Saturday, December 18, 2010

Prometheus Patents Unbound

The Titan Prometheus suffered from a chronic liver condition.  The diagnosis was fairly straightforward:  every day, a great eagle would devour his liver, which then regenerated, affording the eagle its next meal.  Preventive medicine to avoid this condition might have involved Prometheus not stealing fire from the gods, and then giving it to humanity, since these actions caused Zeus to impose his brutal aquiline punishment.

On December 17, 2010, a more modern Prometheus, Inc. - a San Diego-based biotechnology company - received news that its torment in the Federal court system might ease.  In Prometheus Laboratories, Inc. v. Mayo Collaborative Services and Mayo Clinic Rochester (hereafter, "Prometheus v. Mayo"), the Court of Appeals for the Federal Circuit ("Federal Circuit") reversed a district court's grant of summary judgment that claims in Prometheus' exclusively licensed patents (U.S. Pat. Nos. 6,355,623 and 6,680,302) were invalid because they were drawn to non-statutory subject matter under 35 U.S.C. §101.  In an eagerly anticipated decision, a unanimous Federal Circuit panel, made up of Chief Judge Rader and Circuit Judges Lourie and Bryson, "again [held] that Prometheus' method claims recite patentable subject matter under §101."  The court's previous finding that Prometheus' claims constituted statutory subject matter was successfully appealed by defendants-appellees Mayo Collaborative Services and Mayo Clinic Rochester (hereafter, "Mayo") to the Supreme Court, which vacated and remanded the Federal Circuit's decision on April 29, 2010, "for further consideration in light of Bilski v. Kappos," a business method patent case the Supreme Court had decided the day before.

The claims at issue cover methods for determining the optimal dosage of thiopurine drugs, such as 6-mercaptopurine and azathiopurine, used to treat inflammatory bowel diseases that include Crohn's disease and ulcerative colitis.  For example, claim 1 of the '623 patent involves (1) administering a drug capable of producing 6-thioguanine inside a patient suffering from a gastrointestinal disorder, (2) determining the concentration of 6-thioguanine in the patient's blood, and (3) indicating the need to increase or decrease the drug's dosage depending on whether the drug's blood concentration is outside of the therapeutically desired range of 230-400 pmol per 80,000,000 red blood cells.

The Federal Circuit's decision in Prometheus v. Mayo supports the potential patentability of inventions that claim "therapeutic methods that determine the optimal dosage level of a course of treatment," (Opinion, page 24) including the inventions claimed in Prometheus' patents, that is, "a series of transformative steps that optimizes efficacy and reduces toxicity of a method of treatment for particular diseases using particular drugs (Opinion, page 25).  More broadly, this decision may raise optimism within the biotechnology and pharmaceutical industries that methods of personalized medicine, including individually tailoring therapies based on specific genomic information, may be patentable, and, thus, worth investment in research and development.   

More biolaw at LEXVIVO.


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