Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. et al.

I'll research the case details to provide an accurate overview.

I have good material on the merits. Let me verify the district court details, the Supreme Court filings, and any parallel PTAB proceedings.

Let me verify the IPR details and the final Supreme Court outcome.

Case Overview and Background

Parties, product, and patent. Plaintiff Novartis Pharmaceuticals Corp. is a Delaware-chartered operating company headquartered in East Hanover, New Jersey (a subsidiary of Swiss-based Novartis AG) that markets Gilenya® (fingolimod 0.5 mg), the first oral, daily disease-modifying therapy for relapsing-remitting multiple sclerosis (RRMS), FDA-approved in 2010 and generating on the order of $3 million per day in U.S. sales at the time of the appeal. The defendants were roughly two dozen generic-drug manufacturers that filed abbreviated new drug applications (ANDAs) for generic fingolimod 0.5 mg capsules — including caption defendant Accord Healthcare, Inc., plus Apotex, Mylan, Strides, Sun, Teva/Actavis, Argentum, Bionpharma, and others. Every generic settled except HEC Pharm Co., Ltd. (a Chinese manufacturer based in Yidu, Hubei) and HEC Pharm USA Inc. (Princeton, NJ), which litigated through trial, appeal, and the Supreme Court. The accused product is HEC's ANDA generic version of Gilenya; the district court found induced and contributory infringement because HEC's proposed label instructed physicians to administer 0.5 mg daily "without a loading dose," i.e., to perform every step of the asserted method claims (D. Del. D.I. 769, Findings of Fact & Conclusions of Law, Aug. 10, 2020). The sole patent-in-suit, U.S. Patent No. 9,187,405 ("S1P receptor modulators for treating relapsing-remitting multiple sclerosis," issued Nov. 17, 2015; priority June 27, 2006; Orange Book-listed for Gilenya), claims methods of treating RRMS, reducing/preventing/alleviating relapses, or slowing progression by orally administering fingolimod (or its HCl salt) "at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen" — the negative "no-loading-dose" limitation, added during prosecution to overcome prior art, that became the litigation's central battleground. All six claims were asserted.

Procedural posture. The case is the Federal Circuit appeal (No. 21-1070) from consolidated ANDA litigation in the District of Delaware, 1:18-cv-01043-KAJ, filed July 16, 2018 — the dominant venue for Hatch-Waxman cases, chosen because Novartis is a Delaware corporation and most defendants were incorporated there (the court separately dismissed Mylan from the action for improper venue in June 2019, per Mintz). After Chief Judge Leonard P. Stark granted Novartis a preliminary injunction (finding HEC "not at all likely to prevail"), the case was transferred to Third Circuit Judge Kent A. Jordan, sitting by designation, who held a four-day bench trial (Mar. 2–5, 2020), upheld validity and infringement (D.I. 769), and entered final judgment and a permanent injunction on Dec. 2, 2020 (D.I. 808). On appeal, a first Federal Circuit panel (Moore, C.J., Linn, O'Malley) affirmed on Jan. 3, 2022 (21 F.4th 1362), with Judge O'Malley writing and Chief Judge Moore dissenting that "silence is not disclosure." After Judge O'Malley retired (March 2022) and Judge Hughes joined the panel, the reconstituted panel granted HEC's rehearing petition and on June 21, 2022 vacated the prior decision and reversed (38 F.4th 1013), holding claims 1–6 invalid for lack of written description of the no-loading-dose negative limitation because the specification nowhere disclosed or suggested excluding a loading dose; Judge Linn dissented, arguing the majority imposed a new "necessary exclusion" requirement. Rehearing en banc was denied, and the mandate issued around Oct. 18, 2022 after a rare emergency detour: Chief Justice Roberts temporarily stayed the mandate (Sup. Ct. No. 22A272, Sept. 29, 2022), but the full Court denied the stay, and the Supreme Court later denied Novartis's petition for certiorari in 2023 (per counsel profiles), clearing the way for HEC's generic launch.

