On March 29, 2010, the American Civil Liberties Union (ACLU) scored a stunning victory in the battle over gene patenting. The District Court in the Southern District of New York held that genes are unpatentable products of nature. Diagnostic methods that involve analyzing and comparing gene sequences were also found to be unpatentable, as were methods for identifying cancer therapeutics by comparing growth rate of engineered cells.
Although it is certain to be appealed, this decision has already generated shock waves across the biotech and pharmaceutical industry. With many economists and big pharma CEOs declaring that the pharmaceutical industry’s future lies in biologic products and stratified patient populations (which require genetic testing), the potential implications of this decision are enormous. What happens to the industry if both of its primary economic drivers are simultaneously declared unprotectable?
The gene patentability question long predates this decision. Genes are the basic units of heredity in a living organism; each one contains instructions (in the form of its sequence) to build a machine (usually a protein) that does the work of living cells. Clearly, genes in their natural state are products of nature.
On the other hand, genes that have been isolated from their natural state or have been manipulated by scientists are not products of nature. For example, a rock is a product of nature; a rock carved into a statue is not.
The patent law has always held that, once a natural product has been manipulated by the hand of man, it is no longer a product of nature and is now available for patenting. The fundamental patent statute, 35 U.S.C. §101, states: “Whoever invents or discovers any new and useful . . . composition of matter . . . may obtain a patent therefore . . .”, and this statute has been broadly interpreted. The Supreme Court’s landmark decision Diamond v. Chakrabarty (1980) held that “Patentable subject matter includes . . . anything under the sun that is made by man.”
The U.S. Patent and Trademark Office (USPTO) has issued about 35,000 patents reciting a gene sequence in their claims. These gene patents protect isolated or purified DNA sequences (many of which encode to therapeutic proteins including biologic drugs), RNA sequences (many of which relate to therapeutic RNAs such as interfering RNAs, antisense RNAs, and ribozymes), vectors, nucleic acid-based vaccines, cells engineered with gene sequences, and various uses of gene sequences (e.g., methods of treatment, methods of diagnosis, or the use of genes as research tools).
Gene patenting has been controversial from the beginning. Civil liberties proponents find gene patenting offensive and view gene patents as unacceptable barriers to the free exchange of information and ideas. The biotech industry passionately defends gene patents as the foundation of the industry and necessary to protect risky R&D investments.