Untitled case

Case Overview: Apotex Inc. v. Novartis Pharmaceuticals Corp., No. 2018-2209 (Fed. Cir.)

Parties and accused technology. This is a Federal Circuit appeal from an inter partes review, captioned Apotex Inc. v. Novartis Pharmaceuticals Corp., No. 2018-2209. The appellant, Apotex Inc. (with Apotex Corp.), is a Canadian-headquartered generic pharmaceutical manufacturer that filed ANDA No. 207993 for a generic version of Gilenya (fingolimod) 0.5 mg capsules. Novartis — the appellee and patent owner — is a large Swiss innovator/operating company; Novartis AG held U.S. Patent No. 9,187,405 and assigned it to Novartis Pharmaceuticals Corporation (the real party in interest per the PTAB's final written decision). The '405 patent, titled "S1P receptor modulators for treating relapsing-remitting multiple sclerosis," is Orange Book-listed for Gilenya and claims (claims 1–6) a method of reducing, preventing, or alleviating relapses in relapsing-remitting multiple sclerosis by orally administering fingolimod at a daily dosage of 0.5 mg "absent an immediately preceding loading dose regimen" — i.e., a no-loading-dose, 0.5 mg/day method-of-treatment claim covering the commercial Gilenya regimen. Gilenya, the first oral disease-modifying therapy for MS (FDA-approved 2010), was a multi-billion-dollar franchise (~$2.8 billion in 2021 revenue per BioPharma Dive).

Procedural posture and venue. Apotex filed IPR2017-00854 on February 3, 2017, challenging claims 1–6 on three grounds: two § 103 obviousness combinations and one § 102 anticipation ground based on a 2010 New England Journal of Medicine article. Three substantively identical follow-on petitions — Argentum Pharmaceuticals (IPR2017-01550), Sun Pharma entities (IPR2017-01929), and Actavis Elizabeth LLC/Teva Pharmaceuticals USA (IPR2017-01946) — were instituted and joined into the Apotex-led proceeding. The Board (APJs Robert A. Pollock, author; Christopher M. Kaiser; Kristi L. R. Sawert) issued a Final Written Decision on July 11, 2018 (Paper 109) holding claims 1–6 not shown unpatentable: no reference disclosed a 0.5 mg daily fingolimod dose without a loading dose, the art was found to teach away, and the NEJM article was not prior art to the patent's June 27, 2006 priority date. Apotex appealed on August 2, 2018. The appeal was dismissed — per the Federal Circuit's later opinion in Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., 956 F.3d 1374 (Fed. Cir. 2020), "Apotex settled after argument and Appeal No. 18-2209 was dismissed" (docket databases list the dismissal decision around February 12, 2020). The parallel appeals by Sun (18-2230) and Teva/Actavis (18-2260) were also dismissed, and Argentum's appeal (18-2273) was dismissed for lack of Article III standing. Venue matters because the Federal Circuit is the exclusive appellate forum for PTAB IPR appeals (35 U.S.C. §§ 141–144, 319), so the PTAB's merits ruling on the '405 patent never received substantive appellate review. In parallel, Novartis's ANDA infringement suits against the generics were consolidated in the District of Delaware before Judge Leonard P. Stark (Novartis v. Accord Healthcare, 18-cv-1043-LPS, with 18-cv-1038 against Apotex); Apotex's Delaware action was stayed pending the IPR appeal, with Apotex stipulating to be bound by the consolidated validity adjudication (CourtListener Docket #237).

