You can’t patent the human genome or any gene

Based on a unanimous decision handed down today in the Supreme Court of the United States, no one can claim they own the patent on the human genome or any segment of it, since it is strictly a naturally occurring product.

In the case known as Association for Molecular Pathology v. Myriad Genetics, Inc., justices confirmed that naturally occurring DNA, which is part of every cell in our bodies, is not patent-eligible. Myriad Genetics, based in Utah, holds the patent for two genes, BRCA1 and BRCA2, which, if certain mutations occur, suggest a woman has a much higher chance of developing breast or ovarian cancer than a female who has those genes without the mutation. Scientists at the company said the act of finding the location of those genes in DNA extracted from the blood stream and studying it in a lab was an “invention.”

The Court said (PDF), however, that the company hadn’t invented anything at all but merely discovered the location and normal sequence of the two genes, which barred their claim to patent eligibility:

Myriad’s DNA claim falls within the law of nature exception. Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Diamond v. Chakrabarty, 447 U. S. 303, is central to the patent-eligibility inquiry whether such action was new “with markedly different characteristics from any found in nature.” Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry. See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127. Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible “new … composition[s] of matter.”

On the other hand, cDNA, which stands for complementary deoxyribonucleic acid, is patent eligible, since as used by Myriad Genetics in other work, it doesn’t occur in nature and must be manufactured, the Court ruled:

cDNA is not a “product of nature,” so it is patent eligible under §101. cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.

I never thought I would live to see the day when the Supreme Court used the words ‘exon’ and ‘intron’ correctly in a ruling, but there they are. Well, “order of the exons” is not the only thing about a cDNA molecule that is “dictated by nature,” but everybody knows what Justice Clarence Thomas, who wrote for the Court, is talking about.

Furthermore, in humans, he’s correct about “naturally occurring,” but just for the record, cDNA does occur naturally in retroviruses, such as HIV-1, HIV-2, and Simian Immunodeficiency Virus. However, any cDNA molecule from a retrovirus would have a completely different sequence from any cDNA the Court might have considered in this case, which most certainly does not occur naturally.

I have to qualify this logic a little, but it really isn’t the domain of the Supreme Court to teach biology. I think the decision is bullet-proof, but I have to note that DNA molecules are in the shape of a double helix, two “strands” wound around each other like a double spiral staircase. During a process known as replication, a daughter cDNA is synthesized—in nature—from each of the existing DNA strands. These are usually replicated in strands that are very short and discontinuous. The step-by-step process first creates so-called “Okazaki fragments,” then naturally occurring cDNA from our genetic material. So, the Court’s finding that cDNA doesn’t occur in nature is somewhat flawed.

Although there was no dissenting opinion entered, Justice Antonin Scalia did question the molecular biology underlying the decision. As the eligibility for the patent of cDNA hinged on whether it was a true product of nature or a product that had to be manufactured, he wasn’t so sure about that part:

… going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation and not normally present in nature.

Good call, Justice Scalia! If a genetics company ever wants to get a patent on the cDNA from retroviruses, we’ll have to tell them they can’t use this case to support their claim. The cDNA strand made in Myriad’s screening test, however, is not normally present in nature, and if a Supreme Court justice couldn’t understand the biology textbook portion of the ruling, how must molecular biologists feel, given its holes?

In related news, within minutes of the decision, the stock price for Myriad Genetics ticked upward, according to a report by the Wall Street Journal. This happened perhaps because of the partial victory they had won on the cDNA part of the decision. They lost two patents on the genes BRCA1 and BRCA2—which they never rightfully held anyway—but gained the Supreme Court-supported right to obtain patents on molecules of cDNA, which they might use in cloning work and other procedures.

Later in the day, the stock price fell, however. The ruling is expected to make the genetic test for a disposition to breast and ovarian cancer more available to women who don’t have lots of money to spend on the test. Certainly, companies that compete with Myriad Genetics will start developing the technology to offer the test to women at an even lower price.

It’s my opinion that this ruling makes good sense. If the Court had ruled in favor of Myriad in terms of patenting a naturally occurring molecule, it occurred to me that I might apply for a patent on sugar. With all the high-sugar soda and processed food products sold in the US, I would make a fortune.

About the Author

Paul Katula
Paul Katula is the executive editor of the Voxitatis Research Foundation, which publishes this blog. For more biographical information, see the About page.