HARVARD/DUPONT’S CANCER MOUSE PATENT NIXED BY PARENT PATENT’S TERMINAL DISCLAIMER

Michael Caridi | November 11, 2014

President and Fellows of Harvard v. Lee

October 29, 2014

Panel:  Lourie, Moore and O’Malley.  Opinion by Moore

Summary

Harvard/DuPont appealed the Virginia Eastern District’s Summary Judgment grant of the USPTO’s finding of their cancer mouse patent (USP 5,925,803) expired due to a terminal disclaimer filed in the parent patent disclaiming term for any future patents.  Harvard/DuPont argued that the terminal disclaimer was not properly entered because the requisite fee was not paid and therefore ineffective.  The Federal Circuit affirmed the USPTO’s finding on the basis that the ruling was not arbitrary, capricious, an abuse of discretion, or contrary to law under the APA standard.

Factual Background

During an exparte reexamination of the ‘803 patent the reviewing Examiner declared the patent expired due to a terminal disclaimer filed during prosecution of the parent ‘571 patent.  Harvard/Dupont had attempted to cancel and replace the claims of the ‘803 but the Examiner refused to enter the amendment based on the expiration of the patent.  The disclaimer had been in response to a double patenting in view of the grandparent ‘866.  The terminal disclaimer disclaimed any 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.”  No other arguments were made to overcome the double patenting rejection.  The Examiner had subsequently allowed the application resulting in the ‘571 patent. The ‘803 patent was a continuation of the ‘571 and thus claimed priority under 35 U.S.C. §120.

In response to the Examiner issuing a certificate noting the expiration, Harvard/Dupont petitioned to the PTO Director arguing that there was no evidence that they had ever paid the requisite fee for the terminal disclaimer.  The Director sided with the Examiner and dismissed the Petition.  Harvard/Dupont then filed an Administrative Procedure Act (APA) action in the Eastern District of Virginia asserting that there was no evidence that they had ever paid the terminal disclaimer fee.  The Eastern District of Virginia granted Summary Judgment in favor of the USPTO.  Harvard/Dupont appealed to the Federal Circuit.

Discussion

The controlling standard from the APA whereby the court can “hold unlawful and set aside agency action, findings, and conclusions found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). The burden of showing the agency action was arbitrary and capricious lies with the plaintiff.  Ohio Valley Envtl. Coal. v. Aracoma Coal Co., 556 F.3d 177, 192 (4th Cir. 2009).

To support their case that the USPTO’s finding that the ’803 patent had expired as a result of the terminal disclaimer was arbitrary and capricious Harvard/Dupont put forth a plethora of evidence that the fee for the Terminal disclaimer had not been paid.  This included declarations from both the prosecuting attorney and the controller of the law firm at the time of the ‘571 patent (20 years ago) that they had no record that the fee had been paid and that by their recollection it had not been.

Harvard/Dupont also asserted that the error by the USPTO of not properly recording the terminal disclaimer resulted from the fact that the fee had never been paid.  Specifically, the PTO did not list the terminal disclaimer on the “Contents” page of the prosecution history of the ’571 patent or give it a paper number.  The terminal disclaimer was not date stamped and the issued ‘571 patent and ‘803 patent do not indicate a terminal disclaimer. Finally, Harvard/Dupont asserted that the Examiner of the ‘571 did not indicate that the terminal disclaimer was the basis for her removing the double patenting rejection.

The Federal Circuit responded by first noting that they are bound by the high standard of the APA that the government’s action must be “arbitrary [and] capricious.”  The Court even goes so far as to state: “While we might have reached a different result if we were weighing the evidence in the first instance, this we cannot do.”  The agency only has to show rationality and consideration of relevant factors.

Under this standard, the Federal Circuit concluded there is a rational basis to support the USPTO’s factual finding that Harvard paid the terminal disclaimer fee, noting that the terminal disclaimer states that the fee is accompanying and that there were no other arguments against the double patenting rejection made to the Examiner yet she withdrew the rejection.  Finally, the Court noted that the USPTO’s mishandling of the terminal disclaimer does not make the document invalid.

Takeaway

  • Care should be taken in choosing to file a terminal disclaimer when further continuations or divisionals are planned or pending.
  • The arbitrary, capricious standard of the APA is prohibitively high. Any logical rationale supporting the government’s actions will likely prevail.

Full Opinion

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