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Patenting Genes

The Patent Process

Once the patent application is filed, the application is assigned to a patent examiner, who then has the responsibility of reviewing the application and determining whether the invention is entitled to patent protection. Often, the examiner initially rejects the claims that indicate what the inventor wants to protect. This occurs when the examiner finds these claims to be too broad or unfounded. This leads to a procedure known as the "prosecution" of the application, in which the examiner and the patent attorney or patent agent attempt to resolve the problems. If they are successful, a patent will be issued; otherwise, the examiner will refuse allowance of the patent. If the patent is denied, the inventor can then either appeal the decision or simply abandon the efforts to gain patent protection.

There are various other considerations in filing for patent protection in the United States and other countries. For example, in the United States there is a "duty of candor." This means that anyone filing a patent application must provide truthful information to the examiner, along with copies of all publications and other materials that might be relevant to the examination of the application. Failure to meet these honesty requirements can result in the invalidation of patents, the disbarment of the patent attorney or patent agent involved, or both.

In addition to patent protection in the United States, many inventors apply for protection in other countries. Most countries, including Japan, Mexico, Canada, Australia, and the nations of Western Europe, recognize genes as being patentable subject matter. However, these other countries have different standards for patentability than those followed in the United States, and many do not allow patents for medical devices. Although there are some patent attorneys who are licensed to practice both in the United States and abroad, most inventors employ the services of foreign patent attorneys who are familiar with the patent laws and rules in the foreign country of interest.

Kamrin T. MacKnight


Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980).

In re Application of Bergy, 563 F.2d 1031, 195 USPQ 344 (CCPA 1977).

In re Kratz, 592 F.2d 1169, 201 USPQ 71 (CCPA 1979).

U.S. Patent and Trademark Office. Manual of Patent Examining Procedure. Washington, DC: Superintendent of Documents, U.S. Government Printing Office, 2000.

Additional topics

Medicine EncyclopediaGenetics in Medicine - Part 3Patenting Genes - Patent Requirements, The Patent Process