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Legal Affairs : Sep 1, 2009 (Vol. 29, No. 15)

Timing Rules for Biological Deposits in Flux

Proposed Provisions May Wind Up Discouraging Many Patent Applicants
  • Joseph Hsiao

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.”

Rule Changes

Under the proposed rule change, “any deposit of biological material [must] be made before publication of a patent application, and…all restrictions on access to the deposited material [must] be removed upon publication.”

One of the rationales for the proposed rule changes proffered by the USPTO is that the changes aim to bring USPTO practice regarding biological deposits in line with the practice of publishing patent applications under the American Inventors Protection Act (AIPA) of 1999. Under the AIPA, patent applications, subject to certain exceptions, are published 18 months from their earliest priority date. In exchange for publication, the applicant has a provisional right to a reasonable royalty from an infringer from the time of publication of the application to the issuance of the patent under 35 U.S.C. § 154(d).

The USPTO argues that 35 § U.S.C. 122, as amended by the AIPA, stipulates that only those publications that provide an enabling disclosure are entitled to provisional rights. Although noting that several Federal Circuit decisions, including In re Argoudelis and In re Lundak, held that deposits were required prior to, or at the time the patent became public, i.e., the issue date, the USPTO argues that such cases were decided before, and therefore, superseded by, the AIPA.

Forced Public Availability

The proposed rule changes seriously disadvantage biotechnology applicants. They  unfairly burden such applicants by requiring a deposit of the biological material itself, as well as making it available to the public even if a deposit is actually not required.

A deposit of a biological material is not always required in order for a patent application for an invention involving a biological material to be enabled. This is because the main provisions of 37 C.F.R. § 1.809(a) are retained in the proposed rule changes; that is, the examiner in each application for a patent shall determine whether a deposit is needed, and if needed, whether a deposit actually made is acceptable for patent purposes.

However, given current USPTO delays due to a backlog of hundreds of thousands of applications, it would be highly unlikely that an application for an invention involving a biological material would reach an examiner for his or her review and determination of whether a deposit is needed before the 18-month publication date. Therefore, the proposed rule changes would effectively eviscerate current rules, particularly 37 C.F.R. § 1.809(a).

As a result, an applicant for an invention involving a biological material would effectively be required to deposit the biological material in order to preserve his or her provisional rights under 35 U.S.C. § 154(d), even if the applicant may be able to successfully argue that such a deposit is not required.

Moreover, if an applicant is able to successfully argue that such a deposit should not have been required, the proposed rule changes do not provide any provisions to safeguard the applicant’s biological material that has already been deposited before or at the time the application was published.

Once the deposit is made and all restrictions on availability removed, the invention involving the biological material has essentially been made available to the public without recourse. Therefore, any competitor will have access to the invention itself and the means to make and use it though conventional molecular biology techniques.

Futile Provisional Rights

While an applicant for an invention involving a biological material is entitled to a provisional right to a reasonable royalty against an infringer from the time of publication of the application to the issuance of the patent under 35 U.S.C. § 154(d), given that all requirements have been satisfied, such a provisional right may be ineffective.

Under 35 U.S.C. § 154(d) the provisional right to a reasonable royalty is available only if the invention as claimed in the patent is substantially identical to the invention as claimed in the published patent application. On the other hand, claims to an invention involving a biological material are often subject to a restriction requirement and/or are amended during prosecution to avoid prior art.

As a result, a requirement for a deposit prior to substantive examination of the application would likely make provisional rights unavailable on the basis that the claimed invention at issuance is not substantially identical to the invention claimed in the publication.

Therefore, if the proposed rule is enacted, an applicant for an invention involving a biological material, in order to retain post-publication damages, will be saddled with a de facto requirement to make his or her invention available to the public without recourse, even if a deposit requirement was ultimately not necessary. Given this unfair burden placed on an applicant for an invention involving a biological material, the negative impacts of the proposed rules greatly outweigh any rationale presented by the USPTO.