For the half-year to 30 June 2014, the IPKat's regular team is supplemented by contributions from guest bloggers Alberto Bellan, Darren Meale and Nadia Zegze.

Two of our regular Kats are currently on blogging sabbaticals. They are David Brophy and Catherine Lee.

Sunday, 24 January 2010

Letter from AmeriKat I: Wyeth v Kappos

Unfortunately for the Amerikat, most people general despise the month of January and shut themselves away in the warmth of their homes, to await the ides of March. So just as she does so every year at this time, the AmeriKat generally purrfers to stay at home with a cup of tea, reading the latest scandalous biography of some roaring Twenties bright young thing. Having read all she could get her paws on about the Mitford sisters, she is now currently reading the excellent The Bolter by Sarah Osborne about the gloriously fearless Idina Sackville (right). These women would have never gone a year without celebrating a new year in roaring style. Therefore the AmeriKat, respecting tradition, will be celebrating the month of January in a style that any Mitford girl would admire ... even though she may miss out that trip to Claridges.

Times up for USPTO in Wyeth v Kappos

Patent owners may also be celebrating this month with the recent decision of the Court of Appeals for the Federal Circuit that held that the USTPO had erred in calculating patent term adjustments for two patents owned by Wyeth and Elan Pharma International. The Federal Circuit affirmed the District Court’s earlier summary judgment in favor of the plaintiffs which held that the USPTO misapplied 35 USC § 154(b)(2)(A) and therefore denied Wyeth part of the patent term to which they were legally guaranteed. Judge Rader, joined by Judges Plager and Moore, held that proper application of Section 154(b) entitled Wyeth et al to extended patent term adjustments.

Section 154(b)(1) includes three patent term guarantee provisions. Wyeth v Kappos concerned the interrelationship between two of these; that of Sections 154(b)(1)(A), and 154(b)(1)(B):

* the “A guarantee/delay” provides for a one-day term extension for every day that issuance of a patent is delayed due to the failure of the USPTO to comply with statutory deadlines;

* the “B guarantee/delay” provides for a one-day term extension for every day that issuance of a patent still has not occurred three-years after the filing date.
These provisions are limited by Section 154(b)(2)(A) which states that, where there are periods of overlap between these provisions, “the period of any adjustment granted under this subsection shall not exceed the actual number of days the issuance of the patent was delayed.” ‘Double recovery’ for an overlapping delay is therefore prohibited. This makes sense to even the AmeriKat’s unrefined patent mind, but apparently the USPTO had some problems with this application. For excellent schematics of Wyeth’s and USPTO’s differing interpretations please see this diagram from PatentDocs.

The confusion originated in 2000 when the Patent Office issued 37 CFR Section 1.703(f) which stated that
“to the extent that periods of adjustment attributable to the [guarantees] overlap, the period of adjustment granted under this section shall not exceed the actual number of days the issuance of the patent was delayed.”
Four years later “period of adjustment” was replaced with “period of delay”. The USPTO was under the belief that the former language misled applicants into believing that A delays and B delays were only overlapping if the period of A delays occurred more than three years after the actual filing date. Judge Rader stated that this new definition, using the ‘period of delay’, “caused the B guarantee to start with the filing of the application, not three years later.” Therefore the USPTO “uses either the greater of the A delay or the B delay to determine the appropriate adjustment but never combines the two.” This application was incorrect. At page 7, Judge Rader writes:
“This court detects no ambiguity in the terms "periods of delay" and "overlap". Each term has an evident meaning within the context of section 154(b). The limitation in section 154(b) only arises when "periods of delay" resulting from violations of the three guarantees "overlap." Significantly, the A and B guarantees expressly designate when and for what period they each respectively apply.”
In summary, the Federal Circuit confirms that:
1. An A delay runs from the date the USPTO misses a statutory deadline to the date of response to that deadline.
2. A B delay can only run from a date that is three-years after filing of the patent.
3. Therefore, there can be no overlap between an A delay and a B delay if it occurs prior to the three-year anniversary of filing.
4. There is no overlap between these delays unless the violations occur at the same time.
5. The court will not afford any special deference to the USPTO’s interpretation under either Chevron USA v Natural Resources Defense Council (1984) or Skidmore v Swift (1944) when the statutory language is so “clear, unambiguous and intolerant” of such interpretation (see page 13 of the judgment).
The USPTO issued a statement stating that they and the Department of Justice “have decided not to seek further review of the Federal Circuit’s decision” and that they are “preparing guidance for expediting requests for recalculation of patent term adjustment by the USPTO in light of the Wyeth decision.”

The AmeriKat suggests you get your re-reviews into the USPTO now!

For more information regarding patent term extensions please see this link from PatentTermOnline (thanks to Filemot for alerting the AmeriKat to this resource).

2 comments:

Anonymous said...

Quite appropriate for the AmeriKat to read a book about the Mitford sisters, considering that one of them was mother to Max, no stranger to scandal himself, and, as an indirect result, the subject of a couple of previous IPKat posts.
(Of course, the truly infamous character was Max's father, very deservedly lampooned by P.G. Wodehouse as "Sir Roderick Spode", but that's quite another matter...)

Rob Harrison said...

Over at IP Finance I've been mulling the financial consequences of the decision for pharmaceutical companies having blockbuster patents. Have a look at: http://ipfinance.blogspot.com/

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