Pass the Red Dye No. 2. The Federal Circuit has tweaked the recipe for determining the patentability of DNA. According to a divided panel in Association for Molecular Pathology v. Myriad Genetics, Inc., a claimed DNA molecule is patentable when it presents a distinct chemical identity from the molecule as it exists in nature. Myriad offers guidance for determining when DNA discoveries become patentable and the opinion might spark bigger cravings in those hungry to unravel-and patent-the remaining uncharacterized molecules of the human genome.
Myriad is a molecular diagnostic company specializing in diagnostic products for cancers. Its patents rights cover the gene sequences in the BRCA genes and diagnostic methods of identifying mutations in those genes. Mutations in the BRCA genes are connected to a higher incidence of breast and ovarian cancer.
Plaintiffs brought a declaratory judgment action against Myriad, claiming that seven of the BRCA patents claimed patent-ineligible subject matter. The district court invalidated both Myriad's composition and method claims. The district court found that the composition claims involving "isolated" DNA molecules were patent-ineligible because they covered "products of nature" -one of the judicially created exceptions to the broad scope of patentable inventions under 35 U.S.C. § 101. The court also invalidated the challenged method claims, finding that "analyzing" or "comparing" DNA sequences constituted non-patentable mental processes.
Reversing on appeal, the Federal Circuit gave guidance on the patentability of both the composition and method claims. With respect to the composition claims, the Federal Circuit relied on Supreme Court precedent-Chakrabarty and Funk Brothers-in determining whether isolated DNA molecules were patentable. Both cases involved claims directed to bacteria. In Funk Brothers, the claims related to a newly discovered trait of nitrogen-fixing bacteria associated with plants. In Chakrabarty, the claims related to bacteria that were genetically engineered to be able to break down crude oil more effectively than any naturally-occurring bacteria. While a newly discovered trait of naturally-occurring bacteria in Funk Brothers was not patentable, Chakrabarty's bacteria were patentable because they had "markedly different" characteristics from any bacteria found in nature.
There is no dispute that claimed "isolated" DNA exists in a chemical form that is distinct from any form found naturally in the body. "Native" DNA exists in chromosomes, which consist of large DNA molecules, containing multiple genes that are packaged with certain proteins. By contrast, "isolated" DNA-often one specific gene or a fragment thereof- is cleaved from other DNA with which it is normally associated. Once cleaved from its surrounding DNA, "isolated" DNA cannot be viewed simply as a "purified" form of a natural material. A molecule now exists that is not found in nature. Writing for the majority, Judge Lourie said it is immaterial that the native form and the isolated form share some informational content. What is patentable is not knowledge of nature, but reducing a portion of nature to a concrete form.
Judge Lourie also noted that the PTO has issued gene patents for 30 years, and that patents cover 20% of human genes (in non-native form). If the law on the patentability of genes is to be changed, the court said the decision belongs to Congress.
With respect to the method claims, the court concluded that all but one claim was patent ineligible. Simply "comparing" or "analyzing" two gene sequences claim only an abstract mental process. Myriad's efforts to read into the method claims steps of extracting DNA from a human tissue sample and sequencing the BRCA gene were rejected.
But a different claim was patent-eligible because it included more than just an abstract mental step. The patentable claim recited a method that involved manipulating the cells and their growth medium, an inherently transformative step. Under Bilski, such a transformative step is an "important clue" to patentability.
The other panel members concurred with some, but not all, of the main opinion. Judge Moore would have future courts look more at the utility of the claimed molecule, rather than simply its structure. Concurring in part and dissenting in part, Judge Bryson argued that the process of isolating DNA was not enough to make the resulting molecule a patentable invention.
Myriad might have a short shelf life. The plaintiffs most likely will seek review of the decision and Myriad might also challenge findings made regarding the sufficiency of plaintiffs' standing. Whether it's an en banc Federal Circuit re-hearing or the Supreme Court, some court is sure to want to fix the funny aftertaste left by the divided panel's opinion. As a result, inventors manipulating DNA molecules will need to keep waiting to find out the exact additives needed to protect-and patent-their inventions.
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