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Prometheus v Mayo

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1. Prometheus Laboratories, Inc. v. Mayo Collaborative Services & Mayo Clinic Rochester (Decided December 17, 2010)

2. Citation: http://www.cafc.uscourts.gov/images/stories/opinions-orders/08-1403.pdf(external link)

Prometheus is the only and exclusive licensee of two method patents– 6,355,623 (the ‘623 patent) and 6,680, 302 (the ‘302 patent). Both patents in question claim methods for optimizing the dosage of thiopurine drugs used to treat gastrointestinal and non-gastrointestinal autoimmune diseases. The drugs used in the method claims include 6-mercaptopurine (“6-MP”) and azathiopurine (“AZA”). AZA is a pro-drug that converts to 6-MP when administered to a patient. Both drugs are used to treat diseases like Crohn’s disease and other inflammatory bowel diseases (“IBD”). Once it is administered to a patient, 6-MP is broken down by the body into 6-MP metabolites. 6-methylmercaptopurine (“6-MMP”) and 6-thioguanine (“6-TG”) and their nucleotides are examples of various 6-MP metabolites.

The drugs AZA and 6-MP have been in use for years in treating autoimmune diseases, but in some cases drug toxicity and non-responsiveness may cause complications in some patient’s treatment. Because of possible complications Prometheus developed the methods in controversy. The methods claimed in Prometheus’ patents seek to optimize therapeutic efficacy while minimizing toxic side effects.

Prometheus’ claimed methods (most of the claims) include two separately lettered steps in their written description. The two steps are (a) “administering” a drug that provides 6-TG to a patient and then (b) “determining” the levels of the drug’s metabolites (6-TG and/or 6-MMP) in the patient. Following the administering and determining steps the measured metabolite levels are taken and compared to pre-determined metabolite levels, “wherein” the comparison between the levels will “indicate a need” as to whether the level of the drug to be administered should be decreased or increased in order to minimize toxicity and maximize the efficacy of the treatment.

Prometheus marketed its method test as a PROMETHEUS Thiopurine Metabolites test that utilized the methods covered by the ‘623 and ‘302 patents at issue. Mayo Collaborative Services and Mayo Clinic Rochester (together “Mayo”) had purchased and used Prometheus’s test until 2004 when it announced that it would be using its own test in its clinics, which would also be available for sale to hospitals. Mayo’s test measured the same metabolites, 6-TG and 6-MMP, as Prometheus’s test, but used different levels to determine toxicity of the metabolites.

Procedural Posture:
Prometheus sued Mayo on June 15, 2004 for infringement of the ‘623 and ‘302 patents, asserting independent claims 1, 7, 22, 25, and 46 of the ‘623 patent and independent claim 1 of the ‘302 patent and on November 22, 2005 the Southern District Court of California held on cross-motions for summary judgment that Mayo’s test was a literal infringement of claim 7 of Prometheus’s ‘623 patent. Subsequently, on January 29, 2007 Mayo filed for summary judgment in the Southern District Court of California. Mayo argued that Prometheus’s patents were invalid because they claimed natural phenomena, subject matter non-patentable under §101 of the Patent Act.

On March 28, 2008 the district court granted summary judgment in favor of Mayo and held the patents invalid under §101 because they (1) only claimed correlations and (2) that the correlations were natural phenomena because the correlations resulted from a natural body process and were therefore non-patentable under §101. On appeal by Prometheus the Federal Circuit reversed the district court’s decision and upheld the methods claims as valid under the machine-or-transformation test. The machine-or-transformation test was, at the time of ruling, the court’s definitive test for determining whether a process is patentable subject matter under §101. BUT, the United States Supreme Court remanded this case back to the Federal Circuit for further consideration in light of the Court’s decision in Bilski v. Kappos.

In Bilski the Court rejected the machine-or-transformation test as the definitive test for patentability of a process under §101. The Court did not adopt any rules and instead returned to the well-established exceptions for laws of nature, physical phenomena, and abstract ideas. In reaching its decision, the Court did not reject the machine-or-transformation test entirely, but instead deemed the test as being a useful tool in determining whether a process is patentable under §101.

Holding: On remand, the Federal Circuit again upheld the validity of Prometheus’s method claims as patentable subject matter under §101.

Important Dicta:
The machine-or-transformation test is not the exclusive test for determining whether a process is patentable subject matter under §101, but that “transformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines.” Bilski, 130 S. Ct. at 3227. The Federal Court took the Court’s Bilski decision and applied the machine-or-transformation test to Prometheus’s claims, using the “useful and important clue, an investigative tool” to reach the conclusion that the methods claims at issue are valid under §101 because they do not encompass laws of nature or preempt natural correlations.

The Federal Circuit then applied the machine-or-transformation test in order to show that Prometheus’s claimed methods were patentable and not claims to laws of nature or preemptions of natural correlations. But rather, it asserted that “the inventive nature of the claimed methods stems not from preemption f all use of these natural processes, but from the application of a natural phenomenon in a series of steps comprising particular methods of treatment.” It then reaffirmed that the methods asserted in Prometheus’s claims satisfied the transformation prong of the machine-or-transformation test. The court concluded that this factor of analysis further supported the inventiveness of the claims, which Prometheus made clear in the patents’ specifications.

Future Importance:
The Federal Circuit’s application of the machine-or-transformation test in reaching its decision that Prometheus’s patents were valid under §101 is sure to have an effect on future court’s decisions regarding the patentability of processes. In Bilski the Supreme Court did not disavow the machine-or-transformation test entirely, but rather left the door open for lower courts to use it as an analytical tool in determining the patentability of a process under §101. While it was held that it is no longer a definitive test and cannot be used exclusively to determine a process’s patentability, it seems it will have little future effect on the test as a deciding factor in the analysis.

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