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Drug & Device News
At High Court's Request, Fed Circuit Reconsiders Patent Decision
Last July, the U.S. Court of Appeals for the Federal Circuit handed a favorable ruling to drug manufacturers in Association for Molecular Pathology v. Myriad Genetics, a case concerning the patentability of isolated genes. That case was brought by The American Civil Liberties Union (ACLU) and the Public Patent Foundation against several defendants, including Myriad Genetics Inc., which lost its method patents but won its fight to protect patents on two genes chemically separated from DNA associated with ovarian and breast cancer. On July 20 of this year, however, the parties were back in court, arguing before the Federal Circuit over whether the March 2012 U.S. Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories Inc. dictates a different outcome. In Mayo, the Court invalidated patents on a method for determining the optimum drug dosage for individuals with certain diseases. The Supreme Court reasoned that the disputed method involved “laws of nature,” but not in an inventive manner, so no patent could be awarded on it. After issuing its Mayo decision, the Court invalidated the Federal Circuit's 2011 ruling and returned the case to it for reconsideration in light of Mayo. On re-argument, Jones Day partner Gregory Castanias asserted that the Federal Circuit had already concluded in its previous decision that the patents it upheld in Myriad involved “non-naturally-occurring, human-made inventions.” Thus, the Mayo decision should not alter the outcome, he said. The ACLU countered that Mayo applies to Myriad because it dealt with the issue of whether a disputed patent prevents scientists from conducting research involving a law or product of nature. If it does, and the patent is upheld, it could squelch scientific research and hinder the invention of useful products.
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.