The U.S. Supreme Court was expected to include the highly publicized case of Assn. Molec. Path. et al. v. USPTO et al. (ACLU/Myriad“, a/k/a “the gene patenting case”) on its Orders List today thereby granting or denying certiorari. Unexpectedly, the case was absent thereby postponing the news whether or not the Supreme Court will weigh in on this controversial issue.  As noted in our December 19, 2011 post, the Public Patent Foundation petitioned the U.S. Supreme Court  for review of two issues: 1) whether human genes should be patented, and 2) whether persons who lack evidence of personal and direct threat of an infringement action lack standing to challenge a patent. 

Myriad’s Position on the Issues

On the controversial issue of whether or not human genes should be patented, Myriad argued that a review of the issue is unnecessary.  Myriad noted that isolated DNA molecules are not new and as such, patents have been issued on isolated genes and fragments for many years.  The US PTO has reviewed the patentability of genes and gene fragments and after public comment in 2001, determined that isolated DNA is patent-eligible as a composition of matter. As a matter of policy, the biotechnology industry has relied upon the steady understanding that an isolated DNA molecule is patent-eligible and has made the reasonable decision to invest large amounts of time and money into the identification, isolation and characterization of genes. Myriad also stated that isolated genes and fragments of genes are structurally and functionally different from those found in nature and therefore satisfy the test for patent-eligible subject matter as set forth in the Supreme Court’s Diamond v. Chakrabarty decision (447 U.S. 303, 310 (1980)).

On the issue of whether the lone plaintiff Dr. Ostrer now lacks standing to bring the action, Myriad pointed to his change of employment from NYU to Montefiore, an institution with which Myriad has never had a controversy and where plaintiffs lack an arguable claim to a controversy.

Myriad also argued that as a matter of fact and contrary to petitioner’s assertions, the patents in issue have not hindered research on the BRCA 1/2 genes. In support of this assertion, Myriad noted that 18,000 researchers have conducted studies on these genes and over 130 clinical trials regarding BRCA 1/2 genes have been commenced since the inventors disclosed their inventions to the public. Moreover,  the record in the case supports the fact that there are multiple laboratories that provide “second opinions” regarding BRCA 1/2 test results for deleterious mutations. 

The Amici Briefs

Ten amici brief were filed in support of petitioner’s request for Supreme Court review.  Briefly, the amici argued that patents on isolated DNA are against public interest because they interfere with genetic testing for the diagnosis and treatment of patients. Patenting of isolated DNA also is argued to prevent the improvement of genetic tests and unnecessarily impedes innovation and research. Substantively, the Federal Circuit’s decision to support the patenting of human genes was argued to run counter to Supreme Court precedent because isolated DNA is not markedly different from products of nature under the Chakrabarty standard.

What Lies Ahead

Some have argued that advances in technology, such as high-throughput gene sequencing, have diminished the patentability of isolated DNA because the isolation and characterization of DNA is now routine and less likely an achievement warranting patent protection. Arguably, a Supreme Court decision limiting the present patent-eligibility of isolated DNA could therefore have minimal impact on the biotechnology industry. However, a Supreme Court decision limiting the patentability of such technologies could spill over and impact other biotechnologies, such as the patenting of stem cells and regenerative medicine, which also rely on isolated naturally-occurring products.