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The Golden Rule of Biological Inventions And the Written Description Requirement
Patent practitioners are the legal world's great interpreters. Clients rely on these attorneys for their ability to speak two languages: the language of the law and the language of science. A company with a well-organized in-house legal department can take proactive steps in the growth of the company's intellectual property to ensure that when legal protection is sought in the form of a patent, certain statutory requirements have been met and that the legal instrument through which patent protection is sought (a specification or “the disclosure”) adequately describes the invention. Furthermore, legal counsel can be positioned to provide oversight during the inventive process by focusing researchers' attention on properly documenting patentable ideas. Additionally, among other things, legal counsel can help researchers identify patentable ideas. What might be considered minor and not noteworthy to a researcher may be sufficiently inventive to warrant patent protection. In the biotech or pharmaceutical industry, a strong patent position is often defined not by a single pioneering and patented invention but by numerous smaller inventions comprising a
patent portfolio.
In an ideal world, a business would have a patent practitioner everywhere at once: in the lab, in the office, and in the boardroom. The purpose of this article is to interpret a sphere of patent law related to the description of biological inventions in terms that are practical for researchers and business managers in the biotech industry who live in a non-ideal world. While a proper patent application is best drafted by an experienced patent professional, understanding the requirements of a properly drafted specification can save a business frustration, cost, and the loss of intellectual property protection. In particular, because the “written description” of a patent application is the product of the inventor, a basic legal understanding of the requirements of this section can also inform a researcher's documentation and inventive path, resulting in stronger IP protection.
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.