Harvard’s US OncoMouse Patents are All Expired (For the Time Being)

By Dennis Crouch

Harvard College v. Kappos, 12-cv-1034 (E.D.Va. 2012)

Harvard’s patented OncoMouse has been a bestseller for cancer research here in the US. Two Harvard researchers took an available laboratory mouse and inserted a heritable cancer-causing gene into the creature’s DNA. In the US, Harvard owns three patents covering aspects of the mouse and its creation that are exclusively licensed to Du Pont. U.S. Patent Nos. 4,736,866, 5,087,571, and 5,925,803. The patents were filed pre-1995 and thus have a term that lasts for 17 years from the patent issuance. The first two 17-year terms have expired, but the third could last until 2016 – except for the terminal disclaimer discussed below.

In 2010, an anonymous third party requestor (TPR) filed a reexamination request for the ‘803 patent. Last June, the USPTO confirmed the patentability of the challenged claims. However, the USPTO agreed with the TPR that a broadly worded terminal disclaimer filed in the parent ‘571 application meant that the’803 patent also expired in 2005. Thus, it doesn’t matter whether the claims are valid over the prior art because they are expired. Because the patent had expired, the USPTO refused to allow Harvard to add additional claims to the patent during reexamination.

In the terminal disclaimer filed in the parent case, the patentee agreed to disclaim the term of the parent patent as well as any patent claiming benefit of the patent under 35 U.S.C. §120. Since the ‘803 patent claims priority to the parent under §120, that disclaimer seems to be effective to limit the ‘803’s term as well. However, the disclaimer was never particularly filed in the ‘803 case (only its parent). Further, nothing in the record indicates that the examiner acknowledged receipt of the disclaimer in the parent case and there is no evidence that the terminal disclaimer fee was actually paid. The examiner did, however, remove the double patenting rejection had been blocking the issuance of the parent case and the filed terminal disclaimer authorized payment of the fee.

In the reexamination, the USPTO gave full support the examiner’s decision that the terminal disclaimer limited the ‘803 patent term – finding that Harvard could have corrected the problems with the filing back when the patents were pending but that it is too late now.

It is only now that the non-standard disclaimer language of the terminal disclaimer filed in 1989 has an effect … [that] the patent owner [is] attempting to argue that ther terminal disclaimer had no legal effect. . . . [B]ecaues patent owner did not timely seek withdrawal of the terminal disclaimer from the parent patent as per the procedures in MPEP [at the time], patent owner cannot seek now to nullify the effect of the terminal disclaimer after the issued patent has reached its expiry date.

In response, Harvard has now filed a civil action in the Eastern District of Virginia asking the court to overturn the USPTO decision. For now, however, it appears that the mice are finally free although their title (OncoMouse) is still a registered trademark owned by DuPont.

CAFC Finally Affirms a Finding of Infringement by Equivalents

PatentLawPic391Dr. Voda v. Cordis Corp. (Fed. Cir. 2008)

Dr. Voda’s case is an exciting tale of an individual inventor litigating against a major corporation in the red sandy soil of western Oklahoma. 

A jury found that Cordis catheters infringed Voda’s patents and adjudged a reasonable royalty to be 7.5% of gross sales. The jury also found the infringement willful and the patents not invalid.  The district court then affirmed the jury verdict but denied Voda’s request for injunctive relief.

Claim Construction: Voda’s claim included the requirement that the catheter be engaged “along a line” of the aorta. The district court, however, found that the claim is not limited to linear portions of the aorta. On appeal, the CAFC confirmed the construction — reminding us that “the context in which a term is used in the asserted claim can be highly instructive.” Phillips. When engaged, it is clear that the catheter may curve along the aorta.

The specification does indicate that the “present invention [includes a] straight portion.” However, the CAFC refused to see that statement as a “clear disavowal of claim scope” because the specification discusses other instances where the same portion could be curved.

Doctrine of Equivalents: Cordis had redesigned some of its products to avoid literal infringement. However, these were found to infringe under the Doctrine of Equivalents. In particular, a “second straight portion” claim element was not literally found in the Cordis products, but the jury found that the products did include an equivalent element.

At the court’s option, either of two tests of equivalent may be used:

Under the insubstantial differences test, “[a]n element in the accused device is equivalent to a claim limitation if the only differences between the two are insubstantial.” Honeywell Int’l Inc. v. Hamilton Sundstrand Corp., 370 F.3d 1131, 1139 (Fed. Cir 2004). Alternatively, under the function-way-result test, an element in the accused device is equivalent to a claim limitation if it “performs substantially the same function in substantially the same way to obtain substantially the same result.” Schoell v. Regal Marine Indus., Inc., 247 F.3d 1202, 1209-10 (Fed. Cir. 2001).

The CAFC looked to Voda’s experts to find evidence of insubstantial difference. In particular, Voda’s expert testified that the Cordis “curve portion” was essentially straight and that “cardiologists would have difficulty distinguishing the two during use.”  In addition, Voda introduced evidence that the Cordis curve portion “performed the same function as a straight portion, in the same way, to achieve the same result. . . . Accordingly, we affirm the jury’s findings of infringement with respect to these claims.”


  • EBay: Voda argued for an injunction based on the irreparable harm to its exclusive licensee. The CAFC rejected that justification — finding that the irreparably harmed must be the party seeking the injunction.
  • Seagate: The CAFC vacated the willfulness finding that was based on pre-Seagate law.
  • Festo: The CAFC did find that some of Voda’s claims were not infringed under the DOA. Those claims had been narrowed during prosecution and were subject to prosecution history estoppel.
  • Prior Appeal: In the 2007 appeal in this case, the CAFC held that Voda could not assert its foreign patents covering the same product in US courts. [LINK]


Inducement Requires Knowledge of The Patent and Culpable Mens Rea

PatentlyO2006017DSU Medical v. JMS (Fed. Cir. 2006) (en banc)

The interesting portion of this opinion rests in Section III.B, where the CAFC convened an en banc panel to clarify that “inducement” of infringement requires intent to induce actual infringement, which necessarily requires knowledge of the patent.

Section 271(b) of the Patent Act spells out the tort: “Whoever actively induces infringement of a patent shall be liable as an infringer.”

Applying the language of Grokster, the CAFC clarified that in patent cases, “the intent requirement for inducement requires more than just intent to cause the acts that produce direct infringement. . . . [I]nducement requires evidence of culpable conduct, directed to encouraging another’s infringement.”  According to the court, this culpable conduct requires knowledge of the patent and an intent to induce infringement of the patent.

As Kevin Noonan has noted, the distinction in this case is that “there was evidence (an opinion of counsel and testimony from corporate officials) that the defendant believed that the accused behavior was not infringement. Thus, CAFC said the evidence supported the trial court’s finding that the defendant did not intend to induce infringement, which was the mens rea required for liability under 35 USC 271(b).”