In April, Judge James Cacheris of the US District Court for the Eastern District of Virginia granted GSK's and inventor Triantafyllos Tafas's motion for summary judgment.
Cacheris said in his opinion that the proposed rules were substantive, rather than procedural, and that the Office therefore did not have the authority to implement them.
In May, the Office officially filed a Notice of Appeal with the CAFC.
The opening brief, filed on July 18, argues three main points: first, that the revised rules are within the scope of the Office's statutory rulemaking authority; second, that the revised rules do not conflict with the Patent Act; and third, that the Office need not provide public notice and comment for rules that are not subject to notice and comment under the Administrative Procedure Act.
With respect to the issue of substantive rulemaking authority, the ground upon which the permanent injunction was granted, the USPTO argued that "the court made no effort to measure the Final Rules against the actual terms of Section 2(b)(2) [of the US Patent Act], nor did the court give the USPTO's interpretation of that provision the deference required by Chevron USA v Natural Resources Defense Council (1984)".
Section 2(b)(2) of the Patent Act authorizes the USPTO to engage in rulemaking to establish regulations that "govern the conduct of proceedings in the Office", "facilitate and expedite the processing of patent applications" and "govern the recognition and conduct of agents, attorneys, or other persons representing applicants or other parties before the Office".
Chevron set forth a two-factor test for determining whether to defer to a government agency's rulemaking authority, which the Office argued the district court failed to consider.
The case is expected to be argued in late 2008, with a decision not likely before a new presidential administration takes over in January 2009.
