Novartis Pharmaceuticals Corporation v. HEC Pharm Co., Ltd. et al.

Case Overview

Parties and roles. Plaintiff Novartis Pharmaceuticals Corporation (NPC) is a Delaware corporation and the U.S. operating subsidiary of Swiss pharma giant Novartis AG; it markets Gilenya® (fingolimod HCl 0.5 mg capsules), an oral disease-modifying therapy for relapsing-remitting multiple sclerosis (RRMS) first approved by the FDA in September 2010. NPC is a classic innovator/operating company, not a non-practicing entity. The defendants are the HEC generic group — Chinese API/manufacturer HEC Pharm Co., Ltd., its New Jersey subsidiary HEC Pharm USA, Inc., Chinese affiliate Sunshine Lake Pharma Co., Ltd., and U.S. distributor CANDA HEC-1 LLC (whose Rule 7.1 disclosure identifies Burford Capital LLC as a corporate parent) — plus Rising Pharma Holdings, Inc. (Delaware, d/b/a Rising Pharmaceuticals), all ANDA filers seeking to market generic fingolimod. Glenmark Pharmaceuticals Ltd. appears in the case metadata and was one of roughly twenty ANDA filers in the earlier Gilenya wave, but it does not appear among the active parties answering the operative amended complaint (D.I. 371–373), so its current role in this action is not well sourced. NPC is represented by McCarter & English (Delaware counsel, including Daniel Silver) and Gibson Dunn; the HEC group by Stamoulis & Weinblatt.

Accused product and patents. The accused product is HEC's generic fingolimod HCl 0.5 mg capsules (ANDA No. 207939), whose FDA-approved label instructs physicians to use the drug in ways that allegedly infringe two Orange Book-listed method patents. U.S. Patent No. 9,187,405 ("S1P receptor modulators for treating relapsing-remitting multiple sclerosis") claims treating RRMS by administering fingolimod 0.5 mg/day "absent an immediately preceding loading dose regimen." U.S. Patent No. 10,543,179 ("Dosage regimen of an S1P receptor modulator," issued January 28, 2020 — the same day suit was filed) claims a sequential method of (a) identifying RRMS patients at risk of varicella zoster virus (VZV) infection by testing for VZV history, (b) vaccinating those patients, and then (c) administering fingolimod 0.5 mg/day to limit VZV infection risk. Both patents expire December 25, 2027 (per Orange Book and a terminal disclaimer in the '179 file history). The '405's history is unusual: in the parallel ANDA case Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 18-1043-KAJ (D. Del., Judge Kent A. Jordan sitting by designation), the district court found the '405 valid and infringed (Aug. 10, 2020); the Federal Circuit affirmed on January 3, 2022 (21 F.4th 1362), but after Judge O'Malley's retirement and Judge Hughes's addition to the panel, a reconstituted panel reversed on rehearing on June 21, 2022, holding the "no loading dose" negative limitation unsupported by written description — "silence is generally not disclosure" (38 F.4th 1013). The Supreme Court denied certiorari (143 S. Ct. 1748 (2023)), so the '405 is invalid; the live dispute in this action now centers on the '179.

Procedural posture and significance. Filed January 28, 2020 in the District of Delaware (1:20-cv-00133), the case was originally assigned to Judge Leonard P. Stark, later to Judge Gregory B. Williams, and on January 8, 2024 was reassigned to Judge Jennifer L. Hall (now 1:20-cv-00133-JLH). It was consolidated with 1:21-cv-01530 (filed Oct. 27, 2021, after HEC's second '179 notice letter and its November 10, 2021 FDA final approval) and 1:23-cv-00026 (filed Jan. 11, 2023) by Judge Williams's August 30, 2023 order (D.I. 236). Judge Williams issued claim construction on April 6, 2023 (D.I. 234), construing the '179 preamble as a limiting statement of purpose and the testing/vaccinating/administering steps as sequential. After HEC launched at risk around October 2022 (following the '405's invalidation), Novartis filed a First Amended Complaint on July 23, 2025 (D.I. 369) seeking post-launch damages for label-induced infringement, and both sides filed competing summary judgment and Daubert motions in August 2025 (D.I. 380–393) addressing infringement under § 271(e), obviousness, § 101 eligibility, and derivation; briefing continued into early 2026 and the case remains active. Delaware is the venue because Rising Pharma is incorporated there (making it "at home" in the district), the HEC entities are alleged to have substantial Delaware contacts and sales, and Delaware is the de facto hub for Hatch-Waxman litigation. The case is notable as a bellwether for lifecycle management of blockbuster drugs through method-of-treatment claims: it follows the Federal Circuit's controversial written-description reversal of the '405 (a "judicial shell game" per Patently-O), pits a test-vaccinate-then-dose regimen claim against obviousness, § 101, and derivation challenges, and comes after HEC's at-risk launch — making damages and label-based inducement the stakes. It also sits within the broader Gilenya patent war, which previously saw the PTAB invalidate the related '283 formulation patent in IPRs brought by Torrent, Apotex, and Mylan (affirmed by the Federal Circuit in 2017), while no IPR on the '405 or '179 was identified in searches. Novartis's own disclosures pegged the U.S. sales impact of a generic launch at roughly $0.3 billion in 2022 alone, underscoring the commercial weight of this dispute.