Why the case is notable. The case is a landmark on written description for negative claim limitations: the en banc–denied 38 F.4th 1013 decision holds that silence in the specification generally cannot support a later-added negative limitation, which must instead be backed by a disclosed "reason to exclude" or a showing that skilled artisans would necessarily understand the limitation as excluded — a rule that exposed any patent with prosecution-added negative limitations to validity challenge and was litigated against the backdrop of the Supreme Court's then-pending written-description petition in Juno Therapeutics v. Kite Pharma. It is equally notable for its procedural whiplash: the same appeal produced two split 2–1 outcomes of opposite sign solely because a judge retired mid-appeal, prompting criticism of panel-composition gamesmanship in rehearing practice. On the market side, invalidation of the '405 patent — which had previously survived inter partes review (IPR2017-00854, Apotex v. Novartis, instituted July 18, 2017 and joined by Argentum, Actavis/Teva, and Sun; final written decision July 11, 2018 upholding all claims on all three grounds, with an IPR certificate confirming patentability issued Feb. 10, 2020) — removed the last major patent barrier for Gilenya after a separate IPR (IPR2014-00784) had already invalidated Novartis's fingolimod composition patent (U.S. 8,324,283). That IPR survival had itself triggered the wave of ANDA suits; the eventual invalidation in district-court litigation then let HEC become the first generic fingolimod entrant into a market worth billions, with Novartis scrambling for a post-invalidation TRO against Mylan (granted by Judge Jordan on Oct. 11, 2022). One caveat: the exact docket date of the Supreme Court's cert denial was not independently verified in my sources, though counsel profiles confirm the petition was defeated and the stay denied.

Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. et al. — Key Legal Developments & Outcome

Case posture: ANDA (Hatch-Waxman) infringement suit over Gilenya® (fingolimod 0.5 mg) and U.S. Patent No. 9,187,405 (method of treating relapsing-remitting multiple sclerosis [RRMS] with 0.5 mg fingolimod daily "absent an immediately preceding loading dose regimen"). D. Del. No. 1:18-cv-01043; Fed. Cir. No. 21-1070. Final outcome: claims 1–6 of the '405 patent held invalid for lack of written description on panel rehearing; Novartis's certiorari petition denied.

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1. Filing & initial pleadings

• 2016-01-11 – Accord notified Novartis of its ANDA filing (first paragraph IV notice); other filers (including HEC, Bionpharma, Apotex, Teva, Sun, Mylan, etc.) followed through mid-2018. (Ex Parte docket analysis)
• 2018-07-16 – Novartis filed its complaint (D.I. 1) in D. Del. against roughly 25 generic manufacturers, alleging infringement of the '405 patent (the docket also lists U.S. Patent No. 8,324,283, but the litigated and appealed claims center on the '405 patent) under 35 U.S.C. § 271(e)(2) based on paragraph IV ANDAs for fingolimod 0.5 mg capsules. Case assigned to Judge Leonard P. Stark (lead case 18-1043-LPS). (CourtListener docket; drugpatentwatch)
• 2018-10-25 – The court consolidated 18-1043 with related actions (18-1038 Apotex; 18-1039 Teva; 18-1040 Sun, and others) for all pre-trial purposes, with 18-1043 as lead case. (D.I. 237 stipulation recitals)
• Late 2018 – Defendants answered, denying infringement (though the ANDA filing itself was generally not contested) and asserting invalidity (anticipation by Kappos 2006, lack of written description, lack of enablement/utility) and unenforceability counterclaims. I could not confirm the exact docket numbers/dates of each answer from my sources; the record confirms consolidated invalidity contentions on the '405 patent served by HEC, Mylan, and others. (CourtListener; D.I. 293, 354)

2. Parallel PTAB IPR proceedings (significant strategic overlay)

• 2017-02-03 – Apotex filed IPR2017-00854 challenging claims 1–6 of the '405 patent. Three substantially identical petitions were joined: IPR2017-01550 (Argentum), IPR2017-01946 (Teva/Actavis), IPR2017-01929 (Sun). (PTAB FWD; D.I. 237)
• 2018-07-11 – PTAB Final Written Decision (Paper 109): claims 1–6 not shown unpatentable on any of the three instituted grounds. The Board also construed the claim preambles as limiting (informing "said subject") — a construction the district court later adopted. (PTAB FWD; D. Del. D.I. 561)
• 2018-07-27 – Apotex appealed to the Federal Circuit (Appeal No. 18-2209); Teva/Actavis (18-2260), Sun (18-2230), and Argentum (18-2273) also appealed. Teva/Actavis and Sun settled and dismissed before argument; Apotex settled after argument and dismissed; the Federal Circuit dismissed Argentum's appeal for lack of Article III standing (Argentum Pharms. LLC v. Novartis Pharms. Corp., No. 18-2273, Fed. Cir. 2020). (CourtListener opinion)
• 2020-02-10 – IPR certificate issued confirming patentability of claims 1–6. (Ex Parte case timeline)
• Practical effect: With the IPR appeals resolved in Novartis's favor (or dismissed), no IPR estoppel barred the district court litigation, and the only remaining validity battleground was the district court. The IPR's success also fed Novartis's preliminary injunction showing.

