Washington Law Review


Debra K. Leith


The standard for biological deposits necessary for compliance with the enablement provisions of the Patent Act of 1952 (codified at Title 35 U.S.C.) has been altered by the Federal Circuit Court of Appeals in In re Lundak. Before Lundak, patent applications dependent on the use of biological materials called for the deposit of a biological sample in an independent depository, out of the inventor's control, on or before the filing date. The Lundak decision now permits an inventor to retain control of the deposit during prosecution of the patent application, so long as the public is guaranteed access to the invention upon issuance of a patent grant. At first impression this modification of the deposit procedure appears to be relatively innocuous. However, the decision inserts uncertainty and potential for abuse into the protocol for biological deposits. The attractiveness of post-filing deposits is outweighed in most cases by the risk of losing foreign patent protection through failure to deposit on or before filing. In addition, the practical need to provide adequate corroborating evidence of the chain of custody of the deposit from private hands to an independent depository acts as a further disincentive to depositing after the filing date. Thus, pre-filing deposit of the biological material remains the safest route to sufficient disclosure of the patentable subject matter required for attainment of both foreign and domestic protection of proprietary rights.

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