Novartis Pharmaceuticals Corp. v. HEC Pharm Co., Ltd., et al., No. 1:20-cv-00133 (D. Del.)

Important framing note. This docket (filed 2020-01-28) is one of three related Hatch-Waxman actions Novartis brought against HEC over generic fingolimod 0.5 mg capsules (Gilenya®). It is the '179 patent case (U.S. Patent No. 10,543,179, VZV-testing/vaccination dosing regimen), consolidated with 1:21-cv-01530 (filed 2021-10-27) and 1:23-cv-00026 (filed 2023-01-11). The companion '405 patent litigation (no-loading-dose claims, U.S. Patent No. 9,187,405) proceeded principally in 1:18-cv-01043-KAJ (D. Del.) and on appeal as No. 2021-1070 (Fed. Cir.) — that parallel track is covered below because it directly dictated the posture of this case (including HEC's at-risk launch). The case remains active as of the most recent docket activity (early-to-mid 2026); no trial or final judgment has occurred in this docket.

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1. Filing & Initial Pleadings (2020–2023)

• 2020-01-28 — Novartis filed the original complaint (D.I. 1), asserting both the '405 patent (issued 2015; dosing regimen claims) and the '179 patent (issued the same day, 2020-01-28; method-of-treatment claims requiring VZV-risk testing, vaccination of at-risk patients, then 0.5 mg daily fingolimod). The complaint invoked the Hatch-Waxman scheme, 35 U.S.C. § 271(e)(2), against HEC's ANDA No. 207939. Originally assigned to Judge Leonard P. Stark. (DrugPatentWatch docket entries; ExParte complaint analysis of D.I. 1.)
• 2020-02-10 — Stipulated dismissal as to Apotex Inc./Apotex Corp. (D.I. 7). Multiple other ANDA filers named in the original complaint (Bionpharma, Prinston, Strides, Emcure, Heritage, Glenmark, etc.) were dismissed or resolved early, mirroring settlements in the parallel '405 case. (UniCourt docket entries.)
• 2021-10-27 — Novartis filed 1:21-cv-01530 (second suit) after HEC's second notice letter of 2021-09-14 concerning the '179 patent; ANDA supplemental info confirms patent expiration date of 2025-12-25/2027-12-25 with pediatric exclusivity and no 30-month stay (N/A). (1:21-cv-01530 docket; Paragraph Four filing, DEDC 21cv1530.)
• 2022-11-04 — Court entered a scheduling order for the related cases. (ExParte timeline.)
• 2023-01-11 — Novartis filed 1:23-cv-00026 (third suit) after HEC obtained final FDA approval (2021-11-10) and launched its generic at risk on 2022-10-17 — i.e., this action added post-launch damages claims. (ExParte case analysis of 1:23-cv-00026.)
• 2023-01-27 to 2023-02-08 — Service/waiver returns for HEC Pharm Co., Ltd., HEC Pharm USA Inc., Canda HEC-1 LLC, and Rising Pharma Holdings, Inc. (Patexia docket entries, 1:23-cv-00026.)
• 2025-07-23 — First Amended Complaint filed in the consolidated action (post-launch, damages-focused; added Sunshine Lake Pharma Co., Ltd. and Rising Pharma d/b/a Rising Pharmaceuticals, Inc.). (ExParte analysis of the FAC.)
• 2025-08-08 — Redacted answers and counterclaims filed by HEC Pharm Co./HEC Pharm USA/Sunshine Lake (D.I. 372 redacted version) and Canda HEC-1 (D.I. 371) and Rising Pharma (D.I. 373), following the FAC. (CourtListener docket.)

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2. Pre-Trial Motions of Substance

Motion to dismiss (§ 101) — denied

• 2023-06-01 — HEC defendants (Canda HEC-1, HEC Pharm Co., HEC Pharm USA, Rising Pharma) moved to dismiss the consolidated complaint for failure to state a claim, arguing the '179 patent claims are directed to a patent-ineligible natural phenomenon (D.I. 12 in 1:23-cv-00026; opening brief D.I. 14; reply D.I. 23, 2023-07-13). Novartis opposed on 2023-06-29 (D.I. 19–20).
• 2024-03-12 — Judge Jennifer L. Hall denied the motion to dismiss. The Court held the '179 claims are directed to a method of treating MS by specific steps — identifying at-risk patients by VZV testing, vaccinating, and administering a specific dose of a specific compound — not an ineligible natural phenomenon, citing Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), and a parallel ruling in Novartis Pharm. Corp. v. Handa Neuroscience, LLC, No. 22-353-MN (D. Del. May 10, 2022). The Court ordered the parties to submit an amended consolidated schedule by 2024-03-26. (CourtListener docket; order in consolidated 1:20-cv-00133-JLH / 1:23-cv-00026-JLH.)

