Scott Forsyth, The Daily Record Newswire
Monday, April 15, the Supreme Court hears oral argument in a patent dispute, a matter which does not often make its way to the Supreme Court. Even rarer, the ACLU is representing the challengers of the patents, a collection of medical researchers, cancer patients and patient advocates. The issue touches all — the patentability of human genes, Association for Molecular Pathology v. Myriad Genetics, 689 F.3d 1303 (Fed. Cir. 2012), cert. granted, 133 S. Ct. 694 (Nov. 30, 2012) (No. 12-398).
The main respondent is a biotechnology company by the name of Myriad Genetics. It holds patents on the BRCA1 and BRCA2 genes, which are found in every human body.
Through a complicated process, Myriad was able to isolate the genes from their host chromosome. The isolation was not a first, but the company was the first to apply for a patent on the isolated genes, back in the mid 1990s. The U.S. Patent and Trademark Office has regularly issued patents on genes and it did so again.
The patents on the genes are very broad, extending to the genes whenever, however and wherever they are isolated. The patents cover all mutations of the genes. They cover all uses of the genes.
Medical professionals consider the genes to be very valuable because they can predict the incidence of breast and ovarian cancer. Once the genes are isolated, they can be tested to see if they are normal or have mutated. If they have mutated, a woman has an up to 85 percent greater chance of developing breast cancer and an up to 50 percent greater chance of developing ovarian cancer.
A patent acts as a monopoly. If a woman wants to assess her risk for cancer, she can have a lab extract the genes from blood or saliva taken from her body. However, once the lab isolates the genes, it cannot test them without the permission of Myriad. Myriad can withhold its permission or a charge a fee of any amount for its permission.
Similarly, a scientist cannot conduct research on the genes without the permission of Myriad. The genes may contain other beneficial properties besides being a predictor of cancer. Those properties cannot be discovered until a license is obtained.
Most of the argument Monday will turn on the meaning of Section 101 of the Patent Act and several Supreme Court decisions holding the law has inherent limitations.
Section 101 provides: “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 thereof ....”
Although the act does not limit patentable subject matter, the Supreme Court has, excluding “laws of nature, natural phenomena, and abstract ideas,” Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
Myriad asserts the two genes are not natural phenomena, because they do not exist in nature in an isolated state. Furthermore, the genes have a utility in their isolated state — they can predict the incidence of cancer — a utility they do not have as part of their host chromosome.
The ACLU counters that Myriad did not discover the genes, did not “add” utility to the genes and did not invent something using the genes. The genes have value to Myriad and all other users precisely because of the genes’ composition, which is the same inside and outside the host chromosome.
A classic case of utility added to a natural phenomenon is Chakrabarty. A microbiologist combined in a single, previously benign bacterium four plasmids used to degrade spilled oil. The combination was a first. The Supreme Court upheld his patent claim. Myriad has not done anything comparable to the genes.
The ACLU took on the case because it saw in the Patent Office’s practice of granting patents on genes a violation of the First Amendment.
Presently, 20 percent of human genes have been patented. As the number increases, fewer and fewer persons will be able to work with genes, without the consent of the patent-holders.
Government will have walled off to a select few an entire body of knowledge. This is impermissible under the First Amendment.
To quote the Supreme Court: “First Amendment freedoms are most in danger when the government seeks to control thought or to justify its laws for that impermissible end,” Ashcroft v. Free Speech Coal., 535 U.S. 235, 253 (2002).
Thought, or the productions of ideas, is a precondition to speech. Without thought we would not have a marketplace of ideas to protect.
Look for the Supreme Court to hand down a decision in June that holds genes to be ineligible for patents. That way it can avoid the constitutional issue.
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Scott Forsyth is a partner in Forsyth & Forsyth and serves as counsel to the local chapter of the ACLU. He may be contacted at (585) 262-3400 or scott@forsythlawfirm.com.
