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'Add-on Patents': Innovation or Sham?
Some recent estimates suggest that by 2007 brand name pharmaceutical companies will lose more than $80 billion in drug sales because of patent term expirations. Patent term expirations, of course, usher the entry of generic drugs into the marketplace. On average, the market share for branded products decreases by 15% to 30% when a first generic version reaches the market, and as much as 75% to 90% when subsequent generics launch. Such significant losses provide incentive to extend patent life and maximize the period of market exclusivity for a patented drug.
One approach for brand name pharmaceutical companies is to develop so-called “add-on” patents to those for existing drugs. Add-on patents typically address different aspects or new uses of an existing drug. These add-ons are also referred to as “second-generation patents,” “secondary patents” or “late-filed patents.” Some critics refer to add-on patents as sham patents, claiming that they often address insignificant elements of a drug, having less to do with any improved patient benefits and more to do with maintaining profits.
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.