Why the case is notable. The '405 patent was the critical later-expiring method-of-use patent shielding Gilenya after the Board had already invalidated related composition claims in Torrent v. Novartis (IPR2014-00784); the PTAB's decision here upholding the method claims — while acknowledging the composition claims fell — prompted a wave of paragraph IV ANDA litigation against at least a dozen generic entrants and exemplified the coordinated multi-petitioner IPR/joinder pattern used to attack a blockbuster Orange Book franchise. The IPR appeal's procedural termination (settlement and standing dismissals) meant the decisive validity fight shifted to the Delaware ANDA litigation, where the "absent an immediately preceding loading dose" negative limitation produced the closely watched, deeply divided Novartis v. Accord Healthcare/HEC Pharm decisions: a January 3, 2022 panel affirmance (O'Malley, Linn; Moore dissenting) followed by a rare June 21, 2022 panel rehearing in which Chief Judge Moore's majority reversed and held the claims invalid for lack of written description, declaring that "[s]ilence is generally not disclosure" for negative claim limitations (21 F.4th 1362, vacated on rehearing). That ruling became the leading modern authority on negative claim limitations, and Novartis sought Supreme Court review — in October 2022 Chief Justice Roberts stayed the mandate pending the petition (BioPharma Dive). Note: my searches confirmed the cert-stage stay and the June 2022 CAFC invalidation, but I could not independently verify the Supreme Court's final disposition from the available sources; secondary reporting indicates the Court later vacated and remanded in light of Amgen v. Sanofi. Also, the panel composition, argument date, and counsel for Appeal No. 2018-2209 itself were not identified in the sources I retrieved, and the dismissal order itself (docketed ~Feb. 12, 2020) is only corroborated by docket-aggregator records rather than PACER directly.

Key Legal Developments & Outcome — Apotex Inc. v. Novartis Pharms. Corp., No. 2018-2209 (Fed. Cir.) and the Underlying Gilenya® ANDA Litigation

Scope note

The metadata case (Fed. Cir. No. 18-2209) is itself an appeal from the PTAB's IPR decision, not an infringement action, and it was dismissed without a merits ruling (~2020-02-12) after Apotex settled. The "patent infringement litigation" proper is the parallel consolidated ANDA action in the District of Delaware, Novartis Pharms. Corp. v. Accord Healthcare, Inc. et al., No. 18-cv-1043-LPS/KAJ (lead), which produced the trial, injunction, two Federal Circuit decisions, and Supreme Court denial of certiorari. The timeline below covers both strands, in order.

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1. Parallel PTAB IPR proceedings (2014–2018) — the litigation's trigger

• IPR2014-00784 (Torrent) — composition patent: Before the '405 litigation, the PTAB invalidated the related Gilenya composition patent (U.S. Patent No. 5,604,229), and the Federal Circuit affirmed the obviousness holding (per Jones Day's contemporaneous account; pin cite not independently verified). That left the later-expiring method-of-treatment claims of U.S. Patent No. 9,187,405 as the critical remaining Orange Book protection.
• IPR2017-00854 (Apotex lead): Filed 2017-02-03 by Apotex Inc./Apotex Corp. challenging claims 1–6 of the '405 patent; instituted ~2017-07-18; joined with substantively identical petitions by Argentum (IPR2017-01550), Sun (IPR2017-01929), and Actavis/Teva (IPR2017-01946).
• Final Written Decision: 2018-07-11 (Paper 109) — claims 1–6 not shown unpatentable on any of the three grounds (two § 103 combinations; § 102 anticipation via the 2010 NEJM article, which was held not prior art to the June 27, 2006 priority date). The Board also found the art taught away from a 0.5 mg no-loading-dose regimen. (PTAB Litigation Blog / Jones Day, July 30, 2018.)
• Effect on the infringement litigation: the July 2018 FWD upholding the method claims immediately preceded Novartis's July 2018 wave of ANDA suits in Delaware. The district court later noted its trial ruling was "consistent with a prior [PTAB] decision in an IPR proceeding on the '405 Patent" (D.I. 583 at 6, quoted in the Cadwalader appellate brief).

