Harvard Can't Extend OncoMouse Patent Protection Despite ‘Mishandled' Disclaimer

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By Tony Dutra

Oct. 29 — Harvard will not get a chance to add new claims to a patent on its cancer-susceptible “Harvard Mouse,” killing its attempt to extend protection until 2016.

In an Oct. 29 nonprecedential decision, the Federal Circuit affirmed a lower court decision that, though the Patent and Trademark Office “procedurally mishandled” Harvard's patent term disclaimer, Harvard had indeed tied the later patent to the original patent's 2005 expiration date.

Procedural Mishandling

The President and Fellows of Harvard College own three related patents (U.S. Patent Nos. 4,736,866, 5,087,571 and 5,925,803) that disclose a transgenic research animal with a genome that makes the animal highly susceptible to developing cancer. E.I. du Pont de Nemours and Co. is exclusive licensee.

The '866 patent was issued April 12, 1988, so it expired 17 years later in 2005. An examiner rejected the divisional application for the '571 patent until Harvard filed a terminal disclaimer in 1989. Harvard disclaimed any portion of the term “of any patent granted on the above-identified application or on any application which is entitled to the filing date of this application under 35 U.S.C. §120.”

The disclaimer further said that the appropriate Section 120(d) fee accompanied the disclaimer, but no attorney has any record of a fee being paid, and the PTO's records do not go back that far. Further, the '571 patent was issued without any indication of the terminal disclaimer.

The '803 patent was filed in 1991 as a continuation of the '571 patent, and it was issued on July 20, 1999, again with no indication of a disclaimer. If it were not subject to the disclaimer, then, it would not expire until 2016.

An ex parte reexamination was initiated in April 2010 and, ultimately, Harvard tried to add new claims to the '803 patent. The PTO determined that the disclaimer did apply and that the patent had thus expired, barring new claims.

Judge Liam O'Grady of the U.S. District Court for the Eastern District of Virginia agreed with the PTO. Harvard appealed.

Finding That Fee Paid Not Arbitary, Capricious

Harvard's primary argument before the Federal Circuit was that its attorneys had failed to pay the fee and the PTO had acted accordingly, so the disclaimer had never been in effect.

“While we might have reached a different result if we were weighing the evidence in the first instance, this we cannot do,” the court said, because the case, brought under the Administrative Procedure Act, required review under an arbitrary and capricious standard.

Harvard had “expressly stated” that the fee had accompanied its disclaimer, the court said. And the PTO had acted—while prosecuting the '571 patent application—as if Harvard had agreed to the terminal disclaimer.

The court also rejected the idea that the PTO's acting contrary to its “regular practice” was sufficient to eliminate the disclaimer.

The PTO had mishandled the terminal disclaimer “by failing to affix certain notations to the terminal disclaimer or the ultimate patent, and by failing to place the terminal disclaimer on the contents page of the prosecution history,” the court said.

But Vectra Fitness, Inc. v. TWNK Corp., 162 F.3d 1379, 1381-82, 49 U.S.P.Q.2d 1144 (Fed. Cir. 1998), held that a disclaimer applied “regardless of mishandling by the PTO,” the court said, suggesting that there was no reason to vary from that view.

The court thus concluded that the district court's judgment that the fee had been paid had “a rational basis” and was not an arbitrary or capricious decision.

Judge Kimberly A. Moore wrote the opinion of the court, which was joined by Judges Alan D. Lourie and Kathleen M. O'Malley.

Donald R. Dunner of Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Washington, represented Harvard. Assistant Attorney Dennis C. Barghaan Jr. of the Department of Justice represented PTO Deputy Director Michelle K. Lee.

To contact the reporter on this story: Tony Dutra in Washington at adutra@bna.com

To contact the editor responsible for this story: Tom P. Taylor at ttaylor@bna.com

Full text at http://www.bloomberglaw.com/public/document/President__Fellows_Of_Harvard_v_Lee_Docket_No_1301628_Fed_Cir_Sep.