Drug development process patents

In-licensing opportxmihes can enter the drug development process at the level of phase trials and the on patent stage. In either case, the simulahon model can assign a cost necessary to obtain in-licensed compoxmds (cost per in-licensed compound), which can be compared... 

The first edition1 of this book was published approximately 13 years ago. Its primary objective was to present an overview and a "roadmap" of the process of new drug discovery and development, particularly oriented to individuals or companies entering the pharmaceutical field. It was written by one of the authors (Smith), with no contributors, and drawn on Smith s experiences in the industry and field over the course of nearly 40 years. In the second edition, the scope of the first book has been expanded and technical details in the form of hard data have been included. In addition to the editors own commentary and contributions, the major part of the book is the result of contributions of experts in the industry. New chapters on risk assessment, international harmonization of drug development and regulation, dietary supplements, patent law, and entrepreneurial startup of a new pharmaceutical company have been added. Some of the important, basic operational aspects of drug discovery and development (e.g., organizational matters, staff requirements, pilot plant operations, etc.) are not repeated in this book but can be found in the first edition. 

During the development process or even while in the on patent stage, drug compoxmds sometimes develop what are called LEs new indications, methods of adminisfration, or... 

Even this step did not have a profound effect, because the ANDA mechanism was only available to generic copies of drugs first approved before 1962. But in 1984, as part of the compromise to obtain restoration of patent life that was being lost during the drug development and review process, the pharma industry agreed to extension of the ANDA requirement to copies... 

Generation of potential human metabolites for structural identification prior to administration of the drug candidate to humans can be performed with either cDNA-expressed enzymes or tissue fractions. This allows identification of potential human metabolites and development of appropriate analytical methods prior to clinical trials. Generation and identification of pharmacologically active human metabolites early in the development process can be beneficial for obtaining appropriate patent protection. 

In Part IV, we turn to the issue of patents and pharmaceuticals. Adam Mannan and Alan Story argue that drug access could be improved if product patents were abolished. They argue that even if a process patent is present, competitors can find alternative processes or uses for the chemical compound and create price competition. To further support their argument, the authors explain how the patent system was created not because it had to create conditions for sustainable innovation, but for market protection. They note that, until recently, few countries even recognized pharmaceutical product patents and some countries, such as India, were able to develop a thriving industry as a result of the absence of product patents. 

Structural novelty of the compounds (i.e., can this product be patented ), complexity of synthetic routes, scalability (can the syntheses be scaled up in an industrial way ) and the cost of starting materials (cost of goods at the end of the game), and potential environmental and toxicity issues will all need to be closely examined at early stages of the drug discovery and development processes. It is never too early to put these thoughts into action. 

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