Transfer / stay-pending-IPR motions

• None identified in the available docket record. No motion to transfer venue or to stay pending PTAB review appears in the searched sources (consistent with the parties' heavy prior investment in the parallel '405 case and the absence of any instituted IPR on the '179 patent).

Summary judgment & Daubert motions (pending as of the present posture)

• 2025-08-07 — Cross-motions filed:
  • Novartis (D.I. 384, 385, 387): partial summary judgment of (i) no patent ineligibility under 35 U.S.C. § 101; (ii) no derivation under 35 U.S.C. § 102(f); and (iii) infringement under 35 U.S.C. § 271(e)(2).
  • HEC defendants (D.I. 380, 381): summary judgment of non-infringement (with Daubert challenge) and summary judgment of obviousness (with Daubert challenge to Novartis damages expert Christopher A. Vellturo, Ph.D.).
• 2025-09-12 — Redacted versions filed (e.g., D.I. 445, Novartis's partial-SJ/non-infringement/hypothetical-negotiation-date motion and Daubert motion to exclude Dr. Vellturo). (CourtListener D.I. 445; DrugPatentWatch.)
• 2025-10 to 2026-03 — Successive redacted briefing rounds (opening briefs 2025-10-21; oppositions 2025-10-24; replies 2025-10-27; further answer/opposition briefs 2026-02-25; transcript-redaction proceedings 2025-12 through 2026-03). The motions remain undecided as of the latest available docket activity (mid-2026). (CourtListener docket.)

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3. Claim Construction (Markman) — Decided 2023-04-06

• 2023-04-06 — Judge Gregory B. Williams issued a Memorandum Opinion (D.I. 234) construing the '179 patent claims (case then designated 1:20-cv-00133-GBW). Key rulings (Justia D.I. 234; D. Del. opinion PDF; Casetext):
  • Agreed terms adopted: "testing said patient for a history of infection caused by varicella zoster virus" = "Checking said patient for a history or evidence of prior infection or vaccination"; "thereby limiting the risk of infection caused by varicella zoster virus" = a non-limiting statement of intended results.
  • Preamble/"a patient": construed as "a RRMS patient"; the Court rejected HEC's proposed limitation that the patient must not be presently taking 0.5 mg fingolimod, finding the specification and prosecution history did not support that exclusion (the claimed method applies to both treatment-naïve patients and those who previously received MS treatment, including patients who interrupt fingolimod for vaccination).
  • Steps (a)–(c): construed to require sequential performance — identifying, vaccinating, and administering in order and for the purpose of treating RRMS with fingolimod.
  • The opinion also referenced the parties' competing constructions of the '405 patent from the parallel litigation (Novartis Pharmaceuticals v. Accord Healthcare, 1:18-cv-01043), incorporating that claim-construction history into the consolidated '179 case.

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4. Discovery Milestones with Strategic Significance

• 2019–2020 (parallel '405 case): Novartis obtained a preliminary injunction (2019-08-01) with a $50M bond; a four-day bench trial followed in March 2020 (see § 6). That record — including expert reports from Dr. Vellturo (Novartis damages) and rebuttal reports from Ivan Hofmann (HEC) — was later imported into the damages phase of this case. (JD Supra; Supreme Court docket appendix 22A272.)
• 2022 depositions (conducted in the related/consolidated proceedings before the 2025 amendments): depositions of Novartis personnel Pascale Burtin (2022-08-25), Craig Boulton (2022-09-23), Robert Schmouder (2022-10-21), and Thomas Dumortier (2022-10-14) — all cited in Novartis's 2025 SJ papers (CourtListener D.I. 445).
• 2024–2025 expert phase (this case):
  • 2025-01 to 2025-02 — Fact depositions of HEC/Rising witnesses: Dorina Bischof (2025-01-09), Joshua Harris (2025-01-30), Ira Baeringer (2025-02-11).
  • 2025-04-15/16 — Opening expert reports: HEC invalidity/non-infringement expert Samuel Pleasure, M.D., Ph.D. (invalidity 2025-04-15; non-infringement rebuttal); Novartis infringement expert Joseph R. Berger, M.D. (2025-04-16); HEC's Fred D. Lublin, M.D. (2025-04-15); damages expert Dr. Vellturo (2025-04-15).
  • 2025-05-20 — Novartis rebuttal validity expert Lawrence Steinman, M.D.
  • 2025-06-17 — Reply expert reports (Pleasure reply on invalidity; Berger reply on infringement).
    These reports formed the evidentiary backbone of the August 2025 cross-SJ motions. (CourtListener D.I. 445 exhibit list.)
• Discovery strategy significance: The core contested issues are (i) whether HEC's label induces infringement of the sequential test-vaccinate-administer method claims (with the "at-risk" patient population question framed by the 2023 Markman ruling), (ii) obviousness/derivation/§ 101 validity challenges, and (iii) damages from the 2022-10-17 at-risk launch, including the hypothetical-negotiation date.