3. Pre-trial motions of substance

• Stays pending IPR (stipulated, not contested): On 2018-11-05 (D.I. 237) Novartis and Apotex stipulated to stay all claims/defenses/counterclaims between them pending the IPR appeal, with Apotex bound by the consolidated action's validity adjudication. Similar settlement/stay stipulations followed for other filers (e.g., Sun stayed December 2019). I found no evidence of contested motions to dismiss or transfer; the litigation was driven by stipulations and settlements.
• Preliminary injunction (the major substantive pre-trial motion): Novartis moved to enjoin at-risk generic launches (motion ~March 2019; D.I. 359–362 with expert declarations from Drs. Lublin, Steinman, Jusko). Defendants opposed (D.I. 470, filed 2019-04-16) on anticipation (Kappos 2006), written description, and enablement/utility. After an evidentiary hearing, Judge Stark granted the preliminary injunction on 2019-06-24 (Novartis Pharms. Corp. v. Accord Healthcare Inc., C.A. No. 18-1043-LPS, 2019 U.S. Dist. LEXIS 104969): infringement admitted for PI purposes; defendants unlikely to prove invalidity (wrong POSA — a clinician+pharmacologist team; Kappos 2006 disclosed only a hypothesis, not treatment; written description attack largely "legal irrelevancies"); irreparable harm shown (up to six at-risk launches, ~$1.8B/year market); $50M bond posted. (JD Supra/Robin Kaplan summaries; D.I. 583)
• Case reassignment: At some point the case was reassigned from Judge Stark to Judge Kent A. Jordan (Third Circuit, sitting by designation) — the trial, post-trial, and remand decisions bear the KAJ initials. (D.I. 769, 808; Fed. Cir. caption)

4. Claim construction (Markman)

• 2019-04-23 – Claim construction hearing (D.I. 498).
• 2019-06-05 – Memorandum Opinion, D.I. 561, published at Novartis Pharms. Corp. v. Accord Healthcare Inc., 387 F. Supp. 3d 429 (D. Del. 2019) (Stark, J.):
  • Claim preambles (claims 1, 3, 5 — "reducing or preventing or alleviating relapses," "treating," "slowing progression" of RRMS): limiting statements of purpose because they supply antecedent basis for "said subject" and breathe life into otherwise identical claims — but the court rejected Novartis's attempt to read an efficacy limitation into the preambles.
  • "Daily dosage of 0.5 mg": construed as the amount of fingolimod administered per day over a multi-day treatment (consistent with the PTAB's construction).

5. Discovery milestones

• 2019 – The consolidated cases ran expert and fact discovery on validity and infringement. Depositions of Novartis experts (e.g., Drs. Lublin, Steinman, Jusko) and defendants' experts (e.g., Dr. Giesser from the IPR) occurred through late 2019 (deposition notices for Drs. Savic and Fujinami, Nov. – Dec. 2019). (CourtListener docket)
• 2019-12 – Sun stipulated to a stay (settlement-driven), narrowing the case. (CourtListener docket)
• 2020 – Motions to exclude certain prior-art opinions (D.I. 663 and related briefing) were litigated pre-trial as part of the HEC-only trial preparations.

