United States: Patent Protection For Human Genes Ends In The US

In Myriad the Supreme Court excluded naturally occurring DNA, such as genes, from the scope of patent protection. It is not yet clear what impact the decision will have and that very uncertainty is fuelling concern throughout the medical and biotech industries

On 13th June 2013 the Supreme Court unanimously ruled in Association for Molecular Pathology v Myriad Genetics Inc that segments of naturally occurring DNA, such as genes, are not eligible for patent protection. The court held that these isolated but otherwise unmodified segments of human DNA are products of nature and fall into an exception to the class of patent eligible subject matter set forth in 35 USC §101. In contrast, the court held that "synthetic DNA" is patent eligible. With both sides claiming partial victory, the ultimate impact of Myriad on the medical and biotechnology industries is unclear. What is certain is that the US Patent and Trademark Office's (USPTO) 30-year practice of allowing claims directed to naturally occurring DNA segments has come to an end.

The defendant - Myriad Genetics Inc - discovered the location and sequence of the human BRCA1 and BRCA2 genes. Mutations in theses genes are associated with a higher risk of developing certain types of breast and ovarian cancer.

Myriad obtained several patents related to its discovery of the BRCA genes, including claims directed to the genes themselves. One representative claim encompassed "an isolated DNA coding for a BRCA1 polypeptide" which covered naturally occurring BRCA1 genes that have been isolated (ie, removed from the natural cellular environment and not bound to a much longer strand of chromosomal DNA).

Myriad also had claims directed to partial BRCA gene sequences. In addition, Myriad had claims directed to complementary DNA (cDNA), which is a sequence of nucleotides that contains only the proteincoding portions of a gene.

The plaintiffs were a coalition of institutions, doctors, patients and researchers who wanted to perform (or undergo) BRCA genetic testing or research, but were allegedly blocked by Myriad's patents. They brought a declaratory judgment action against Myriad, challenging the patent eligibility of its claims. Section 101 of the Patent Act defines the categories of patent eligible subject matter. The range of patentable subject matter is generally broad, but the Supreme Court has recognised three exceptions: laws of nature, natural phenomena and abstract ideas.

The Supreme Court concluded that claims drawn to isolated segments of naturally occurring DNA fall within the product of nature exception and thus are not patent eligible. Citing its precedent, the court distinguished between "discovery" and "invention", with only the latter being eligible for patent protection. The court noted that Myriad did not create the BRCA genes; it merely discovered them and their correlation with certain cancer risks. While this was an important medical breakthrough, the court stated that "groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry".

The court further rejected the argument that the act of isolating a segment of natural DNA is enough to render a claim to the isolated molecule patent eligible. Although a targeted segment of DNA typically does not exist in nature in isolated form and comes into existence only through an act of human intervention, the court focused on the fact that the isolated segment contains the same genetic information as the untouched DNA. Moreover, Myriad's claims were not expressed in chemical terms and did not rely on any chemical changes that resulted from the isolation process.

Further, the court was unmoved by the notion that the USPTO has been allowing claims such as Myriad's for over three decades. The court found that Congress had never expressly approved of the practice and noted that the US government had taken the position, in its brief to the court, that such claims are not patent eligible despite the USPTO's practice.

Yet while the court eliminated one mode of obtaining patent protection for DNA-based discoveries, it did not foreclose other ways of protecting such innovations. In particular, the court held that claims directed to non-naturally occurring "synthetic" DNA molecules, as well as claims to new applications of knowledge gained through genetic research, are patent eligible. For example, Myriad's claims to lab-created cDNA molecules survived.

The Myriad decision leaves many questions unanswered. For example, the court made it clear that more human intervention and modification of naturally occurring DNA, beyond mere isolation, is required to move claims to these molecules outside the scope of the product of nature exception. However, it offered little guidance as to how much more modification is required, expressly stating, for example, that it was not considering the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.

Similarly, the long-term effects of Myriad on the medical and biotech industries remain unclear. Many have predicted that its impact will be small, given that many of the patents that include human DNA claims (including the Myriad claims) will soon expire. Yet it is possible that the decision will reduce incentives to conduct genetic research, resulting in fewer discoveries. It is also possible, as the plaintiffs argued, that the elimination of these isolated DNA patents will give researchers more freedom to operate, potentially leading to more innovation.

Further complicating the issue is the possibility that the decision will prompt biotech companies to rely increasingly on trade secrets rather than patents to protect their new discoveries and research investments. The net result of these competing variables is uncertain, clouding any predictions on Myriad's ultimate impact.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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