By Christopher P. Singer --
In a Federal Register notice published on February 20, 2008, the U.S. Patent and Trademark Office announced proposed changes to the rules regarding submission of biological deposits in patent applications. In particular, the revised rules would require that any deposit of biological material be made before the application publishes, and that all restrictions on access to the deposited material imposed by the depositor be removed upon publication. The motivation behind this change, as articulated in the Notice, is to provide equal access to all information referred to in the published patent application, whether that information is contained in another patent document or in a biological deposit. The changes address the interplay of biological deposits, written description and enablement (35 U.S.C. § 112), and publication of U.S. patent applications under the AIPA.
A brief overview of biological deposits
Internationally, biological deposits are governed by the Budapest Treaty. In the U.S., a deposit of biological material can provide adequate written description for a biological invention (see, e.g., Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002)). For purposes of enablement, the Federal Circuit has held that even "the availability of a sample to the public after the patent has issued will meet the enablement requirement." In re Lundak, 773 F.2d 1216, 1223 (Fed. Cir. 1985). Since the AIPA went into effect, certain commentators have argued that because the publication of a U.S. application can create provisional rights for the applicant, the published application must be in compliance with the enablement and written description requirements of § 112. This means that, if needed for § 112 purposes, a deposit of biological material would need to be made prior to publication (i.e., that the AIPA supersedes the rule stated in Lundak). A more detailed and complete description of the rationale behind these proposed rule changes is provided in the Notice.
Certain notable rule changes include:
Section 1.804 would provide that if a biological material is necessary to preserve the availability of provisional rights under 35 U.S.C. § 154(d), the deposit of the biological material must be made prior to filing an application or during the pendency of an application, provided that the deposit is made before technical preparations for publication of the application as a patent application publication have begun (see § 1.215(a)).
Section 1.808(a)(2) would provide that all restrictions imposed by the depositor will be irrevocably removed upon the earlier of publication of the application under § 1.211 and 35 U.S.C. § 122(b) or grant of the patent, and to indicate that the rule applies regardless of whether the deposit was made to satisfy a statutory provision.
Section 1.808(b) would add "before the patent is granted or" before "term of the patent."
Section 1.808(c) would provide that the Office will, on request, certify that an application referring to the deposit has been filed, that the subject matter of that application involves the deposited biological material or the use thereof, that the application has been published or patented or is otherwise open to public inspection, and that the requesting party has a right to a sample of the biological material. This is required by Rule 11.3 of the Regulations Under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. WIPO provides a form, BP/12, for this purpose (see "Forms under the Budapest Treaty and Regulations").
Section 1.809(e) would delete "before or with the payment of the issue fee (see § 1.312)" and insert "(1) within a period of sixteen months after the date of filing of the application or, if the benefit of an earlier filing date is sought under 35 U.S.C. 119(e), 120, 121, or 365(c), within the later of four months of the actual filing date of the later-filed application and sixteen months from the filing date of the prior-filed application; and (2) before or with any request for early publication (Sec. 1.219)."
The Patent Office is accepting written comments to these rule changes, by e-mail, regular mail, or facsimile. To be ensured of consideration, any comments must be received on or before April 21, 2008. Comments are preferably sent by e-mail addressed to AB99.Comments@uspto.gov. Alternatively, comments can be submitted by regular mail addressed to: Mail Stop Comments--Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313-1450, or by facsimile to (571) 273-7754, marked to the attention of Kathleen Kahler Fonda. Comments may also be sent by e-mail via the Federal eRulemaking Portal, which can be accessed here.
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