In a ruling likely to be appealed to the U.S. Supreme Court, a divided Federal Circuit Court of Appeals panel has determined that genetic discoveries may, to a certain extent, be patented. The Ass’n for Molecular Pathology v. U.S. Patent and Trademark Office (Myriad Genetics, Inc.), No. 2010-1406 (Fed. Cir., decided July 29, 2011). The case involved a challenge to patent claims relating to “isolated gene sequences [composition claims] and diagnostic methods of identifying mutations in these sequences [method claims].” A district court had determined that isolated DNA molecules and methods of comparing molecules to determine whether a patient’s genes have mutations that could cause breast and ovarian cancer could not be patented; the Federal Circuit reversed in part and affirmed in part.

According to Judge Alan Lourie, writing for the majority, one plaintiff had standing to bring the claims because Myriad Genetics, the patent holder, had sued him for patent infringement and he indicated that his lab would immediately begin again to perform genetic testing using the isolated DNA molecules at issue if the patents were invalidated. Explaining that “Myriad’s claimed isolated DNAs exist in a distinctive chemical form—as distinctive chemical molecules—from DNAs in the human body, i.e., native DNA,” the court concluded that “the challenged claims are drawn to patentable subject matter because the claims cover molecules that are markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature.” According to the court, isolated DNA “is a free-standing portion of a native DNA molecule, frequently a single gene. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule.”  

The appeals court agreed with the district court that most of Myriad’s challenged method claims were patent-ineligible because they involved just one step of “comparing” or “analyzing” two gene sequences. Still, the court ruled that one method claim (20 of the’282 patent), involving “growing,” “determining” and “comparing” steps, “claims patentable subject matter.”

A concurring judge joined the majority as to standing and the patentability of the method claims at issue, but wrote separately believing that “claims directed to isolated DNA sequences present a different set of issues.” Judge Kimberly Moore focused on the law’s distinction between “products of nature” and “human-made inventions,” emphasizing the courts’ flexible approach to the analysis. She meticulously distinguished between the different isolated DNA claims at issue, noting that the cDNA claims were based on sequences with “a distinctive name, character, and use, with markedly different chemical characteristics from either the naturally occurring RNA or any continuous DNA sequence found on the chromosomes.”  

According to Judge Moore, other DNA at issue, “shorter isolated DNA sequences,” were patentable because they “have a variety of applications and uses in isolation that are new and distinct as compared to the sequence as it occurs in nature.” “Longer strands of isolated DNA, in particular isolated strands which include most or all of the entire gene,” Judge Moore observed, present a “much closer case.” She concluded that these DNA molecules were patentable, but “for a reason different than for the shorter sequences.” While they are different chemically, the longer isolated segments’ “chemical and structural differences . . . do not clearly lead to an ‘enlargement of the range of . . . utility’ as compared to nature.” Yet, Judge Moore would allow them patent protection for policy reasons, that is, Congress and the U.S. Patent and Trademark Office have allowed patents on isolated DNA sequences for decades, and the court should defer to them, as well as to “settled expectations.”

Concurring and dissenting Judge William Bryson agreed with the court’s judgments on standing, the patentability of the cDNA claims and the method claims, but disagreed as to “Myriad’s BRCA gene claims and its claims to gene fragments.” According to Judge Bryson, the question presented by the case was “whether an individual can obtain patent rights to a human gene.” He concluded that the process of isolating genetic material from a human DNA molecule does not make the isolated genetic material a patentable invention. Noting that Myriad “was not the first to map a BRCA gene to its chromosomal location,” Judge Bryson called “the discovery of the sequences . . . an unprotectable fact,” although he would have allowed Myriad “to patent applications of its discovery.” Because some of the company’s “challenged composition claims effectively preempt any attempt to sequence the BRCA genes, including whole-genome sequencing,” Judge Moore would have found these claims unpatentable, “and a contrary ruling is likely to have substantial adverse effects on research and treatment in this important field.”