Leading the Way in Life Science Technologies

GEN Exclusives

More »

Legal Affairs

More »
Sep 1, 2009 (Vol. 29, No. 15)

Timing Rules for Biological Deposits in Flux

Proposed Provisions May Wind Up Discouraging Many Patent Applicants

  • 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.



Related content

Be sure to take the GEN Poll

Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

More »