On Thursday, June 13, 2013 a unanimous Court handed down its much-anticipated decision in Association of American Pathology v. Myriad Genetics. The 9-0 decision was entirely consistent with the positions taken in HDP’s amicus brief, that isolated, synthetic DNA polynucleotides are patent-eligible subject matter.
This appeal followed a divided, three-way split decision at the Federal Circuit. Ass’n for Molecular Pathology v. USPTO, 689 F.3d 1303 (Fed. Cir. 2012). Following an order vacating an earlier Federal Circuit decision and remanding for reconsideration in light of the Supreme Court’s Prometheus decision, the Federal Circuit upheld Myriad’s patent claims to both the full-length isolated BRCA1 and BRCA2 gDNA (genomic-chromosomal) sequences, and synthetic cDNAs coding for the BRCA1 and BRCA2 proteins. The Supreme Court granted certiorari from this decision to consider the overly-broad (and vague) ACLU-framed question: “Are human genes patentable?”
At oral argument, the discussion focused on two matters: (1) the §101 eligibility of full-length, isolated BRCA1 and BRCA2 gDNA sequences; and (2) the §101 eligibility of cDNAs encoding the BRCA proteins. In its amicus curiæ brief, HDP took no position on the ﬁrst point, but urged the court to hold that cDNAs are the product of human agency, and thus patent-eligible.
The Supreme Court’s 9-0 ruling was entirely consistent with positions urged by HDP, that:
— (a) AMP v. Myriad is not simply a “gene-patenting” case, and ACLU-framed issue conﬂates (& confuses) patent-eligibility criteria articulated in case-law; and
— (b) Myriad demonstrated sufﬁcient structural-manipulation or transformation of “natural DNA” to satisfy Chakrabarty criteria for §101-eligibility in synthesis of Myriad’s new & useful man-made DNA BRCA-probe recited in Myriad U.S.’282 Claim 2 (see attached HDP amicus brief Figure 1, which outlines transformative-steps Myriad used).
Although the court unanimously concluded that a full-length gDNA sequence does not become patent eligible simply because of its isolation from its natural, chromosomal context, the Court also held that cDNA, which does not normally exist in human cells, is patent eligible under §101. The Court made clear (slip op. at 16, n.8) that the fact that some mRNAs are occasionally reverse transcribed by viral reverse transcriptases does not mean that lab-made cDNAs are “products of nature.” The Court was also careful to note that this decision says nothing about the patentability of any given cDNA, which could still fail the requirements of §§102 and 103.
PATENT PROSECUTIONS IMPLICATIONS
The Court explicitly did not consider (slip op. at 18) DNA “in which the order of the naturally occurring nucleotides has been altered.” Even the ACLU, however, agreed that such sequences are patent eligible. Meanwhile, structurally-novel (& useful) DNA segments arising from synthetic methods (e.g., solid-phase chemical synthesis), or “isolated” and “structurally-manipulated” or transformed by human-intervention, remain patent-eligible. Such DNA segments include single-stranded DNA or RNA, oligonucleotides, antisense strands, plasmid, viral sequences, monoclonal-antibody coding-fragments, and, perhaps, DNA-hybridizing-probes, such as gene-speciﬁc EST-probes.
The biotech industry can now move forward, conﬁdent about the patentability of its inventions. This conﬁdence is reﬂected in the sharp upswing in the price of Myriad’s stock, as investors realized that the cDNA claims, which protect important aspects of Myriad’s commercial products, are still valid.
BRIEF APPENDIX: Figure 1
Transformative-Steps to Make Myriad Synthetic DNA BRCA-Probe Recited in U.S.’282 Claim 2