Legal issue disclosure

The legally trained member of the interdisciplinary committee should provide insight as to the significance of the technological advance and as to whether any commercial product ultimately derived from the invention could be protected by an issued patent. Another important function of this person is to determine the scope of the invention based on preceding events, pubHcations, or activities which may have otherwise limited the breadth of the invention. To this end, U.S. law requires that an invention satisfy a number of prerequisites or requirements before issuing a patent novelty, nonobviousness, utiHty, and disclosure. 

There will come a time, however, when the information required from a company which will permit a decision on whether or not to continue with an enquiry is of a confidential nature, such as a trade secret, some form of know-how or an as yet unfiled patent which cannot be shared without legal protection for the company divulging the information. The means to avoid this issue is by drawing up of a confidential disclosure agreement (CD A) sometimes called a non-disclosure agreement (NDA). The latter acronym may confusing... 

The FDA s role is to assure that all advertising and promotion of prescription drugs is accurate, provides full disclosure of risks and is fairly balanced. There are two legal bases for FDA jurisdiction over all advertising and promotional materials and programs issued by or sponsored (i.e. funded) by drug companies. 

Corporate legal departments serve as the guardians of IP, and if any issues relating to disclosure come up they need to be consulted and their advice followed. Mechanisms exist within each company to regulate what information can go out in posters, talks, and publications. Often an online or paper permission request needs to be filled out and approved by managers and corporate attorneys before presentations can be given or manuscripts sent out to journals, and this can take some time, so potential speakers and authors need to learn the system and apply early. 

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