Howard Silverstein
Deputy Assistant, General Counsel for Patents
Office of the General Counsel, USDA
Washington, DC
and
William Tallent
Assistant Administrator
Agricultural Research Service, USDA
Washington, DC
The U.S. Department of Agriculture (USDA) awards plant genome grants to universities and other organizations in support of the Department's Plant Genome Program. In many of the genome mapping projects funded by the grants, DNA sequences for economically important genes will likely be generated.
These genome mapping efforts raise some important patent-related questions: (1) Who is the owner of the intellectual property rights in these discoveries? (2) Can USDA release the resultant sequence data to the scientific community? and (3) If yes, when can the data be released?
Ownership
By law (35 U.S.C. 200-204), a grantee would be entitled to ownership of the patent rights in such discoveries. However, the recipient must promptly disclose the maps to the Department and, within 2 years thereafter, apply for patent protection. Otherwise, the Government is entitled to own the patent rights.
Public Disclosure
During these option periods, the Government's disclosure of the maps or sequences to the public would be inappropriate since the grantee's patent rights may be adversely affected. Public disclosure includes printed publications or a public-accessible database. After the option periods have expired, or after a grantee elects not to file for patents, the information may be disclosed by the Government to the public without adversely affecting a grantee's patent rights.
Thus, the Government, in effect, is required to refrain from publicly disclosing a map or sequence for, possibly, up to 3 years. In most instances, the period of confidentiality will be substantially shorter, about 18 months, due to (a) a grantee's interest in early public disclosure, (b) early filing for a patent, or (c) no interest in patenting.
Gene Fragment Question
Still to be answered is the legal question of whether or not patents may be obtained on gene fragments. The recent attempt by the National Institutes of Health (NIH) to patent gene fragments in the United States was met with a "first-round" rejection by the U.S. Patent and Trademark Office.
According to an article in The Washington Post (September 24, 1992), NIH Director Bernadine Healy has asked Congress to clarify this issue through appropriate legislative amendment of the patent laws.