With a contentious case over patenting human DNA sequences back in court, we look to the history of radio for a creative approach to domain over the building blocks of people.[Carsten Reisinger/Shutterstock]
The issue of whether or not we can patent people -- or, at least, the genetic sequences that comprise them -- returned to federal court last week. This comes after two lower courts gave conflicting decisions: one striking down gene patents completely, followed by a higher court partially upholding them. Now an even higher appeals court is trying to sort things out.
The question before the U.S. Court of Appeals for the Federal Circuit is whether a company, university, or individual can patent sequences of DNA. These are the codes that influence everything from disease risk to the color of your eyes. Are these lines sub-microscopic Ts, Cs, Gs, and As coiled inside of our cells naturally occurring and therefore unpatentable?
On the "let's patent" side is Myriad Genetics, which claims patents on several genes that are associated with an increased risk for breast cancer. The health-care company is supported by most of the bio-pharma industry. On the opposing side are the American Civil Liberties Union, several research institutions and individual researchers, and the Obama administration (which filed a friend-of-the-court brief supporting the anti-patent position).
At stake are thousands of patents already issued over the past 20 years by the U.S. Patent and Trademark Office. Biomed companies insist that patents are vital to developing new drugs and diagnostic tests. Without owning genes associated with disease and other traits, they say, no one will invest the millions needed to create new products.
This represents some narrow thinking, however, by the pro-patent people. Indeed, efforts to fit the ownership of DNA into a system established over two centuries ago -- long before molecular entities like genes were even dreamed about -- are like trying to put a round peg in a square hole.
What's needed are more creative solutions to the need for companies to have some exclusivity to bits and pieces of DNA, while acknowledging that genes are in fact naturally occurring.
The ACLU contends that Myriad has made it difficult for outside researchers to study the breast cancer genes, or for patients to get second opinions. The company is also allowed under patent law to charge what they want, pricing their test at $3,000 despite dramatic reductions in recent years in the costs of sequencing DNA.
In a 2010 column I wrote for Fortune, when the original case was being argued before the lower court, I suggested one out-of-the-box idea. It was based on a remarkably similar case that occurred over a century ago when scientists and inventors stumbled on the existence of another spectrum that existed in nature but had been unknown until discovered by scientists.
This spectrum is the pattern of electromagnetic waves that provide us with frequencies for everything from text messages and YouTube videos to the latest sounds of Adele on the radio.
When that earlier spectrum was discovered by the likes of Samuel Morse, Guglielmo Marconi, and Thomas Edison, they and others claimed ownership of radio bandwidths just as Myriad does for certain stretches of DNA on the human genome.
Inventors in that long-ago day argued that not only had they made the discoveries, but also that without ownership investors might not spend money to develop businesses and products that depended on stable and exclusive access to frequencies. Samuel Morse, inventor of the telegraph, even tried to patent what amounted to the entire electromagnetic spectrum.
In 1853, the U.S. Supreme Court rejected Morse's claim, though it took decades of arguing and confusion before Congress decided that patents weren't the way to think about radio waves. Passing the Radio Act of 1927, lawmakers decided that the radio spectrum belonged to everyone, and created the Federal Radio Commission (later the Federal Communications Commission) to regulate it by leasing frequencies to companies that were required to follow certain rules.
It would be worth seriously considering such a public trust option for genes, too. Treating them like we do frequencies on the radio dial would mean that sections could be licensed, with lease holders required to follow certain rules. These might include allowing researchers and patients reasonable access, and requiring that pricing be in line with costs.
Another reason to think creatively is that genetics is still in its early stages as a science, and is likely to go through a number of changes as fresh discoveries are made. Already the notion that one gene marker can best determine a person's risk for a common disease is becoming outmoded.
The latest science suggests that risk factors for maladies such as diabetes are increased by the interaction of dozens -- or even hundreds -- of genes and other molecular structures in the body. A legal system that patents individual genes despite what may actually be a network of multiple genes working together could be shortsighted and chaotic, and might even impede future research.
Legal experts have been expecting Myriad v. ACLU to reach the Supreme Court eventually. However, earlier this year the high court heard a similar case about patents held by a company called Prometheus for a test that detected and measured levels of a chemical in the blood. The result can tell a patient if taking a class of drugs for gastrointestinal disorders is safe.
In a rare unanimous ruling the Supreme Court said no to the patent, arguing that the test measured a naturally occurring substance.
This may affect the Myriad case in the current appeals court case -- or it may not.
Whichever way it goes, let's hope that the biopharma industry and other key players will be as creative in structuring a legal system for the age of genetics as they've been in coming up with the science itself.