Will patents extend to DNA, the basic building blocks of life? Attempting to unravel this helix-laden, complex conundrum, the Supreme Court of the United States recently heard argument in the case of Association for Molecular Pathology v. Myriad Genetics Inc., U.S., No. 12-398 (argued 4/15/13). At stake in Molecular Pathology is the scope and reach of the controversial section of Patent Law, 35 U.S.C. § 101, the section of that law that determines what qualifies for patent protection. That section excepts from patent protection “laws of nature, natural phenomena, and abstract ideas,” and, according to Diamond v. Chakrabarty, 447 U.S. 303, 206 (1980), a “product of nature” as well. The petitioners primary argument throughout the case has been that all patent claims on DNA as a composition of matter fall under that exception, and should not be patentable.
The case has a long and tortuous history of repeated decisions and remands. To simplify things, the U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years, but opponents of Myriad Genetics Inc.’s patents on two genes linked to increased risk of breast and ovarian cancer say patent protection should not be given to something that can be found inside the human body. The lead lawyer argued:
Finding a new use for a product of nature, if you don’t change the product of nature, is not patentable. If I find a new way of taking gold and making earrings out of it, that doesn’t entitle me to a patent on gold. If I find a new way of using lead, it doesn’t entitle me to a patent on lead…Allowing companies like Myriad to patent human genes or parts of human genes will slow down or cripple lifesaving medical research like in the battle against breast cancer…
But Myraid argued that without the ability to recoup their investment through the profits that patents bring, breakthrough scientific discoveries needed to combat all kinds of medical problems will not happen; simply put, without patent protection, these companies will not invest the vast resources needed to unlock the secrets of genes and DNA. Myriad has used its patents to develop its BRCA analysis test that looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer and Myriad sells the only BRCA gene test.
The Federal Circuit, the appeals court that has exclusive jurisdiction over patents, twice ruled that the genes can be patented. The Court held that since the isolated DNA has a “markedly different chemical structure” from DNA within the body, it is patentable. The Supreme Court was clearly troubled by tension created in patenting things that exist in nature and denying patents to companies that invest vast amounts of time, resources and research in isolating such DNA. The Court is expected to rule later this summer. Stay Tuned.
Stephen E. Noona is the head of Kaufman & Canoles’ Trial Section and Co-chair of its Intellectual Property Law and Franchising Practice Group. He has been counsel in hundreds of intellectual property cases in federal courts across the nation, including over ninety (95) patent cases in the Eastern District and is Fellow in the American College of Trial Lawyers. He regularly appears before the judges in all four Divisions of the Eastern District on intellectual property matters of all kinds. –Stephen E. Noona