6. Trial, verdict, and post-trial motions

• 2020-03-02 to 03-05 – Four-day bench trial before Judge Jordan, proceeding only against HEC (all other defendants had settled or been stayed). (D.I. 769)
• 2020-08-10 – Findings of Fact and Conclusions of Law (D.I. 769): HEC liable for induced and contributory infringement (its ANDA label instructs performance of every claimed step); '405 patent not invalid — not anticipated by Kappos 2006, and adequate written description supported the "daily dosage" and "no-loading-dose" limitations (relying on the Prophetic Trial's "initially" language and expert testimony). (D.I. 769)
• 2020-09-11 – Final judgment (D.I. 780) of infringement and no invalidity; permanent injunction entered.
• Late 2020 – The court entered a post-judgment order extinguishing the $50M preliminary injunction bond (the "December order") — an order that later proved dispositive against HEC (see § 8). (Locke Lord/Troutman summary)
• Settlement-driven consent judgments (parallel defendants): Prinston consent judgment and injunction 2020-05-01 (D.I. 754); Apotex negotiated settlement 2020-02-07 with final consent judgment and injunction 2020-12-02 (D.I. 808) (consent decree under 21 U.S.C. § 355(j)(5)(B)(iii), license, dismissal with prejudice, injunction until '405 expiration). Accord and the other named defendants likewise dropped out via settlement/stipulation before or after trial — I could not confirm each defendant's individual dismissal entry from my sources.

7. Appeal — Federal Circuit (No. 21-1070)

• 2020-10 – HEC noticed its appeal of the final judgment (D.I. 780) and permanent injunction to the Federal Circuit. (Locke Lord summary)
• 2022-01-03 – *Original panel opinion, Novartis Pharms. Corp. v. Accord Healthcare, Inc., 21 F.4th 1362 (Fed. Cir. 2022)* (O'Malley, J., author; Linn, J., joined; Moore, C.J., dissenting): affirmed the district court — omission of any loading-dose discussion in the specification adequately supported the negative limitation "absent an immediately preceding loading dose regimen." (Lexology; Patently-O)
• 2022-02/03 – HEC petitioned for panel rehearing (deadline extended 21 days; Novartis responded within four days). Judge O'Malley retired in March 2022 before acting on the petition; the court added Judge Hughes to the panel to decide the rehearing. (Patently-O "Sound of Silence")
• 2022-06-21 – *Rehearing decision, Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013 (Fed. Cir. 2022)* (Moore, C.J.; Hughes, J.; Linn, J., dissenting): granted rehearing, vacated the original decision, and reversed — the district court clearly erred in finding written description support. For a negative limitation, the specification must expressly or inherently disclose the exclusion; silence is generally not disclosure. The "initially" finding was clearly erroneous (the specification's "Initially patients receive treatment for 2 to 6 months" addresses treatment duration, not dosing), and testimony about what a POSA would infer cannot substitute for disclosure. The limitation had been added during prosecution to distinguish prior art — underscoring that it was not inherently disclosed. Claims 1–6 held invalid. (38 F.4th 1013; CAFC opinion PDF)
• 2022-09-21 – En banc rehearing denied without noted dissent. (Patently-O, 2022-09-21)
• ~2022-10-18 – Mandate issued; district court docket terminated 2022-10-20. (case summary; drugpatentwatch)

8. Post-remand and final disposition

• On remand, the invalidity of claims 1–6 became the final judgment in the district court, vacating the infringement judgment and injunction.
• 2023-01-18 – Novartis filed a petition for certiorari (No. 22-1120) raising (1) whether a court of appeals may add a new judge to form a new panel and redecide a case after the original panel entered judgment, and (2) whether § 112 requires only a description understandable to a skilled artisan rather than a heightened express/inherent-disclosure standard. (Lexology; KTS blog)
• 2023-02-21 – Five retired Federal Circuit judges filed an amicus brief supporting Novartis on the panel-composition question. (KTS blog)
• 2023 – The Supreme Court denied certiorari, making the invalidity holding final. My sources do not give the exact denial date; the denial occurred in 2023 (reported as such in the July 2024 Locke Lord/Troutman summary). (Troutman/Locke Lord)
• 2024-07-09 – Memorandum Opinion (Judge Jordan, sitting by designation) denying HEC's motion to recover $50 million in preliminary-injunction bond damages. Because HEC did not separately appeal the December 2020 order extinguishing the bond (even though it appealed the merits judgment), the bond order was final and issue preclusion barred recovery — notwithstanding HEC's ultimate victory on validity. (D. Del. 18-1043, Mem. Op. 2024-07-09; JD Supra/Troutman)

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Bottom line

Novartis won every stage through trial and the original Federal Circuit affirmance (including a preliminary injunction, a favorable Markman ruling, IPR survival, and a bench-trial win on infringement and validity). But on HEC's panel rehearing — after Judge O'Malley's retirement changed the panel's composition — the Federal Circuit reversed and invalidated claims 1–6 for lack of written description of the "absent an immediately preceding loading dose regimen" negative limitation (38 F.4th 1013). En banc review was denied, certiorari was denied, and the mandate issued in October 2022. The final disposition is invalidity of the asserted claims, with a coda: HEC's failure to appeal the bond-extinguishing order cost it the $50 million bond (July 2024).

