BRCA1 protein rendering.
On July, 29, 2011, a US appeals court sided with Myriad Genetics, Inc’s patents on the BRCA1 and BRCA2 genes. The court ruled 2-to-1 in favor of Myriad, citing that genes in isolation are not naturally occurring and are therefore allowed to be patented. Many researchers believe that any part of the human genome is naturally occurring and should not be patented.
The ruling overturned a decision made by a US district court in New York City in March 2010. In that case, Judge Robert W. Street and the court concluded that isolated DNA is a discovery, not an invention, because an isolated portion of DNA differs little from non-isolated DNA since it leaves the nucleotide sequence intact.
In this current decision, Judge Alan D. Lourie wrote that the appeals court reversed the district court’s decision “that Myriad’s composition claims to ‘isolated’ DNA molecules cover patent-ineligible products of nature…since the molecules as claimed do not exist in nature.”
With this decision, Myriad’s existing patents, along with thousands of other gene patents, are protected for the moment. Lourie wrote that “…the mere fact that the larger chromosomal polymer includes the same sequence of nucleotides as the smaller isolated DNA is not enough to make it per se a law of nature and remove it from the scope of patentable subject matter…Instead, the claimed isolated DNA molecules, which are truncations (with different ends) of the naturally occurring DNA found as part of the chromosome in nature, are not naturally produced without the intervention of man.”
The controversial case has divided the scientific research community. Biotechnology companies have been patenting gene sequences for years as a routine part of developing drugs, with more than 4000 genes already patented. The process also creates financial incentives, since companies are able to lay claim to those genes when developing new diagnostic techniques, genetic tests, and novel treatment options. However, many in the research community are of the mind that opportunities for using gene sequences for research are being restricted by the very same process.
BRCA2 protein rendering.
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