Introduction
The AMP v. Myriad opinion discusses the eligibility of patent protection for genes. Although the opinion is directed to the eligibility of patent protection for genes, this opinion is also applicable to understanding how the Federal Circuit will apply Prometheus.
This opinion was decided by a fractured three-member panel. Although a majority was formed as to the eligibility of the claimed invention at issue, the reasons diverged on one or more of the issues. (see matrix below).
Eligibility for patent protection of cDNAs
All three circuit judges agreed that cDNAs, the method for screening potential cancer therapeutics are eligible for patent protection. The majority opinion cast a wide net as to what is eligible for patent protection. Any composition that has a different structure compared to what is found in nature is eligible for patent protection. The concurring and dissenting opinions held that only those compositions that have a different structure and a different function from what is found in nature are eligible for patent protection.
All three Circuit Judges agreed that the cDNAs at issue are eligible for patent protection because they have a different structure from the naturally occurring genes. These cDNAs have all of the introns removed and only contain the coding nucleotides. They are capable of expressing a protein in a cell that does not normally produce it.
Eligibility for patent protection of isolated DNA molecules
As for the isolated DNA molecule, Circuit judges Lourie and Moore held that the claims directed to isolated DNA molecules are eligible for patent protection. Circuit Judge Bryson dissented and would have held these claims ineligible for patent protection.
Circuit Judge Lourie looked solely at the structure of the claimed invention and decided that isolated DNA molecules are not found in nature. They are always found within the overall DNA molecule. Hence, eligible for patent protection.
Circuit Judge Moore agreed that the isolated DNA molecule is eligible but not for the same reason. Rather, Moore wanted to maintain the status quo since the PTO has been granting patents to these types of discoveries for a long time and the inventing community expected these types of discoveries to remain eligible for patent protection.
Moore also explained that but for the settled expectations of the inventing community, she would have held isolated DNA molecules ineligible for patent protection. Isolated DNA molecules are exactly the same as found in nature except for the cleaved covalent bonds on opposed ends of the gene are missing. They performed no new function as isolated DNA molecules.
Circuit Judge Bryson held that the settled expectations is not a good enough reason to include isolated DNA molecules within the scope of patent-eligible subject matter. He indicated that isolated DNA molecules contain the same information as that found naturally within the context of the whole DNA and did not have any unique function when isolated. They performed the same function.
Eligibility for patent protection of a method for screen potentially cancer therapeutics
All three Circuit Judges agreed that the method for screening potentially cancer therapeutics is also eligible for patent protection because the method steps were tied to use of a transformed host cell. In particular, the method claim recited the step of growing a host cell transformed with an altered gene.
Eligibility for patent protection of methods of comparing and analyzing sequences
All three circuit judges agreed that the methods of comparing and analyzing sequences are not eligible for patent protection. They are merely abstract mental steps.
Applicability of Mayo v. Prometheus
In coming to the various conclusions, all three opinions discussed the applicability of Mayo v. Prometheus. All three circuit judges agreed that Prometheus does not control the issue regarding eligibility of compositions of matter but does provide some guidance. More particularly, all three circuit judges agreed that application of the holding in Prometheus is directed to laws of nature embodied in a method claim, not compositions of matter.
According to Circuit Judge Lourie, Mayo provides insights and illuminate broad, foundational principles. Mayo is instructive regarding the scope of the law of nature exception which ought to apply equally to manifestations of nature or compositions said Circuit Judge Moore. Circuit Judge Bryson explained that Prometheus does not decide this case but is instructive. The instant opinion is important to the broader question of how will the Federal Circuit apply Prometheus in analyzing patent eligible subject matter issues.
Holding of Association for Molecular Pathology v. PTO
The circuit judges also discussed their understanding of prior Supreme Court precedent controlling issues related to patent eligibility of compositions of matter, namely, Funk and Chakrabarty. Although all three Circuit Judges discussed Funk and Chakrabarty, two of the three came to the conclusion that compositions of matter must be structurally different from what is found in nature and have a different function as a general rule. One of the circuit judges held that only a different structure is required. Isolated DNA molecules were held to be eligible for patent protection due to the settled expectations of the inventing community.
Based on the underlying reasons explained by the Circuit Judges, compositions of matter having a different structure and different function compared to what is found in nature is eligible for patent protection. If the structure of the new composition is different from what is found in nature but does not have a significant new function, then in my opinion, it does not appear to be eligible for patent protection unless denying eligibility would interfere with the settled expectations of the inventing community.
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