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SCOTUS Confirms that Secret Sales Continue to Qualify as Prior Art Under the AIA
On Jan. 22, 2019, the U.S. Supreme Court issued a unanimous opinion, authored by Justice Thomas, in Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 586 U.S. __ (2019) (http://bit.ly/2Eixoxq), holding that an inventor's sale of an invention to a third party who is obligated to keep the invention confidential can qualify as prior art under 35 U.S.C. §102(a).
In early 2000, Helsinn Healthcare S. A. (Helsinn), a Swiss pharmaceutical company, submitted protocols to the Food and Drug Administration (FDA) for clinical trials of 0.25mg and 0.75 mg doses of palonosetron a drug for treating chemotherapy-induced nausea. Subsequently, Helsinn entered into a license agreement, and a supply and purchase agreement for palonosetron with MGI Pharma, Inc. (MGI).
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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.
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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.