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 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).


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