Source: https://www.personalizedmedicinebulletin.com/2011/06/01/patent-eligibility-of-diagnostic-method-claims-what-have-courts-considered-so-far/
Timestamp: 2019-04-25 15:41:33+00:00

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Home > 35 U.S.C. 101 > Patent Eligibility of Diagnostic Method Claims - What Have Courts Considered So Far?
Patent Eligibility of Diagnostic Method Claims - What Have Courts Considered So Far?
Even for patent attorneys who specialize in personalized medicine, confusion still exists as to the best way to pursue and enforce diagnostic method patent claims in light of patent eligibility considerations under 35 U.S.C. §101. While the Supreme Court and Federal Circuit have provided some guidance regarding patent eligibility of certain method claims, details of how to proceed when drafting relevant claims, and which existing diagnostic method claims are viable, remain unclear to many.
It is possible that the Federal Circuit and/or Supreme Court may provide additional direction in cases yet to be decided. Such cases include the AMP et al. v. USPTO et al. (Myriad) “gene patenting” case (pending at Federal Circuit after oral argument on April 4, 2011), Classen Immunotherapies v. Biogen IDEC (pending at the Federal Circuit after remand by the Supreme Court in 2010) and Prometheus Labs., Inc. v. Mayo Collaborative Servs. (awaiting decision by Supreme Court on certiorari petition-again).
In the meantime, patent attorneys glean what they can from cases decided before and after Bilski v. Kappos (2010), such as In re Grams (Fed. Cir. 1989), Justice Breyer’s dissent from dismissal of the grant of certiorari in Lab. Corp of America Holdings v. Metabolite Labs., Inc. (2006), as well as the most recent Federal Circuit decision in Prometheus Labs., Inc. v. Mayo Collaborative Servs. (Fed. Cir. 2010) (albeit cert. pending at Supreme Court).
While such pending and decided cases are not an exhaustive list of ones that may impact patent eligibility of diagnostic method claims, it is informative to look at claims at issue in these cases. Below provides a brief summary of representative claims, and what the courts have said about them so far.
[e] identifying as a result of said testing a complementary subset of parameters corresponding to a combination of constituents responsible for the abnormal condition, said complementary subset comprising the parameters eliminated from the set so as to produce a subset having said non-significant deviation from a normal condition.
In this 1989 decision on appeal from the USPTO Board of Patent Appeals and Interferences, the Federal Circuit determined that the essence of the claimed process was a mathematical algorithm, and not any transformation of the tested individuals. The court concluded the process was merely an algorithm combined with a data-gathering step, i.e., performing a clinical test. The claims did not require the performance of clinical tests on individuals that were transformative. Instead, the tests simply obtained data.
correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.
This pre-Bilski decision may provide insight into the thinking of at least some Supreme Court Justices, especially after the Court said nothing when remanding Prometheus and Classen in light of Bilski (a case relating to business method claims, not diagnostics). In this opinion, Justice Breyer (joined by Justices Stevens and Souter) found that claim 13 was “not a process for transforming blood or any other matter,” but rather “instructs the user to (1) obtain test results and (2) think about them.” The fact that the assaying step involved the transformation of blood through an unpatented procedure was unavailing.
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
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.
comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.
wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.
While DNA composition claims in Myriad gets much attention because they potentially relate biotechnology patent estates overall (and certainly personalized medicine IP), method claims at issue in this case are also worth noting. Arguments on both sides regarding these method claims may spur the Federal Circuit to provide more insight regarding patent eligibility of diagnostic claims that differ from those at issue in Prometheus.
comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.
While Prometheus has garnered more attention, the Federal Circuit has not yet issued a decision in Classen, a case remanded in 2010 on the same day as Prometheus in light of Bilski. According to public record, parties in Classen filed supplemental briefs with the Federal Circuit in October 2010, and presumably the case is still live. Again, because the claims here differ from those in Prometheus, it is possible that the Federal Circuit could use this case to provide additional insight into exactly what types of diagnostic methods are (or are not) patent eligible.

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