In a modern patent case -- with dozens of claims and zillions of similar accused products -- there are innumerable possible permutations of infringement and invalidity outcomes.
This can make it pretty difficult to craft a stipulation on undisputed issues.
This was the hard lesson in Janssen Pharms, Inc. v. Tolmar, Inc., C.A. No. 21-1784-WCB, D.I. 198 (D. Del. June 13, 2024). In that ANDA case, the defendant had stipulated that "if any of claims 1–7, claim 15, and claims 17–21 (as dependent from claims 1 and 4) of the ’906 patent are not found to be invalid in this Action, Tolmar will agree to entry of a judgment of infringement and order pursuant to 35 U.S.C. 271(e)(4)(A) with respect to such claim.” Id. at 7 (quoting D.I. 86).
The whole thing went to trial and all of those claims were found not to be invalid. However, each of the above claims required a specific dosage strength, while Tolmar's ANDA covered several other doses in addition to the claimed ones. So, after trial they amended their ANDA to remove the infringing dosage and subsequently moved to amend the judgment to all the FDA to approve the amended ANDA for the (allegedly) non-infringing dosages.
Judge Bryson denied the motion however, holding that whatever the merits of a motion to amend the judgment based on the revised ANDA, the defendant was bound by their stipulation:
The court will not amend or otherwise grant relief to Tolmar from the final judgment. Even if this court were to exercise its discretion in considering the effect of Tolmar’s amendment eliminating the 150 mg-eq dosage size from its ANDA . . . it would not affect the outcome of this case, because the parties’ stipulation applies to infringement of all dosage amounts.
Id. at 8 (internal citations omitted).
From the tenor of the above, it's not clear that Judge Bryson would have granted a motion to alter the judgment in the absence of the stip, but the stip was the real nail in the coffin.
It will be interesting to see if we start seeing some reservation of rights language aimed at this issue in similar stipulations in the future. We'll let you know if any pop up.
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