2. The IPR appeals — including the metadata case (18-2209)

• Four appeals were taken from the FWD: 18-2209 (Apotex), 18-2230 (Sun), 18-2260 (Teva/Actavis), and 18-2273 (Argentum).
• 18-2209: Notice of appeal filed 2018-08-02; briefing through 2019 (appellants' briefing by Teresa Stanek Rea, Crowell & Moring; appellee Novartis by Jane M. Love et al., Gibson Dunn); oral argument 2020-01-09; dismissed 2020-02-12 after settlement (docket-aggregator "Decision 02/12/20"; corroborated by Argentum Pharms. LLC v. Novartis Pharms. Corp., 956 F.3d 1374 (Fed. Cir. 2020): "Apotex settled after argument and Appeal No. 18-2209 was dismissed").
• 18-2230 / 18-2260: voluntarily dismissed under FRAP 42(b) after settlement (per Patexia docket excerpts).
• 18-2273 (Argentum): dismissed 2020-04-23 for lack of Article III standing — 956 F.3d 1374 — after the other petitioners settled and Novartis flagged standing as a threshold issue.
• Net effect: the PTAB's validity ruling in Novartis's favor never received substantive appellate review; the decisive validity fight moved entirely to Delaware.

3. Delaware ANDA litigation — filing & initial pleadings (2018)

• Complaints: 2018-07-13 (per the parties' stipulation) through mid-July 2018, Novartis filed suit under 35 U.S.C. § 271(e)(2) against generic fingolimod filers: 18-cv-1038-LPS (Apotex Inc./Apotex Corp., ANDA No. 207993), 18-cv-1039 (Teva), 18-cv-1040 (Sun), and 18-cv-1043-LPS (Accord Healthcare, Inc., et al.) — the latter a master action that ultimately drew in ~23 generic manufacturers (per Judge Jordan's Dec. 15, 2020 bond opinion, D.I. 809/899 record; Troutman/Locke Lord summary).
• Answers & counterclaims: Defendants answered with invalidity defenses (35 U.S.C. §§ 101, 102, 103, 112), § 288 cost defenses, and declaratory-judgment counterclaims of non-infringement and invalidity (e.g., Apotex's answer; HEC's answer/DJ counterclaims at D.I. 134). Apotex admitted ANDA No. 207993 constituted an act of infringement under § 271(e)(2) while contesting validity.
• Consolidation: 2018-10-25 — consolidated for all pre-trial purposes, lead case 18-cv-1043-LPS (per D.I. 237 stipulation).
• Apotex stay: 2018-11-05 — stipulated stay of all claims between Novartis and Apotex pending the 18-2209 appeal, with Apotex bound by the consolidated validity adjudication (D.I. 237).
• Reassignment: the case was transferred from Judge Leonard P. Stark (LPS) to Judge Kent A. Jordan of the Third Circuit, sitting by designation (KAJ), who presided over the PI bond, trial, and post-judgment proceedings.

4. Pre-trial motions of substance (2019)

• Preliminary injunction (the major pre-trial event): 2019-02-19, Novartis moved to enjoin at-risk launches by Accord, Alkem, Aurobindo, Dr. Reddy's, HEC, Hetero, Mylan, Torrent, and Zydus/Cadila (D.I. 357).
• PI granted 2019-06-24 — Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 18-1043-LPS, 2019 U.S. Dist. LEXIS 104969 (D. Del.) (Stark, J.): infringement uncontested at that stage; defendants' invalidity theories (anticipation by the "Kappos 2006" abstract, written description, enablement) found unlikely to prevail; irreparable harm shown through likely price erosion in an ~$1.8B/year market; balance of harms and public interest favored Novartis.
• PI order & bond: 2019-08-01 PI order entered (D.I. 629); Novartis posted a $50 million unsecured bond under Rule 65 (D.I. 632) — the bond that would spawn a final postscript in 2024.
• Stays/summary judgment: No contested stay orders identified; the Apotex stay was by stipulation. I did not verify any summary-judgment rulings (the PI court itself noted the invalidity arguments "may withstand summary judgment or even prove correct after trial," implying SJ was contemplated; no SJ opinion was found in my searches).
• Claim construction: No standalone Markman opinion was verified. The key terms — the negative limitation "absent an immediately preceding loading dose" and the 0.5 mg daily dosage — were effectively construed in the PI opinion (POSA defined as a team including a clinician and pharmacologist) and, in depth, in the post-trial findings (loading dose = "higher-than-daily dose … usually given as the first dose").

