Rumors of the death of biotech patents have been greatly exaggerated. The U.S. Supreme Court recently held "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated."1 This holding sent shock waves throughout the biotech IP community not only because the court invalidated a class of commonly issued patent claims, but also because it established a bright-line distinction between naturally and non-naturally occurring compounds. However, a calmer reading of Myriad reveals that its reach may be more limited than first reported. The holding is likely to be limited to information-containing compositions and not to methods or applications of knowledge. Also, the holding will likely be narrowly interpreted because the Federal Circuit has historically given patent eligibility under 35 USC §101 wide latitude.2
It all started in the mid-1990s when Myriad Genetics discovered the location and sequence of two cancer susceptibility genes: BRCA1 and BRCA2. Mutations in these genes were found to correlate strongly to breast and ovarian cancer. Myriad also developed a test for detecting mutations in these genes in patients and obtained patents covering isolated native BRCA DNA (called genomic DNA) and synthetic BRCA -DNA (called complementary or "cDNA"). Myriad threatened doctors and institutions who used the BRCA DNAs to test for the genetic predisposition to these cancers with patent lawsuits if they did not immediately cease testing. The ACLU, along with the Association of Molecular Pathology and several affected individual doctors and patients challenged Myriad's patents, arguing that human genes are not patent eligible and as such Myriad's patents were invalid.
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