Breast cancer research is the focus of the hotly debated Myriad Genetics gene patent. Myriad has developed a test kit which can predict a woman's risk of developing breast or ovarian cancer.

Justin Sullivan/Getty Images

Legal Challenges

The crux of the legal controversy over gene patenting is the debate between "products of nature" and "compositions of matter." Gene patenting opponents argue that there is no more fundamental product of nature than the genes found inside our own bodies, and therefore they are not patentable. Proponents of gene patents assert that once a gene is removed from the body and manipulated in any way it qualifies as a "composition of matter" which is legally patentable.

One of the most closely watched court cases involving these issues is the one involving Myriad Genetics. The company filed seven patents relating to genes BRCA1 and BRCA2, which are associated with breast and ovarian cancers, and it developed a test kit which helps predict a women's risk of those diseases.

In March 2010, a U.S. District Court ruled that the company's patent claims were invalid because genetic material was, in fact, a product of nature. The ruling judge called the idea that genes outside of the body were no longer products of nature "a lawyer's trick" [source: Schwartz].

However in July 2011, the Court of Appeal for the Federal Circuit overturned the lower court's decision saying that the genetic material isolated in a lab had significantly different chemical makeup than when it is found inside the body [source: Pollack].

Some say this ruling throws open the patent office doors to biotech companies while others posit that this is just one more legal tussle in the ongoing debate over who owns the rights to our genetic material -- one that was eventually decided by the U.S. Supreme Court. The court decided that a gene, even after being isolated and identified, was not eligible for a patent -- so, BRCA1 and BRCA2 could not be patented. But that the creation of something new -- in this case, Myriad's synthetic cDNA -- could be patented, even though its creation involved genes.

Next: The debate over gene patents isn't only about legal issues.