By Christopher P. Singer --
The Intellectual Property Owners Association (IPO) recently published a letter in opposition to the Federal Register Notice outlining proposed rule changes regarding biological deposits (see "Proposed Rule Change to Timing of Filing a Biological Deposit"). In particular, in its letter, signed by President Steven W. Miller, the IPO addresses the reasons why it believes the proposed rules are contrary to existing law and will have an adverse impact on applicants. The IPO further urges that, in the event that the proposed rules changes are nevertheless adopted, certain additional protective rules be incorporated similar to those existing in the European Patent Office.
Briefly, the proposed rules would enact a requirement that applicants submit a deposit of biological materials prior to the publication of an application, and make it available to the public, without restriction. In the Federal Register notice, the USPTO stated that its motivation for the rule changes included the AIPA, a desire to promote parity of disclosure across various technology areas, and to move toward international harmonization of rules regarding biological deposits.
The IPO first addresses and refutes the argument that the AIPA essentially requires these changes and that it overrules the CAFC's decision in In re Lundak. In noting that the language of the AIPA fails to suggest the need for any deposit practice change, the IPO also cites to a GAO report that was commissioned by Congress during consideration of the AIPA. Quoting from the report's conclusion that "the statute does not require an associated release of a biological deposit concurrent with 18-month publication," Deposits of Biological Materials in Support of Certain Patent Applications, GAO-01-49 (Oct. 2000) at 5, the IPO concludes that Congress was aware of the potential impact that the application publication rule could have on biological deposits. Noting the lack of any language in the AIPA that addresses the need for changing the existing deposit practice, the IPO concludes that Congress in the AIPA did not overrule the controlling law (i.e., Lundak) for biological deposits.
Moving next to the PTO's argument that the rule changes would provide parity of treatment of inventions and disclosures across various technologies, the IPO again provides a persuasive argument that the proposed changes go too far. The PTO's argument to this point is that a published application containing a reference to a biological deposit may not be adequately enabled for purposes of its use as a prior art reference under 35 U.S.C. § 102. While conceding that published applications requiring a deposit of biological material for purposes of § 112 enablement would fail to qualify as prior art to another application with claims directed to the same biological material, the IPO argues that such situations would not be typical. The IPO argues that the required enabling disclosure of a cited art reference is similar in scope to the enablement requirement of § 112 to support a claimed invention, citing to the PTO's use of non-patent literature and abstracts in art-based rejections. Many such references fail to contain as much disclosure as a patent application, and fail to provide restriction-free access to the biological materials they describe. In concluding this point, the IPO states that even with restricted access to a deposit during prosecution of an application, its eventual publication coupled with the existence of the deposit would likely qualify as prior art under 102(g).
As to harmonization, the IPO notes that while the proposed rules would encompass aspects of the deposit rules of the EPO, they completely fail to provide any of the protective rules also encompassed within the EPO's rules.
The IPO also argues that the rules changes would unfairly impact those applicants that make deposits, because a biological deposit effectively provides a mini, self-replicating factory for making an applicant's invention. The IPO argues that while all inventions must contain adequate description for § 112 purposes, these rule changes would effectively require that a finished sample of the claimed invention be made available to any third party, without restricted use, prior to the issuance of the patent. This situation creates a burden unique to those applicants making biological deposits. While acknowledging that such potentially infringing activity could be curtailed by the threat of provisional rights that would provide a reasonable royalty for infringing acts, the IPO notes that such rights would exist only when the issued claim is substantially identical to the published claim. Further, given that prosecution of a published application is publicly accessible using PAIR, third parties can feely monitor the course of prosecution and base their actions on amendments made to the application.
Hopefully, the USPTO will take the IPO's comments seriously and, if not abandon the changes entirely, consider at least amending the proposed rules to incorporate certain protections for applicants that make a biological deposit.
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