CHAPTER 8

Orphan Black and the Ethics of
Patenting Human Life

Intellectual property relating to biotechnology is one of the most exciting and also one of the most complicated areas of modern law, encompassing state, federal, and international statutes, as well as dozens of agencies such as the NIH, FDA, and State Department issuing regulations short of laws that still govern scientists. The best law students at Stanford and Yale work mightily to try to understand these issues and discover just solutions—no easy task, for them or us.

Early on in Orphan Black, we learn two amazing things: first, that each sestra clone’s DNA includes a unique “tag” by which she can be identified; and second, that these tags are patented by the Dyad Institute, or perhaps Topside.

Is this science fiction or real science? What exactly is a DNA tag? And can it be patented?

DNA TAGS

DNA tags—or more accurately, expressed sequence tags (ESTs)—mark short sequences of much longer strands of DNA and are used to easily identify such longer sequences for legal and scientific purposes. Although not an exact analogy, ESTs are a bit like emblems on automobiles made by Mercedes, Toyota, or Nissan that clearly show the manufacturer.

Human DNA is made up of three billion base pairs. We have 23 pairs of chromosomes, each varying in length between 750,000 and 250 million base pairs. Our 140,000 genes—sequences of DNA that can vary in length between 781 and 2 million base pairs—don’t make up a huge percentage of those base pairs, but they govern many aspects about us by directing cells’ production of the proteins that are used to regulate our biological functions.

Using enzymes, it is possible to find markers for the DNA sequences that control specific proteins—these markers are ESTs. Controversial entrepreneur Craig Venter, the pioneer of synthetic biology I mentioned in the previous chapter, was also the leader in identifying such ESTs, using powerful computers on behalf of the NIH. (Venter has replaced James Watson as the most visible molecular biologist in North America and, maybe, the world.)

Why are ESTs useful? A list of ESTs provides a template for individual genes’ locations in our DNA, allowing scientists to experiment and discover what functions each gene, or batches of genes, might control.

So given that the sestras are originated by cloning, and so had some scientist could have tinkered with their individual copies of Kendall Malone’s genome, it would be possible to use a unique DNA tag to identify them. Whether that tag could, or should, be patentable is another question.

PATENTING LIFE

Historically, US patent law does not allow patents on naturally occurring things such as rocks, plants, and chemical elements. However, in Diamond v. Chakrabarty (1980), the US Supreme Court ruled that geneticist Ananda Chakrabarty could patent a genetically modified organism designed to clean up oil spills. The Court said that because Chakrabarty had changed the genes of a preexisting organism, the new organism became a “human-made invention,” not something occurring wild in nature, and therefore could be patented.

A year later, in the In re Bergy case (1981), a lower court explicitly, and controversially, emphasized that “the fact that microorganisms . . . are alive is a distinction without legal significance.” Critics immediately complained that Bergy treated life as “an industrial tool,” not as something sacred, and claimed that “life itself, even at its lowliest, is invested with a sanctity that the patent process defiles.” They saw Chakrabarty as championing the worldview that nature is something to be owned and manipulated.

About a decade later, Craig Venter, who was at the time working to locate and mark genes for the NIH, tried to get the agency to patent his discoveries. The NIH submitted an application, but due to criticisms from both academic researchers and religious groups about patenting life, the Patent and Trademark Office rejected NIH’s application, and in 1994, NIH withdrew it. (Venter himself left NIH shortly after its initial application in 1991 to continue to search for DNA tags as part of his nonprofit, TIGR, as mentioned. He also formed its for-profit partner, Human Genome Sciences, which notably beat NIH in sequencing the human genome. Its backing came from venture capitalists hoping to profit from drugs and proteins developed from TIGR’s knowledge.)

Despite the NIH’s application not resulting in any patents, the three-year process sparked controversy. It also spurred private companies to apply for patents on their own DNA tags and other gene sequences—some of which were granted in a very liberal interpretation of existing laws (a problem we’ll discuss later in this chapter).

