orwich’s ANDA product. Salix filed a patent infringement suit pursuant to the Hatch-Waxman Act.At the time of trial, Salix asserted that Norwich’s ANDA product infringed three groups of patents with claims directed to rifaximin polymorphic form β, methods of treating HE, and methods of treating IBS-D. Following a bench trial, Judge Richard G. Andrews of the District of Delaware held that Norwich’s ANDA product would infringe claims from all three groups of asserted patents, but further held that the polymorph and IBS-D patent claims were invalid as obvious. Accordingly, Judge Andrews enjoined FDA from approving Norwich’s ANDA before the expiration of the last to expire HE method of treatment patent, October 2029.Shortly after the district court’s judgment, Norwich amended its ANDA to withdraw its Paragraph IV certifications to the HE method patents and carve out, or “skinny label,” under 21 U.S.C. § 355(j)(2)(A)(viii), the HE indication. Norwich then moved to modify the judgment under Federal Rule of Civil Procedure 60(b) to strike the portion prohibiting approval of the ANDA product until expiration of the last HE patent. Norwich argued that approval of its amended ANDA would no longer be blocked by any valid patents covering a patented use of the ANDA product. The district court denied Norwich’s motion.Salix appealed the polymorph and IBS-D patents’ invalidity holdings, and Norwich cross appealed denial of its Rule 60(b) motion. The Federal Circuit affirmed on all issues.Rifaximin Polymorph Patents Affirmed Invalid as ObviousThe district court held the challenged polymorph patent claims invalid as obvious based on the prior art disclosure of rifaximin preparation protocols and solvent systems that would have yielded the claimed β form, according to expert testimony introduced at trial. While the prior art did not characterize the crystal structure of the rifaximin obtained from the disclosed preparation procedure, the Federal Circuit did not disturb the lower court’s conclusions that “routine charact

administered dose. Salix asserted three "groups" of patents:• U.S. Patent Nos. 8,624,573, 9,421,195, and 10,335,397 directed to HE treatment; • U.S. Patent Nos. 8,309,569 and 10,765,667 directed to treating IBS-D using the 550 mg TID administration protocol; and • U.S. Patent Nos. 7,612,199 and 7,902,206 directed to rifaximin polymorph bThe District Court held* that claim 2 of U.S. Patent No. 8,309,569, claim 3 of U.S. Patent No. 10,765,667, claim 4 of U.S. Patent No. 7,612,199, and claim 36 of U.S. Patent No. 7,902,206 were obvious, and that claim 8 of U.S. Patent No. 8,642,573, claim 6 of U.S. Patent No. 9,421,195, and claims 11 and 12 of U.S. Patent No. 10,335,397 were not invalid and infringed, and entered judgment that the FDA not approve Norwich's ANDA for HE indications until the final patent in this group expired in October 2029. Norwich amended its ANDA to provide a Section viii "carveout" of indications related to HE treatment and filed a motion to modify the judgment under Fed. R. Civ. Pro. 60(b) which the District Court denied. This appeal by both parties of the adverse decisions below followed.The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judge Chen in toto and by Judge Cunningham in part, who also dissented in part. Regarding obviousness of claims to IBS-D treatment, the opinion sets forth claim 2 of the '569 patent as being representative:1. A method of providing acute treatment for diarrhea-associated Irritable Bowel Syndrome (dIBS) comprising: administering 1650 mg/day of rifaximin for 14 days to a subject in need thereof, wherein removing the subject from treatment after the 14 days results in a durability of response, wherein the durability of response comprises about 12 weeks of adequate relief of symptoms.2. The method of claim 1, wherein the 1650 mg is administered at 550 mg three times per day.The District Court's decision was based on the combination of a Phase II clinical trial protocol disclosing twice-daily dosing of IBS patients with 55

