On Friday, November 2, 2018, the USPTO released its interim procedure for patentees to request recalculation of the patent term adjustment with respect to information disclosure statements accompanied by a proper safe harbor statement under 37 CFR. 1.704(d) (83 Fed. Reg. 55102 (Nov. 2, 2018); see text at: https://www.gpo.gov/fdsys/pkg/FR-2018-11-02/pdf/2018-24004.pdf). The interim procedure is effective from the date of the notice until the USPTO can update the patent term adjustment computer program and provide notice to the public that the program is updated.
Patent term adjustment is time added to the terminal period of a patent term as a result of certain delays by the USPTO during the examination with an offset for delays attributable to the patentee. In the life sciences, medical devices, and pharmaceutical fields, patent term adjustment is often of particular importance due to the possible commercial lifespan of any covered products or methods in this space. Over the past decade, there have been many cases challenging the USPTO’s interpretation of the patent term adjustment statute, which have often been successful. To their credit, the USPTO has tried to keep up with the changes and update its internal algorithms used to calculate patent term adjustment. Sometimes they are successful, but other times the USPTO is slow to recognize or address deficiencies.
The new interim procedure is long overdue as the USPTO openly acknowledges in the notice that the “computer program used for this automated calculation cannot determine whether a compliant safe harbor statement under 37 CFR 1.704(d) accompanied an information disclosure statement. Thus, this computer program calculates the patent term adjustment total as if no compliant safe harbor statement under 37 CFR 1.704(d) was made.”
The safe harbor statement at issue applies when each item of information contained in the information disclosure statement:
(i) Was first cited in any communication from a patent office in a counterpart foreign or international application or from the USPTO, and this communication was not received by any individual designated in 37 CFR 1.56(c) more than thirty days prior to the filing of the information disclosure statement; or
(ii) is a communication that was issued by a patent office in a counterpart foreign or international application or by the USPTO, and this communication was not received by any individual designated in 37 CFR 1.56(c) more than thirty days prior to the filing of the information disclosure statement.
(see 37 CFR 1.704(d)(1)).
The changes arising from the new interim procedure are two-fold.
First, the USPTO is providing a new procedure for patentees to request patent term adjustment recalculation when a safe harbor statement under 37 CFR 1.704(d) was filed and the sole basis for requesting recalculation is the USPTO’s failure to properly recognize the same. The USPTO’s interim procedure waives the fee required under 35 CFR 1.705(b)(1) to file a request for recalculation of patent term adjustment. To avail one’s self to the interim procedure, patentees would need to file Form PTO/SB/134 (available at: https://www.uspto.gov/sites/default/files/documents/sb0134.pdf) within the time period required under 37 CFR 1.705(b) (i.e., within two months of patent grant, extendible up to five months).
The request for recalculation under this interim procedure does not require patentees to articulate what error exists nor when the compliant safe harbor statement under 37 CFR 1.704(d) was made. From the notice, it appears that upon receipt of the request for recalculation under this interim procedure the USPTO will manually review the patent term adjustment de novo. The USPTO will also provide a non-extendible period of two months after recalculation for patentees to file a further 37 CFR 1.705(b) request for recalculation.
Second, the USPTO is providing a new form for applicants to use when making a safe harbor statement under 37 CFR 1.704(d) (Form PTO/SB/133; available at: https://www.uspto.gov/sites/default/files/documents/sb0133.pdf). By using this form, the USPTO’s system will automatically flag the information disclosure statement as being accompanied by a proper safe harbor statement under 37 CFR 1.704(d), which will be properly accounted for in the final patent term adjustment calculation.