Ethics and Gene Patenting

If you bring up the topic of gene patenting with a group of scientists, they are likely to talk about what impact limiting access to DNA sequences will have on research. A similar conversation with lawyers may provoke debate about the utility or inventiveness of particular patent applications. But raise the question of granting intellectual property rights over pieces of the human genome in any gathering of regular folks, and the initial response is probably going to be, "Yuck."

Intellectual property attorney William L. Anthony Jr., a partner at Orrick, Herrington & Sutcliffe LLP, frequently discusses these issues with jury focus groups. At a recent conference, "Patenting Human Life," held at Santa Clara University, Anthony described his experience: "Almost invariably, if I talk about patenting something that has to do with human beings, the first reaction is revulsion."

While it may be tempting for people in the biotechnology field to dismiss this response as untutored, it points to a significant ethical issue that should be of concern to people at all levels of scientific and legal understanding: There is something about the human genome that is different from other subjects of patent application, and the difference is encapsulated in the adjective. Human DNA symbolizes something essential about humans themselves, and, as such, raises the issue of human dignity. While we may be able to respect that dignity and still offer the intellectual property protections crucial to drug development, it is unwise to ignore widespread public concern about how we deal with the building blocks of human life.

Dignity was just one of the ethical issues raised at the "Patenting Human Life" conference, sponsored by SCU's High Tech Law Institute and Markkula Center for Applied Ethics and the Bay Area Bioscience Center. Other ethical questions included: What system of intellectual property protection would produce the best therapeutics and so improve human well-being? And what system would come closest to ensuring that these discoveries are accessible to all who need them?

Dignity

When the average person expresses reservations about patenting DNA, they are often reacting to the idea of owning something fundamental to human personhood. A lawyer would probably respond that a patent doesn't confer ownership. John Barton, professor of law at Stanford University , described intellectual property protections as "a set of statutory exclusion rights." In other words, the holder of a DNA patent does not own the gene sequence; he or she simply has the right, for a limited period of time, to prevent others from using it.

True, but not enough to entirely moot the concern over dignity. Patenting DNA still suggests to many that human genes are commodities. It's an equation that troubled Suzanne Holland, associate professor of religion at University of Puget Sound and affiliate associate professor in medical history and ethics at the University of Washington School of Medicine. "Biotechnology products are not widgets," she said. Holland worried that patenting genes may "erode our dignity, as the process results in increasing acceptance that it's okay to buy and sell things that speak to us of our humanity."

Of course, there are those who believe that humans don't deserve any specially protected status and that such dignity concerns reveal a sort of hubris. In his conference keynote, Rigel Pharmaceuticals President Brian Cunningham sounded this note: "It seems to be okay to patent every animal in the zoo but us, a reflection of our need to believe that we are special-not part of the continuum of nature."

Margaret R. McLean, director of biotechnology and health care ethics at the Markkula Center for Applied Ethics, took a middle view. While accepting the basic notion that humans "ought not to be used," she allowed that patenting DNA "doesn't necessarily imply commodification of human persons." The trick, McLean argued, is to distinguish between genetic identity and personal identity. "A human is more than the sum of his or her genes," she said. In discussing the patent issue, we must be careful not to suggest that humans can be reduced to a piece of code, she continued, which would indeed be an assault on dignity.

Promoting Human Health

While patenting DNA runs the risk of diminishing respect for human dignity, some risk might be acceptable if the end result were an increase in human well-being. Most people in the biotechnology industry start with this understanding and proceed to the instrumental ethical question: If the goal is to improve human health by the creation of diagnostics and therapeutics, does the patent system help to achieve that goal?

There was almost universal agreement among lawyers and biotech professionals at the conference that some form of intellectual property protection was necessary to encourage investment in the development of new drugs. Investors will not put money into a company without evidence that the firm has secured protection for its intellectual property, Sue Markland Day, president of the Bay Area Bioscience Center, argued. As an example, she cited the plunge in biotech stock prices when Former President Bill Clinton and British Prime Minister Tony Blair issued a joint statement March 14, 2000, which was interpreted to advocate limits on gene patenting. "Patents," Markland Day said, "are the lifeblood of biotechnology."

That does not mean that people in the biotech industry want to ignore the ethical dimension of gene patenting, simply that their ethical questions tend to be not "Whether to?" but "How to?" Thane Kreiner, vice president for corporate affairs at Affymetrix, posed the issue this way, "It's not a question of whether patents are right or wrong, but where to set the bar."

Kreiner was referring to the guidelines for patentability and how they are applied to biotechnology. There are three key criteria in this regard: novelty, inventiveness, and usefulness. As the United States and other signatories to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) evaluate whether to grant patents on gene sequences, they must decide whether to apply these standards stringently (that is, to set the bar high) or loosely (to set the bar low). A high bar might require, for example, that applicants state the specific utility of a sequence and include evidence that the gene actually does what the applicant claims. A low bar might allow applications to rest on the theoretical possibility that a gene might have a certain utility.

