Federal Circuit Still Says Genes Can Be Patented

By Robyn Hagan Cain on August 16, 2012 | Last updated on March 21, 2019

The Federal Circuit Court of Appeals ruled on Tuesday that isolated human genes can be patented, reports The Wall Street Journal.

This is the second time the Federal Circuit has reached this conclusion. The Supreme Court remanded the case in light of its Mayo Collaborative v. Prometheus decision in March.

The case, Association for Molecular Pathology v. USPTO, pitted the biotechnology industry against public interest groups on the issue of whether seven existing patents on two genes associated with increased breast and ovarian cancer risk — BRCA1 and BRCA2 — are valid, or whether the genes can’t be patented because they are products of nature.

Myriad Genetics, the company that holds the patents, claims that isolating the BRCA1 and BRCA2 genes from a person results in a new material that has utility beyond the DNA that naturally occurs in the human body. According to Myriad, extracting the genome makes it patentable. The Federal Circuit Court of Appeals seems to agree.

In July, a three-judge panel — Judges Alan D. Lourie, William Curtis Bryson and Kimberly Ann Moore — heard arguments once again in the case. The panel’s task in rehearing was to evaluate Mayo’s impact on the theory of gene patentability. The court’s response was that it didn’t really have an impact, according to Patently-O. The results were largely the same as the first time the panel heard the case. Genes, according to the court, are still patentable.

The opinion, however, was not a grand slam for Myriad. The appellate court also ruled that Myriad’s method claims directed to comparing or analyzing gene sequences are not patentable, reports Patently-O.

Based on the list of counsel and amici that preceded the opinion, there are approximately three patent attorneys in the U.S. who aren’t involved in this case. If you’re one of the three, hop on the bandwagon! Of course there will be another appeal, whether it’s a petition for en banc rehearing or certiorari. It’s not too late to join the myriad Myriad amici.

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