5. Discovery and trial (2019–2020)

• Discovery milestones: Specific strategic milestones were not independently verified beyond: expert discovery and depositions reflected on the docket (e.g., deposition notices), a proposed pretrial order (D.I. 715, filed 2020-02-29), and the evidentiary hearing held in connection with the PI motion (2019). Fact discovery centered on the ANDA labels (HEC's ANDA No. 207939), the '405 specification, and expert testimony on POSA understanding of dosing and loading doses (reflected in the FFCL).
• Settlements whittled the case to one defendant: By trial, all defendants except HEC had settled or been stayed — including stipulated dismissals with Zydus/Cadila and Hetero (2019-02-29 stipulation; dismissed 2020-03-02) and a proposed consent judgment with Biocon (2019-12-18).
• Bench trial: 2020-03-02 through 2020-03-05 (four days), Judge Jordan, HEC the sole remaining defendant.

6. Trial outcome, judgment, and post-trial motions (2020–2021)

• Findings of Fact & Conclusions of Law — 2020-08-10 (D.I. 769): HEC liable for induced and contributory infringement of claims 1–6 because its label instructed physicians to perform each claim limitation; the claims were not invalid — adequate written description for both the 0.5 mg daily dose (EAE rat data plus the prophetic human trial) and the no-loading-dose negative limitation; no anticipation by the 2006 Journal of Neurology/ENS abstract ("Kappos 2006"), which was not prior art and did not disclose the regimen.
• Final Judgment & Injunction — 2020-09-11 (D.I. 780): judgment for Novartis under Rule 54(b); under § 271(e)(4)(A), FDA approval of HEC's ANDA could be effective no earlier than the '405 expiration (June 25, 2027; Novartis public statements cite December 2027 including pediatric exclusivity); permanent injunction under § 271(e)(4)(B); fee/cost motions reserved for 60 days after final disposition of any appeal.
• Post-trial motions: HEC's motion to stay the judgment pending appeal — denied 2020-12-15 (D.I. 812). Novartis's motion to extinguish HEC's claim to the $50M PI bond — granted (opinion 2020-12-10; unsealed 2020-12-16) on the ground that the PI merged into the permanent injunction.
• Consent/final judgments against settled defendants (per the paragraphfour docket history): Alkem (2020-09-23), Dr. Reddy's and Sun (2020-10-21), Mylan (2020-10-27), Aurobindo (2021-01-21). Novartis later confirmed (press release 2022-01-04) that settling filers were restricted from launching before agreed dates preceding the December 2027 expiration.

7. Federal Circuit appeal No. 2021-1070 — first decision (2020–2022)

• HEC's appeal: Notice of appeal 2020-10-09 (D.I. 786), appealing the FFCL and final judgment (Skiermont Derby LLP for HEC). Briefing into 2021; oral argument 2021-07-08.
• Affirmance — 2022-01-03: Novartis Pharms. Corp. v. Accord Healthcare, Inc., 21 F.4th 1362 (Fed. Cir. 2022) — panel of O'Malley (author) and Linn, with Chief Judge Moore dissenting — affirmed the district court under clear-error review: the 0.5 mg dose was expressly described, and the no-loading-dose negative limitation was adequately supported from the perspective of the POSA; no "heightened standard" for negative limitations (Inphi, Santarus).

8. Panel rehearing — reversal and invalidation (2022)

• HEC's rehearing petition was granted; Judge O'Malley (who authored the January opinion) retired in March 2022 and was replaced by Judge Todd Hughes on the reconstituted panel.
• Reversal — 2022-06-21: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 2204163 (Fed. Cir. June 21, 2022) (precedential, 2–1) — Chief Judge Moore (author) and Judge Hughes vacated the prior decision and reversed, holding claims 1–6 invalid for lack of written description of the negative limitation "absent an immediately preceding loading dose": for a negative claim limitation, the specification must describe a reason to exclude or the exclusion must be inherent; "[s]ilence is generally not disclosure" (Judge Linn dissenting). This became the leading modern authority on negative claim limitations.
• Rehearing en banc denied ~2022-09-21 (Novartis press release 2022-09-21); mandate to issue 2022-09-27 (D.I. 818).

