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Medical Diagnostic Methods More Freely Patentable in Europe
The European Patent Organisation ('EPO') has previously strictly prohibited protecting methods for medical treatment and diagnosis. However, a recent decision by the Enlarged Board of Appeals has clarified and restricted the grounds for rejection under Article 52(4) EPC on the basis of non-patentable subject matter. Thus, many diagnostic methods that were previously unprotectable in Europe may now be patented so long as they comply with the basic guidelines set forth in the opinion.
In G1/04 the Enlarged Board of Appeal stated that, to sustain a rejection for non-patentable subject matter, a claimed method must include steps from all of the following categories:
(i) an examination phase, during which data is collected;
(ii) a comparison of the data to standard values;
(iii) detection of a significant deviation in the course of the comparison; and
(iv) an attribution of the deviation to a particular clinical picture (i.e., a deductive decision phase).
Steps (i) to (iii) include technical and/or non-technical steps for making a diagnosis ' i.e., for collecting information and determining the way or ways in which the data differ from standard data representing, for example, characteristics of individuals free from a condition. That is, step (iii) may represent the identification of a symptom, while step (iv) is regarded as the diagnosis stricto sensu, involving the identification of a particular condition as the cause of the determined deviation or symptom. The step or steps constituting this diagnosis stricto sensu may be performed by a medical practitioner or automatically through the implementation of a device.
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.
Compliance Officers: Recent Regulatory Guidance and Enforcement Actions and Mitigating the Risk of Personal Liability
This article explores legal developments over the past year that may impact compliance officer personal liability.