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Highlights

Under U.S. patent law, a patent must describe the subject invention in enough detail for someone skilled in that field to use or make it. In cases involving biological materials, the inventor may have to submit a sample. Some members of the biotechnology industry believe that biological deposits make patent infringement easier, reasoning that a person or organization can obtain a sample of the deposit and then reproduce the invention with minimal effort and expense. GAO found that access to biological deposits once a patent is granted has not increased the risk of patent infringement for the biotechnology industry. These concerns persist especially since the passage of the American Inventors Protection Act of 1999, which publishes the patent application 18 months from the date of filing and is made available to the public at that time rather than at the time the patent is granted.

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