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5. Trial Events, Verdict, and Post-Trial Motions

• No trial has occurred in 1:20-cv-00133. The defendants made a jury demand, and the case is currently in the summary-judgment/Daubert briefing posture (2025-2026) with no scheduled trial date identified in available sources. (DrugPatentWatch docket listing "Date Terminated: [blank]"; CourtListener docket through March 2026.)
• The only merits trial in the broader fingolimod saga was the 2020 bench trial in the parallel '405 case (see § 6), which produced the 2020-08-10 findings of fact and conclusions of law and the permanent injunction that later dissolved on appeal.

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6. The Parallel '405 Litigation, Appeal, and Its Effect on This Case

The '405 patent was also asserted in this docket's 2020 complaint, but its merits were litigated in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., et al., No. 1:18-cv-01043-KAJ (D. Del.), with HEC as the last remaining challenger:

• 2020-03-02 to 03-05 — Four-day bench trial before Judge Kent A. Jordan (sitting by designation).
• 2020-08-10 — Findings of Fact & Conclusions of Law (D.I. 769): '405 patent valid and infringed (induced and contributory infringement), adequate written description, no anticipation; consistent with the PTAB's IPR decision upholding the '405 patent (D.I. 583).
• 2020-09-11 / 2020-12-02 — Final judgment and permanent injunction (D.I. 780, 808) barring FDA approval of HEC's ANDA until '405 expiration (Dec. 2027 incl. pediatric exclusivity) and resetting HEC's final approval to tentative; HEC's motion to stay denied (Cadwalader opinion reprint).
• 2022-01-03 — Federal Circuit (No. 2021-1070) affirmed (O'Malley, joined by Linn; Chief Judge Moore dissenting), rejecting HEC's written-description challenge to the "0.5 mg daily dose" and "absent an immediately preceding loading dose" limitations. (Reuters; Alston & Bird summary; Novartis press release 2022-01-04.)
• 2022-06-21 — Modified panel reversed. After Judge O'Malley retired and Judge Hughes replaced her on the panel (without public notice), the reconstituted panel adopted the prior dissent: the '405 patent was held invalid for lack of written description of the no-loading-dose negative limitation ("silence is not disclosure"). Novartis announced it would seek rehearing. (Novartis press release 2022-06-21; Patently-O/Denny Crouch, 2023-01-20.)
• 2022-10 — Novartis sought a stay of the mandate (application 22A272, with Vellturo declaration opposing irreparable-harm findings); the stay was denied and the mandate issued.
• 2022-10-17 — HEC launched its generic fingolimod at risk — the triggering event for the 2023 damages action (1:23-cv-00026) now consolidated here.
• 2023-01 (filed)/2023 (decided) — Novartis's petition for certiorari (challenging both the panel-substitution procedure and the written-description standard) was denied, making the invalidity of the '405 patent final. (Crouch/Patently-O post; Studicata 2024 summary.)
• 2024-07-09 — Judge Jordan denied HEC's motion to recover on the $50M preliminary-injunction bond (issue preclusion: HEC never appealed the 2020 order extinguishing the bond). (JD Supra; Studicata.)

Effect on 1:20-cv-00133: With the '405 patent invalidated (post-cert denial), this consolidated action's surviving subject matter is the '179 patent only — infringement, validity (§ 101/§ 102(f)/obviousness), and damages for HEC's at-risk sales from 2022-10-17 forward through the '179 patent's Dec. 2027 expiration (subject to the terminal disclaimer).

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7. Parallel PTAB IPR/PGR Proceedings

• '405 patent (9,187,405): An inter partes review was instituted and resulted in a PTAB final written decision upholding the validity of the '405 patent claims; Judge Jordan expressly relied on that IPR result in his 2020 trial ruling (1:18-cv-01043, D.I. 583; FF&CL at 6). A Federal Circuit appeal of the IPR decision was dismissed (per Novartis's August 2020 statement, which noted the CAFC "dismissed an appeal of the IPR decision... upholding the validity of the dosage regimen patent"). I was unable to confirm the specific IPR number from the available sources — treat the number as unverified.
• '179 patent (10,543,179): No IPR or PGR identified in the searched USPTO/PTAB sources. The '179 patent's validity has been litigated in district court only (including the analogous Handa Neuroscience case and this action).

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8. Present Posture (as of mid-2026)

The case is active and unresolved. Status summary:

• Consolidated under Judge Jennifer L. Hall (1:20-cv-00133-JLH / 1:23-cv-00026-JLH; earlier phases before Judges Stark and Williams).
• The § 101 motion to dismiss was denied (2024-03-12); claim construction is final (2023-04-06).
• Cross-motions for summary judgment and Daubert challenges (filed 2025-08-07) are fully briefed (through early 2026) and pending.
• No settlement has been reported between Novartis and the HEC defendants in this docket (contrast the numerous settlements with other ANDA filers in the '405 case). Glenmark Pharmaceuticals Ltd. appears on the case's party list, but its current status in this docket is unclear from available sources.
• A jury trial would be the next major milestone if the SJ motions do not dispose of the case; no trial date was identified.