Most important, controversial, and bizarre of all, applications proceeded for patents on DNA tags covering large sections of human DNA where researchers had no idea what was going on—whether the proteins regulated by these bits of DNA did a lot or did nothing. In short, patents were being granted even though the holder of the patent didn’t know what his “invention” did. (As we shall see, that is very significant.)

Writing in Science magazine, Leslie Roberts characterized the ability to file such patents as “a land grab, a preemptive strike that would promote a worldwide stampede to garner patents on essentially meaningless pieces of DNA.” Roberts and others worried that such genetic land grabs would result in scientists hoarding their knowledge in hopes of downstream profits, rather than continuing to cooperate in the worldwide sharing of genetic knowledge that had previously characterized work on the Human Genome Project.

RELIGIOUS CRITICISMS OF PATENTING LIFE

Religious leaders also criticized allowing DNA sequences to be patented, claiming that Chakrabarty failed to understand the symbolism of saying that human DNA could be patented, marketed, and commercialized. The president of the Southern Baptist Convention’s Christian Life Commission emphasized that altering or creating new life forms was a “revolt against God’s sovereignty and the attempt by humankind to usurp God and be God”:

Human beings are pre-owned. We belong to the sovereign Creator. We are, therefore, not to be killed without adequate justification (e.g., in self-defense) nor are we, or our body parts, to be . . . sold in the marketplace. . . . Admittedly, a single human gene . . . is not a human being; but a human gene . . . is undeniably human and warrants different treatment than all non-human genes. . . . Furthermore, the right to own one part of a human being is [all other things being equal] the right to own all the parts of a human being. This right must not be transferred from the Creator to the creature.

As sociologists Dorothy Nelkin and M. Susan Lindee argued, many in religion have come to see human DNA and genes as representing “the social and cultural functions of the soul.” They put it this way:

The gene has become a way to talk about the boundaries of personhood, the nature of immortality, and the sacred meaning of life in ways that parallel theological narratives. Just as the Christian soul has provided the archetypal concept through which to understand the persona and the continuity of self, so DNA appears in popular culture as a soul-like entity, a holy and immortal relic, a forbidden territory.

Notably, this is the same logic that underlies religious resistance to cloning. If DNA is akin to a soul, then copying a genotype of another is inherently evil because it captures the essence of the original and, in making a copy, perverts it.

Of course, these ideas underlie Tomas and the (pre-Henrik) Proletheans’ opposition to cloned humans, and explain why Tomas manipulated Helena into killing the other Ledas: As clones, they were corrupt creations of man, perversions that had to be destroyed. In some sense, too, perhaps he believed they had “stolen” the essence of another living person.

WHY WE HAVE PATENTS, AND WHAT RIGHTS THEY CONFER

To understand what is at stake for the public in patenting DNA tags, it is important to take a moment to consider why we have patent laws in the first place. The two chief reasons for having patents are, first, to reward scientists for discovering new inventions and, second, to promote the general good. The way such inventors are rewarded is by hope of economic gain. Those rewards in turn would encourage other scientists to discover other new inventions that benefit humans.

So strong was the belief that these were good reasons that the founders of American government put them into the US Constitution. Article I, section 8, clause 8 gives Congress the authority “to promote the Progress of Science and useful Arts” by issuing copyrights and patents.

However, it is a common misunderstanding to think that patents confer ownership of the thing patented. No particular thing or class of things belongs to a patentee by virtue of her patent. If Anna owns a bicycle, then that particular bicycle belongs to Anna, but if Mark has a patent on Schwinn unicycles, it is entirely possible that Mark does not own or possess a Schwinn unicycle.

So the DNA tag based on ASCII-coded base pairs that makes Alison or Cosima uniquely identifiable may be patentable, but Alison or Cosima herself is not owned under patent law. What is owned is either (a) the right to create a copy of Alison or Cosima, (b) the process that creates such a copy, or (c) both. More important to Orphan Black, what is owned is the right to the process that makes not just another Sarah or Helena, but another Kira (and whatever valuable information studying her may yield, such as how to replicate her healing stem cells).

