New Gene Patent Rules - Pharmaceutical Technology

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

Pharmaceutical Technology
Volume 37, Issue 8, pp. 14-16

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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