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While a chemical compound, such as a drug, cannot be patented twice based on the discovery of a new property of the compound (no matter how important), the patent statutes explicitly authorize patents on new uses for 'old compounds.' While such method-of-use claims can be difficult to enforce, they can be extremely valuable, both to society and to the patent owner. AZT, a failed anti-cancer drug, earned millions and extended lives, after Burroughs Wellcome patented its use to treat HIV/AIDs. While a patent on a new use of an old compound can seem unfair, nothing is taken from the public domain. The patent often only confers the right to prevent others from advertising that the drug can be used to treat condition X as well as its 'old use' to treat condition Y. The public remains free to use the 'old drug' for any unpatented purpose.
Recently, two different three-judge panels of the Court of Appeals for the Federal Circuit came to opposite conclusions as they grappled with the question of whether or not a claimed use for an old compound was in fact new or 'novel,' or whether it was unpatentable as subsumed by, or legally 'inherent' in the 'old use.'
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 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.
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.
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.
This article explores legal developments over the past year that may impact compliance officer personal liability.