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IP Alert
IP Alert: Federal Circuit Issues Landmark Decision Affecting Gene Therapy Patents

August 3, 2011

On July 29, 2011, the Court of Appeals for the Federal Circuit issued a decision that has significant repercussions for DNA-based inventions and the biotechnology industry. In a 2–1 decision in Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., the court held that “isolated” human DNA sequences are eligible for patent protection under the patent statute. The court also held that the claimed methods for “comparing” or “analyzing” DNA sequences were not eligible for patent protection. Finally, the court held that the claimed methods of “screening” potential cancer therapeutics at issue were eligible for patent protection.

The specific DNA sequences at issue in the case were identified as “BRCA1” and “BRCA2,” which are DNA sequences that are useful in diagnosing genetic risk for breast and ovarian cancers. The Myriad case has attracted significant public attention because of the connection to breast cancer diagnoses. The issues in Myriad affect many other inventions in the area of gene therapy. Attesting to the importance of the decision, amicus briefs were filed by many parties, including medical and civil rights groups, as well as the U.S. government.

“Isolated” DNA Sequences Are Patent-Eligible

Human genes are specific sequences of DNA in the human “genome.” Genes operate by encoding proteins. In their natural state within the human body, many separate genes coexist on a single strand of DNA. This single strand of DNA is tightly wound to take the form of a chromosome. The human body contains many chromosomes, each including thousands of individual genes.

The patent at issue in Myriad involved claims to isolated DNA sequences and related methods. “Isolated” sequences are segments of DNA, including individual genes or portions of genes, that constitute a portion of a DNA sequence found on a human chromosome. These isolated sequences are much smaller than those found on the chromosome and must be chemically modified in order to exist outside the chromosome.

The first issue before the court was whether the isolated DNA sequences were eligible for patent protection under the patent statute. The parties and amici curiae opposed to such claims argued that DNA sequences were products of nature; hence, they were not eligible for patent protection.

Notably, while the U.S. Patent and Trademark Office (USPTO) has long considered isolated DNA sequences to be patentable, the U.S. government filed a contrary amicus brief urging the court to hold that unmodified DNA sequences are not patent-eligible. The government proposed a “magic microscope” test, in which a claimed DNA molecule would be unpatentable if a hypothetical magic microscope could focus in on it within the human body.

The court held that claims directed to isolated DNA were indeed eligible for patent protection. The court reasoned that isolated DNA exists in a chemical form that is distinct from the form of DNA found in the human body. An isolated DNA sequence is a freestanding portion of a native DNA molecule and is thus inherently different from naturally occurring gene sequences. The court noted that BRCA2 in its native state is part of a chromosomal DNA sequence made up of approximately 114 million units, while the isolated BRCA2 gene was smaller by several orders of magnitude.

In its opinion, the court distinguished “isolated” DNA from “purified” DNA and, by analogy, from other purified substances. Arguably, purified DNA is an unpatentable “product of nature.” The court observed that the process of isolating DNA requires chemical manipulation that produces a molecule that is “markedly different” from that which exists in the body. Accordingly, held the court, isolated DNA is not a product of nature.

Finally, noting the thousands of patents already issued by the USPTO relating to isolated DNA sequences, the court found that the practice of patenting isolated DNA sequences was longstanding. The court suggested that any fundamental change to the current practice of patenting isolated DNA should be made by statutory amendment to the patent laws rather than by the courts.

Method Claims Directed to “Comparing” or “Analyzing” Sequences Fail to Define Patentable Subject Matter

The court unanimously held that the claimed methods of “comparing” or “analyzing” sequences were not eligible for patent protection because such claims merely specified mental steps. A claim to mere mental steps is not patentable, and the court determined that the patent claims at issue did not require any steps beyond mentally analyzing DNA sequences. In its holding, the court distinguished its prior decision in Prometheus Labs., Inc. v. Mayo Collaborative Services, where the claims required steps of “administering” a drug. In contrast, the court held that the claims in Myriad were to “comparing” and “analyzing” methods that one could practice by “mere inspection alone.”

Method Claims Directed to “Screening” Potential Cancer Therapeutics Are Patent-Eligible When They Necessarily Include Transformative Steps

Finally, the court also unanimously held that the patent claims directed to “screening” procedures were eligible for patent protection under the patent statute. The claims included the steps of “growing” transformed cells or “determining” the cells’ growth rates. Accordingly, held the court, the claims satisfied the so-called “machine-or-transformation” test for patent eligibility.

Absent a subsequent rehearing en banc or an appeal to the U.S. Supreme Court, the Myriad decision will stand as a landmark decision in the genetics field. The decision provides guidance both to those seeking patent protection for DNA sequences and associated methods and to those defending against such patents.

Fitch Even will continue to monitor this case for any future developments and will provide an update should the status of the case change. For more information on the current decision, please contact Fitch Even partner Mark A. Borsos, the author of this alert, or Fitch Even partner Kendrew H. Colton.

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