Caveats on sourcing: I could not verify from my sources the exact docket numbers/dates for each defendant's answer, individual settlement dismissals (other than Apotex and Prinston), the precise certiorari denial date, or the district court's specific remand entry. Those items are characterized at the level of detail the record supports. All other dates and citations above come from the district court docket (D.I. 237, 470, 561, 583, 769, 808), the published opinions (387 F. Supp. 3d 429; 21 F.4th 1362; 38 F.4th 1013), PTAB IPR2017-00854 papers, and the secondary sources cited.

Based on my research across the Federal Circuit docket (21-1070), the district court docket (D. Del. 1:18-cv-01043), the parties' appellate and rehearing filings, and firm bios, here is the counsel of record for plaintiff Novartis Pharmaceuticals Corp. (appellee on appeal).

Lead appellate counsel (Federal Circuit, No. 21-1070)

These three attorneys filed the formal Entry of Appearance for Novartis as Appellee on November 3, 2020 (Docket No. 5), per the Federal Circuit docket as reflected in Unicourt's case summary:

• Jane M. Love, Ph.D. — Lead/appellate counsel; designated "Principal Attorney" on Novartis's rehearing filings. Gibson, Dunn & Crutcher LLP, New York, NY (200 Park Avenue). She signed the entry of appearance, docketing statement, certificate of interest, the merits briefing, and the petition for rehearing/response. Patent litigator with a Ph.D. in chemistry; along with Robert Trenchard she co-led Novartis's Gilenya® (fingolimod) ANDA campaign — including the winning PTAB IPR on the '405 dosing patent, the Delaware bench-trial victory, and the preliminary injunction against at-risk generic launches (per Gibson Dunn bios and the rehearing filings).
• Robert W. Trenchard — Co-lead counsel. Gibson, Dunn & Crutcher LLP, New York, NY. Longtime first-chair life-sciences patent litigator; Gibson Dunn's firm bio specifically credits him with co-leading (with Dr. Love) the Novartis Gilenya IPR and Delaware litigation against 23 ANDA filers, as well as related Gilenya formulation, compound, and polymorph cases and the Reclast/Zometa litigation.
• Paul E. Torchia — Appellate/trial counsel. Gibson, Dunn & Crutcher LLP, New York, NY. IP litigator with seven patent jury trials (D. Del., N.D. Cal., S.D. Cal., E.D. Tex., ITC) for clients including Novartis, Dell EMC, NetApp, and Microsoft (per Legal 500 / Gibson Dunn profile).

Appellate specialists added for rehearing (after the panel initially affirmed on Jan. 3, 2022)

These attorneys appeared on Novartis's petition for panel/en banc rehearing and its response to HEC's rehearing petition (filed Feb.–Mar. 2022; Fed. Cir. Docs. 44/49), per the petition signature block:

• Deanne E. Maynard — Morrison & Foerster LLP, Washington, DC. Nationally recognized Supreme Court and appellate advocate (former Assistant to the Solicitor General); brought in for the rehearing and subsequent certiorari phase.
• Seth W. Lloyd — Morrison & Foerster LLP, Washington, DC. Appellate and Supreme Court litigator; joined on the rehearing petition.
• William M. Jay — Goodwin Procter LLP, Washington, DC. Prominent Supreme Court and appellate litigator; joined for rehearing.
• David Zimmer — Goodwin Procter LLP, Boston, MA. Appellate/IP litigator; joined for rehearing.
• Edwina B. Clarke — Goodwin Procter LLP, Boston, MA. Appellate litigator; joined for rehearing.
• Thomas G. Hungar — Gibson, Dunn & Crutcher LLP, Washington, DC. Gibson Dunn's Supreme Court and appellate practice co-chair (former General Counsel of the House of Representatives and Deputy Solicitor General); added for rehearing and the certiorari petition.
• Jacob T. Spencer — Gibson, Dunn & Crutcher LLP, Washington, DC. Appellate litigator; added for rehearing.

