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Protect Maryland's Bioscience Industry
Date:9/10/2008

ke many chemical prescription medicines, a biologic may have 2,000. The research required to take a biologic through the approval process is daunting, expensive, and mostly unsuccessful.

In fact, it can cost an average of $1 billion to develop a new product and even with all that investment there is no guarantee of success.

To encourage companies to take such risks in the search for new medicines the government offers incentives such as intellectual property protection. Without this protection a new product's patent can be used up while it is still being researched.

In 2005, only one-third of bioscience companies in the state of Maryland were profitable. Part of the reason for that is because the development of a new biological product can take an average of 12-15 years to bring to market.

With this in mind the Food and Drug Administration provides "data exclusivity" to the makers of new, innovative products. This prevents third parties from using the research conducted by innovators for a set period of time providing innovators an opportunity to recoup their heavy investment. Without the opportunity that this exclusivity provides, it would be nearly impossible for companies to embark on the development process.

Federal legislators are now working on establishing the approval process for "follow-on biologics," or third-party imitations of innovative biologic products.

If that legislation does not provide for an adequate period of data exclusivity for the researchers that have spent years -- and millions of dollars -- developing the original products, future research and development could be stifled as backers see no possible return on their already risky investment.

The effect would be felt across the bioscience industry, especially here in Maryland. Large businesses will be damaged and it could topple many small ones. In Maryland more than 60 percent of bioscience companies are made up of less than 20 employees.


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SOURCE Tech Council of Maryland
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