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.