ch filed an Abbreviated New Drug Application (ANDA) for tablets with the same indications as the active ingredient in Salix’s commercial products, certifying that Salix’s patents on the ingredient were invalid. Salix timely sued, asserting that Norwich’s ANDA infringed the patents. Following a bench trial, the district court held that Norwich infringed patents directed to treating hepatic encephalopathy (“HE” patents) and that Norwich had failed to establish invalidity of the asserted claims. The district court also held that Norwich’s ANDA infringed certain other patents (“IBS-D” patents and “polymorph” patents) but ruled that the claims were invalid as obvious over the prior art.As part of the judgment, the district court ordered that the effective date of a final approval of Norwich’s ANDA should not precede the latest expiration date associated with the infringed HE patents. Norwich then amended its ANDA to remove the infringing HE indication and moved to modify the judgment under Federal Rule of Civil Procedure 60(b), asserting that the amendment negated any possible infringement, but the district court denied the motion.The parties cross-appealed, with Salix challenging the invalidity holdings and Norwich challenging both the ruling on the final approval of its ANDA and the denial of its motion under Rule 60(b). The Federal Circuit affirmed on all issues.As to the obviousness of the IBS-D patents, the Federal Circuit held that the district court did not err in determining that a skilled artisan would have had a reasonable expectation of success in using the claimed dosage to treat IBS-D based on the disclosures in the prior art. As to the polymorph patents, the court held that the district court did not clearly err in determining that there would have been a reasonable expectation of success in obtaining the form of the substance recited in the claims.Turning to Norwich’s appeal, the Federal Circuit held that the district court did not err in ordering that the final approval of Norwich’s ANDA cou

mootness fee, the court applied the wrong standard. According to the plaintiffs, the Walgreen and Trulia “plainly material” standard only applies to class settlements, and a lower standard applies to the dismissal of individual claims. The plaintiffs also argued that the district court erred by considering only the disclosures they sought in their complaints and not the full set of additional disclosures for which they claimed responsibility. Finally, the plaintiffs argued that the district court “misapprehended the significance” of Akorn’s additional disclosures. Mr. Frank argued that the additional disclosures were worthless by any standard.The Seventh Circuit’s RulingThe Seventh Circuit panel, consisting of Judges Frank H. Easterbrook and Diane P. Wood, held that the district court did not have the inherent authority to re-open the merger challenge and review the mootness fee following the action’s voluntary dismissal. It could only re-open the case following a formal motion under Rule 60(b) of the Federal Rules of Civil Procedure, which had not occurred. But as the Seventh Circuit pointed out, Mr. Frank had moved to intervene in the case and, had his motion been granted, he could have filed a motion to re-open under Rule 60(b).The Seventh Circuit then turned to whether the district court should have granted Mr. Frank’s motion to intervene. After rejecting the plaintiffs’ arguments that Mr. Frank lacked standing and was required to bring a derivative action, rather than personally intervene, the Seventh Circuit held that the district court erred when it addressed only Mr. Frank’s proposal to intervene as of right and not his proposal to intervene permissively under Federal Rule of Civil Procedure 24(b). The Seventh Circuit found that as an investor in Akorn whose shares’ value was affected by the merger and mootness fee as well as a member of the proposed class, Mr. Frank plainly had a claim in common with the main action. And reasoning that “class counsel and Akorn [we]re looking out for their own interests ra

objection and reducing the claim to zero.In September 2023, Pier 1 filed and served a Notice of Allowed General Claims, providing notice that unsecured creditors with valid claims might receive an interim distribution of 8% to 9%, but also that the claim was allowed in the amount of $0.00. Despite multiple mailings, GDI claimed that its agent, Savitar Realty Advisors (Savitar), did not receive any mailings. GDI also alleged that Savitar received an email inquiry from an unrelated third party about purchasing the claim. Savitar reached out to Pier 1 about the claim but was informed that GDI would not receive any distribution because the claim had been reduced to zero. GDI then moved in January 2024 to vacate the order on the claim objection and for leave to file a late response to the claim objection as a motion.In ruling on the motion earlier this month, the court focused on whether GDI may seek relief from the order due to “mistake, inadvertence, surprise, or excusable neglect” under Federal Rule of Civil Procedure 60(b). The court noted that GDI intentionally withdrew from participating in the bankruptcy case and communicating with Pier 1 once it learned that Pier 1 did not expect to make a distribution to unsecured creditors. GDI only began to recommunicate with Pier 1 when it learned about a distribution on unsecured claims from a claims purchaser. The court refused to excuse GDI’s decision to disengage from the bankruptcy case because it believed that Pier 1 would not pay any unsecured claims. It found that granting the motion would prejudice Pier 1 and the unsecured creditors with further delay and affect the interim distribution to creditors actively involved in the case. Specifically, the court resisted allowing GDI to file a late response to the claim objection out of concern that hundreds of other creditors would seek the same relief.The court also concluded that GDI had not rebutted the evidentiary presumption of receipt of the mailings relating to the claim when it failed to present evidenc

