See more posts by this author: Kameron W. Kramer
American intellectual property law has recently come under fire as several corporations test the boundaries of intellectual property protection with gene patents.
One such case currently being weighed by the Supreme Court is Association for Molecular Pathology v. Myriad Genetics.
In this landmark case the Supreme Court will decide if naturally occurring, unaltered, human genes are patentable. Myriad Genetics isolated two gene sequences believed to increase a woman’s susceptibility to breast or ovarian cancer and currently owns the patent for the isolated sequences.
While Myriad does not own the patent for the process used to isolate the genes, the genes are technically the property of Myriad once they have been isolated. The company owns the patents on both the gene sequences and the tests used to screen patients for the genetic mutations. This means only one lab can perform the testing for these gene mutations, which can be performed for $3,000 a test.
The U.S. Patent and Trademark Office has historically granted gene patents such as Myriad’s. However, according to black letter patent law, what occurs in nature, with no further intervention is not patentable, meaning that the unaltered human genes can’t be patented by Myriad.
Opponents of gene patent protection argue that, in addition to contravening patent law, continuing to allow companies to patent genes will have an adverse impact on healthcare. They argue that the isolated genes are not deserving of patent protection because they are not an invention.
Opponents also argue that given the massive international effort to decode the human genome, Myriad’s discovery was inevitable. In fact, had the technologies used to analyze the genes been patented, Myriad would not have even made their discovery. Additionally, they argue that Myriad is preventing healthcare providers from performing life saving screening tests by sitting on the patents for the test.
Myriad contends that preventing companies from patenting discoveries such as Myriad’s stifle innovation. The company rejects the allegation that their discovery does not conform to patent requirements, contending that their extraction of the genes was an invention of sorts. Myriad claims that the isolation of naturally occurring genes outside of the body requires ingenuity, and therefore deserves patent protection. Myriad compares their discovery to a baseball bat; while baseball bats come from naturally occurring trees, they are extracted from the tree, and therefore patentable. The Supreme Court Justices struggled with this analogy during oral arguments, seeming preoccupied with concerns that discovery is not invention. However, the Justices seemed equally concerned with the ramifications of a decision to curtail gene patent protection entirely.
While the Supreme Court’s decision could have a major impact on intellectual property law, genetics experts argue it will have little real world significance. Some experts say that this type of genetic patent is losing value because very few companies rely on such patent protection. However the case is decided, Association for Molecular Pathology v. Myriad Genetics will prove to be an important case in the development of patent law and its interaction new scientific discoveries.