Intellectual Property: Deposits of Biological Materials in Support of Certain Patent Applications
Abstract
The public's access to biological deposits once a patent is granted has not to date increased the risk of patent infringement for the U.S. biotechnology industry. On the basis of our review of court cases and our discussions with biotechnology industry representatives and other officials, we found no documented cases of a person or an organization having ever obtained a sample of a biological deposit and then using it to infringe on the patent. This result to date of course does not mean that no potential risk exists. To the contrary, because samples of a biological deposit can be obtained once a patent is granted, the potential exists today and will exist into the future that an individual or an organization could use the deposit to infringe the patent. To gain some perspective on the number of patents potentially at risk-since there are no comprehensive data showing the total number of patents outstanding that are supported by biological deposits-we analyzed all of the 52,841 patents the United States granted during the last 3 months of 1999. We found that 308, or about 0.6 percent, were supported by biological deposits in U.S. facilities. Furthermore, we found that patents for seeds-a field of biotechnology in which the deposit itself is seen by the seed industry as providing the "factory" for the seeds' reproduction- represent an even smaller subset, accounting for 53 of the 308 patents. The new 18-month publication requirement for patent applications need not have any effect on risks for patent infringement because this requirement does not change when biological deposits can be released to persons other than the applicant. Generally, the statute requires that patent applications be published at 18 months from the date of filing and be made available to the public at that time, unless the applicant certifies that he or she is not and will not be applying for a patent in any other country or under a multinational agreement that requires 18-month publication.c
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2000
- Accession Number
- ADA384497
Entities
Organizations
- United States Government Accountability Office