Two significant developments arose out of Bilski regarding life science patent claims. First, the Supreme Court’s endorsement of the machine-or-transformation test as one tool to analyze claims under 35 U.S.C. §101 provides some guidance to patent applicants and litigants. Second, the Court’s suggestion that the Federal Circuit develop “other limiting criteria” to analyze claims under §101 provides additional flexibility to develop tests more applicable to the life sciences, where the machine-or-transformation test is not particularly appropriate.
The Federal Circuit will have an opportunity to provide additional guidance in two pending cases: Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 2008-1403, and Classen Immunotherapies, Inc. v. Biogen Idec, Nos. 2006-1634 and 2006-1649. The Prometheus and Classen cases were both remanded to the Federal Circuit for additional consideration in light of Bilski. Prometheus involves claims
directed to a method of treating an immune-mediated gastrointestinal disorder by administering a drug and then determining appropriate dosage by measuring changes in the patient’s metabolite levels. See Prometheus, 581 F.3d 1336, 1339-40 (Fed. Cir. 2009). The Federal Circuit previously found the claims valid under §101 after applying the machine-or-transformation test. Id. At 1345-48. In view of the Supreme
Court’s holding in Bilski that the machine-or-transformation test is a valid tool for analyzing claims under §101, it seems likely the Federal Circuit will reach the same result on remand.
In Classen, however, the Federal Circuit invalidated claims directed to immunizing a treatment group and comparing the incidence of chronic immune-mediated disorders in the treatment group to a control group. See Classen, 2008 WL 5273107, at *1 (Fed. Cir. Dec. 19, 2008). The court indicated it had applied the machine-or-transformation test but provided no substantive discussion of the merits. Id. Although the likely result in Classen is more questionable in the wake of Bilski, the more interesting question is what other “limiting criteria” or analytical tools the Federal Circuit will develop to analyze the validity of the claims under §101.
In addition to Prometheus and Classen, the Federal Circuit is currently receiving briefing in Ass’n for Molecular Pathology v. U.S. Patent and Trademark Office (Myriad). In Myriad, the district court invalidated method and composition claims related to BRCA gene sequences under §101. See Myriad, 2010 WL 1233416 (S.D.N.Y. Mar. 29, 2010). The method claims at issue are directed to determining susceptibility to disease by comparing the patient’s DNA sequence to normal and mutant BRCA gene sequences. Id. at *28. The district court found the method claims were invalid because they were not tied to any particular machine and did not result in a tangible transformation. Id. at *47-49. Although the composition claims at issue in Myriad may implicate §101 issues related to the patentability of naturally occurring substances, the method claims will provide the Federal Circuit with another opportunity to define the limits of patentable subject matter in the wake of Bilski.
On balance, Bilski raises as many questions as it answers for the life sciences industry. Although the Supreme Court’s endorsement of the machine-or-transformation test provides some guidance, it remains to be seen what additional “limiting criteria” the Federal Circuit will develop to analyze the validity of claims under §101, or how the court will apply the test’s “machine” component to life science patent claims, where the “machines” are often intangibles. Until the court answers those questions, applicants and litigants in the life sciences should continue to emphasize the transformative aspects of data and information in their patent claims.