The rules had been set to go into effect on November 1 2007, but were put on
hold
on October 31 last year, when Judge James Cacheris of the US District Court for the Eastern District of Virginia granted
GSK's
and
Tafas'
requests for a temporary restraining order and preliminary injunction staying their implementation until the Court had time to consider the full merits of the case.
In April this year, Cacheris granted GSK's and 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 Federal Circuit.
The USPTO's brief 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.
Oral arguments are scheduled to be heard at the Federal Circuit on December 8.
