On August 16, the Federal Circuit released its second opinion in Assoc. Molecular Pathology et al. v. Myriad Genetics, having reconsidered patent eligibility under 35 USC Section 101 in view of the Supreme Court's decision in Mayo v. Prometheus. Judge Lourie penned the majority opinion, with Judge Moore concurring and Judge Bryson in dissent.
All of Myriad's composition claims to isolated DNA molecules were again held by the Federal Circuit to be patent-eligible subject matter, not "laws of nature." The Court found the composition claims "cover molecules that are markedly different—have a distinctive chemical structure and identity—from those found in nature. Isolated DNA was distinguished as being "more than just removed from its native … environment … it has also been manipulated chemically."
Under the statutory rubric of § 101, isolated DNA is a tangible, man-made composition of matter defined and distinguished by its objectively discernible chemical structure.
Noting a distinction between the position on gene patenting presented by the United States and that presented by the USPTO, the Utility Examination Guidelines published by the USPTO in 2001, and the USPTO's allowance of gene patent claims for almost 30 years, the Court suggested "a change to the settled expectation of the inventing and investing communities must come from Congress, not the courts."
All but one of Myriad's diagnostic method claims under review were found ineligible under section 101 as reciting no more than mental steps that "compared" or "analyzed" gene sequences. Claim 1 recited a method for screening a tumor sample that included the steps of "comparing" a first BRCA1 sequence from a tumor sample with a second BRCA1 sequence from a non-tumor sample, where a difference in the sequence indicates an alteration in the tumor sample. Although the Court stated the application of an abstract idea [law of nature] in a process may be patent eligible subject matter, Myriad's claims were found not to apply the step of comparing the two nucleotide sequences in a process—only the process of comparing was claimed, according to the Court.
In contrast, method claim 20 was found eligible for patenting because it included additional steps that applied the abstract idea. The added steps included growing host cells transformed with an altered BRCA1 gene in the presence of a potential cancer therapeutic; determining the growth rate of the cells with or without the potential therapeutic; and comparing the growth rate of the cells. Claim 20 was found to recite cells transformed with a gene—clearly man-made.
The majority opinion strongly asserted the difference between the issues before the court for a §101 analysis and issues that were not before the court, concluding: "… this case was about patent eligibility and not patentability," referring to the inclusion of indefiniteness, novelty and obviousness concerns by the dissent.
In her concurrence, Judge Moore cited the long-standing expectations of the biotech community, the patent-eligible position of the USPTO, and the thousands of granted patents claiming DNA molecules as her reason for reversing the Second District for the full length DNA claims. In the dissent, Judge Bryson maintained his position that isolated DNA is not patent eligible because it is not a new and different molecule, and that the method claims broadly pre-empt a natural law.
The holding provides a partial victory as well as additional uncertainty to the biotechnology community. It provides a clear view of the Federal Circuit's current stance on the eligibility of isolated DNA molecules and of method claims like Myriad's claim 20 (cells transformed with a gene). But the decision does not provide guidance or certainty for the medical diagnostics industry where patent claims generally follow a standard format. Further guidance is needed to determine how medical diagnostic inventions might be claimed to comply with §101.
Traditional Diagnostics claim: (eligible?)
A method for diagnosing disease X in a subject, comprising:
- Analyzing a biological sample obtained from the subject for the presence of a mutation in gene Y, and
- Correlating/diagnosing the presence of the mutation with the presence of disease X in the subject.
A Myriad claim: (ineligible per Federal Circuit)
A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises:
- Analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample,or
- Analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.
A Prometheus claim: (ineligible per Supreme Court)
A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
- Administering a drug providing 6-thioguanine to a subject having said immune mediated gastrointestinal disorder, and
- Determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.