Patent and Regulatory Issues

There are a number of patents on the microorganisms, fermentation process, and downstream separation of succinic acid. In addition, there are patents that cover the further conversion of succinate to other products and many patents on the competitive chemical processes that make large-volume chemicals such as 1,4-butanediol. A useful summary of the downstream chemical conversion patents appears in Varadarajan and Miller (1999). While patents have been referenced throughout this section on succinic acid, it is of interest to summarize succinic acid fermentation, strain development, and downstream separation patents here. 

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Patent law in the area of pharmaceuticals in general has become more complex, both from the government regulation policy side and in terms of the details of patent term adjustment between the Patent Office and the FDA s approval process. A better understanding of drag patent and regulatory issues will help to maximize protection of an approved drag product. 

The laboratory notebook is a record of your job as an analytical chemist. It documents everything you do. It is the source for reports, publications, and regulatory submissions The success or failure of a company s product or service may depend oh how well you do that documentation. The notebook, becomes a legal document for patent issues, government regulation issues (validation, inspections, legal actions), and the like. Remember, if it isn t written down, it wasn t done. The notebook is where you record your orig- inal ideas thatmay form the basis of a patent arid so it is important to record what went into those ideas and when. 

The five private industry advisory subcommittees formed in these policy areas were supposed to manage their own operations, however, and so the planned structure did not stay that way for long. The Regulatory subcommittee broke up into three groups concerning health, safety, and the environment each group Issued its own report, and the three were Integrated into a first draft report. In Patents and Information, and in Procurement and Direct Support of R D, the subcommittees split and each produced their own reports which stood on their own. So we ended up with seven reports from the private sector Instead of five — if you haven t seen them, they re available from NTIS. We had so many requests for them that we re out. 

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