A federal judge has invalidated several of Myriad Genetic’s patents on two genes linked to breast and ovarian cancer, in a wide-ranging decision that undercuts the legal basis of potentially all genetic patents.
Approximately 20% of all human genes are patented.
In a 152 page decision delivered Monday, Federal District Court Judge Robert Sweet of the Southern District of New York invalidated portions of seven of Myriad’s patents on the genes BRCA1 and BRCA2 on the grounds that the genes are “products of nature,” and therefore not patentable subject matter under 35 USC Section 101.
Myriad had argued that it had created isolated, purified versions of the genes not found in the human body, so they qualified as “manufactures” or “compositions of matter” under Section 101, and were not products of nature.
Judge Sweet disagreed, ruling that, “purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must possess ‘markedly different characteristics’ in order to satisfy the requirements of Section 101.” And the purified forms of the genes were not markedly different from the native forms, ruled the judge, if properly viewed from the perspective of the genes’ information conveying functions, rather than from mere chemical or structural differences– the purified forms are designed to have the same nucleotide sequences as the native genes in order to convey the same genetic information.
However, almost all prior applications for genetic patents claim to meet the Section 101 threshold precisely by identifying a purified form of a human gene. If this ruling survives on appeal, opponents of genetic patents are expected to use it as the basis to challenge thousands of other genetic patents.
The suit was brought by the American Civil Liberties Union on behalf of breast cancer patients and medical researchers, who claimed that Myriad’s patents made detection tests for the genes too expensive (more than $3,000 per test in the United Sates, versus $1,000 in Canada where the tests are not patent-protected), and inhibited further research into new cancer treatments and therapies.
Myriad issued a statement claiming that the decision will not have a great impact on its business, because it struck down portions of only seven of Myriad’s 23 patents on the two genes.
Furthermore, proponents of genetic patents say that Judge Sweet’s opinion badly misinterpreted both the nature of the patented genes, as well as prior case law, and will certainly be overturned on appeal by the patent specialist Court of Appeals for the Federal Circuit.
Judge Sweet’s decision could also be impacted by the Supreme Court’s imminent ruling in In Re Bilksi, which is widely anticipated to recalibrate the definition of “patentable subject matter” for the information age.
The Licensing Law Blog will soon post a preview of the issues at stake in Bilski.