On Wednesday, Judge Andrews issued an order in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals, Inc., C.A. No. 20-430-RGA (D. Del. May 17, 2023) rejecting an attempt to evade judgment in an ANDA action based on the filing of an amended ANDA.
The defendant in the case had won on one method of treatment, and lost on the other. It filed an amended ANDA seeking to remove the infringing treatment from the label:
Defendant filed an ANDA seeking to make and market a drug for two different methods of treatment-the IBS-D indication and the HE indication. I had a bench trial. After trial, I ruled in Defendant's favor on the IBS-D indication (as well as the composition claims), finding all patent claims asserted in relation to those two issues to be invalid. I ruled in Plaintiffs' favor only on the HE indication, finding all claims asserted in relation to that issue to be infringed and not invalid. In the final judgment, I ordered the FDA not to approve the ANDA before the latest expiration (in about 2029) of the patents on which Plaintiffs won. About a month after entry of the final judgment, Defendant filed an amended ANDA that purports to carve out everything relating to the HE indication. Defendant says, if the FDA approves the amended ANDA, Defendant would not be inducing infringement by marketing the pharmaceutical with the amended label.
After filing its amended ANDA, the defendant moved to modify the judgment under FRCP 60(b)(5), which allows relief under some circumstances:
On motion and just terms, the court may relieve a party . . . from a final judgment [if] the judgment has been satisfied, released, or discharged; it is based on an earlier judgment that has been reversed or vacated; or applying it prospectively is no longer equitable.
Judge Andrews did not want to be the first to grant a motion like this, and noted that the relief seems wrong:
Plaintiffs say, and Defendant does not present any argument to the contrary, that what Defendant seeks is unprecedented in an ANDA case. I am hesitant to be the first, because it just seems wrong to me that Defendant can litigate a case through trial and final judgment based on a particular ANDA, and then, after final judgment, change the ANDA to what it wishes it had started with, and win in a summary proceeding.
The Court pointed out that the defendant is basically requesting a full new litigation:
It is not a simple matter to determine whether an ANDA applicant has successfully carved out language from a label to turn infringement into non-infringement. . . . Defendant, other than saying it has successfully carved out the HE indication, and providing me the label, has presented no evidence in support of its assertion. Further, Rule 60(b) "does not allow relitigation of issues that have been resolved by the judgment." . . . Defendant presents no facts indicating that it could not have litigated the carve-out or that it was denied a full and fair opportunity to do so. . . . . Defendant fully litigated the merits of its non-infringement and invalidity case, lost, and now seeks a way around the final judgment through Rule 60(b) that "is tantamount to seeking summary judgment premised on new allegations that only came to exist after the final judgment was rendered . . . ." . . . What Defendant wants would essentially be a second litigation.
The Court also found that the defendant's new ANDA filing was not a changed circumstance sufficient for Rule 60(b):
I do not think "changed circumstances" applies here. The case was tried as essentially three independent up-or-down decisions. In my experience with ANDAs, it is common, and certainly not rare, to have split decisions. ANDA practitioners and pharmaceutical companies surely know this. Thus, there were a limited number of possible outcomes at trial. But, of course, the trial results are not the changed circumstances, as the actual outcomes were previewed two weeks before the final judgment (D.I. 189) and disclosed at the same time as the final judgment. The only changed circumstance is that Defendant decided to amend its ANDA, which it filed on September 6, 2022 (D.I. 206 at 2), nearly one month after the final judgment. The changed circumstance is simply a voluntary decision of the trial loser to change course, which is neither unanticipated nor unforeseeable.
Honestly, just based on what is in the opinion, I'm surprised that this is the first time this has come up in Delaware. But it's good to know.
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