Regulatory Impact and IP Position

Understandably, the majority of biotransformation scientists would not readily consider intellectual property a fundamental aspect of their work. Likewise, the regulatory impact of findings (or their lack of study) is infrequently thought of in the normal course of work. However, it is inarguable that if a drug is not registered there will be no derived therapeutic benefit. Without therapeutic benefit, the entire discovery and development endeavor is simply a very, very expensive set of experiments. 

Registration and marketing approval of a new chemical entity (NCE) is increasingly difficult. In short, the era of the contemporary pharmaceutical industry has provided a long list of lessons learned from the accumulation of good and bad experiences. The inevitable evolution and improvements derived from this have benefited society with more efficacious and better tolerated drugs. As a consequence, the formalization of these lessons learned has created a seemingly incomprehensible list of points to consider. 

It should not be overlooked either that label claims are often the basis of marketing advantages. It is quite common that a drug s dispositional characteristics provide benefit to the patient relative to other agents in the class. Without doubt, this differentiation may play a prominent role in subsequent marketing efforts. Thus, there is a financial imperative that differentiating features be perceived properly, as well as the ethical obligation that they are described accurately. 

FIGURE 1.1 Examples of biotransformation reactions leading to a preferred marketed drug (Fura et al., 2004). 

Brodie BB, Reid WD, Cho AK, Sipes G, Krishna G, Gillette JR. Possible mechanism of liver necrosis caused by aromatic organic compounds. Proc Natl Acad Sci USA 1971 68(1) 160-164. 

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