[author: Donald Zuhn]

In its amicus brief filed in Association for Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad"), the United States focuses solely on applicability of the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. on the patent eligibility of isolated genomic DNA.  The U.S. brief takes no position with respect to the impact of Mayo on Myriad's method claims (in particular, claim 20 of U.S. Patent No. 5,747,282), and concedes that "man-made complementary DNA molecules (cDNA) -- which comprise nucleotide sequences that do not exist in nature -- are patent-eligible subject matter under 35 U.S.C. § 101."

The brief notes, however, that "[a]s the United States explained in its original amicus brief, unlike cDNA, isolated but otherwise unmodified DNA molecules are not patent-eligible because they are 'products of nature,' not 'human-made inventions.'"  According to the U.S. brief, the Supreme Court's guidance in Mayo that "[p]atent protection is not available to those who simply discover existing aspects of nature, even if the discovery requires arduous work, represents keen scientific insight, and is of great value to society," simply "reinforces the conclusion that Myriad cannot patent DNA it discovered in and isolated from nature."

The brief characterizes the "principal issue" on appeal as being "whether composition claims for isolated genomic DNA are directed to patent-eligible subject matter," or worded another way, as "whether such claims are impermissible attempts to patent products of nature."  Citing Diamond v. Chakrabarty, the U.S. brief contends that "[t]o be eligible for a patent, a claimed composition must be 'human-made' and 'markedly different' from a naturally occurring substance."  The brief points out that the last time the Federal Circuit decided this case, "[t]he members of this panel agreed on that basic proposition," but "disagreed about whether distinctions between isolated and genomic DNA are significant enough to render isolated DNA 'markedly different' for § 101 purposes."

According to the U.S. brief:

The Supreme Court's decision in Mayo provides guidance regarding that question.  To be sure, that guidance is indirect.  Mayo involves process, not composition, claims, and the Court's analysis focuses on the standards for determining whether a claimed process effectively claims a law of nature.  Thus, Mayo does not directly address the criteria to be used in deciding the parameters of the product-of-nature exception, and every nuance of the Court's analysis may not mechanically extend to products of nature.  Nevertheless, in at least one respect, Mayo provides an important point of reference for deciding whether a claimed composition and a naturally occurring substance are "markedly different" for purposes of § 101.

In analyzing the claimed methods in Mayo, the Supreme Court repeatedly emphasized the need to ensure that claims not "tie up" laws of nature by preventing the public from exploring and exploiting those laws.

For the U.S government, "[t]he concerns implicated by patent claims that 't[ie] up the use of the underlying natural laws,' and thereby 'inhibit[] their use in the making of further discoveries,' may also be present when a patent contains a composition claim that relates to a product of nature."  The brief notes that "Mayo suggests that a court should ask whether a patent on the claimed composition has the practical effect of preempting the public's ability to use the product of nature itself."  The brief explains, therefore, that the genetically altered bacterium in Chakrabarty constituted patent eligible subject matter because it "would not have interfered with the public's ability to investigate or further modify the original bacterium or to experiment on the DNA plasmids that the patentee inserted into it to create the 'new bacterium.'"  "Similarly," the brief indicates, "cDNA molecules, which must be synthesized by scientists in the laboratory, are not created in the process of studying native DNA and pose little risk of preempting study of naturally occurring DNA."  The U.S, argues, however, that "patents on isolated but otherwise unmodified DNA would significantly impair the public's ability to study and make use of genomic DNA."

As for "Chakranbarty's 'markedly different' rubric," the brief disagrees with how the panel applied that standard in its first opinion, arguing that "[i]n light of Mayo, this Court should not rest patent-eligibility on the bare fact that isolating genes or gene segments involves the breaking of chemical bonds, or on the fact that scientists can use small gene segments to exploit the inherent chemical properties of DNA in ways that cannot be done with complete genes," and instead should ask "whether the differences identified in the original panel decision are sufficient to leave the public free to study and exploit the native BRCA1 and BRCA2 genes."

The U.S. brief concludes by briefly noting that the Supreme Court's refusal in Mayo to determine whether it was desirable to increase protection for discoveries concerning diagnostic laws of nature further illuminates the § 101 analysis.  The brief suggests that "[i]n this case, Myriad has argued that the extension of patent protection to isolated DNA is necessary in order to preserve financial incentives for making DNA discoveries."  The brief argues, however, that "Mayo strongly suggests that the judicial inquiry should not focus on industry-specific incentive arguments of this sort, pro or con, and instead should focus on 'established general legal rules.'"

For additional information regarding this topic, please see:

• "IPO Amicus Brief Argues for Patent Eligibility of Myriad's Isolated DNA Claims and Method Claim 20," July 9, 2012
• "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad," June 27, 2012
• "Parties and Amici File Briefs in Myriad Case," June 17, 2012