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The U.S. Patent and Trademark Office has granted patents on at least 4,000 human genes to companies, universities and others that have discovered and decoded them. Patents now cover some 40 percent of the human genome, according to one study.
ANGELINA JOLIE MASTECTOMY
The question was whether the genes Myriad patented concerned its successful isolation of the two genes, BRCA1 and BRCA2.
Mutations detected in the genes can help determine heightened risk of breast cancer. Myriad’s work in the area, including a screening test, gained worldwide attention this year when actress Angelina Jolie announced she had a double mastectomy after undergoing a test and finding she had a risk of developing breast cancer.
In the court’s opinion, Thomas wrote that the U.S. Court of Appeals for the Federal Circuit was wrong to find that isolated human DNA and cDNA were both patent eligible.
Under the federal Patent Act, an inventor can obtain a patent on various new processes and products but “laws of nature, natural phenomena and abstract ideas” are not patentable.
Thomas wrote that cDNA “does not present the same obstacles to patentability as naturally occurring isolated DNA segments.”
In examining the differences between the two, Thomas concluded that cDNA is not naturally occurring. A laboratory technician, he wrote, “unquestionably creates something new when cDNA is made.”
Thomas noted so-called method patents, which concern technical procedures for carrying out a certain process, are not affected by the ruling.
The decision will stop the practice of the U.S. Patent and Trademark Office granting patents to companies that isolate DNA but will allow patents for firms that build DNA from its basic chemicals, said Ed Reines, of Weil, Gotshal & Manges LLP.
“The patent office was granting patents on isolated biological composition, such as DNA (for years). That will not be happening in the future,” Reines said.
“Given recent Supreme Court skepticism in the patent area, it is not surprising,” he added. “There shouldn’t be much in this decision that surprises industry or the financial markets.”