The Wearing of Designer Genes

Discovery is expensive, often risky and frequently with little or no guarantee of success. While the Native Americans were decimated by European efforts to “discover” their world, the Spanish crown massively invested and the crews of Christopher Columbus’ three ships took incredible personal risks in their quest to find a new passage to the spice rich “Indies.” What they found instead altered civilization. And yes, such explorers had the strong habit of claiming “new lands” for the nations who commissioned their journey. These nations “owned” the results of such voyages and explorations, often warring with themselves, ignoring the indigenous peoples, over the boundaries of their discoveries.

I use the word “discovery” very carefully to distinguish it from “invention.” While the captains and crews manning these sailing ships re-mapped our planet, there are modern explorers equally obsessed in mapping the huge – the universe “out there” – and the incredibly tiny – genomic microcosm that defines every living creature, and in particular, human beings. They aren’t inventing anything, except perhaps the tools of their exploration, but their efforts are expensive and lifetime-consuming. They have spent small fortunes to generate the educational skills just to get them in the door and dedicated themselves to finding the unknown. Private companies, seeking a greater understanding of the human anatomy in order to design new pharmaceuticals and treatments for the litany of ailments that kill us every second, have borne more than a small part of the cost of this investigatory quest.

Which brings us to the issues of who owns information about “stuff” that wasn’t invented, only “found”? Is there any level of “exclusivity of use” for those who have invested the time and effort? Is there a return on investment for the effort? Put another way, do you believe it is appropriate for the scientists (and the companies that funded them) who discover “stuff” about your own body exclusively to control the use of that information for at least the duration of an American patent for their profit? Even if that knowledge becomes so expensive to access that many people cannot afford the payment that may be required to save or improve their lives? About their own bodies?

The United States Supreme Court is currently addressing that issue. The case (Association for Molecular Biology vs. Myriad Genetics, Inc.) “involves patents held by Myriad Genetics on two human genes, which, when mutated, give a woman a high risk of getting breast or ovarian cancer. The patents give Myriad a monopoly on testing for these mutations, a highly lucrative business.” New York Times, April 14^th. The issues are very clear: “Opponents of gene patents say no company should have rights to what is essentially part of the human body. They contend that Myriad’s monopoly has impeded medical progress and access to testing — in some cases denying patients their own genetic information.

“Myriad and its allies in the biotechnology industry counter that a ruling that invalidates gene patents would upend three decades of patenting practice and undermine billions of dollars of investments to develop not only genetic tests but also biotech drugs, DNA-based vaccines and genetically modified crops… Myriad and allies argue that patents can and have been granted on products derived from nature — like the immune-suppressing drug rapamycin, which comes from a bacterium — as long as sufficient inventiveness is involved.” NY Times.

The answer may reside in a statutory alternative that rewards “discovery” with some sort of compulsory licensing determined by an appropriate tribunal – differentiating expensive and complex efforts focused on “discovery” from “inventions” – but that is a legal tool that is not available to the Supreme Court. The Court is relegated to deciding if patents are appropriate for such discoveries.

Myriad’s case has sustained two efforts before United States Court of Appeals for the Federal Circuit by a 2 to 1 margin, reversing a New York federal trial court, denying the patent, that held the relevant “isolated DNA was the same as DNA in the body in what really mattered — the genetic information it carries.” You can understand both sides of this argument very clearly. What, after all, is the motivation of private industry to explore and discover if they cannot recoup the cost of their efforts and generate a rate of return? Yet there is something galling about patenting information about our own bodies.

The genomic mapping of the human body – known collectively as the Human Genome Project – was the result of a massive government and privately funded efforts. It involved a number of private entities agreeing collectively tocontribute their very costly efforts into a single database that was free to all. The value: without access to the entire map, the ability to create new cures and new treatments became overwhelmingly frustrating and complicated. This collective response was a benefit to all. Whatever the result of the Myriad case, it will be incomplete, frustrating and imperfect, but the future of medical research now resides with the Court.

I’m Peter Dekom, and I wonder how you feel about this complex issue.