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Combination Drug Patents in the Post-KSR World
Combination drug therapies play an important role in today's pharmaceutical marketplace because they can provide additional protection on therapies developed by a company and access to significant revenue streams. As an example, Advair' (GlaxoSmithKline), a combination drug containing fluticasone and salmeterol, which was covered by U.S. Patent Nos. 4,992,474, 5,126,375, and 5,225,445, earned $5.3 billion in sales in 2007.
Combination drug therapies can present unique patent issues, particularly when they employ individual drug compounds that are known in the art. In such situations, the patentee must demonstrate that the combination is not obvious over the prior art. In KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007), the U.S. Supreme Court clarified the paradigm for analyzing a claim's obviousness. Since KSR, the courts have had limited review of cases involving combination drug therapies. However, the Board of Patent Appeals and Interferences (“BPAI”) of the U.S. Patent and Trademark Office (“USPTO”) has reviewed a number of such cases. In this article, we survey post-KSR decisions in an effort to assess what impact, if any, that Supreme Court decision may have had on the patentability/validity of combination drug therapies.
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.