The US Department of Justice has filed an amicus brief in a case before the US Court of Appeals for the Federal Circuit (“CAFC”) opposing the issuance of gene patents to naturally occurring DNA sequences that are merely isolated from existing organisms without additional alterations or manipulations.

With the possible approval of the first Genetically Engineered (“GE”) animal being approved by USFDA for human food and the controversial labeling issues surrounding this approval, the issues surrounding gene patents are assuming major importance in Regulatory Food Science.

The case, United States Patent and Trademark Office v. Myriad Genetics, Inc., will be widely discussed in the press and we caution readers from drawing broad conclusions from the CAFC upholding this relatively narrow decision at the trial court below (Association for Molecular Pathology v. USPTO) issued on March 29 by Federal Judge Robert Sweet (SDNY).

The New York Times has published a review of the case which can be found at:

 The complete text of the amicus brief is attached below along with the trial court decision.