epatic encephalopathy (“HE”) recurrence in adults. Norwich wants to market a generic version of the drug, and is awaiting final approval from the FDA. The filing of Norwich’s original ANDA constituted an act of infringement of the Orange Book-listed patents that Salix listed to protect Xifaxan from generic competition. Salix sued Norwich, which lead to a district court decision that invalidated two drug substance patents and the two method-of-use patents covering the IBS-D indication. That court also found that Salix’s three HE method-of-use patents were valid and infringed. Based on that finding, the court entered an order directing “that the effective date of any final approval order of the [FDA] of Norwich’s ANDA ... is to be the date not earlier than the expiration of the” HE method-of-use patents—that is, October 2, 2029.Given the district court’s decision, Norwich filed an amended ANDA with the FDA, omitting the HE indication from its proposed label. It then filed a motion under FRCP Rule 60(b) in the district court seeking to modify the judgment to permit the FDA to approve the amended ANDA without delay. The district court denied that motion. Norwich appealed that decision and the underlying merits decision. The FDA then tentatively approved Norwich’s ANDA, but it declined to grant final approval before October 2, 2029, in compliance with FDA’s reading of the district court’s final judgment.Norwich filed this action challenging FDA’s decision to tentatively—not finally—approve Norwich’s amended ANDA. It sought injunctive and declaratory relief directing the FDA immediately to approve Norwich’s amended ANDA. The FDA and Salix opposed, cross-moving for summary judgment. The court denied Norwich’s motion and granted FDA and Salix’s cross motions for summary judgment.Why FDA and Salix Prevailed: Norwich argued that FDA’s determination that the Delaware District Court’s final judgment precluded it from granting final approval to Norwich’s amended ANDA prior to October 2, 2029,

he imprimatur of judicial sanction; and to enforce them should defendants ever step out of line.Judge Abrams found that the SEC’s practice “raises the specter of violating the unconstitutional conditions doctrine,” by which the government “conditions” receipt of a particular benefit on giving up certain rights (including the right to criticize the government). She also stated that the SEC’s practice has “all the hallmarks of a prior restraint on speech.” Nevertheless, Judge Abrams reluctantly felt compelled underSEC v. Romerilto approve the settlement; but she refused to “do so silently.”In its 2021Romerilopinion, the Second Circuit Court of Appeals held that the defendant waivedany First Amendment right when he signed an SEC settlement agreement containing a gag order. The Second Circuit remarked that “even assuming that Romeril is correctthat the no-deny provision violates his First Amendment rights,”he failed to satisfy either of the prerequisites for voiding a judgment pursuant to Federal Rule of Civil Procedure 60(b)(4): lack of jurisdiction, which the district court had, or lack of due process (notice and opportunity), which Romeril had received. Relying on cases that permit waiver ofproceduralrights in a criminal case, and also relying on cases involving private (not governmental) parties, the Second Circuit boldly jumped to the conclusion that thefundamentalconstitutional right of the First Amendment is “no exception.” The opinion seems wrongly decided.The U.S. Supreme Court has yet to provide a definitive analysis. A string of Supreme Court cases upholds the waiver of certain criminalproceduralrights — such as the right to trial, the right to confront witnesses, and appellate review — when the waiver is “knowingly, voluntarily, and intelligently” made. But none of thosecases deal with the waiver of afundamentalright like those protected by the First Amendment.Snepp v. United Statesis the only case in which the U.S. Supreme Court hasimpliedthat a defendant may waive First Amendment rights in a con

d a defense verdict was reversed with a remand for additional discovery.Morgan demonstrates:(1) the need for timely discovery requests;2) the importance of specific and timely objections to discovery; and,3) that “hide the ball” tactics won’t work.Michael Berman.Morgan demonstrates: (1) the need for timely discovery requests; (2) the importance of specific and timely objections to discovery; and, (3) that “hide the ball” tactics won’t work.Plaintiff, Mr. Morgan, alleged that he was battered by a police officer while he was handcuffed. He sued pursuant to 42 U.S.C. §1983. The police officer denied the allegations. The Fourth Circuit wrote:The central issue in this appeal involves a discovery violation that was not revealed to the requesting party until near the end of trial. A jury found in favor of a police officer on allegations of excessive force and other claims. We consider whether the district court erred in denying the plaintiff’s post-trial motion for relief from judgment under Federal Rule of Civil Procedure 60(b)(3), based on the officer’s failure to disclose another, similar excessive-force lawsuit that had been filed against him.Upon our review, we conclude that this discovery violation was misconduct under Rule 60(b)(3), and that the plaintiff satisfied the other factors required for relief under that Rule. We therefore hold that the district court abused its discretion in denying the plaintiff’s request for relief under Rule 60(b)(3). We reverse the district court’s ruling, vacate the court’s entry of final judgment against the plaintiff, and remand the case to the district court with instructions to award the plaintiff a new trial.Morgan v. Tincher, No. 21-2060, __ F.4th __ (4th Cir. Jan. 3, 2024).The Court further explained that:Well before trial, but ten days after the deadline established by the district court’s scheduling order, Morgan submitted discovery requests to Officer Tincher. As relevant to the present appeal, Morgan asked Officer Tincher in the interrogatories to disclose any al