9. Supreme Court and finality (2022–2023)

• Emergency stay: Novartis sought a stay of the mandate; after the CAFC refused, Chief Justice Roberts granted an emergency stay on 2022-09-29 — a rare Circuit-Justice action — but the full Court dissolved that stay on 2022-10-13 (per KTS/Lexology account).
• Cert petition: filed as No. 22-671 (extension request dated 2022-12-06); certiorari denied 2023-04-17 (confirmed by Judge Jordan's 2024 opinion: "April 17, 2023, when the Supreme Court denied Novartis's motion for certiorari"). The invalidity judgment is therefore final.
• ⚠️ Correction to the prior case overview: the earlier summary speculated that the Supreme Court "vacated and remanded in light of Amgen v. Sanofi." The verified record shows certiorari was denied outright (2023-04-17), not a GVR. The Amgen speculation should be disregarded.

10. Post-finality proceedings (2024)

• PI bond dispute: After finality, HEC moved to recover on the $50M preliminary-injunction bond (arguing it had been wrongfully enjoined). Judge Jordan denied the motion 2024-07-09 (D.I. 899, Mem. Op.), holding HEC waived its claim by failing to appeal the December 2020 order extinguishing the bond; the order was a separately appealable final post-judgment order, and the stay HEC obtained did not preserve its rights (issue preclusion/direct estoppel). (Troutman/Locke Lord, JD Supra, ipde blog, July 2024.)
• Post-mandate docket activity: Novartis filed an emergency TRO/PI motion on 2022-10-05 (D.I. 820) and obtained a TRO on 2022-10-11 (D.I. 829) with a PI hearing set for 2022-11-17; the basis and ultimate disposition of that motion were not verified and are flagged as unconfirmed context from the docket.

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Bottom line — outcome

• PTAB (IPR2017-00854): claims 1–6 upheld (2018-07-11); no merits review on appeal — the four IPR appeals (18-2209 Apotex, 18-2230 Sun, 18-2260 Teva/Actavis, 18-2273 Argentum) were all dismissed by 2020-04-23 (settlement or standing).
• District of Delaware (18-cv-1043, consolidated): bench trial win for Novartis (infringement; validity upheld; permanent injunction; § 271(e)(4)(A) effective-date bar to 2027), 2020-08-10/09-11.
• Federal Circuit: affirmed 2022-01-03 (21 F.4th 1362), then reversed on panel rehearing 2022-06-21 — the '405 patent's claims 1–6 are invalid for lack of written description of the no-loading-dose limitation.
• Supreme Court: cert denied 2023-04-17 — invalidity is final; HEC and other FDA-approved ANDA filers were freed to launch generic fingolimod 0.5 mg, and HEC's post-judgment attempt to recover on the $50M PI bond failed (2024-07-09).

Key sources: IPR2017-00854 Paper 109 (PTAB 2018-07-11); Argentum Pharms., 956 F.3d 1374 (Fed. Cir. 2020); D. Del. D.I. 237 (stay, 2018-11-05), D.I. 357/629/632 (PI, 2019), D.I. 769 (FFCL, 2020-08-10), D.I. 780 (final judgment, 2020-09-11), D.I. 786 (HEC notice of appeal), D.I. 818 (rehearing denial/mandate), D.I. 899 (bond ruling, 2024-07-09); Novartis v. Accord Healthcare, 21 F.4th 1362 (Fed. Cir. 2022) and 2022 WL 2204163 (Fed. Cir. 2022); Novartis press releases (2022-01-04, 2022-09-21); Supreme Court docket No. 22-671; Law360 (2020-01-09); KTS/Lexology (2022-10); paragraphfour docket history; Patexia CAFC docket excerpts. Unverified items (no independent confirmation found): specific discovery milestones, any summary-judgment ruling, the basis/disposition of the Oct. 2022 TRO, and the exact D. Del. dismissal entry for the Novartis–Apotex claims following the February 2020 settlement.