District court trial team (D. Del. 1:18-cv-01043, Judge Stark/Jordan)

The Dec. 15, 2020 district court opinion (D.I. 813, reported at Novartis Pharm. Corp. v. Accord Healthcare Inc., 2020 WL 7333098) and the parties' rehearing certificate list the broader Gibson Dunn trial team:

• Laura Corbin and Kyanna Sabanoglu — Gibson Dunn, New York, NY (trial team).
• Andrew P. Blythe — Gibson Dunn, Los Angeles, CA (333 South Grand Avenue) (trial team).
• Christine L. Ranney — Gibson Dunn, Denver, CO (listed on rehearing certificate).
• Sung Bin Lee, Shyam Shanker, Jordan Bekier, Emil N. Nachman — Gibson Dunn, New York, NY (additional associates/counsel on the trial team per the rehearing certificate).

Delaware local counsel (district court)

• Daniel M. Silver — McCarter & English, LLP, Wilmington, DE (Renaissance Centre, 405 N. King St., 8th Floor). Lead Delaware local counsel; signed numerous key district court filings (e.g., D.I. 266 scheduling letter).
• Michael P. Kelly — McCarter & English, LLP, Wilmington, DE. Delaware litigation partner.
• Benjamin A. Smyth — McCarter & English, LLP, Wilmington, DE. Local/trial counsel.
• Alexandra M. Joyce — McCarter & English, LLP, Wilmington, DE (appears on the rehearing certificate as local counsel).

In-house counsel

I did not identify any named Novartis in-house counsel in the public docket entries, appearances, or briefs reviewed. The certificates of interest identify the corporate parties (Novartis Pharmaceuticals Corp., Novartis AG, Novartis Pharma AG) but no individual in-house attorney appears on the record; the case was handled by outside counsel throughout.

Key sourcing caveats

• The formal "counsel of record" on the Federal Circuit appeal (per the docketed Entry of Appearance, No. 5) is the trio of Love, Trenchard, and Torchia (all Gibson Dunn, NY). The other attorneys above appeared via the rehearing petition/response signature blocks and the district court record, not via a separate Federal Circuit entry of appearance.
• The Novartis rehearing filings are available via the Federal Circuit Blog (fedcircuitblog.com): Petition for Panel and En Banc Rehearing (Feb. 2022) and Response (Doc. 49, filed Mar. 4, 2022), both citing Gibson Dunn (NY, DC, Denver, LA) and McCarter & English (Wilmington) as counsel.
• I could not access PACER directly to verify every attorney's precise designation ("lead" vs. "of counsel") as recorded on the district court's attorney appearance docket; designations above reflect the filings, firm bios, and court opinions located. No filings appear to be sealed that would hide counsel; the only limitation is that some junior attorneys' exact roles are not individually documented in public sources.

Counsel of Record — Defendants in Novartis v. Accord Healthcare (Fed. Cir. 21-1070 / D. Del. 1:18-cv-01043)

Important caption note: Although the case is titled Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., the only defendants who actively litigated to judgment and appealed were HEC Pharm Co., Ltd. and HEC Pharm USA Inc. ("HEC"). The district court's findings state that "the cases as to those other defendants all settled or were stayed prior to trial, which proceeded only as to HEC" (Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013 (Fed. Cir. 2022)). Accord Healthcare, Inc. therefore has no counsel of record in the Federal Circuit appeal — the appeal was prosecuted solely by HEC.

A. HEC Pharm Co., Ltd. (and HEC Pharm USA Inc.) — Defendants-Appellants

Lead / appellate counsel — Skiermont Derby LLP (the firm of record on all Federal Circuit briefs and the entry of appearance):

Sources: Fed. Cir. docket entry of appearance ("Entry of appearance for Paul J. Skiermont; Mieke K. Malmberg; Sarah E. Spires as counsel for Appellants HEC Pharm Co., Ltd. and HEC Pharm USA Inc." — Unified Patents portal for 2021-1070); HEC's Notice of Appeal (RPX/insight copy, D. Del. Oct. 9, 2020, listing Malmberg, Skiermont, and Spires as pro hac vice "Of Counsel" and Stamoulis & Weinblatt as attorneys of record); HEC's petition for panel rehearing and appellants' response (fedcircuitblog.com copies of 21-1070 Docs. 46 and 51, signed by Mieke K. Malmberg, listing Skiermont, Spires, Udick, Hartsell, and Stamoulis).

