Harvard’s Freed OncoMouse


The OncoMouse, which has been engineered by insertion of a heritable cancer-causing gene into it’s DNA, has been used to study cancer. In the US, Harvard owns three patents (licensed by DuPont) covering aspects of the mouse and its creation, including U.S. Patent Nos. 4,736,866, 5,087,571, and 5,925,803. Since patents were filed before 1995, the patent term runs for 17 years from patent issuance. The first two 17-year terms have expired, but the third could last until 2016  except for the terminal disclaimer.

An anonymous third party requestor (TPR) filed a reexamination request for the ‘803 patent in 2010.  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.

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 to 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.

In response, Harvard filed a civil action in the Eastern District of Virginia asking the court to overturn the USPTO’s decision. For now, the mice are finally free – although their title OncoMouse – is still a registered trademark owned by DuPont.

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