A Landmark Case for Biotech: Is Isolated Human DNA Patentable?

The Federal Circuit court is ruling to determine whether isolated DNA patent-eligible subject matter. Experts from Morrison & Foerster explain how the case could shift the biotech landscape.

By Jeffrey M. David and Kristin L. Yohannan, Morrison & Foerster LLP

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On April 4, 2011, in what could be a landmark biotechnology patent case, the Federal Circuit heard oral argument in Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. If the plaintiffs are able to survive the lack of standing challenge, the Court will decide whether isolated human DNA is patent-eligible. A district court in the Southern District of New York invalidated under 35 U.S.C. § 101 (section 101) certain patents to genes known to be risk indicators for breast cancer owned by Myriad Genetics, Inc. (Myriad). This decision is in stark contrast to the stated policy and actions of the United States Patent and Trademark Office (Patent Office), which has traditionally granted patents to isolated DNA. The United States Department of Justice, representing the federal government in the case, has taken the position that certain isolated gene patents should be invalidated but that other gene patents, where the genetic product does not exist in nature, should be upheld.

The Federal Circuit is addressing two questions on appeal: 1) whether plaintiffs had standing to file a declaratory judgment action against Myriad seeking to invalidate its patents; and, if so, 2) whether isolated DNA is patent-eligible subject matter. A decision affirming the district court and finding that isolated human DNA is not patent-eligible subject matter would be a substantial shift in patent law.

In 2001, the Patent Office published revised examination guidelines concerning the patent eligibility of isolated genes and stated that an isolated and purified gene may be the basis for a patent as long as the patent discloses that the specified gene expresses a useful protein. This case challenges those guidelines and the validity of Myriad’s patents. At issue are fifteen claims from seven patents relating to the human genes known as Breast Cancer Susceptibility Genes 1 and 2 (BRCA1 and BRCA2, respectively). Mutations in these genes are associated with significantly increased risks of breast and ovarian cancer. Myriad is the holder, or exclusive licensee, of these patents. In practical terms, this makes Myriad the only company in the United States able to produce and derive results from tests of these genes.

The plaintiffs in this case are a range of doctors, scientists, patients, and organizations related to breast cancer research and testing. They argue that they are being injured by the improperly granted patents. The doctors, scientists, and clinics argue that they cannot continue their research or treat their patients. The patients argue that they are being denied testing and treatment because of the restrictions imposed by Myriad. If the patents are invalidated as ineligible patent subject matter, the plaintiffs argue that their issues will be resolved.

There are two types of patent claims in this case: composition claims and method claims. The composition claims are directed to isolated DNA that translates into a certain protein. The method claims are directed to a process of comparing a subject’s DNA with a baseline sample to identify the specific mutations in the DNA that signal an increased risk of breast or ovarian cancer.

District Judge Robert Sweet, in a 152-page opinion, declared the subject matter of the claims of the patents-in-suit ineligible for patenting. The district court’s inquiry focused on whether or not the claimed invention fell within the “products of nature” exception to patentable subject matter, which excepts naturally occurring phenomena from being patentable.

Judge Sweet found both the composition claims and the process claims were invalid. Citing Supreme Court precedent that patentable “products of nature” must be markedly different from natural phenomena to be patent-eligible, the court found there was no change in what occurred in nature by simply removing a section of DNA from the entire genome but not otherwise altering the DNA. Judge Sweet reasoned that purification, by itself, did not render the isolated DNA patenteligible because the basic structure and function of the DNA remained the same. As for the method claims, the court found that they were only directed to the abstract process of “comparing” and “analyzing” gene sequences, and did not contain the transformative act necessary for patenting because preparatory physical transformations do not qualify for patenting.

Myriad appealed Judge Sweet’s decision to the Federal Circuit. As to the composition claims, Myriad argues that isolated DNA molecules are “compositions of matter eligible for patenting” and that “products of nature” are not categorically ineligible for patenting. As to the method claims, Myriad argues that the extracting, processing, and analyzing of the DNA creates a transformation sufficient for patentable subject matter.

The plaintiffs respond by arguing that DNA is a natural phenomenon found in nature and isolating a product of nature does not make it eligible for patenting under Supreme Court precedent because the changes made to the DNA in the lab do not give isolated DNA a distinctive name, character, or use.

On appeal, the Solicitor General’s Office of the United States has taken the almost unprecedented step of filing its own amicus curiae brief in support of neither party. . The United States’ brief divides the types of claims at issue differently. It argues that Judge Sweet correctly invalidated the isolated DNA claims, but incorrectly invalidated the engineered DNA molecule claims. Arguing that all “human-made inventions” are patentable, the United States would have the Federal Circuit reverse the district court in part and validate the claims limited to cDNA, a human-engineered molecule.

There is a chance the Federal Circuit will not reach the merits of the patentable subject matter issue. The Federal Circuit may decide the plaintiffs lack standing to challenge Myriad’s patents because there is no actual “case or controversy,” rather than a hypothetical dispute, between the parties.

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