Delaware local counsel — Stamoulis & Weinblatt, LLP (Wilmington, DE):

Sources: HEC's Notice of Appeal signature block ("STAMOULIS & WEINBLATT, LLP /s/ Stamatios Stamoulis"); district court memorandum opinion caption (CourtListener No. 809, listing "Stamatios Stamoulis, Richard C. Weinblatt, Stamoulis & Weinblatt, LLP … Counsel for Defendant HEC Pharm Co. Ltd." and "Mieke K. Malmberg, Skiermont Derby LLP … Paul J. Skiermont, Sarah E. Spires … Counsel for Defendant HEC Pharm Co. Ltd."); subsequent post-mandate filings in 1:18-cv-01043 were still signed by Stamoulis (e.g., D.I. 901/902 Notices of Appeal, Aug. 2024, PacerMonitor).

Experience note (one line each):

• Skiermont is the founding partner of the Dallas-based patent boutique Skiermont Derby (formerly head of McKool Smith's patent practice) and is a prominent Hatch-Waxman/ANDA litigator; Malmberg is a partner there focused on pharmaceutical patent litigation (the firm's public bios confirm this practice focus, though I did not verify specific past case wins beyond this matter).
• Stamoulis & Weinblatt is a Wilmington IP boutique that regularly serves as Delaware local counsel for generic-drug (ANDA) defendants; Stamoulis also appeared for Accord/Intas in the related 2022 Delaware case (see below).

In-house counsel: None identified from the public docket — HEC's appearances in the District of Delaware and Federal Circuit were exclusively through outside counsel (Skiermont Derby + Stamoulis & Weinblatt). If in-house counsel participated, their names do not appear on the public filings I located.

B. Accord Healthcare, Inc. — Named defendant in D. Del. (no active role on appeal)

• Federal Circuit (21-1070): Accord Healthcare, Inc. is named in the case caption but filed no brief and had no counsel of record; only HEC appeared as appellant. The panel opinions describe the case as HEC's appeal (21 F.4th 1362; 38 F.4th 1013).
• District court (1:18-cv-01043): Accord was an original ANDA defendant that settled/dismissed before trial, so its district-court counsel is not reflected in the trial record or the appeal. I did not locate a verified attorney-of-record entry for Accord in 1:18-cv-01043 in my searches — its early counsel are not reliably sourced, and I will not speculate.
• Related later case: In the separate 2022 suit Novartis v. Accord Healthcare Inc. and Intas Pharmaceuticals Ltd. (D. Del. 1:22-cv-00744), Stamatios Stamoulis (Stamoulis & Weinblatt) entered an appearance for Accord/Intas, with pro hac vice motions filed for Aaron F. Barkoff and Ben J. Mahon (D.I. 13–14, June 2022). I could not verify those attorneys' firms from the snippet, so I flag that as unverified.

C. Quick docket/citation grounding

• Fed. Cir. merits opinion (reversed on rehearing): Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013 (Fed. Cir. June 21, 2022) (Moore, C.J., majority; Linn, J., dissenting), vacating 21 F.4th 1362 (Jan. 3, 2022).
• Rehearing en banc denied; mandate issued ~Oct. 17–18, 2022 (D. Del. docket, D.I. entries re USCA order; district court's later Mem. Op., D.I. 899 at n.1, states mandate issued Oct. 17, 2022).
• District docket: CourtListener Docket 7445353 (1:18-cv-01043-KAJ, Judge Kent A. Jordan); PacerMonitor case 25084470 (lists Stamoulis, Udick, etc., for HEC).

Bottom line: The defendants' counsel of record are Skiermont Derby LLP (Paul J. Skiermont, Mieke K. Malmberg, Sarah E. Spires, with Steven J. Udick and Steven W. Hartsell on filings) as lead/appellate counsel for HEC, and Stamoulis & Weinblatt LLP (Stamatios Stamoulis, Richard C. Weinblatt) as Delaware local counsel. Accord Healthcare, Inc. did not appear or participate in the appeal, and I found no verified counsel of record for Accord in the underlying district case.