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Key sources

• CourtListener docket, Novartis Pharmaceuticals Corp. v. HEC Pharm Co., Ltd., 1:20-cv-00133 (D. Del.) (entries 234, 371–373, 384–387, 398, 445, and 2025–2026 briefing entries).
• Memorandum Opinion, D.I. 234 (D. Del. 2023-04-06) (also at Justia and D. Del. opinion PDF "20-133.pdf").
• Order denying motion to dismiss, consolidated cases (2024-03-12) (CourtListener entry).
• Novartis Pharms. Corp. v. Accord Healthcare, Inc., 1:18-cv-01043-KAJ (D. Del.): FF&CL (D.I. 769, 2020-08-10); final judgment/injunction (D.I. 780, 808); bond decision (2024-07-09).
• Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070 (Fed. Cir.): opinion 2022-01-03 (O'Malley, Linn; Moore diss.); modified-panel opinion 2022-06-21 (Moore, Hughes; Linn diss.).
• Novartis press releases (2022-01-04; 2022-06-21); Reuters (2022-01-03); Patently-O (Crouch, 2023-01-20); JD Supra (2024); DrugPatentWatch case pages; ExParte complaint analyses; UniCourt; Patexia.

Caveats on sourcing: The specific IPR number for the '405 patent, the exact certiorari denial date, Glenmark's procedural status in this docket, and any formal dismissal of the '405 claims from the 2020 complaint could not be verified from the sources retrieved; those items are flagged above as unconfirmed.

I'll research the press coverage of this case, starting with the known articles and branching out.

Good material. Now let me verify the specific listed articles and look for additional coverage.

Press coverage of the Novartis/HEC fingolimod litigation

A critical framing point up front: essentially all of the news coverage I could find concerns the companion Gilenya case — the '405 patent (U.S. 9,187,405) litigation captioned Novartis Pharms. Corp. v. Accord Healthcare/HEC — and the Supreme Court/Federal Circuit saga over that patent. I found no press reporting specifically about docket 1:20-cv-00133, this case's '179 patent, its April 2023 Markman ruling, or the 2025–2026 summary-judgment and Daubert motions. The coverage below is therefore relevant to this docket only insofar as the '405 outcome triggered HEC's at-risk launch and the damages claims now consolidated here.

The cert denial (the most-covered event). The dominant story is the April 17, 2023 denial of certiorari. Reuters (Blake Brittain, carried in syndication at ET HealthWorld and PharmaLive) reported that the Justices turned away Novartis's bid to revive "a key patent on its blockbuster multiple sclerosis drug Gilenya that was invalidated amid a legal dispute with China's HEC Pharm Co Ltd," noting Novartis sold $1.1 billion of Gilenya in the U.S. in 2022, a 19% drop from 2021 "caused in part by generic competition," and that Novartis had settled with some generics to allow entry before the patent's 2027 expiration. Reuters recounted that the Federal Circuit had invalidated the patent in a 2-1 decision that reversed its own earlier split ruling, that the Supreme Court had rejected Novartis's emergency bid to pause the decision the prior October, and that Novartis had warned of harm "impossible to calculate at an after-the-fact damages trial." It quoted Novartis's statement that it "acknowledges the decision … and remains deeply committed to the MS community," and quoted HEC's brief that the Federal Circuit "followed its own rules." (The same Reuters dispatch appears under the Investing.com, FX Empire, and Marketscreener headlines listed in the index, but I could not open those specific URLs to confirm their text.)

Trade-press and legal-analysis coverage. IPWatchdog (Steve Brachmann, Apr. 19, 2023) framed the denial as leaving in place a decision "derided by commentators as 'procedural insanity,'" quoting IPWatchdog's Gene Quinn calling the panel-rehearing maneuver "literally unprecedented," and summarizing HEC's March 3 brief in opposition on the 28 U.S.C. § 46 panel-assignment issue. Managing IP ran an opinion column arguing the Court "was wrong … to fail to correct the procedural missteps," explaining that Judge O'Malley's retirement let a different panel (Moore and Hughes) reverse the original (O'Malley/Linn) ruling. National Law Review / McDermott Will & Emery had earlier covered the rare emergency stay Chief Justice Roberts granted on Sept. 29, 2022, staying a mandate due to issue Oct. 4. Substantive written-description analysis came from Wilson Sonsini ("How Novartis Lost a $2.8 Billion Drug to Generic Drug Makers," June 29, 2022), Akin ("Silence is Rarely Sufficient…," July 15, 2022), Robinson+Schiller's Hatch-Waxman bulletins, and Alston & Bird's patent case summaries, all of which stressed the negative-limitation/"silence is not disclosure" holding.

