Reference no: EM133304840

DNA's informational sequences and processes occur naturally within cells. Scientists can, however, extract DNA from cells using well-known laboratory methods. These methods allow scientists to isolate specific segments of DNA-for instance, a particular gene or part of a gene-which can then be studied, manipulated, or used. It is also possible to create DNA synthetically through processes similarly well-known in the field of genetics. This synthetic DNA created in the laboratory is known as complementary DNA (cDNA). Myriad Genetics, Inc., discovered the precise location and sequence of what are now known as the BRCA1 and BRCA2 genes. Mutations in these genes can dramatically increase an individual's risk of developing breast and ovarian cancer. The average American woman has a 12 to 13 percent risk of developing breast cancer, but for women with certain genetic mutations, the risk can range between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer.

Knowledge of the location and sequence of the BRCA1 and BRCA2 genes enabled Myriad to develop medical tests that are useful for detecting mutations in a patient's BRCA1 and BRCA2 genes and thereby assessing whether the patient has an increased risk of cancer. Myriad then sought and obtained a number of patents, which would, if valid, give it the exclusive right to isolate an individual's BRCA1 and BRCA2 genes. The patents would also give Myriad the exclusive right to synthetically create BRCA cDNA. In Myriad's view, manipulating BRCA DNA in either of these fashions triggers its "right to exclude others from making" its patented composition of matter under the Patent Act. The plaintiffs, including medical patients, advocacy groups, and doctors, filed this lawsuit in U.S. District Court seeking a declaration that Myriad's patents are invalid. The District Court granted summary judgment to the plaintiffs based on its conclusion that Myriad's claims, including claims related to cDNA, were invalid because they covered products of nature. The U.S. Court of Appeals for the Federal Circuit initially reversed, but on remand the Federal Circuit found both isolated DNA and cDNA eligible for a patent.

Arguments:

This case was ultimately reviewed by the Supreme Court. The case hinged on the following argument from the Defendant and Plaintiff...

Because laws of nature, natural phenomena, and abstract ideas are not patentable, a naturally occurring DNA segment is a product of nature and not eligible for a patent.

Because it has been isolated and synthetically created, cDNA is eligible for a patent because it is not naturally occurring.

Questions:

1. Should the Supreme Court uphold the patent?

2. Explain your ruling.