The Federal Circuit Provides Protection to Medical Diagnostics
By Brittany Blueitt – Edited by Caity Ross
Prometheus Labs., Inc. v. Mayo Collaborative Servs., Case No. 2008-1403 (Fed. Cir. Sept. 16, 2009)
The United States Court of Appeals for the Federal Circuit (“Federal Circuit”) reversed the ruling of the United States District Court for the Southern District of California granting summary judgment of invalidity of U.S. Patents 6,355,623 (“the ’623 patent”) and 6,680,302 (“the ’302 patent”) under 35 U.S.C. § 101.
Circuit Judge Lourie delivered the opinion of the court, holding that patents claiming a method of treatment were drawn to patentable subject matter based on transformative administering and determining steps of the process. In so holding, the court noted that the “key issue for patentability” is “whether a claim is drawn to a fundamental principle or an application of a fundamental principle.” Prometheus Labs., Inc. v. Mayo Collaborative Servs., No. 2008-1403, slip op. at 8 (Fed. Cir. Sept. 16, 2009).
The ’623 and ’302 patents claim “methods for calibrating the proper dosage of thiopurine drugs” by measuring certain metabolites. Prometheus Labs., No. 2008-1403, slip op. at 2. Prometheus Laboratories, Inc. (“Prometheus”), the exclusive licensee of the ’623 and ’302 patents, marketed a test that used the technology claimed in the patents. Mayo Collaborative Services and Mayo Clinic Rochester (collectively, “Mayo”) began using and selling a test that measured the same metabolites as the Prometheus test. On June 15, 2004, Prometheus sued Mayo for infringement of various claims of the ’623 and ’302 patents. On January 29, 2007, Mayo filed a motion for summary judgment of invalidity, asserting that the patents were invalid for claiming unpatentable subject matter under 35 U.S.C. § 101. Finding the correlations measured by the claimed method to be natural phenomena resulting from a natural body process, the district court granted Mayo’s motion for summary judgment and held the patents invalid under § 101. Prometheus appealed the district court’s grant of summary judgment of invalidity.
In reversing the district court’s ruling, the Federal Circuit applied the test for patentability articulated in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (2009). Under the Bilski test, a claimed process is directed to patentable subject matter if (1) “it is tied to a particular machine or apparatus,” or (2) “it transforms a particular article into a different state or thing.” Id. at 953. Furthermore, under the Bilski “machine or transformation” test, “the use of a specific machine or transformation of an article must impose meaningful limits on the claim’s scope to impart patent-eligibility,” and “the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity.” Id. at 961-62. Applying Bilski, the court concluded that the claimed methods of treatment “transform an article into a different state or thing,” and that such a transformation is “central to the purpose of the claimed process.” Prometheus Labs., No. 2008-1403, slip op. at 14. The court reasoned that the transformation takes place within the human body following the administration of the drug, and the various physical and chemical changes allow the concentrations of the metabolites to be determined. The court emphasized that when a drug is administered, “the human body necessarily undergoes a transformation,” as “[t]he drugs do not pass through the body untouched without affecting it.” Id. at 16.
Furthermore, the Federal Circuit held that the transformation in the claimed process is “not merely insignificant extra-solution activity.” Id. at 18. The court reasoned that the administering step, which provides the drugs, and the determining step, which measures the drugs’ metabolite levels to assess the drugs’ dosage during treatment, are both a part of a “treatment protocol” and that those steps were both transformative. Id. Finally, the court noted that a subsequent mental step in the process does not undermine the transformative nature of the prior steps. Id. at 20.
The Federal Circuit’s successful application of the Bilski “machine-or-transformation” test to the treatment method in Prometheus secures patent protection for the medical diagnostics industry. This security may be temporary however as the diagnostics industry anxiously awaits the Supreme Court’s review of Bilski later this year.