I have the key identification now: CAFC No. 18-2209 is Apotex Inc. v. Novartis Pharmaceuticals Corp., an appeal from the PTAB's Final Written Decision in IPR2017-00854 (joined IPR2017-01550, -01929, -01946), not a district court patent infringement action. Let me dig into the docket and counsel records to be precise about who appeared.

Threshold clarification: No "plaintiff" exists in this case

Before listing counsel, it's important to correct the premise. CAFC No. 18-2209 is not a patent infringement case. It is the appeal caption Apotex Inc. v. Novartis Pharmaceuticals Corp. (filed Aug. 2, 2018), arising from the PTAB's Final Written Decision in IPR2017-00854 and joined proceedings IPR2017-01550 (Argentum), IPR2017-01929 (Sun), and IPR2017-01946 (Teva/Actavis), in which the Board upheld all claims 1–6 of U.S. Patent No. 9,187,405 (the Gilenya® 0.5 mg fingolimod method-of-treatment patent). See Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (PTAB July 11, 2018) ("Claims 1–6 Not Shown to Be Unpatentable").

The parties on appeal were appellants (the IPR petitioners — generic/ANDA companies) and appellee (patent owner Novartis Pharmaceuticals Corporation), not plaintiff and defendant. The case ended by dismissal: per the Federal Circuit's opinion in the companion appeal, Argentum Pharms. LLC v. Novartis Pharms. Corp., 956 F.3d 1374 (Fed. Cir. 2020) (No. 18-2273), "Apotex settled after argument and Appeal No. 18-2209 was dismissed." Oral argument was held Jan. 9, 2020; the appeal was dismissed in early 2020.

Counsel of record on the 18-2209 appeal

For the appellants (IPR petitioners — the would-be generic entrants; the closest analogue to an adverse "plaintiff" posture)

Sun Pharma and Teva/Actavis were also appellants but settled with Novartis and withdrew from the appeal before briefing was completed; I could not verify their separate appellate counsel from the available sources.

For the appellee (Novartis Pharmaceuticals Corp. — patent owner and the plaintiff in the underlying D. Del. ANDA cases)

Sources for docket entries: PACER-syndicated CAFC docket for 18-2209 (via Patexia), showing entries by Jane Love [614079/614080/614082], Robert Trenchard [608011/603053/597990], and Charles Klein [617045]; and the Law360 report reproduced by Crowell & Moring (Jan. 9, 2020).

If you meant the underlying infringement action's plaintiff

If "plaintiff" was intended literally, the infringement case is Novartis Pharmaceuticals Corporation v. Apotex Inc., et al., D. Del. No. 1:18-cv-01038-LPS, consolidated with Nos. 18-cv-1039 (Teva), 18-cv-1040 (Sun), and 18-cv-1043 (Accord Healthcare) — ANDA suits over the '405 patent filed July 13, 2018, in which Novartis is the plaintiff. The 18-2209 appeal was stayed/affected by those parallel cases, and the PTAB decision is what was appealed. I did not locate a verified attorney list for the D. Del. plaintiff-side docket in my searches, so I will not name district-court counsel without confirmation. There was also no separately retained local counsel in the Federal Circuit appeal (local-counsel requirements do not apply there), and I found no evidence of in-house Novartis or Apotex counsel appearing on the CAFC briefs.

Bottom line

The only counsel independently verified as appearing on the record in 18-2209 are Teresa Stanek Rea (Crowell & Moring LLP, Washington, DC) for appellants Apotex/Argentum and Jane M. Love, Robert Trenchard, and Charles Klein (Gibson Dunn & Crutcher LLP, New York) for appellee Novartis. The case was dismissed after Apotex's post-argument settlement, and the Federal Circuit never reached the merits of the Board's decision — consistent with the "Dismissed (reported)" status in the case metadata.

