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Is the Federal Circuit Playing with Fire?
Less than two months before the Supreme Court is scheduled to review the Federal Circuit's en banc decision in In re Bilski that found Bilski's business method claims unpatentable under 35 U.S.C. ' 101, the Federal Circuit held in Prometheus Labs., Inc. v. Mayo Collaborative Servs. (Fed. Cir. 2009) that claims to a diagnostic method are patent-eligible subject matter. The Federal Circuit reversed the district court's decision and held that Prometheus' personalized medicine claims satisfied the machine or transformation test set out in Bilski. 545 F.3d 943 (Fed. Cir. 2008) (en banc), cert. granted, argument set for Nov. 9, 2009. The timing of this decision cannot be overlooked. While the claims at issue in Bilski were drawn to business methods, many groups (as evidenced by the amicus briefs) are concerned that application of the strict machine or transformation test would render diagnostic and personalized medicine methods, particularly in the medical and biological fields, invalid and unpatentable under ' 101.
The court's decision in Classen Immunotherapies, Inc. v. Biogen Idec (Fed. Cir. 2008), rendered shortly after Bilski, turned the concern of those interested in patenting diagnostic methods into fear. Classen's claims were held invalid under ' 101 because the claims were neither tied to a particular machine nor did they transform a particular article into a different state or thing. The claim at issue was drawn to a method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-related disorder. The claim recited immunizing mammals with immunogens according to a schedule and comparing the incidence, prevalence, frequency, or severity of the chronic immune-related disorder in the treatment group to a control group. The Classen decision seemed to indicate that the Federal Circuit would follow the views expressed in Justice Breyer's dissent in Laboratory Corp. v. Metabolite Labs., Inc. 548 U.S. __ (2006) (“LabCorp“) in which he criticizes the scope of claims directed to identifying a vitamin deficiency based on measuring increased levels of homocysteine in blood. The patent eligibility of diagnostic or personalized medicine methods was uncertain.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.