Clinical trials yield scientific discovery and enable new technologies to come to market. But with these developments come a complex web of legal obligations and potential liabilities requiring well-drafted and negotiated contracts between a large number of players.
Continued robust innovation is in many ways, dependent upon fairly-allocated risks among clinical trials sponsors, sites, and investigators. The challenges are many in such a heavily regulated industry, but it’s very fulfilling to play a central role in the advancement of medical discovery.
Molly Huggins counsels health care clients, including sponsors of clinical research and academic medical centers, on a wide range of regulatory and operational matters involving clinical research issues.
Intellectual property protection is becoming more creative by necessity: the life cycles of many new technologies are such that they will have burgeoned and become obsolete before the patent process can be completed.
As a result, it is more important than ever to engage an experienced patent attorney to craft the patent claims that have the best chance of being allowed expeditiously, while standing the legal test of time if challenged during their term. Since under U.S. Patent Law, patents confer no affirmative right to practice the claimed invention (patents merely confer the right to exclude others from making, using, selling, offering for sale or importing the claimed invention), it is extremely important to engage highly experienced patent counsel to conduct clearance and non-infringement opinions before a patented invention is commercialized.
Dave Krasnow was recently named to Business North Carolina’s Legal Elite, Intellectual Property, 2010.
It’s now more common for employers to monitor employees’ work email accounts. We routinely advise clients, however, not to access employees’ personal email accounts without written consent, even if those accounts are occasionally used to conduct company business.
A U.S. Court of Appeals decision in 2009 held that an employee can recover statutory damages of $1,000 per violation of the Stored Communications Act and possibly punitive damages, attorneys’ fees, and costs for accessing, without authorization, private emails or other stored communications.
Patti Ramseur routinely counsels businesses on labor and employment matters. She was recently named one of Business North Carolina’s Legal Elite’s Young Guns for 2010.
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