The Supreme Court issued GVR Orders* on two important biotech cases:

Classen Immunotherapies, Inc. v. Biogen IDEC et al. (08-1509)

The petition for a writ of certiorari is granted. The judgment is vacated, and the case is remanded to the United States Court of Appeals for the Federal Circuit for further consideration in light of Bilski v. Kappos, 561 U.S. ___ (2010). This case, a § 101 matter that parallels the issues in Prometheus v. Mayo, involves patents involving a mechanism for evaluating the safety of vaccine administration schedules by comparing or identifying the adverse events associated with various vaccine schedules.

The claims in Classen are directed to methods of selecting vaccine regimens by comparing two regimens and identifying the regimen less likely to cause chronic autoimmune disorders. The patent was killed as directed to patent ineligible processes under Section 101 under the belief that the immunization step was an “insignificant post-solution activity” and the claims were merely an indirect attempt to patent the idea that there is a relationship between vaccine schedules and chronic immune mediated disorders and “an attempt to patent an unpatentable natural phenomenon.”

The Federal Circuit affirmed the district court’s grant of summary judgment that these claims are invalid under 35 U.S.C. § 101 “in light of our decision in In re Bilski.” The held that the claims were neither “tied to a particular machine or apparatus” nor do they “transform[] a particular article into a different state or thing.”

Mayo Collaboratives Svcs., et al. v. Prometheus Laboratories (09-490)

The petition for a writ of certiorari is granted. The judgment is vacated, and the case is remanded to the United States Court of Appeals for the Federal Circuit for further consideration in light of Bilski v. Kappos, 561 U.S. ___ (2010). The Federal Circuit, reversing the district court, upheld Prometheus’s patent claims covering a means to measure the level of 6-thioguinine (6-TG) and 6-methylmercaptopurine (6-MMP), which indicates that an adjustment in drug dosage may be required at certain metabolite levels.

The patent includes only two active steps, “administering” the drug and then “determining” metabolite levels.  The claim really just explains the correlation between metabolite levels and therapeutic efficacy and “what the inventors claim to have discovered is that particular concentrations of 6-TG and 6-MMP correlate with therapeutic efficacy and toxicity in patients taking AZA drugs.”  The district court decided as a matter of law that the asserted claims were drawn to non-statutory subject matter and as such, unpatentable.

Thankfully, cooler heads appear to have prevailed and the US Court of Appeals for the Federal Circuit has held that methods of treatment claims fall squarely within the realm of patentable subject matter. Prometheus Laboratories, Inc. v. Mayo Collaborative Services (08-1403).  The Federal Circuit may now have a chance to take up some issues that were avoided due to the earlier Bilski decision.

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*The Supreme Court of the United States may issue GVR orders (stands for grant, vacate, and remand). These orders are especially appropriate when there has been a change in the law subsequent to the lower court or agency’s decision such as with Bilski. GVR orders are not full explications.

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