Since When Can You Patent A Gene?

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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.