Myriad Genetics Case Alert
On March 29, 2010, the Southern District of New York issued an order in Association for Medical Pathology et al. v. USPTO, Myriad Genetics & the Directors of the University of Utah Research Foundation (S.D.N.Y.), finding on summary judgment that all 15 of the challenged claims are invalid under 35 U.S.C. § 101. Although the majority of the 152-page opinion focused on the invalidity of the 9 composition claims (which may essentially render any composition-of-matter claim covering isolated and purified DNA invalid), this update focuses on the invalidity of the remaining 6 method claims because from a validity standpoint, method claims in the life science industries appear to be more viable.
The District Court found that the method claims at issue fail Bilski’s “machine-or-transformation” test. Slip Op. at 141-47; see also In re Bilski, 545 F.3d 943, 950 (Fed. Cir. 2008) (en banc). Myriad argued that while data-gathering steps are not expressly claimed, Bilski’s transformation requirement is nevertheless satisfied because data gathering is necessary to carry out the claimed “analyzing” and “comparing” steps. Specifically, Myriad argued that such transformation is (1) implied by the inclusion of the phrases “from a human subject” or “from a tumor sample” in the claim language, (2) found in the specifications’ description of the process of obtaining DNA sequences, (3) found in the isolating and sequencing DNA steps described in the dependent claims, or (4) implied by the fact that isolating and sequencing DNA is required for “analyzing” or “comparing.” Slip Op. at 141-47. In rejecting Myriad’s arguments, the District Court primarily relied on the Federal Circuit’s decision in Prometheus Labs. v. Mayo Collaborative Services, 581 F.3d 1336 (Fed. Cir. 2009).
Briefly, the claim in Prometheus covered a method for determining the proper dosage of thiopurine drugs and disclosed three steps: (1) administering (e.g., a drug), (2) data gathering, and (3) correlating. See Prometheus, 581 F.3d at 1340. The Federal Circuit held that the data gathering step satisfied Bilski’s transformation requirement because it included the extraction and measurement of the metabolite concentrations, which implied a transformation of a patient’s tissue samples.[1] Id. at 1346-47.
The District Court distinguished the method claim in Prometheus from the method claims at issue in Myriad. The court noted that unlike the Prometheus claim, Myriad’s claims only recite the abstract mental steps of “analyzing” or “comparing” DNA sequences. Slip Op. at 141-47. The court also rejected Myriad’s arguments that data-gathering steps are necessary to carry out the “analyzing” and “comparing” steps under scrutiny, and therefore should be read into the claims. Instead, the court maintained that because Myriad’s claims only recite mental steps, the challenged claims are invalid under 35 U.S.C. § 101. Id. at 149.
The District Court further entertained the notion that even if the challenged method claims were read to include the transformations associated with isolating and sequencing human DNA, these “transformations” would still fail the Bilski test because they would be mere data-gathering steps that are “not central to the purpose of the claimed process.” Id. at 145-47. According to the court, a claim reciting a step of “performance of clinical laboratory tests on an individual to obtain data for the parameters” is a mere data-gathering step to obtain clinical data. Id. at 145-46 (quoting In re Grams, 888 F.2d 835, 837 (Fed. Cir. 1989). Like the Federal Circuit in Grams, the District Court found that isolating and sequencing DNA, even if incorporated into the method claims, would be “nothing more than data-gathering steps on which to perform the claimed comparison or analysis.”[2] Slip Op. at 146.
While this is certainly an extremely important—and controversial—decision to the biotechnology and pharmaceutical industries, it will take time to sort out its implications, as it will certainly be appealed to the Federal Circuit. Notably, the Supreme Court’s forthcoming decision in Bilski will likely impact the Federal Circuit’s analysis of the Myriad court’s ruling. Nevertheless, if the District Court’s decision is left unaltered, it is fair to speculate that most—if not all—composition claims covering isolated and purified DNA sequences would be rendered invalid.
The same, however, does not hold true of method claims directed to correlations. Indeed, method claims, such as those in Prometheus, which recite transformative administering and data-gathering steps, could still be relied upon to protect important innovations in the life sciences. Moreover, the Myriad court’s analysis suggests that claims reciting only data-gathering and correlating steps (such as those discussed in Justice Breyer’s dissent in Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 126-27 (2006)), would also be valid so long as claimed data-gathering steps satisfy Bilski’s requirement that such steps are not mere “extra-solution activity” and are “central to the purpose of the claim.”
Thus, the practitioner should be careful to ensure when drafting such claims that: (1) to the extent possible, do not rely only on a data-gathering step to satisfy Bilski’s transformation requirement; (2) when relying on a data-gathering step, disclose that step expressly in the claim; and (3) make sure that the expressly claimed data-gathering step is “central to the purpose of the claim,” and not superfluous.
[1] The Prometheus court also held that the administering step satisfied Bilski’s transformation requirement because it resulted in changes to both the patient’s biochemistry and the drug metabolites. Prometheus, 581 F.3d at 1346.
[2] It should be noted that the Federal Circuit in Prometheus distinguished Grams because in the Prometheus claims, “the administering and determining steps … are part of treatment regimes for various diseases” and therefore “not insignificant extra-solution activity.”
