April 15 is a big day for biotechnology, pharmaceutical, and medical diagnostic companies at the Supreme Court, as justices begin a new session by hearing oral arguments in a landmark case involving the patentability of isolated nucleic acids in Association for Molecular Pathology, et al. v. Myriad Genetics, et al.

Since at least the 1980s, the United States Patent and Trademark Office (USPTO) has granted patents on "isolated nucleic acids," including nucleic acids that correspond to human gene sequences. According to the USPTO, nucleic acids do not naturally exist in an isolated state, thus isolated nucleic acids are purely human-made compositions. Isolated nucleic acids are therefore patent-eligible as long as they have a specific and substantial practical utility. These patents are incredibly important to biotechnology, pharmaceutical and molecular diagnostics companies, as they are the most effective way (and often the only way) to recoup the substantial R&D investments required to develop new therapeutics and diagnostic tests.

Myriad Genetics and Laboratories, Inc. owns a patent covering isolated nucleic acids corresponding to the gene sequence of BRCA1, a gene locus related to breast cancer. Myriad’s nucleic acids are useful as probes for detecting mutations in this locus that correlate with a high risk of breast cancer. The American Civil Liberties Union (ACLU), on behalf of several medical groups, patient advocacy groups and individual patients and doctors, challenged the validity of this patent, arguing that naturally occurring nucleotide sequences cannot be patent-eligible simply by isolating them, because their functionality is defined by their naturally-occurring sequence.

The U.S. District Court for the Southern District of New York agreed with the ACLU, holding that the patents are invalid for relating to patent-ineligible natural products. The Court of Appeals for the Federal Circuit reversed that decision, generating three separate opinions.

Speaking for the court, Judge Alan D. Lourie reasoned that isolated nucleic acids are patent-eligible because their isolation requires peptide binds to be broken, resulting in a distinct chemical entity. Judge Kimberly A. Moore, in concurrence, reasoned that isolation of natural products can result in patent-eligible subject matter, but only if the isolation is linked to a substantial new utility that is distinct from the product's natural function. Thus, if decided on a blank slate, Judge Moore would have found "fragments" of a naturally occurring nucleotide sequence to be patent-eligible, because they have various uses in isolation that they would not have in nature, but the full-length gene sequence would not be patent-eligible because the only substantial use is to express a protein, which is what it does in nature. Nonetheless, because the government acquiesced in the issuance of such patents for so long, she concurred in judgment with Judge Lourie to avoid upsetting the "settled expectations of the patenting community."

Judge William C. Bryson dissented in part, reasoning that isolation of the naturally-occurring product is patent-ineligible unless some "essential character" of the natural product has been changed. Contiguous nucleotide sequences that occur in nature therefore are patent-ineligible because any utility they may have is a consequence of the naturally-occurring sequence.

Immatics Biotechnologies, GmbH and Baker Donelson submitted an amicus brief in support of Myriad. In particular, we reasoned that Supreme Court precedent only requires that the natural product be presented in a "new form capable of use and designed to be used in such new form," which is satisfied by showing that isolation places the product into a form that is capable of a substantial utility. Importantly, this test does not require either a change in the chemical composition or a change in the function of the natural product. We further emphasized the importance of these products to the biotechnology industry, and the potential economic consequences of an adverse decision. The amicus brief can be found here.

The Supreme Court is scheduled to hear oral arguments in Association for Molecular Pathology, et al. v. Myriad Genetics on April 15.