On February 20, 2008, the U.S. Patent and Trademark Office (USPTO) published a notice of proposed rule changes, revising the time for filing a biological deposit and the date of availability of the biological deposit. The period of comment ended April 21, 2008, and the proposed rules are presently still under consideration.
Under the proposed rule changes, a deposit of biological material referenced or in support of an application for a patent must be made before publication of the application, and all restrictions on access to the deposited material imposed by the depositor must be removed upon publication. Presently, the USPTO requires biological deposits to be made, along with removal of all access restrictions, by the issuance of the patent.
In exchange for a patent, the applicant must—among other requirements—provide a written description of the invention that would enable a person skilled in the art to make and use the claimed subject matter. This requirement, codified in 35 U.S.C. § 112, requires the applicant to provide “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.”
The complexities of a biological organism may make satisfying the requirement for written description and enablement requirements difficult. Recognizing the challenge to “sufficiently disclose by written word how to obtain [a] microorganism starting material from nature,” the Federal Circuit, in Enzo Biochem, Inc. v. Gen-Probe Incorporated, confirmed that “reference in the specification to a deposit in a public depository, which makes its contents accessible to the public when it is not otherwise available in written form, constitutes an adequate description of the deposited material sufficient to comply with the written description requirement of [35 U.S.C. § 112, ¶ 1].”
The current rules governing the depositing of biological materials provide that a deposit may be made at any time before filing the application for patent or during pendency of the application for patent, and that “all restrictions imposed by the depositor on the availability to the public of the deposited material [must] be irrevocably removed upon the granting of the patent.”