that Hacienda continued to violate the federal Controlled Substances Act (“CSA”) by holding stock worth about $35 million in a Canadian cannabis company to which it transferred assets after ceasing operations in February 2021, and asserting that Hacienda’s intention to sell such stock to pay creditor claims violated federal criminal and money laundering statutes. The UST also cited authority “that debtor has not taken sufficient steps to withdraw from an ongoing conspiracy to violate the CSA.” On September 20, 2023, Judge Bason doubled down on his prior ruling, and entered an order denying the UST’s second motion to dismiss. Although Judge Bason agreed with the UST that he mistakenly overlooked the evidence in granting the first motion to dismiss that Hacienda sold more than intellectual property, which could have conceivably changed his views, Judge Bason agreed to take a discretionary fresh look at the situation even though the UST had not met the standard for reconsideration under Federal Rule of Civil Procedure 60(b). Judge Bason found that unlike the first motion to dismiss, the UST satisfied its burden in the second motion to dismiss “to establish that, more likely than not, Debtor is engaged in a postpetition violation of the CSA by not withdrawing from a prepetition conspiracy with Lowell Farms to profit from its business involving controlled substances.” However, Judge Bason concluded that even assuming that there was any postpetition violation of criminal law, that does not necessarily mean the appropriate remedy is to dismiss the bankruptcy case. Judge Bason held that federal bankruptcy law does not restrict companies engaged in illegal activity from making payments to legitimate creditors: “It would be odd to read the Bankruptcy Code as implicitly barring any payments to legitimate creditors when that is what federal criminal law itself provides.” Judge Bason, relying on his prior analysis in his first order denying the UST’s motion to dismiss, noted that Congress did not adopt a “zero tol

plies to challenges to any integral provision of an order approving a sale, such as a settlement); In re Trism, Inc., 328 F.3d 1003, 1007 (8th Cir. 2003) (mooting under section 363(m) "a challenge to a related provision of an order authorizing the sale of the debtor's assets" because the related provision was integral to the sale of the assets and reversing the provision would alter the parties' bargained-for exchange); see also Matter of Alabama-Mississippi Farm, Inc., 791 F. App'x 466, 470 (5th Cir. 2019) (section 363(m) does not preclude an appeal seeking a security interest in sale proceeds because "nothing in the record suggests that the sale … was dependent on how the proceeds of that sale were to be distributed"). Section 363(m) has also been read to go further than simply limiting appellate review and to protect broadly the interests of any good-faith purchaser by subjecting any collateral attack made against a section 363 sale to a good-faith purchaser to the requirements of Rule 60(b) of the Federal Rules of Civil Procedure, which governs motions for reconsideration of or relief from prior court judgments or orders. SeeIn re Edwards, 962 F.2d 641 (7th Cir. 1992) (holding that a collateral attack on sale to a good-faith purchaser must be made pursuant to Fed. R. Civ. Proc. 60(b)); In re Veg Liquidation, Inc., 572 B.R. 725, 737 (Bankr. W.D. Ark. 2017) ("To the extent the trustee is alleging that fraud was involved, his remedy is under Rule 60, not [section] 363(m)."), aff'd, 583 B.R. 203 (B.A.P. 8th Cir. 2018), aff'd, 931 F.3d 730 (8th Cir. 2019); see alsoIn re Alan Gable Oil Dev. Co., 978 F.2d 1254 (4th Cir. 1992) ("[T]hough section 363(m) does not in the strictest sense apply to [a movant's] 60(b) motion, the policy favoring protection of good faith purchasers of estate property does. Not only does [the movant] bear the burden of establishing that the district court abused its discretion, he must do so in light of the strong policy favoring good faith purchasers of bankruptcy assets."); In re Nilhan Devs