DNA (cDNA); this cDNA is also useful for research and further innovation. Inventors at Myriad discovered the precise location and sequence of two human genes, known as BRCA1 and BRCA2, mutations of which can sub- stantially increase the risks of breast and ovarian cancer in those patients in which the mutations are present. The inven- tors isolated the genes from the human genome and developed tests to determine if individuals have the genetic mutations and therefore the increased cancer risk. The tests require the DNA to be isolated before testing can occur. Myriad obtained a number of patents based on this discovery, including patents claiming the isolated DNA cod- ing and isolated cDNA coding for the BRCA1 and BRCA2 genes. With these patents, Myriad asserted the exclusive right to administer the genetic tests for the mutations of these genes that would indicate an increased cancer risk. The PTO has been issuing these types of patents since Chakrabarty. Specifically, isolated DNA and cDNA do not exist in nature separated and isolated from the remainder of the human genome. Therefore, they are not naturally occurring and qualified for patents as "manufactures" or "compositions of matter." A group of doctors and patients, led by the American Civil Liberties Union, sued Myriad and the PTO, seeking a declaration that the claims of the patents were invalid and that these inventions were not eligible for patent protection. If the court agreed with the plaintiffs, they would be free to administer the tests at facilities not administered by Myriad, and they would not have to pay license fees to Myriad for performing such tests. Supreme Court, Justice Thomas wrote for a unanimous Court that claims to isolated DNA are not patent eligible, while claims to the synthetically created cDNA are. of § 101, but then recognized several judicially created exceptions to the broad wording of the statute: laws of nature, natural phenomena and abstract ideas. be considerable danger that the grant of patents would "tie up" the use of [basic tools of scientific and techno- logical work] and thereby "inhibit fu- ture innovation premised upon them." DNA, the Court reasoned that Myriad did not create anything. Its principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. The Court determined that "separating [those] gene[s] from [the] surrounding genetic material is not an act of invention." The extensive effort indicated by Myriad does not warrant a patent under § 101. The Court did recognize that cDNA is a different matter. Isolated cDNA se- quences do not exist within nature or the human body. They retain some charac- teristics of naturally occurring DNA, but are sufficiently distinct to warrant patent eligibility. fact that the plaintiffs did not acquire the relief initially sought. In the original complaint, the plaintiffs also challenged Myriad's claims to methods of screening cancer patients. It pursued these claims through most of the litigation, arguing that they were directed to abstract ideas and were thus not patent eligible. The Federal Circuit upheld these method claims and the Supreme Court declined to review that decision. Thus, the win is in a sense a Pyrrhic victory: the claims to methods of screening cancer patients for the genetic mutation remain in force. Nobody else can practice these methods without infringing the claims. The historical underpinnings for a patent system generally stem from the desire to encourage investment in inno- vation and also to encourage disclosure of innovative discoveries and advance- ments. In exchange for disclosure of new exclude competition for a limited time and to charge monopoly profits dur- ing the limited term of the patent. The Myriad opinion instead seems to suggest that patents inhibit rather than encour- age research. How will this opinion affect the bio- technology industry? Given the extensive costs of research in these areas, will companies continue to make large scale investments? Following recent Supreme Court opinions on patentable subject matter, including Myriad, it seems that patents in the area of personalized medicine will be difficult to obtain and enforce. Further, many biotechnology companies are working on ways to grow organs that can be transplanted into the human body to replace defective organs. The goal is for these organs to be as similar to the natural organs as possible. This opinion seems to indicate that such organs could not be patented. As far as specific guidance, the Supreme Court opinion did not provide a great deal of help. The Court specifically noted that it was not considering the patent eligibility of DNA where the order of the naturally occurring nucleotides has been altered. Where is the line? How different, how "inventive" does the new molecule or sequence need to be to be eligible? The Court also noted that no method claims were at issue. Innovative methods of manipulating genes would appear to still be patent eligible. Further, no ap- plications of knowledge about the genes were at stake. If the claims were limited to such applications, they would presum- ably also be patent eligible. The Supreme Court has been review- ing a number of recent cases regarding patent eligibility. It has come down on the side of ineligibility in each one, thereby limiting the subject matter that can be patented. Will the Court continue to limit what can be patented or will it now let the dust settle for a while? |