Could you patent a human clone?

“They’re coding the genes using ASCII, lols”

My new favourite show is Orphan Black, a Canadian BBC production set in a world where human cloning was achieved 30 years ago. I’ve just finished watching the first season on Netflix, and I’m thoroughly hooked. Tatiana Maslany is the greatest actress of her generation. Just trust me and watch it. Oh, and stop reading and come back after season 1.

[SPOILER ALERT]
This article contains a major plot twist for the Series 1 of Orphan Black
[SPOILER ALERT]

There are four main Orphans in the first season: Sarah, the English punk con-artist; Helena, the psycho Ukranian; Cosima, the science geek; and Alison, the soccer mum (they’re not called clones, “we don’t use the C Word” says Alison). The season 1 finale has a very interesting plot twist. Cosima gained access to her genetic sequence, and found that the cloning process used to create them included some coding into their genes which is unique to each Orphan, but also includes an encrypted message. After decrypting it, she finds the following text:

“This Organism and Derivative Genetic Material is Restricted Intellectual Property.“

The Orphans are patented, and they and their children are owned by the shadowy Dyad Institute.  Fantastic plot twist that is used to set the stage for the second season. But what are the legalities of such a clause?

This is a fascinating question spanning several new topics: human cloning, synthetic biology, designed genetic material, and bio patents, just to name a few. The question can be separated into several legal issues.

First the easiest part of the assumptions made in the episode, you cannot own a human being through patents, and no type of intellectual property would give anyone else ownership over another, even if that person was somehow designed. To allow for such ownership would go against a good number of human rights provisions almost universally accepted in jurisdictions around the world.

Would it be possible to get a patent for human cloning? This is where things get interesting, and we could distinguish from the process of human cloning, and the cloning itself. There are already several US patents granted for the process of cloning in animals obtained by the Roslin Institute (of Dolly the Sheep fame). Similarly, there are other patents for some biological processes, such as stem cell lines (see US patent 8647872). There is however, no patent for human cloning, as the law seems to be reluctant to allow this, at least at this time. In Europe, the Directive on the legal protection of biotechnological inventions (98/44/EC) allows for the protection of several biotechnology products, but not the human body. Art 5 clearly states that the the human body and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, will not be subject to a patent. Similarly, Art. 6 considers human cloning to be an invention unpatentable where their commercial exploitation would be contrary to ordre public or morality.

All of the above is compounded by the fact that recently the Roslin Institute lost a 10 year legal battle in the United States to patent the result of cloning. After obtaining the aforementioned patents for cloning processes, they also filed an application to have the sheep, goats, pigs and cattle resulting from the patented process to be subject to protection themselves. The US Patent and Trademark Office rejected the application as the “laws of nature, natural phenomena, and abstract ideas” are not patentable subject matter. The Roslin Institute appealed, and the U.S. Court of Appeals for the Federal Circuit maintained the rejection of the patent application. It is evident that the original sheep cannot be patented, but the Roslin Institute claimed that the resulting animals would be patentable because they are not natural products, they are the handiwork of human beings, and therefore subject to patentability. In the decision of In Re Roslin Institue, the CAFC commented that:

“While Roslin does not dispute that the donor sheep whose genetic material was used to create Dolly could not be patented, Roslin contends that copies (clones) are eligible for protection because they are “the product of human ingenuity” and “not nature’s handiwork, but [their] own.” Roslin argues that such copies are either compositions of matter or manufactures within the scope of § 101. However, Dolly herself is an exact genetic replica of another sheep and does not possess “markedly different characteristics from any [farm animals] found in nature.” Chakrabarty, 447 U.S. at 310; see Reply Br. 13 (stating that “the clones are genetic copies”). Dolly’s genetic identity to her donor parent renders her unpatentable.”

A final question remains, and that is whether an artificial genetic sequence would be subject to a patent, or maybe even copyright. This is more open to legal interpretation. The idea behind synthetic biology is that it is possible to either re-engineer or build from scratch an entire genome, or a part of it. This could create living organisms that would otherwise not be able to exist in nature.  Back in 2010, a group led by Craig Venter managed to put together an artificial genome and create a replicating cell. The IP ownership of these organisms is however not very clear. Arti Rai and James Boyle sounded the alarm already in 2007, warning that we may be faced with a perfect storm of bad biotech law and bad software law. Similarly, some synthetic organisms could fall under the prohibition to issue patents that go against the public order and morals. Moreover, the fact that synthetic biology involves several processes, it is possible that the resulting organism would be a mishmash of existing patents, requiring licensing agreements.

So I guess that the answer is that we won’t be seeing human cloned slaves walking amongst us in the near future, and the law would not allow for the protection of such practices, at least for now.

Unless they clones are already here [Insert sinister laugh]…

Edited to add

I’m guessing that the producers heard some complaints about the patenting issue, they included references to a Supreme Court decision on the very first episode of Season 2 in which there is a legal distinction made between synthetic DNA and natural DNA, paving the way for the patenting of human clones.