Friday, September 20, 2013

Intellectual Property: Supreme Court Rules Isolated Human Genes Unpatentable

By Stephen G. Anderson, Ph.D.

On June 13, 2013, the United States Supreme Court issued its opinion in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013), holding that merely isolating a naturally occurring DNA molecule from its surrounding genetic material does not render it patentable subject matter. Writing for a unanimous court, Justice Clarence Thomas emphasized that “patent protection strikes a delicate balance between creating incentives that lead to creation, invention, and discovery and impeding the flow of information that might permit, indeed spur, invention.” Id. at 2116 (internal citation omitted). In striking that balance, the court also held that certain DNA molecules synthesized in a laboratory, known as complementary DNA (cDNA), are eligible for patent protection because they are not technically found in nature.  The decision will undoubtedly have a substantial effect on existing biotechnology patent portfolios, as well as significant implications for the future of the biotechnology industry.

At the center of the dispute in Ass’n for Molecular Pathology was U.S. Patent No. 5,747,282, issued to Myriad Genetics, Inc., which claimed the isolated DNA of two genes, known as BRCA1 and BRCA2. Mutations in the BRCA genes are linked to an increased risk of breast and ovarian cancer in women. Armed with the ’282 patent, Myriad retained the exclusive right to isolate these genes, a necessary step in screening patients for the cancer-causing mutations. Competitors and others filed suit.

The court first addressed whether isolated DNA molecules are patentable subject matter. Section 101 of the Patent Act states “[w]hoever invents or discovers any new and useful ... 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. Implicit exceptions to Section 101 include laws of nature, natural phenomena, and abstract ideas, which are “the basic tools of scientific and technological work that lie beyond the domain of patent protection.” 133 S. Ct. at 2116. 

By claiming the naturally occurring DNA sequences of the BRCA genes, “Myriad did not create anything,” the court said. Id. at 2117. In fact, “[t]he location and order of the nucleotides existed in nature before Myriad found them.” Id. at 2116. Thus, the isolated DNA molecules were held unpatentable subject matter.

The court, however, reached a different conclusion with respect to cDNA.  Generally, human genes are divided into protein-coding regions (“exons”) and non-coding regions (“introns”). An isolated gene contains both the exon and intron DNA sequences, but a cDNA molecule contains only the exon DNA sequences. Thus, according to the court, “a lab technician unquestionably creates something new when cDNA is made.” Id. at 2119. Even though the cDNA contains the naturally occurring exon sequences, the court determined that it “is not a product of nature and is patent eligible under § 101.” Id.

The ultimate effect of the court’s decision on the biotechnology industry remains to be seen.  In the meantime, allowing patents on cDNA but not on mere isolated DNA balances the goals of the Patent Act, creating an incentive for invention, while freeing up the basic tools of scientific research and development for future innovation.