For instance, the United States Patent and Trademark Office is barred from issuing patents “directed to or encompassing” human organisms, although embryonic stem cell lines have proven patentable.  Furthermore, a clone’s genetic identity to its donor parents may render the clone unpatentable for failing to exhibit any marked difference from a natural product.  Nevertheless, there may be patentable subject matter concerning the method of producing the clone, or concerning bioengineered clones that exhibit properties markedly distinct from their natural donors. 

[1] www.china.org.cn/china/2018-10/23/content_67680637.htm

[2] https://www.cnn.com/2017/12/25/health/china-dog-cloning-for-disease-intl/index.html

[3] https://viagenpets.com/product/initiate-cloning

[4] https://www.nytimes.com/2018/02/28/science/barbra-streisand-clone-dogs.html

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

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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