The panel decision in AMP v. Myriad Genetics, written by Judge Lourie, contained law and fact rulings consistent with the Amicus Brief submitted by HDP on behalf of Gilead Sciences, Inc., Biogenerator and Elan Pharmaceuticals, Inc. The CAFC held that a synthetic cDNA construct is patent-eligible subject-matter under 35 U.S.C. §101, agreeing with HDP’s assertion that this was not a “gene patent” case, but a case to decide whether or not a man-made, synthetic cDNA construct is patent-eligible subject-matter under §101. The following summary focuses solely on the issue of the §101 subject-matter eligibility of man-made, synthetic cDNA.
Appeal to the CAFC followed a 2008 grant of summary judgment which:
- Invalidated Myriad claims to synthetic, man-made BRCA1/2-related cDNA.
- Invalidated Myriad claims to screening methods to identify BRCA1/2-gene defects.
- Held §101 patent-eligible subject-matter must be “markedly different” from a product of nature
MYRIAD SYNTHETIC cDNA CONSTRUCT CLAIMS ARE PATENT-ELIGIBLE UNDER §101
Judge Lourie’s opinion (with Judge Moore concurrence) emphasized chemical distinctions between Myriad’s man-made cDNA constructs and native cellular DNA, confirming HDP Amicus Brief assertion that focus should be on the synthetic chemical nature of Myriad’s cDNA construct (~6000 bp), assembled through 24 transformative-steps, resulting in a cDNA construct “markedly different” from native chromosomal BRCA gene (~100,000 bp); Fig. 1.
Specifically, the CAFC found that the 5’ and 3’ ends of the cDNA construct lack the covalent bonds found in native cellular DNA. Thus, Myriad man-made cDNA construct is not a “product of nature.” Beyond the Court’s recognition of the 5’/3’ broken covalent bond distinction, the fact that the Myriad cDNA construct has only about 6% of the length of native chromosomal gene, excludes introns, and is the result of 24 transformative steps from the native gene, surely meets the “markedly different” standard set forth by the District Court.
The CAFC addressed the following points:
- Analysis must focus on the chemical nature of the claimed cDNA (and not solely the information encoded,) taking into account the transformative steps Myriad took to create cDNA from native cellular DNA.
- The “magic microscope” information-oriented test proposed by Solicitor General is rejected by CAFC as being too simplistic and improper.
- The USPTO has been properly issuing patents on isolated DNA sequences for thirty years, and no court has ever ruled synthetic DNA constructs or cDNA as not patent-eligible subject-matter under §101. It is up to Congress, not the courts, to create a categorical exemption in §101 for “isolated” DNA.
Judge Bryson dissented from the majority conclusion that “isolated,” intron-inclusive DNA and short ~15-mer DNA primers and probes are patent-eligible, but Judge Bryson agreed that cDNA sequences are patent-eligible because cDNA sequences cannot be found in nature. Thus, all three CAFC judges agreed with HDP’s Amicus Brief position that man-made, synthetic cDNA constructs are patent-eligible subject-matter under §101.
Further appeals are expected, either en banc to CAFC or to Supreme Court. Meanwhile, this ruling represents a re-affirmation of long-standing precedent and offers inventors the intellectual property assurances they need to move forward in many important fields of biotech innovation.