Important threshold clarification: this is not a patent infringement case

The case in your metadata — No. 18-2209 (Fed. Cir.), Apotex Inc. v. Novartis Pharmaceuticals Corp. — is an appeal from the PTAB's Final Written Decision in IPR2017-00854 (and joined IPRs 2017-01550, 2017-01929, 2017-01946) involving U.S. Patent No. 9,187,405 (the Gilenya®/fingolimod method-of-treatment patent). It is an administrative appellate proceeding, not a § 271 infringement action, so there are no "defendants" in the conventional sense. The parties are appellants (the unsuccessful IPR petitioners, who were the would-be generic competitors and the defendants in the parallel Delaware ANDA infringement suits) and the appellee (patent owner Novartis).

The PTAB upheld the patent (Paper 109, July 11, 2018). All IPR petitioners appealed, but the appeals were separately resolved: Sun's appeal (18-2230) and Teva/Actavis's appeal (18-2260) were dismissed after settlement; Apotex settled after oral argument and 18-2209 was dismissed (≈ Feb. 12, 2020); Argentum's appeal (18-2273) was dismissed for lack of Article III standing in Argentum Pharms. LLC v. Novartis Pharms. Corp., 956 F.3d 1374 (Fed. Cir. 2020), which expressly notes "Apotex settled after argument and Appeal No. 18-2209 was dismissed."

Below is the counsel of record for the parties in No. 18-2209 — the closest analogue to "defendant-side" representation (the generic appellants were the infringement defendants in the related D. Del. ANDA actions, e.g., Novartis Pharms. Corp. v. Apotex Inc., No. 18-1038-LPS, and consolidated cases).

Counsel for the appellants / generic defendants (Apotex Inc., Apotex Corp., Argentum Pharmaceuticals LLC)

IPR-stage counsel for Apotex (context): Steven W. Parmelee, Michael T. Rosato, and Jad A. Mills of Wilson Sonsini Goodrich & Rosati appeared as petitioners' counsel in IPR2017-00854 (per the PTAB service certificates on Novartis's Updated Mandatory Notice, Sept. 5, 2017). The Federal Circuit docket reflects that appellate briefing shifted to the Crowell & Moring team.

Counsel for the appellee / patent owner (Novartis Pharmaceuticals Corporation)

Disposition and verification notes

• No sealed filings identified; however, I could not access the full PACER docket for 18-2209, so the formal "attorney appearance" list (with all counsel of record, including any local or of-counsel designations) should be confirmed against PACER entries for 18-2209. The roster above is reconstructed from Law360 (Jan. 9, 2020 oral-argument article), the Patexia docket entry excerpts (entries 88–101, showing Rea, Trenchard, and Klein as signing attorneys), and the published Argentum opinion (956 F.3d 1374, n.2).
• If you actually intended the underlying district court infringement cases (e.g., Novartis Pharms. Corp. v. Apotex Inc., D. Del. No. 18-1038-LPS, and the related actions against Teva, Sun, and Accord Healthcare), the defendants there were Apotex Inc./Apotex Corp., Teva Pharmaceuticals USA Inc., Sun Pharmaceutical Industries, and Accord Healthcare, Inc. — but those dockets are separate from No. 18-2209 and would need to be pulled from D. Del. PACER to identify their Delaware counsel; I did not verify those rosters and will not invent them.
• Bottom line: For the case in your metadata (Fed. Cir. 18-2209), the "defendant-side" counsel of record are Teresa Stanek Rea (Crowell & Moring, Washington, DC — lead, argued) and Charles Klein (docket counsel) for the Apotex/Argentum appellants, with Jane M. Love (Gibson Dunn — argued) and Robert Trenchard (Gibson Dunn — docket counsel) for appellee Novartis.