March 15, 2013 was a big deadline for patent applicants seeking to secure first-to-invent filing dates for U.S. patent applications, but April 15 will be a big day for the biotechnology industry, when the Supreme Court hears oral arguments in The Association of Molecular Pathology v. Myriad Genetics, Inc. (also known as the ACLU/Myriad “gene patent” case). Here I provide a brief summary of the parties’ briefs to the Supreme Court.
The Question Presented
The Supreme Court granted certiorari to consider the following:
Are human genes patentable?
The AMP Petitioner’s Brief
AMP’s Petitioner’s Brief raises arguments similar to those that were successful at the district court, but unsuccessful at the Federal Circuit:
- Isolated DNA is not “markedly different” from naturally occurring DNA
Isolated DNA does not have markedly different characteristics from DNA in the body – either in structure or function. Only because isolated DNA is not markedly different can Myriad tell patients if they face an increased risk of breast or ovarian cancer after performing diagnostic testing.
- The challenged claims are not based on any inventive concept but instead claim products and laws of nature
(referencing the analytical framework from Mayo v. Prometheus)
Myriad identified the naturally-existing gene, which embodies the natural law that some naturally occurring mutations of that gene increase a woman’s risk of breast and ovarian cancer. Myriad isolated those genes, but isolation of DNA was a well-known technique at the time these patents were sought, and continues to be a routine, conventional preparatory step for using human genes in research and clinical practice.
- The challenged claims preempt uses of products and laws of nature
Because virtually every conceivable scientific use of DNA requires that it be isolated, and because the patents do not specify a single BRCA molecule or a single use of the DNA but instead cover all of them, the patents give exclusivity over the BRCA1 and BRCA2 genes itself, and their preemptive effect mandates a finding of invalidity.
- cDNA also is not patent-eligible
Even though cDNA is generally made in the laboratory, that fact alone does not render it patentable subject matter. The nucleotide sequence of cDNA is dictated by nature ….
- The Supreme Court should not give deference to the past conduct of the USPTO
- The claims violate the First Amendment because they give Myriad “entire control over a body of knowledge” and “pure information”
The Myriad Respondent’s Brief
Myriad’s Respondent’s Brief raises arguments similar to those that were successful at the Federal Circuit, but also raises issues that may not be up for review. In particular, Myriad reargues the standing issue that it lost at the Federal Circuit, arguing the Dr. Ostrer neither had nor has a “real and immediate dispute” that could support declaratory judgment jurisdiction.
On the question presented, Myriad argues:
- The challenged claims are directed to patent-eligible compositions of matter
- It took human intervention to identify and isolated the BRCA1 and BRCA2 genes
- The claimed isolated DNA molecules have “significant utility” not present in native DNA, such as their use as probes and primers in a diagnostic context
- The patent-eligibility of isolated DNA comports with longstanding USPTO practice and international standards
- The USPTO’s interpretation of 35 USC § 101 as embracing isolated DNA is more consistent with the statute and Supreme Court precedent than the Solicitor General’s position that cDNA, but not isolated genomic DNA, is patent-eligible.
The Solicitor General’s Amicus Brief
The U.S. Solicitor General filed an amicus brief that presents the same position presented before the Federal Circuit:
Synthesized genetic materials such as cDNA molecules are patent-eligible subject matter, while isolated but otherwise unmodified genomic DNA is not.
The Solicitor General’s brief makes the following arguments:
- The Supreme Court does not owe deference to the USPTO
- Isolated DNA is more akin to the bacterial compositions held unpatentable in Funk Brothers than the genetically engineered microorganisms held patent-eligible in Chakrabarty
- Under Mayo, “a person should not receive a patent for simply discovering the existence and useful properties of something that already exists in nature”
- Field-specific concerns about encouraging innovation do not justify treating isolated DNA as patent-eligible
Other Amicus Briefs
At least 46 other amicus briefs were filed (available on the ABA website here), with thirteen in support of the petitioner (AMP), 23 in support of the respondent (Myriad), two “in support of affirmance,” and eight “in support of neither party.”
The brief from Target Discovery, Inc. in support of affirmance makes the argument that all isolated biological molecules are patentable. According to its brief, Target “discovers, validates and uses” newly identified protein isoforms as biomarkers “to improve clinical diagnosis and management of disease.” Thus, Target is rightly concerned about the effects that a general pronouncement against patent-eligibility could have on a much broader range of inventions than the “human genes” at the center of the question presented.
The Supreme Court Decision
The Supreme Court will hear oral arguments on April 15, 2013. A decision is expected by the end of the Court’s term in June.