On November 1, 2012, Judge T.S. Ellis of the U.S. District Court
for the Eastern District of Virginia decided Exelixis, Inc. v.
Kappos (Case No. 1:12-cv-00096). Ruling against the U.S.
Patent & Trademark Office (USPTO), Judge Ellis granted summary
judgment to the Patentee and held that a Request for Continued
Examination (RCE) filed more than three years after the
effective filing date of a patent application has no impact on
Patent Term Adjustment (PTA). (
See November 2012 IP Buzz). Since the Exelixis
decision, there have been a few important developments.
On December 31, 2012, the USPTO filed its notice of appeal in
Exelixis. Given the traditional pace of the Federal
Circuit, we expect the Federal Circuit will decide the appeal
around the end of 2013.
In addition, since Exelixis, approximately fifty cases
have been filed by Patentees in the Eastern District of Virginia
seeking to take advantage of the decision. As of this
writing, it is not clear whether the Court's other judges will
adopt Judge Ellis' reasoning, follow Exelixis, and
quickly grant summary judgment to the patentee. Instead other
judges could stay a case relying on Exelixis pending
outcome of the USPTO's appeal – as was done when
Wyeth v. Kappos was pending during appeal.
Finally, on November 15, 2012, in Novartis A.G. et al. v.
Kappos, the U.S. District Court for the District of Columbia
(Case No. 1:10-cv-01138-ESH) sided with the reasoning of
Exelixis and issued a similar ruling. Here again,
the USPTO will likely appeal. Thereafter, we anticipate that
the USPTO will either move to consolidate the Novartis and
Exelixis appeals or instead request that the
Novartis appeal be stayed pending the outcome of the
Exelixis appeal.
Since decision in Exelixis, the USPTO has not yet issued a
notice as to how it is handling PTA calculations for affected
patents. Nor is the USPTO likely to provide any guidance
until the issue is resolved by the Federal Circuit or Supreme
Court. While the ultimate outcome of Exelixis cannot
be predicted, if a patentee does not properly and timely challenge
the PTO's determination of PTA, then the patentee waives that
right to challenge even if there is a subsequent court decision
favorably affecting PTA. Accordingly, in the interim,
patentees should take steps and preserve their rights for issued
and soon to be issued patents affected by Exelixis and
Novartis.
Patentees seeking to challenge the USPTO's determination of PTA
can petition the USPTO for a recalculation and/or file a civil
action. A civil action challenging a PTA calculation is
subject to a 180-day statutory deadline measured from the issue
date of the patent. Thus, if a Patentee is interested in
pursuing a civil action to challenge the PTO's determination of
PTA such a decision should be made well in advance of the 180-day
deadline.
Venable's patent prosecutors and intellectual property
litigators have considerable experience litigating in the Eastern
District of Virginia. Our attorneys include many former
Eastern District of Virginia judicial clerks and are leaders in the
Northern Virginia Chapter of the Federal Bar Association. We
welcome the opportunity to discuss and analyze with you the
possibility of bringing an action in the Court to obtain a patent
term adjustment. Please do not hesitate to contact us if have
any questions regarding PTA calculations or challenging PTA with a
civil action.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.