Summary of the Budapest Treaty for Biological Deposits
The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other biological material to meet patent disclosure requirements. The agreement was first ratified in 1977, and was later modified in 1980. In other words, this is an international agreement regarding biotech patent law that predates PCR (invented 1983), Western blotting (invented 1981), massively parallel signature sequencing (MPSS, invented 1992), and a host of other molecular biological techniques that are the commonplace workhorses of biotech today.
The treaty was intended to address the challenge—as it existed at the time—of adequately describing transgenic organisms in patent applications, back in the day when it was impractical or even impossible to describe a transgenic organism in precise terms that would enable others to replicate the organism and practice the invention. The treaty allows applicants to deposit biological material with a recognized institution instead of providing a detailed description, so as to ensure accessibility to others in the art for purposes of satisfying patent law enablement requirements. The treaty provides for:
- International Depositary Authorities (IDAs), i.e., cell banks, tissue banks, and seed banks designated by treaty signatory governments to store biological material. IDAs are required under the treaty to meet standards for secure storage, impartiality, and accessibility;
- Single Deposit Recognition, i.e., a standard whereby a deposit made with any IDA is recognized by all contracting states for patent purposes, eliminating the need for multiple deposits in different countries; and
- Requirements, specifying timing and quantities by which the material must be deposited, the terms on which deposited material is available to interested parties, and the terms under which applicants must replace or replenish a deposit with the same material if a deposit becomes non-viable or depleted.
Those requirements—especially the requirements to make available and to replenish—can be noisome to businesses. For example, although some depository institutions have a box on their depository paperwork that the depositor can check requesting that the IDA notify the depositor every time that a withdrawal is made, there is no mechanism to enforce this notice provision, and no easy way for the depositor to know that it has been violated until after the harm (i.e., the unreported dissemination of the depositor’s patented materials) has already occurred. Moreover, the need to replenish the supply as (often unauthorized) withdrawals deplete the deposited supply can be a costly and time-consuming nuisance for the depositor. However, if a patent is granted on the basis of a Budapest treaty declaration having been given to the patent office, then failure to comply with these requirements could later prejudice the validity of the patent. 37 C.F.R. § 1.805.
Tips
For these reasons, many patent applicants prefer not to give a Budapest treaty declaration during patent prosecution. To avoid the need for a Budapest Treaty deposit during patent prosecution, consider the following three tips:
- Provide a Comprehensive Written Description: The Budapest treaty was negotiated back in a time when it was difficult or even impossible to know the genetic sequences of the organism or germ plasm being deposited. Today, however, whole genome sequencing often can be done fairly inexpensively. If the material for which patent protection is being sought (e.g., seeds, bacteria, plasmids) can be fully described (e.g., through genetic sequences, chemical composition, etc.) then this information can be included in the application in lieu of a deposit.
- Distribute the Materials Yourself: The logic behind the Budapest treaty is that sometimes one needs access to a particular biological material (e.g., a transgenic bacterium) to practice the claimed invention. But the IDAs are not the only plausible source of the material. If the material is accessible to the public through a known commercial vendor, this is also the sort of availability that can enable practice of the invention.
- Demonstrate That the Materials Are Already Available to the Public Elsewhere: It is commonplace in the “materials & methods” sections of scientific publications to see a line to the effect of “E. coli strain DX5K9 was a kind gift of _____ of ____ University….” If one can point to scientific publications showing that the material for use in the invention to be patented is already in circulation among scientists in the relevant field, this is also the sort of availability that can enable practice of the invention.
These strategies depend on the invention’s specifics and jurisdiction requirements. Consulting a patent attorney is advisable to assess whether a deposit can be avoided while meeting disclosure obligations.
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