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In re Kubin: Federal Circuit Ignores Principles of Structural Obviousness in Applying 'Obvious to Try' Test
On April 3, 2009, a three-judge panel of the Court of Appeals for the Federal Circuit unanimously affirmed the decision that the Board of Patent Appeals had reached in Ex Parte Kubin, 2007 WL 2070495 (B.P.A.I. May 31, 2007), thereby reinforcing and extending the applicability of the “obvious to try” test in biotechnology patent law practice. In furthering the “obvious to try” standard, however, the Federal Circuit also undermined its own precedent regarding biochemical structural obviousness ' namely, that the nucleotide sequence of a previously unknown DNA sequence encoding a known or partially known polypeptide is non-obvious. Thus, In re Kubin, 2009 WL 877646 (Fed. Cir. April 3, 2009), now appears to be the first case in which a defined biochemical structure was found to be obvious despite the fact that the structure was previously unknown and unpredictable.
In Ex Parte Kubin, the Board determined that a DNA sequence encoding a functionally characterized but unisolated receptor protein (the NAIL protein, which is located on the surface of certain types of immune cells) was obvious under 35 U.S.C. ' 103(a). The patent examiner had rejected Kubin's claims as obvious over a combination of prior art teachings disclosing: 1) the functional characteristics of the NAIL protein on cultured cells, 2) a monoclonal antibody that binds to a portion of the NAIL protein, and 3) a prophetic example of how to isolate NAIL DNA and the protein using conventional cloning and sequencing methodologies. Notably absent from the prior art, however, was any teaching or suggestion of either the amino acid sequence (complete or partial), or any working example of a method by which to obtain the amino acid or DNA sequence of the NAIL protein.
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.
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.
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.