Thus, patent rights do not give complete ownership rights, only partial ones. It is also true that just because I have a patent right does not mean I have the other rights commonly associated with a piece of property or idea. Granting someone a patent on a particular human gene or a DNA segment, for example, does not give the holder of the patent ownership of that gene or DNA segment in all (or any) humans. The holder of the patent would not have the right to extract this DNA from anyone who had it.

Finally, an important function of patents is to facilitate the spread of new knowledge. Once a patent application is accepted, its information by law becomes public knowledge. Anyone can go to the US Patent Office and inspect something’s patent to see how it works. Thus, by giving inventors the right to exclude others from making, using, or selling the invention for twenty years (from the date of filing of the application), patents also encourage making the underlying knowledge that led to the invention public.

Thus the Dyad Institute cannot hold patents on DNA tags in the Ledas without making such patents public knowledge—meaning somewhere in some patent office is a public document detailing how and why the Ledas came about, as well as why they claimed creating the Ledas is beneficial to humanity. Otherwise, no patents could have been issued.

THE USEFULNESS OF A THING PATENTABLE

If originally patents were not supposed to be granted on things that occur naturally in the world, but instead on something created or invented, how then can DNA segments be patented? One answer, from a 1997 survey in a law journal:

Although patent claims to naturally occurring DNA sequences might be expected to trigger the “products of nature” rule, courts have upheld patent claims covering “purified and isolated” DNA sequences as new compositions of matter resulting from human intervention. Thus, DNA that has been isolated and sequenced in considered patentable subject matter under Patent Statute.

Even so, there is a further test of patent legitimacy: that the invention has concrete usefulness and isn’t just a theoretical idea. Simple identification or sequencing of DNA segments appears to flatly violate this requirement because knowledge of such segments is valuable only as a research tool, not as a way of making useful products for humans.

This certainly makes us wonder what the creators of the Castors and Ledas truly intended with their cloning project. What exactly was the concrete thing that, to be patented, must have been proven to be useful? Or were the Ledas and Castors patented simply as “research tools”? Based solely on past interpretations of US patent law, that patent would seem almost impossible to obtain (unless somewhere in its application is something about their usefulness that we do not know).

In February 1997, the US Patent Office controversially decided that DNA sequences like the one patented in the Ledas fulfilled the requirement for practical utility because they “were useful for purposes including chromosome mapping, chromosome identification, and tagging genes of known and useful function.” This decision was disputed by scientists working for NIH and in academia, who repeated their claim that such DNA segments were useful primarily as tools to further basic research.

Many bioethicists, including this one, thought the Patent Office made a mistake in allowing patents on human DNA tags, first because the patents were on things that really were products of nature, and second because patents had been granted for things with no known practical utility. It would be like finding a symbol for a new car (at least you think it’s a symbol for a new car) and then filing an application in the US Patent Office for use of that symbol on all cars sold in America, even though you didn’t know if any such cars exist or are planned to exist in the future.

In sum, considering the US Constitution, if the goal of granting of patents is to promote “Science and the useful Arts,” then such promotion should occur through specific products and inventions, not monopolistic control of merely possible future products and inventions. Bioethicists and academic scientists have argued that patenting DNA sequences restricts the free exchange of ideas about genetics. In this particular case, the eagerness of the Patent Office and government to help Big Biotech backfired; it provoked an outcry from bioethicists and scientists working independent of Big Pharm and Big Biotech.

WHY PATENTS ON DNA FRAGMENTS ARE VALUABLE

Patents on DNA fragments like ESTs are valuable in different ways. Most obviously, the holder of the patent can sell his right to a research company that might use it to develop midstage products like medicine or a diagnostic test for a disease associated with the DNA segment, or to reproduce the DNA segment. For example, the biotech company Amgen obtained a patent for a gene sequence that governed the creation of a protein missing in the blood of people in renal failure (and hence on hemodialysis, a process that cleanses the blood of people with failed kidneys). Through licensing companies to make this protein, Amgen earned $400 million in 1991 alone. And so far, this is mainly how holders of patents on DNA sequences have made money.