Market and business impact. pharmaphorum reported that Gilenya generated $2.8 billion in 2021 revenue (half from the U.S.) and that Novartis warned fiscal-2022 sales could fall by $3 billion if generics launched early; a second pharmaphorum piece put the company's own near-term hit at $300 million in 2022 and reported HEC's argument that Novartis earns $3.8 million per day on Gilenya in the U.S. while charging "at least 10 to 20 times" generic prices, with generics poised to launch Oct. 4 and "up to 20 generic versions" at risk. A third pharmaphorum article documented the January 2022 appellate win and injunction running to December 2027. Citeline headlined the cert denial as "cementing" generic competition. SaludyFarmacos republished the June 2022 Reuters report in Spanish.

Where reporting differs or goes beyond the record. Reporters and commentators diverge on why the case matters: business outlets emphasize lost sales and generic-entry timing, while IPWatchdog and Managing IP treat the cert denial as a Federal Circuit governance story about Chief Judge Moore and panel composition. On damages, note the wide range of figures in circulation — pharmaphorum itself reported both $300 million and $3 billion figures from Novartis at different points, while HEC's "$3.8 million/day" and "10–20×" pricing claims are HEC's litigation advocacy, not findings. Business-press numbers like the "$1.1 billion" 2022 U.S. figure come from company reports, not the court record. Finally, caution on one index item: the listed SCOTUSblog article "Justices asked to weigh in again on 'mixed' questions in immigration appeals" appears, by its title and date, to concern immigration law rather than this litigation, and I could not confirm any Gilenya content in it — treat that association as unverified. The Bloomberg (Jan. 3, 2022) and "theiplawblog" (June 23, 2022) items from the index also could not be opened during this search, so I have not relied on them.

Sources

• IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
• IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
• Redacted Document – #445 in Novartis Pharmaceuticals Corporation v. HEC Pharm Co., Ltd. (D. Del., 1:20-cv-00133) – CourtListener.com - modified upon the release or availability of generic fingolimod
• description to satisfy section 112, see Union Oil Co
• Novartis Pharm. Corp. v. Accord Healthcare, Inc.
• Complaint – #1 in Novartis Pharmaceuticals Corporation v. HEC Pharm Co., Ltd. (D. Del., 1:20-cv-00133) – CourtListener.com - Case 1:20-cv-00133-UNA Document 1 Filed 01/28/20 Page 14 of 40 PageID #: 14
• 220. For these reasons, and for other reasons that will be presented to the Court if jurisdiction is challenged, the Court has p...
• IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
• Novartis announces U.S. Court of Appeals for the Federal Circuit (CAFC) upholds validity of Gilenya® (fingolimod) dosage regimen patent
• Novartis Pharm. Corp. v. Accord Healthcare, Inc.
• Hec - Latest hec , Information & Updates - Health -ET HealthWorld
• US Supreme Court rebuffs Novartis bid to revive MS drug Gilenya patent - - Pharma

I'll research the counsel of record for Novartis in this Delaware Hatch-Waxman case.

Let me get more detail from the docket and firm pages to confirm the full plaintiff-side team.

Let me check the complaint and the full docket attorney roster, plus any lead-counsel designations.

Based on the public docket (CourtListener docket 16769154; PACER filings), the plaintiff Novartis Pharmaceuticals Corporation is represented by two firms: Gibson, Dunn & Crutcher LLP (national/lead counsel) and McCarter & English LLP (Delaware local counsel). The most recent signature blocks (e.g., D.I. 316, filed 02/28/2025, and D.I. 445, filed 09/12/2025) confirm this split, with McCarter & English listed as "Attorneys for Plaintiff Novartis Pharmaceuticals Corporation" and Gibson Dunn attorneys designated "Of Counsel."

Lead counsel

Jane M. Love, Ph.D. — Lead counsel; Gibson, Dunn & Crutcher LLP, New York, NY.

• Gibson Dunn's firm bio confirms she is lead counsel in Novartis's ANDA litigation against multiple generic defendants enforcing the Gilenya® (fingolimod) patents—this HEC case included—and she is chair of the firm's Life Sciences and IP Litigation practices. She argued the related Gilenya appeal in Novartis Pharm. Corp. v. Accord Healthcare, Inc., No. 21-1070 (Fed. Cir.), and was named a Law360 "Life Sciences MVP" (2017, 2019, 2021) and an NLJ Health Care/Life Science Trailblazer specifically for her Gilenya work. The D.I. 316 meet-and-confer certification (which requires "at least one Delaware Counsel and at least one Lead Counsel per party") lists "Jane M. Love, Ph.D. (For Plaintiff)" as lead counsel.

Delaware (local) counsel — McCarter & English LLP, Wilmington, DE

Daniel M. Silver (#4758) — Lead Delaware/local counsel; McCarter & English LLP, 405 N. King Street, 8th Floor, Wilmington, DE.

• The CM/ECF filing attorney for the plaintiff on nearly every docket entry (complaint-era filings through D.I. 316 and D.I. 445); a longtime Delaware Hatch-Waxman practitioner who also served as Novartis's Delaware counsel in the parallel Accord Healthcare Gilenya litigation (C.A. No. 18-1043-LPS).

