The Patenting of Human Genes

In 1980 The U.S. Supreme Court ruled, under section 101 of the Patent Act, that a live, artificially engineered microorganism is patentable. The patenting of human genes is much like any other patent, but more recently, the commercialization of those patents can be seen as a monopoly. Myriad Genetics was granted a similar patent in 1999, which was seen by many, to limit research and raise the cost of Breast and Ovarian cancer test. In March of 2010, the U.S. District Court for the Southern District of New York issued a summary judgement that invalidates certain of Myriad Genetics’ patents related to the BRCA1 and BRCA2 genes.

Twenty years ago, Myriad Genetics & Laboratories discovered a location on the human chromosome which contains a gene associated with an increase risk of breast and ovarian cancer. These genes BRCA1 & BRCA2 are human tumor suppressor genes which code for proteins responsible for locating, correcting, and destroying the damaged DNA in breast tissue. Between 1994 and 1995 Myriad was granted patents on the specific amino acid sequences in BRCA1 and BRCA2 genes. Since 1999, Myriad’s patents on the genes gave them exclusive rights to perform diagnostic testing, which required all patient samples to be sent to their Salt Lake City headquarters for analysis. A process which cost nearly $3000.

In March of 2010, the court separated Myriad’s patent claims into two major groups. First, those claiming isolated DNA sequences and second, those claiming methods for comparing or analyzing gene sequences to locate the presence of mutations related to Breast or Ovarian cancer. Both of these patents were rejected under Section 101 of the Patent Act, because the isolated DNA and naturally occurring DNA possess the same “fundamental quality” or biological information, and are not markedly different.

Most recently, in November of 2010, the Department of Justice proposed to reverse three decades of legal precedent by imposing limits on gene patents. This contradicts the longstanding policy of the United States Patent and Trademark Office, stating that isolated human genes, without further modification, are a product of nature and do not constitute patent-eligible subject matter under section 101 of the Patent Act. This decision draws a specific line between what kind of gene should be eligible for patent protection and what kind is not. One is perfectly free to patent a process of modifying a gene, but in this case, Myriad’s process of merely isolating a naturally occurring gene or distilling its naturally occurring properties is not legitimately patentable.

Scientist have long voiced their opposition to the patenting genes for more than 30 years. Arguing that a patent on something so unique, in this case genetic code, means no one else can alter or improve on the product. When a process or method for bettering the world is found or created, future scientist and researchers take that process and better it, furthering our progression as a society. In this case, a monopoly on the gene sequence means that no one can invent or improve the product, because the gene itself is patented. This is the major problem with gene patents in general.