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Warning: Research Dollars At Risk!
Before the clinical trials are run, before the Food and Drug Administration approves, before hope is held out to millions of patients, new drugs start with scientists asking elemental questions about human life. Now, the pipeline that leads from their laboratories through drug development to the FDA may be shut off at the source.
Contrary to the interests of everyone, the monies that fund small biotechnology companies and university labs could dry up. The villains are a few seemingly unrelated judicial decisions and the increasing complexity of biotech research itself. Together, they may serve to discourage the basic science on which medical advancement depends. Biotech companies anchor one end of the pipeline that produces new drugs. Along with major universities, they perform the risky experiments that lead to possible breakthroughs in medicine. They also develop the cutting-edge tools that permit this research, such as screening methods for new chemicals that might be transformed into medical cures, and computer programs to better design those chemicals. Then, their patented ideas are licensed or sold to the large pharmaceutical companies. The strength of “Big Pharma” lies in refining those research results into the next generation of medical treatments and devices – and then selling them. To keep the new drugs flowing, therefore, it is critical that patent law and practice support the ability of biotech companies and universities to stay in the lab. Unfortunately, the balance between the needs of patent holders and researchers may be upset.
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.
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.
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.
CLE Shouldn't Be the Only Mandatory Training for Attorneys
Each stage of an attorney's career offers opportunities for a curriculum that addresses both the individual's and the firm's need to drive success.
Discovery of Claim Construction and Infringement Analysis May be Compelled Prior to a Markman Hearing
A defendant in a patent infringement suit may, during discovery and prior to a <i>Markman</i> hearing, compel the plaintiff to produce claim charts, claim constructions, and element-by-element infringement analyses.