Since When Can You Patent A Gene?

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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.”

Before 1980, at the Patent Office, “We were under the impression that life isn’t patentable.”

As for nonobviousness, 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.