Pardon My Patent

By Lazar J. Greenfield, M.D.

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How well do you know the Incyte Corp.? You really should get to know it, because it owns the commercial rights to the gene for one of your histamine receptors. What about the gene that controlled your spinal cord development? Harvard owns the rights to that one. In fact, as of 2005, the U.S. Patent and Trademark Office had issued patents to corporations, universities, government agencies, and nonprofit groups for about 20% of the 23,688 genes that constitute the human genome (Sci. Am. 2006;294:76-83). "Wait a minute," you say. "How can someone own property rights on something they didn't really invent?"

The story goes back to 1972, when a General Electric microbiologist named Ananda Chakrabarty, Ph.D., filed for a patent on a single strain of Pseudomonas that could break down oil slicks more efficiently. He had inserted plasmids from other strains rather than alter the DNA, since recombinant splicing methods were not yet available. The patent office rejected the claim, but by the time of the appeal in 1980, molecular biology was in high gear with DNA techniques capable of synthesizing interferon. Congress had passed the Bayh-Dole Act, which allows universities to license technology they have patented, and then the Stevenson-Wydler Act, which allowed the National Institutes of Health and other federal agencies to do the same.

The Supreme Court heard arguments from Genentech Inc. and universities in favor of the patent while several activist groups predicted environmental disasters and protested what they called the commodification of life. The court ruled 5-4 that Chakrabarty's "product of human ingenuity" was patentable, as was "anything under the sun that is made by man," (Diamond v. Chakrabarty, 447 U.S. 303, 1980).

Patents subsequent to this landmark case tended to follow the precedent established for chemicals; for example, a patent on a cloned gene and the protein it produces granted the owner exclusive rights to market the protein, as with insulin or human growth hormone. But technology pushed the analogy with chemistry aside when researchers started filing patents for expressed sequence tags (ESTs)--short segments of DNA that can be used as a probe to fish out the full-length gene from a chromosome. Numerous researchers filed patents for ESTs without knowing the biologic function of the gene. Their rationale was that ESTs could serve as research tools, but this raised concerns that patent owners would demand that other researchers license the tools, potentially restricting the development of new diagnostics and therapeutics.

The pool of knowledge that scientists share freely includes abstract ideas that have not been considered patentable. Because the ESTs that are used to locate genes exist in a database rather than in a laboratory, they exist as information rather than as the "processes, machines, manufactures, and compositions of matter" that are defined as categories eligible to be patented. It is unreasonable to think that patent infringement would occur if common information were used in the course of medical research. So in 2001, the patent office issued guidelines requiring examiners to look for "a specific and substantial utility" in granting biotech patents. The U.S. Court of Appeals for the Federal Circuit upheld this last September when it denied Monsanto Co.'s application for a patent on five plant ESTs that would have given the company "a hunting license because the claimed ESTs can be used only to gain further information about the underlying genes," (In re Fisher, No. 04-1465 [Fed. Cir. Sept. 7, 2005]).

After the "utility" guidelines were issued, the number of patent applications involving nucleic acids--which peaked at 4,500 in 2001--declined substantially.

In November 2005, the National Academy of Sciences reported on a survey of 655 investigators on the effects of life patents. The survey found that only 8% of the investigators in the previous 2 years had research that involved patents held by others; 19% did not know if there was overlap; and 73% said they did not need to use others' patents. But there is still concern about intellectual property barriers; indeed, Myriad Genetics Inc. has already used its patents to stop cancer centers from developing cheaper tests for the breast cancer genes BRCA1 and BRCA2.

Our specific willingness to patent life--as demonstrated by the 1988 patent for the Harvard OncoMouse, which carries a gene for developing cancer--has not been upheld in other countries. The Supreme Court of Canada rejected the OncoMouse patent, and the European Patent Commission narrowed its interpretation.

This summer, the U.S. Supreme Court let stand a patent for the correlation between an elevated homocysteine level and a deficiency of two B vitamins (Laboratory Corporation of America v. Metabolite Laboratories, Inc., 548 U.S., 04-607, [Fed. Cir. June 22, 2006]). Metabolite holds the patent on the technique for measuring homocysteine and licensed it to LabCorp, which paid fees to Metabolite until it found a better test by Abbott Laboratories. Lower courts upheld the right of Metabolite to continue to get fees on the alternative test, as well as its claim for control of doctors' efforts to use the correlation to diagnose vitamin deficiencies in a patient.

In an unusually detailed dissenting opinion, Justice Stephen Breyer pointed out that the correlation is a "natural phenomenon" ineligible for patient protection. It seems clear that he is providing a road map for another case to reverse this claim on physicians' thought processes.

But for now, you infringe the patent just by reading the test and thinking about the relationship, and LabCorp is guilty of inducing doctors to infringe the patent by advertising the test and educating them about the correlation.

Had any patentable thoughts lately?

Dr. Greenfield is professor of surgery and chair emeritus at the University of Michigan, Ann Arbor.

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