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In a recent case, Judge Robert Sweet of the U.S. District Court of the Southern District of New York held that isolated DNA sequences are not patentable because they belong to naturally occurring DNA. This holding has the potential to invalidate patents covering all DNA-based inventions.
The American Civil Liberties Union, suing on behalf of various non-profit medical and research or-ganizations, scientists, and cancer patients, challenged two patents owned by Myriad Genetics and the University of Utah Research Foundation that relate to the sequencing of the BRCA1 and BRCA2 genes. Mutations in these two genes are associated with higher risks of breast cancer. The patents-at-issue enable genetic testing and the isolation of these genes.
The legal question in the case is whether isolated DNA sequences and inventions based on those se-quences are patentable subject matters. 35 U.S.C. §101 (1952) stipulates that "whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and re-quirements of this title." Gene patents have always been controversial. Many scientists object on the ground that the subject matters of these patents are pre-existing products of evolution. Judge Sweet likewise concluded that isolated DNA is not patentable because it has the same fundamental qualities as naturally occurring DNA. He found that isolated DNA does not differ structurally or functionally from naturally occurring DNA. The judge also held that the method claims of the patents-at-issue constituted "abstract mental processes," which are also not patentable according to the recent Federal Circuit opinion of In re Bilski.
Recent federal decisions do not lend much support to Judge Sweet's conclusions. However, if this ruling survives on appeal, the patentability of DNA-based inventions may be determined by the U.S. Supreme Court. Lee and Li will continue to keep track of any developments and update the readers accordingly.
