Genes Can Not Be Patented, Synthetic DNA Can

Tuesday, July 9, 2013

The U.S. Supreme Court recently ruled that human genes cannot be patented, but that genetic material created in the lab is eligible for patent protection. In Association for Molecular Pathology, et al v. Myriad Genetics, Inc., the Court handed down a unanimous decision that naturally-occurring genes should remain in the “public storehouse of knowledge.” This decision is sure to have wide-ranging effects on biotechnology patent law in the days and years to come.

Myriad is the company that first isolated the genes known as BRCA1 and BRCA2, which indicate a higher risk of breast and ovarian cancer, and the company markets tests for those genes. The BRCA1 gene was recently in the news when actress Angelina Jolie determined she carried the gene and opted for a preventive double mastectomy. The risk for breast cancer in the average woman in this country is 12 to 13 percent. But for people with certain genetic mutations, the risk can range between 50 and 80 percent. The numbers are analogous for ovarian cancer.

Myriad was granted a patent for these two genes by the U.S. Patent and Trade Office, which has, since 1982, granted 4,000 patents for human genes. When doctors from New York University, the University of Pennsylvania, and elsewhere began to test their patients for the BRCA1 and BRCA2 gene, they were informed by Myriad that they were committing patent infringement. The Association for Molecular Pathology, a group of researchers and doctors, challenged the patent in court.

The central dispute was whether the act of isolating and identifying DNA is an inventive act. Also at issue was the exception, in patent law, for natural phenomena. In its decision, the Supreme Court said that while Myriad did identify these important genes, they did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes, so there was no “new…composition of matter” as required by Section 101 of the Patent Act. Furthermore, the Court wrote, as natural phenomena, genes represent “the basic tools of scientific and technological work” that lie beyond the domain of patent protection. According to the Court, granting patents on genes could “inhibit future innovation premised upon them.”

On the other hand, this decision allows Myriad’s patent on synthetic DNA to stand. Also known as complementary DNA or cDNA, it is eligible for patent protection because as the decision reads, the scientist “unquestionably creates something new,” something that is not naturally occurring.  This type of synthetic DNA retains some of the naturally occurring components of DNA, but not all, and is therefore distinct from the DNA from which it was made. Therefore, it is not technically a “product of nature.”

On Wall Street, this decision seemed to be considered at least a partial victory for Myriad, whose stock went up by 10 percent when the ruling was made known. As biotechnology patent attorneys, Berenato & White will be staying up to date on this dual decision and the ramifications it will have in the future.