The issue is complicated by the fact that the science is in such rapid flux. The discovery of a sequence that might have represented considerable novelty and inventiveness in the 1990s-such as the connection of the BRCA1 gene with breast cancer-might be less impressive now that technology has made it much easier to identify disease susceptibility genes.

Another complication has to do with the scope of the patents. Many applications have been filed for fragments of genes-ESTs and SNPs-and it is unclear whether patents on these fragments extend to uses of the entire gene.

These were among the issues that troubled Stanford's Barton, who was a member of the roundtable that produced the Nuffield Council on Bioethics report on the ethics of patenting DNA. That roundtable concluded:

In general, the law has, in our view, tended to be generous in granting patents in relation to DNA sequences. Not only are many of the patents broad in scope, but they have been granted when the criteria for inventiveness and utility were weakly applied. Many of these patents are broad because an inventor who successfully makes a claim in relation to a DNA sequence will, in effect, obtain broad protection on all uses of the DNA, and sometimes the proteins which the DNA produces.

What does all this have to do with ethics? If the bar for patentability is set too low, it will pervert the incentive structures of the patent system, which should reward new inventions that increase human well-being. Patent holders who may have contributed very little to the understanding of the gene or its function will have too much control over its use in research and development. Especially in the area of genetics, where more than one gene may control a disease process, a company that wants to develop therapeutics may need to buy licenses from multiple patent holders. That, Kreiner argued, could make research prohibitively expensive.

If the bar is set too high, on the other hand, pharmaceutical and biotechnology companies will not put the vast sums necessary into research because they will have no way of protecting their investment. "The patent system doesn't exist to pin a badge of appreciation on the inventor," Anthony said, "but to encourage ordinary people to invest in something that might do some good."

Accessibility

Proper setting of the bar may promote the creation of therapeutics that have the potential to improve human lives. But the ethical story does not end there. Sometimes, our patent policies produce good medicines that are simply too expensive to reach all of the people who need them.

Many who work in biotech agree this is a problem but argue it is not their problem. A company, they point out, is not a philanthropic institution. It exists to make profits. But to raise the issue of accessibility is not to suggest that industry should solve the problem on its own. Industry, however, needs to be part of the discussion, which might begin with an exploration of distributive justice: How can benefits-in this context, therapeutics-be allocated fairly.

One criterion of fairness says that those who have contributed to the creation of the benefit should have a share in it. Usually, there has been some public contribution to successful drug discovery. Of the 50 best-selling drugs in this country, 48 benefited from public money, according to Holland. In the case of genes, the public has certainly contributed to the knowledge base that is producing innovations through government funding of the Human Genome Project and other scientific endeavors. By that measure, the public is entitled to expect some access to the fruits of genetic research.

Can the patent system be adjusted to spread the fruits more widely? Not without tradeoffs, said June Carbone, Presidential Professor of Ethics and the Common Good at SCU and one of the conference organizers:

The real public policy question is whether we want:
a) the existing system, which places a premium on the development of life-saving drugs, even if they are so costly they cannot realistically be made available to everyone;
b) greater redirection of government-subsidized research toward products of more general utility or accessibility, even if that means the development of some life-saving drugs will be delayed or discouraged; or
c) dramatically higher overall public health expenditures.

These public health decisions have important implications for the common good. Physical well-being is not solely an individual matter. For example, we all rely on the public provision of clean water and sewage systems to protect our health. We handle serious infectious disease risks by offering vaccines to everyone because a policy that provided protection only for those who could afford it might eventually harm everyone.

Gene patenting needs to be seen within this common good context, McLean argued. If, as a society, we develop patent policies that direct research only to the development of expensive drugs, we may ultimately bankrupt the health care infrastructure on which we all rely.

Finally, as we think about patents and access, we must invoke the old-fashioned virtue of compassion. Do we really want to be the kind of people who restrict the access of the poor and the uninsured to life-saving therapies? Holland proposes this litmus test for patenting DNA: "What does it do for the most vulnerable members of society?"

These ethical issues might be addressed in any number of ways. We could support government programs that provide DNA-based therapeutics to the underserved. We could support industry efforts, such as the Genentech policy described by Brian Cunningham, through which the company put aside a portion of its profits from Human Growth Hormone to provide the therapy for any child whose family could not afford it. We could force companies to license patents so that research could be expanded and cheaper therapeutics developed.

The resolution of all these ethical dilemmas is limited only by our moral imagination. The only thing we can't do is ignore the ethical dimension of patenting human life.

Miriam Schulman is the director of communications for the Markkula Center for Applied Ethics.

This article originally appeared in the January 2003 issue of BioProcess International (www.bioprocessintl.com) and appears here courtesy of that publication.