In a closely watched case, a federal appeals court ruled on July 29, 2011, that genes can be patented, overturning a lower court decision that had rocked the biotechnology industry. It appears that companies can now patent human genes, at least if the genes are “isolated” and not “a product of nature.”
The Court of Appeals for the Federal Circuit, which specializes in patent cases, said that Myriad Genetics was entitled to patents on two human genes used to predict if women have an increased risk of getting breast and ovarian cancer. The court ruled that while natural DNA cannot be patented, DNA isolated from the body was eligible for patents because it was “markedly different” in its chemical structure from DNA that exists inside the chromosomes in the body.
A coalition of physicians, medical organizations, researchers, genetic counselors, patients, the American Civil Liberties Union, and health advocates challenged the legality of Myriad’s patents, arguing, among other things, that the genes occur in nature, i.e., they are in everyone’s DNA. The District Court agreed with the plaintiffs. But, in a 105-page decision, the appeals court found that “the molecules as claimed” — the “isolated DNA” — in fact “do not exist in nature.” Because the genes are separated from surrounding biological materials, the DNA is patentable, Judge Alan Lourie wrote. (Judge Lourie has a Master’s degree in organic chemistry from the University of Wisconsin, and a Ph.D. in chemistry from the University of Pennsylvania).
Myriad argued an isolated DNA molecule is patent eligible because it is “a non-naturally occurring composition of matter” with “a distinctive name, character, and use.” The court agreed, saying that the composition of molecules in their isolated state is “markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature.” “It is the difference between knowledge of nature and reducing a portion of nature to concrete form, the latter activity being what the patent laws seek to encourage and protect.”
Further analysis would indicate this decision makes sense. Under the Patent Act, “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C. § 101. Any new and non-obvious (“inventive”) use of pre-existing things is patentable. Any new and non-obvious (“inventive”) modifications to an existing thing is also patentable. But, you can’t get a patent on things that occur naturally.
So, natural genes are not eligible for patenting, but artificial preparations of DNA molecules are, because they have new qualities that distinguish them from natural genes. Like other chemicals that are derived from nature (such as antibiotics or natural dyes), preparations of DNA molecules are patentable because they have been transformed through human intervention into something that is so different from the natural state as to qualify as new, useful, and man-made.
It seems that what Myriad has done is to develop new qualities, advantages, and technical applications that allow the molecule to be used in a new way that is not possible with the natural gene. It requires the same level of human ingenuity as synthesizing a new chemical, composing a new metal alloy, or other human creations that are commonly deemed patentable.
The U.S. Patent and Trademark Office (PTO) has already granted thousands of patents on human genes. It is estimated that nearly 20 percent of human genes are patented.
Nevertheless, this court decision is controversial and is drawing comment from across the blogosphere. For now, it seems the question of whether companies can own part of the human genome may not be decided for years, until the case makes its way to the U.S. Supreme Court.