Biotech Values

[genisi]

New Law Provides Hatch-Waxman Exclusivities to Antibiotic Drugs

On October 8, 2008, President Bush signed into law the Qualifying Individual Program Supplemental Funding Act of 2008. Section 4 of the law, titled "Incentives for the Development of, and Access to, Certain Antibiotics," makes the patent and marketing exclusivity provisions of the Hatch-Waxman Act applicable for the first time to many older antibiotic drugs. The stated purpose of the law is to spur the development of new antibiotics, including new uses of existing drugs. It will also expand the U.S. FDA's ability to approve generic versions of some drugs, however, and all companies involved in the development and marketing of antibiotics should immediately begin to focus on this important change in the law.
For further reading:

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2008/09/new-life-for-ol.html