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Isolated Human Genes Do Not Constitute Patentable Subject Matter
- 6/17/2013

On June 13, 2013 the U.S. Supreme Court in, Association For Molecular Pathology, et al. v. Myriad Genetics, Inc., et al., unanimously ruled that isolated human genes cannot be patented, but that synthetically produced genetic material may be patented. To read the full decision click here.

Myriad Genetics, Inc. (Myriad) had obtained several patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer.  Scientists who challenged the patents argued that their ability to carry out research and testing involving these genes was being hindered by the patents at issue.  While not a factor in the case, the particular genes had received significant public attention.   Actress Angelina Jolie revealed in May that she had undergone a preventative double mastectomy after learning that she had inherited a faulty copy of a gene that placed her at high risk for developing breast cancer.

The Supreme Court held that a naturally occurring DNA segment, such as the genes at issue – which Myriad had learned how to isolate from the DNA naturally found in the body – is a product of nature, and thus is not patent eligible merely because it has been isolated.  The Supreme Court did rule, however, that synthetically produced genetic material, e.g., known as composite DNA (cDNA) is worthy of patent protection if it meets all of the other legal standards for patentability.

The patent law permits patents to be issued to, “[w]hoever invents or discovers any new and useful . . . composition of matter’” [35 U.S.C. §101], but laws of nature, natural phenomena and abstract ideas are “basic tools” of scientific and technological work that lie beyond the domain of patent protection. The court held that Myriad’s DNA claims fall within the law of nature exception. In this regard the court stated that, “Myriad did not create or alter either the genetic information encoded in the BRCA1 or the BRCA2 genes or the genetic structure of the DNA.  It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not itself satisfy the §101 inquiry.”

It appears that the Myriad decision will be an important factor in shaping the course of scientific research and medical testing in other fields.  Critics of the decision argue that it may alter the willingness of businesses to invest in the expensive work of isolating and understanding genetic material. For example, the biotechnology industry has warned that the ruling against Myriad’s patents may threaten billions of dollars in investment in this field.  According to news reports, the Patent Office has, previous to this decision, already granted patents on 4,000 human genes, mostly to companies and universities.
In closing, it is important to note that the Myriad decision did not involve patents on method claims (e.g., to a method for detecting the probability of breast or ovarian cancer), patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. In noting this fact, Justice Thomas who authored the opinion of the court, specifically pointed out that companies may still patent novel and unobvious methods of isolating genes and may also obtain patents on new applications of knowledge gained from genetic research.   For more information about this groundbreaking decision, please contact Ostrolenk Faber LLP at dmiro@ostrolenk.com