Since When Can You Patent a Gene?

By the time you read this, the race to decode the entire human genome—transcribing the DNA that makes us what we are—will be over. The race has been a two-way contest between the Human Genome Project, a public consortium coordinated by the U.S. government, and the Celera Corporation, a private business, and its finish will complete one of the great breakthroughs in human scientific knowledge. As the race has progressed, hundreds of patents have been awarded, and thousands more applied for, on human genes, the essential units of information in the genome.

How can this be? How did we get from a patent as protection for an invention like a cotton gin or a steam engine to a patent as ownership, in effect, of the basic chemicals that keep us alive? You must know the answer to that question to understand the controversies over the patenting of genes.

The story begins with the Constitution, in which the framers gave Congress the right “to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” That meant trademarks and patents respectively. Of the three longstanding basic criteria for patentability —that an invention must be new, useful, and nonobvious—the first two go back to those beginning years.

Just how new an invention had to be took a long time to be settled. In 1850, the Supreme Court threw out a patent on a doorknob made of porcelain rather than wood, arguing that although the idea was clearly new, it lacked “that level of skill and ingenuity which constitute an essential element of every invention.” It would have seemed undeniable, then, that you couldn’t patent a product of nature, which depends on no human ingenuity. Indeed, this was confirmed in 1928, when an appeals court rejected General Electric’s attempt to patent tungsten, for that very reason.

In fact, for a long time, the demand for novelty kept getting stricter. In 1880, Supreme Court Justice Noah Swayne ruled that a patentable invention must involve a “flash of genius,” a standard that long held, even though no one knew exactly what it meant. In 1950, Justice William Douglas, ruling on a supermarket checkout device, set the bar almost impossibly high. He wrote that a patent must “push back the frontiers of chemistry, physics, and the like.…The Constitution never sanctioned the patenting of gadgets.” That would have surprised anyone who had spent time among all the old patent models at the Smithsonian.

A new patent law in 1952 helped clear the air Douglas had clouded, introducing the concept of nonobviousness. Since then, an invention has had to be not only new in the most basic sense but also not “obvious at the time the invention was made to a person having ordinary skill in the art.” This has led examiners to think in terms of a hypothetical Mr. Phosita, for “person having ordinary.…” Would he have thought of the thing? If so, it can’t get a patent.

Over the years the realm of what gets invented has broadened enormously. At first inventions were mostly mechanical; the idea of patenting living things first took hold when the Plant Patent Act of 1930 was passed, permitting commercial monopolies on new asexually reproduced varieties, and was reinforced by the Plant Variety Protection Act of 1970, extending protection to sexually reproduced plants as well. But these were a new, limited kind of patent that said nothing about invention, unlike the traditional “utility” patent of the sort that covered the light bulb, the telephone, and now the gene.

On the road to patenting genes, the big turning point was a decision of the U.S. Supreme Court, Diamond v. Chakrabarty , in 1980, interpreting the patent law of 1952. The Patent Office does not set policy; it administers policies decreed by Congress, and as in so many other areas of life, Congress is often vague, evasive, or behind the times, leaving the courts to step in and decide how the law applies.

Chakrabarty was a microbiologist for General Electric who developed a new hybridized bacterium that would eat petroleum, to clean up oil spills. The Patent Office refused to give it a patent; as John Doll, the office’s director of biotechnology, puts it, “We were under the impression that life isn’t patentable.” Chakrabarty appealed all the way to the Supreme Court. In a five-to-four decision, the Court ordered that the patent be issued.

The Patent Act of 1793, written by Thomas Jefferson, had authorized a patent for “any new and useful art, machine, manufacture, or composition of matter, or any new or useful improvement [thereof]” the current 1952 law kept the exact same wording except for the change of “art” to “process.” Chief Justice Burger, in his majority opinion, held that the bacterium was clearly a new, manufactured composition of matter and not anything that existed in nature. As for the argument that Congress had never foreseen the patenting of genetic technology, he replied that Congress had never foreseen any invention—and couldn’t, since inventions must be new.

The Court arrived at its decision right when genetic technology was starting to speed way up. When a patent for a much more complex organism was applied for, the Patent Office again balked, rejecting a genetically engineered oyster—“a higher level life form, a bunch of steps down the road from Chakrabarty’s bacterium,” as Doll says. The Board of Patent Appeals and Interferences threw out that rejection in 1987, largely on the basis of Chakrabarty . The Patent Office was then forced to issue a statement that it “now considers nonnaturally occurring nonhuman multicellular living organisms, including animals, to be patentable subject matter.”

The implications were confirmed the next year, when a patent for a mammal was granted, for the Harvard Mouse, an unhappy rodent altered to contain a human cancer-causing gene. And if a whole mammal was patentable, then a part of one must be too. So the only thing preventing genes from being patented was the requirement that they be new, useful, and nonobvious.

That first necessity might sound impossible, but what gets patented as a gene actually has enormous differences from what’s in your body. Most of the genome, which cannot itself be patented, is white noise or instructions for using genes; a patented gene has had all that extraneous material meticulously winnowed out and has been reassembled and made artificially in a lab. As Doll explains it, “a gene or a gene fragment in nature is part of a very large organic polymer. Man has reached in and taken one small piece, isolated it, and purified it, and at this point it’s a compound not much different from an unorganic polymer.” It is now clearly something new that does not exist in the same form in nature.

What about usefulness? “The burden is on the Patent Office to find non-utility,” Doll says. “You get a patent unless we can tell you why you don’t deserve one, why it doesn’t meet a statutory requirement.” The Patent Office applies three criteria for usefulness: First, the utility must be specific, not shared by many other things of the same class—that is, you must know what a gene does that others don’t do. Second, it must also be substantial. As Doll says, “You can’t say you’re going to make a protein for dog food from the DNA.” Third, the use must be credible. “If you claim you’ve got a cure for AIDS,” Doll says, “we won’t accept that without a certain amount of evidence, given the state of the prior art.”

As for non-obviousness, the Patent Office looks to Mr. Phosita, as with any patent. Among other things, this means that you can get a new patent on an already patented gene if you find a use for it that wasn’t obvious before—just as a new patent was granted for Minoxidil when someone discovered that it could not only lower blood pressure but also make hair grow.

If the history of patent law makes clear why people can patent genes, that still leaves two unsettling questions: Isn’t it morally wrong to, as the activist Jeremy Rifkin put it, “convert the genetic blueprints of millions of years of evolution to privately held intellectual property”? And isn’t it wrong to monopolize any information so medically invaluable?

The first question is the far simpler of the two. If you grant that what is being patented is not what exists in nature, and that by being extracted and purified and manufactured it is made medically useful for the very first time, then it is a medical development as original and valuable as any, and its pursuit is as worthy of the encouragement of the patent system as any.

The problem of having such precious information monopolized is more difficult, but it’s also as old as the patent system itself. After all, the whole idea of the system is to make a tradeoff. The recipient gets the right to prevent other people from using his or her invention for twenty years; society gets all the details of the invention, as laid out in the patent itself, and gets the increased number of inventions that people produce knowing they have a chance to profit from them. In the long term, patents have been a great spur to invention—just as the hope for temporary monopolies has been a big spur to the speedy decoding of the genome. But the price is paid in the short term, and always has been.

Back in July 1788, soon after the Constitution was ratified, one founding father found that price entirely too high. “The benefit even of limited monopolies is too doubtful to be opposed to that of their general suppression,” Thomas Jefferson wrote to James Madison. But he came around. Two years later, as Secretary of State, he was one of the nation’s three first patent- examiners.