Alexandra M. Joyce (#6423) — Delaware/local counsel; McCarter & English LLP, Wilmington, DE.

• Co-signatory on plaintiff filings and identified as Delaware counsel for plaintiff in the D.I. 316 meet-and-confer certification.

Michael P. Kelly — Delaware local counsel at filing; McCarter & English LLP, Wilmington, DE.

• Appears in the Unicourt attorney roster for this case and in the signature block of the related Accord case as Novartis's Delaware counsel. Note: he was listed with McCarter & English at the 2020 filing; I could not verify his current firm affiliation from the sources retrieved, so his present status is unconfirmed.

Gibson Dunn team (of counsel / supporting national counsel)

All admitted pro hac vice in this action (D.I. 36 for Love and Trenchard; D.I. 115 for Huang, Brody, Ranney, Lee, and Nachman) and/or listed on recent filings:

• Robert W. Trenchard — Gibson Dunn, New York, NY. PHV-appeared early (D.I. 36); co-argued/co-briefed the Gilenya appeal in Accord at the Federal Circuit; listed "For Plaintiff" in D.I. 316.
• Sung Bin Lee — Gibson Dunn, New York, NY. PHV-appeared (D.I. 115); listed in D.I. 316.
• Emil N. Nachman — Gibson Dunn, New York, NY. PHV-appeared (D.I. 115); listed in D.I. 316.
• Yi Zhang — Gibson Dunn, New York, NY. Listed in D.I. 316 signature block.
• Andrew P. Blythe — Gibson Dunn, Irvine, CA. Listed in D.I. 316 signature block; also on the Accord appellate team.
• Christine L. Ranney — Gibson Dunn (Denver office, based on the 1801 California St. address used in related filings). PHV-appeared (D.I. 115).
• Anne Y. Brody — Gibson Dunn (Los Angeles office, based on the 333 S. Grand Ave. address in related filings). PHV-appeared (D.I. 115).
• Aileen C. Huang — Gibson Dunn. PHV-appeared (D.I. 115).

In-house counsel

No Novartis in-house attorneys appear as counsel of record in the public docket entries I reviewed; the record reflects only outside counsel. If in-house counsel participate, they are not docketed as appearing attorneys in this case.

Caveats

• I could not independently verify the precise office assignments for Ranney, Brody, and Huang from case-specific documents (the addresses are inferred from signature blocks in the related Accord docket), so those should be treated as approximate.
• The case was reassigned over time (Stark → Noreika → G. B. Williams → now J. L. Hall), but the plaintiff-side team has remained consistent; the claim-construction opinion (D.I. 234, April 6, 2023) and the 2025 filings confirm the same firms and lead attorneys remain active.
• Nothing in the public docket suggests plaintiff-side filings are sealed; the counsel lists are visible in the docket entries cited above.

Defendants' Counsel of Record — Novartis Pharmaceuticals Corp. v. HEC Pharm Co., Ltd., No. 1:20-cv-00133-JLH (D. Del.)

Based on the public docket (CourtListener docket 16769154; Patexia document entries; DrugPatentWatch litigation data; the related Novartis v. Accord Healthcare, No. 18-1043-KAJ appellate record; and the D.I. 316 meet-and-confer certification), the defendant-side representation breaks down as follows. Important framing caveat: the HEC-affiliated defendants (HEC Pharm Co., Ltd.; HEC Pharm USA, Inc.; Sunshine Lake Pharma Co., Ltd.; Canda HEC 1 LLC; Rising Pharma Holdings, Inc.) share counsel, while Glenmark Pharmaceuticals Ltd. is captioned separately and I could not identify its specific counsel of record from the sources retrieved (see caveats below).

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HEC-affiliated defendants — Delaware local counsel

Stamatios Stamoulis (#4606) — Delaware local counsel; Stamoulis & Weinblatt LLC, 800 N. West St., 3rd Floor, Wilmington, DE 19801.

• The primary ECF filing attorney for the HEC defendants throughout this case (e.g., D.I. 201, Notice to Take Deposition of Peter Waibel, filed by HEC Pharm Co., Ltd. and HEC Pharm USA Inc. — docket entry attributed to "(Stamoulis, Stamatios)"; D.I. 197, Joint Claim Construction Brief, filed by HEC). He also signed HEC's Notice of Appeal in the parallel Accord case (No. 18-1043-KAJ, D.I. 782, Oct. 9, 2020) as Delaware counsel. Most recently, the D.I. 316 meet-and-confer certification (Feb. 26, 2025) lists "Stamatios Stamoulis (For Defendants)" alongside lead counsel for plaintiff, confirming he remains active into the current merits phase before Judge Jennifer L. Hall.

Richard C. Weinblatt (#5080) — Delaware local counsel; Stamoulis & Weinblatt LLC, same Wilmington address.

• Co-signatory with Stamoulis on HEC's filings in the related Gilenya/'405 patent litigation (Notice of Appeal in Novartis v. Accord Healthcare, No. 18-1043-KAJ). Longtime Delaware Hatch-Waxman practitioner at the firm.

