The U.S. Justice Department filed a friend-of-the-court brief, supporting the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) in a lawsuit challenging patents on human genes. The government agrees with these groups that isolated DNA is not patentable.
According to the government’s brief, “The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.”
Daniel B. Ravicher, executive director of PUBPAT and co-counsel in the case, states, “The impact of the U.S. now taking the position that isolated or purified genetic sequences are indeed not patentable is a substantial boon for society and the biotech industry.”
The ACLU and PUBPAT filed the lawsuit in May 2009 against Myriad Genetics, the University of Utah Research Foundation, and the USPTO. It challenged the USPTO’s authority to issue patents that relate to products of nature and the legitimacy of claims issued to Myriad Genetics that relate to isolated DNA encoding the breast cancer markers BRCA1 and BRCA2 and to methods of detecting alterations in BRCA1 gene sequence to diagnose cancer. Myriad Genetics develops and sells tests that use these genes to help identify women with breast and ovarian cancer.
ACLU’s lawsuit charged that the patents stifle diagnostic testing and research that could lead to cures and that they limit women's options regarding their medical care. The District Court in the Southern District of New York ruled in March 2010 that the patents on BRCA1 and 2 are invalid. Myriad is appealing that ruling in the U.S. Court of Appeals for the Federal Circuit.
The court held that genes are products of nature and thus unpatentable. 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 rates of engineered cells.
The March ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes, according to the ACLU.
Patent law, however, 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 then available for patenting. The District Court has now declared that both genes and methods of detecting gene sequences are not patentable subject matter.
The court pointed out that patentable subject matter must be markedly different from a product of nature and concluded that isolated DNA including cDNA is not markedly different from natural DNA.
The court also held that diagnostic and screening methods that utilize gene sequence information are also not patentable. This part of the decision was grounded in recent case law regarding technical requirements for writing patent claims to methods.
The USPTO has issued about 35,000 patents reciting a gene sequence in their claims. These gene patents protect isolated or purified DNA sequences, RNA sequences, vectors, nucleic acid-based vaccines, cells engineered with gene sequences, and various uses of gene sequences.