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IP Alert: Recent District Court Decision in Exelixis II at Odds with Exelixis I

February 7, 2013

On January 28, 2013, the U.S. District Court for the Eastern District of Virginia decided Exelixis, Inc. v. Kappos (Exelixis II), a second case involving the patent term adjustment provisions of the patent statute. The court faced a fact pattern similar to that seen in Exelixis I, discussed in an earlier alert, in which Exelixis had filed a request for continued examination (or “RCE”) more than three years after the patent’s filing date, and the parties disputed the effect of the RCE on available patent term adjustment.

Exelixis I was decided by Judge Ellis of the Eastern District of Virginia. The Exelixis II case was decided by Judge Brinkema, another judge within that district. In her decision, she explicitly rejected the Exelixis I decision, holding that the U.S. Patent and Trademark Office (USPTO) had correctly applied the patent statute in determining that the filing of an RCE after the three-year anniversary of the application filing date does toll the Type B delay period. The court concluded that the USPTO’s interpretation of its own regulations was entitled to so-called “Skidmore deference” because “it is a ‘reasonable conclusion as to the proper construction of the statute.’” Judge Brinkema’s opinion has thus created an intra-district split of opinion.

As noted in our earlier alert, the USPTO has appealed the Exelixis I case. The USPTO also appealed in Novartis AG v. Kappos, a case following Exelixis I. An appeal in Exelixis II is expected and it is likely that the Federal Circuit will consolidate at least the Exelixis I and II cases and will issue a clarifying opinion toward the end of 2013.

Written by Fitch Even attorney Jonathan C. Hughley

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