New Gene Patent Rules - The US Supreme Court's Myriad decision satisfied both patient groups and patent holders. Includes bonus online coverage. - BioPharm International


New Gene Patent Rules
The US Supreme Court's Myriad decision satisfied both patient groups and patent holders. Includes bonus online coverage.

BioPharm International
Volume 26, Issue 8, pp. 22-27

The Supreme Court Review
Upon accepting the case for review, the Supreme Court framed the issue as "Are human genes patentable?" The Supreme Court replied: it depends.

Justice Thomas, who delivered the unanimous opinion on June 13, 2013, held that claims to isolated, naturally occurring genes (in this case, the isolated BRCA1/2 genes, represented by claim 1 of the '282 Patent) are excluded from patentability for falling within the product of nature exception to patent-eligibility. The Supreme Court acknowledged that, although Myriad found the location of the genes, that discovery by itself, does not render the genes new compositions that are patent-eligible.

The Court explained that with respect to isolated genes: "Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the Section 101 inquiry" (7).

With respect to gene fragments (represented by claims 5 and 6 of the '282 Patent), the Court did not distinguish between whether the fragment was isolated from a natural source (claim 5) or synthetically made (claim 6) but focused on the chemical sequence of the gene itself rather than how it was made. Therefore, because the gene fragment of claim 6 could also describe a gene fragment isolated from a natural source, the claims were invalid.

In contrast to patenting isolated, naturally occurring genes and fragments, the Supreme Court confirmed that synthetic or altered genes remain patent-eligible (represented by claim 2 of the '282 Patent) stating that:

"[t]he technician creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA but it is distinct from the DNA from which it was derived. As a result, cDNA is not a 'product of nature' and is patent eligible under 101, except insofar as very short series of DNA may have no intervening introns removed when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA" (7).

The Court also emphasized that: "this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. ... Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion on the application of 101 to such endeavors. We merely hold that genes and the information they encode are not patent eligible under 101 simply because they have been isolated from the surrounding genetic material" (7).

The Myriad Impact
The immediate impact of the Myriad decision is, of course, the loss of any patent claim that recites or describes an isolated gene or gene fragment. The ACLU, patient groups, and some researchers have hailed the decision as removing impediments to diagnostic testing and research on genes like the BRCA1/2 gene that spawned the original lawsuit. Freedom to practice this technology is predicated on the absence of any other applicable patent, such as a method of diagnosing or treating a condition using an isolated gene or gene fragment, which could expose commercial laboratories to infringement liability. Academic and medical researchers who use the isolated gene or fragment to further characterize and understand disease and/or gene function, on the other hand, are less likely to infringe diagnostic or treatment patents.

Many in the biotechnology industry were also pleased by the limited scope of the Myriad decision as it pertained to gene patents. The decision confirmed that synthetic genes and modified naturally occurring isolated genes remain patent-eligible. Thus, patents related to the recombinant production of human proteins and chemically modified gene fragments that can be used diagnostically remain patent-eligible.

The Myriad decision also expressly validated that the application of information gleaned from the isolation of the gene or a new method to isolate the gene is patent-eligible. Information obtained from analysis of patient samples and new treatments predicated upon that information, for example, such as the use of diagnostics and targeted therapies that are the core to personalized medicine, remain patent-eligible. Many believe, in fact, that the analysis of large data sets that marry information collected from diagnostic procedures and information technology is the coming phase of innovation in this area.

Interestingly, while the Supreme Court framed the issue before it in terms of whether human genes are patentable, the decision did not expressly limit its holding to human genes. The reasoning that isolation of a material from its native environment does not impart patent-eligibility to an invention, no matter how clever, could be extended to any isolated naturally occurring product. Thus, the impact of Myriad on other life-science patents, such as isolated proteins, antibiotics, viruses used as vaccines, and antisense technologies, is at this date still in question.

On the same day the Myriad decision was issued by the Supreme Court, the USPTO issued instructions to its patent examiners that any claim to an isolated gene or gene fragment that describes the gene as it exists in nature without modification should be rejected for failing to meet 35 U.S.C. 101 (12). The USPTO also noted that in due course it will release additional guidance to US patent examiners on the further application of the Myriad decision.

While the USPTO's interpretation will be instructive to patent applicants on some level, the Myriad decision has shown that even decades of USPTO examination practice is no guarantee that the Supreme Court will not have a different opinion on what is and is not patent-eligible.

Thus, those considering or having patents in naturally occurring isolated products should review the patent claims and align them to Myriad's holding and teachings.

Antoinette Konski is a partner at Foley & Lardner,

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