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HEC-affiliated defendants — national/lead counsel (pro hac vice)

Sarah E. Spires — Lead national counsel (pro hac vice); Skiermont Derby LLP (Dallas, TX office at the time of the related appeal; 1601 Elm St., Suite 4400, Dallas, TX 75201).

• Appears as pro hac vice counsel for HEC in the related Accord appellate record, and the DrugPatentWatch docket aggregation for this case (1:20-cv-00133) lists her as the attorney of record (firm field there reads "Stamoulis & Weinblatt LLC," which may reflect a post-2020 move from Skiermont Derby to Stamoulis & Weinblatt, or may be an aggregation artifact — flagging this as unverified). Experienced Hatch-Waxman/ANDA litigator.

Paul J. Skiermont — Lead/national counsel (pro hac vice); Skiermont Derby LLP, Dallas, TX.

• Signed HEC's Notice of Appeal in Novartis v. Accord Healthcare (No. 18-1043-KAJ) as pro hac vice counsel, confirming his role as HEC's lead trial/appellate counsel in the parallel Gilenya fingolimod litigations. Founding partner of Skiermont Derby, a firm known for high-stakes patent and Hatch-Waxman trial work.

Mieke K. Malmberg — Of counsel/national team (pro hac vice); Skiermont Derby LLP, Los Angeles, CA (800 Wilshire Blvd., Ste. 1450).

• Also signed HEC's Notice of Appeal in the related Accord case. Patent trial lawyer with the same firm.

Verification note: The Accord-case signature block is the strongest documentary evidence for the Skiermont Derby trio's role on HEC's Gilenya defense; the current docket's meet-and-confer certification (D.I. 316) only names Stamoulis for defendants, so I could not independently confirm from the retrieved pages that Skiermont/Malmberg remain the designated lead counsel in this specific consolidated action as of the 2025 filings — though nothing retrieved suggests a change.

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Pro hac vice / additional appearances for the HEC group

Alexander E. Gasser — Pro hac vice attorney for Canda HEC 1 LLC, HEC Pharm Co., Ltd., HEC Pharm USA Inc., Rising Pharma Holdings, Inc., and Sunshine Lake Pharma Co., Ltd.

• Confirmed by the CourtListener docket snippet: "MOTION for Pro Hac Vice Appearance of Attorney Alexander E. Gasser – filed by CANDA HEC-1, LLC, HEC Pharm Co., Ltd., HEC Pharm USA Inc., Rising Pharma Holdings, Inc., Sunshine Lake Pharma Co." and the ensuing order "Pro Hac Vice Attorney Alexander E. Gasser for HEC Pharm Co., Ltd.," signed by Judge Jennifer L. Hall. His firm affiliation could not be verified from the sources retrieved — do not attribute a firm without checking PACER.

Tillman J. Breckenridge — Appears for Canda HEC 1 LLC (per the Ex Parte attorney/case database listing him as counsel for Canda HEC 1 LLC in 1:20-cv-00133, filed 01/28/20). His current firm affiliation was not shown in the retrieved snippet and is unconfirmed. He is a patent litigator who has been involved in Delaware Hatch-Waxman matters, but I would not state more without verification.

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Glenmark Pharmaceuticals Ltd.

The case metadata lists Glenmark as a defendant, and DrugPatentWatch's party list for this case includes "GLENMARK PHARMACEUTICALS LIMITED," but I could not identify Glenmark's specific counsel of record in this action from the pages retrieved. A Unicourt roster for a closely related Novartis fingolimod/ANDA action (captioned there as Novartis v. Apotex Inc. et al., involving HEC Pharm, Glenmark, Bionpharma, Strides, and Prinston) lists defendant-side attorneys Kenneth Laurence Dorsney, Helena C. Rychlicki, Megan C. Haney, Benjamin A. Katzenellenbogen, and Adam Wyatt Poff (a roster consistent with Morris, Nichols, Arsht & Tunnell and Bayard, P.A. in Wilmington) — but I cannot confirm that roster maps to this specific consolidated case number, so I have not attributed those attorneys to Glenmark here. This is a gap to close via PACER's attorney docket or CM/ECF.

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Summary table

Explicit gaps / flags

1. Sealed filings: Nothing in the retrieved pages indicates defendant-side appearances are sealed; the limitation is my search depth, not confidentiality.
2. Gasser's and Breckenridge's firms are not stated in the snippets I obtained; both should be confirmed against the PHV motions (Gasser) and docket entries before inclusion in a filing.
3. Glenmark's counsel is the single biggest open item — check the CM/ECF attorney roster for 1:20-cv-00133 or the joint filings' signature blocks (e.g., D.I. 197/316) for a Glenmark-specific signatory.
4. The Unicourt roster (Dorsney/Rychlicki/Haney/Katzenellenbogen/Poff) likely belongs to a sibling consolidated fingolimod action, not this case number — treat it as leads, not fact, unless confirmed.