Let’s take the example of patients who want to test for genes predisposing them to breast cancer. Patients (and their doctors) want complete results; they do not want to be told that a test can tell them they don’t have half the known genes for breast cancer, but it’s too expensive to test for the rest. This means that whoever controls a patent on a particular DNA fragment associated with breast cancer can effectively control all tests by charging a large fee for the DNA fragment’s usage. Anyone who wants to develop innovative therapies based on those tests must also pay for use of the patented gene, increasing the money that can be made.

In Orphan Black, Helena and Kira obviously possess remarkable powers to heal themselves after injury. Helena is stabbed through her stomach with a steel rod but manages to recover; Kira is hit by a speeding car, taken to the hospital, and soon emerges unscathed. Whatever allows them to do this could possibly be the key to extended life and even immortality, so we are talking about something very valuable—in other words, something big corporations would scramble madly to patent, control, and sell. Because Dyad or Topside owns the patent on creating Helena’s DNA—and on creating the half of Kira’s that came from Sarah—one of the companies could stand to make quite a bit of money one day in the future . . . especially if any DNA sequence that gives them their healing abilities was human made and not naturally occurring.

SUPREME COURT MODIFIES CHAKRABARTY

In 2013, the US Supreme Court ruled in Association for Molecular Pathology et al. vs. Myriad Genetics that human genes for breast cancer were naturally occurring and therefore could not be patented. However, they maintained, new DNA sequences and tags for them could still be patented, especially if something new was created that did not previously exist in nature.

Previously, under a patent it was granted for its discovery of two genes that cause breast cancer, Myriad Genetics blocked downstream tests for breast cancer. Any researcher or doctor wanting to test a woman for those genes had to pay substantial fees to Myriad.

So essentially the Court ruled that although human-made human DNA sequences are patentable, naturally occurring human genes are not, and those who discover such genes (and what they do) cannot patent those genes in a way that blocks others from access to those genes or tests for such genes.

Based on this most recent ruling, could DNA sequences of a Leda be patented in real life? On the one hand, insofar as the Ledas have the same DNA as their ancestor, Kendall Malone, their DNA is naturally occurring and would not seem to be patentable. However, as we have seen, small differences in contributions of mitochondrial genes in the egg that hosts the clone’s nucleus and, as we’ll discuss in future chapters, differences in gestation and forces that act on the expression of genes, could easily make the DNA of the Ledas different than Kendall’s, and moreover, make unique the DNA of each Leda. Obviously, because Sarah and Helena can bear children, something about them is different compared to their sestras. Finally, their unique DNA is, in a profound sense, “human made” and not natural, so it might be eligible for patent protection.

On the other hand, a precedent against patenting human beings has already been set. Around 1997, activist Jeremy Rifkin and New York Medical College biology professor Stuart Newman filed for a patent on a human-animal chimera composed of 51 percent animal DNA and 49 percent human DNA. Although they had not created such a chimera, did not know how to do so, and did not intend to do so, none of that is necessary to get a patent. Moreover, the Patent Office was already issuing patents on DNA sequences from animals and humans for which the filers were similarly ignorant.

The application was a reductio ad absurdum attempt to test the boundaries of how much human DNA could be patented. Of course, the application created a crisis in the Patent Office. To keep politics out of patents, the Patent Office cannot legally reject a patent on moral grounds. Ultimately, although the Patent Office had previously granted patents on smaller sequences of human DNA, this application was rejected for being “too human”—even though it is not clear that the Patent Office had the legal right to reject the application in this way.

So could the Leda and Castor clones’ DNA be patented in the real world? Well, that partly depends on how the various courts in the United States and Canada, including their highest courts, fine-tune their previous decisions. It is predictable that they would allow a patent on a cloned, prized dairy cow, one that produces eighty times the milk of a normal cow. It is much less obvious that a similar patent on producing a superior human being would be possible.