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.