September 6, 2012
As reported earlier, on August 16, 2012, the Court of Appeals for the Federal Circuit issued its much-anticipated opinion in Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., commonly referred to as the Myriad decision. In this case, the court addressed questions of whether DNA-related inventions are eligible for patent protection under the patent statute. Specifically, the court addressed the patent eligibility of three types of inventions: isolated DNA, methods for comparing DNA sequences, and a process for screening potential cancer therapeutics.
Myriad has developed a well-known test for the BRCA1 gene, which is a gene that expresses a protein used by the human body for repairing DNA. If the BRCA1 gene is damaged, then damaged DNA may not be repaired as readily, thus leading to an increased susceptibility to breast cancer and other cancers. In light of the technology involved, the Myriad case has attracted considerable attention; commentators have raised significant policy questions as to whether genetic materials and methods should be the subject of patent protection. Several amici, including the U.S. government and the U.S. Patent & Trademark Office (USPTO) itself, filed briefs opposing patent eligibility, while many other amici filed briefs arguing in favor of patent eligibility.
After determining there was jurisdiction to resolve the dispute, the court first held that Myriad’s claims to isolated DNA were eligible for patent protection. The court reasoned that isolated DNA molecules have a different chemical structure than can be found in nature. Also, the court declined to make a patent eligibility exception for DNA on policy grounds. Noting the competing policy interests for and against the patent eligibility of DNA and the lengthy history in the USPTO of granting patents in this area, the court held that any such exception is not currently contained in the patent statute and that any modification to existing law would be a question for Congress.
Second, the court held that Myriad’s claimed method of screening potential cancer therapeutics via changes in cell growth rates of man-made transformed cells was eligible for patent protection. In its analysis, the court considered the Supreme Court’s recent decision in Mayo Collaborative Services v. Prometheus, Inc. (a case previously discussed here), but concluded that the Prometheus rationale did not apply. Prometheus held that mere application of laws of nature were excluded from patent eligibility under the patent statute, while the issue in this case concerned a method for screening specified method steps that were tied to non-natural, transformed cells.
Third, the court held that Myriad’s remaining method claims directed to “comparing” or “analyzing” DNA sequences were not eligible for patent protection under the patent statute and the Prometheus rationale. Rejecting Myriad’s argument that the claims satisfied the machine-or-transformation test because each claim necessarily requires extracting and sequencing DNA, the court held that these claims did not specify any actions prior to the mental steps of “comparing” or “analyzing” the result. The court also held that the plain meaning of “comparing” and “analyzing” did not include Myriad’s proposed sample processing steps. In its holding, the court did not reject all analytical methods, but rather held that Prometheus foreclosed eligibility for the specific Myriad claims under consideration.
The Myriad decision is significant not only for its holding concerning isolated DNA but also for its guidance on the Federal Circuit’s interpretation of the Prometheus decision. Although it is too soon to determine if any of the parties will seek rehearing en banc or by appeal to the Supreme Court, the court’s decision provides guidance for patent eligibility of DNA-related technologies and also more generally for patent eligibility of method claims after Prometheus.
For more information, please contact Fitch Even partner Calista J. Mitchell, the author of this alert.