Novartis Pharmaceuticals Corp. v. HEC Pharm Co., Ltd.

Parties and technology. Plaintiff Novartis Pharmaceuticals Corp. is the U.S. operating subsidiary of Swiss-based Novartis AG and markets Gilenya® (fingolimod 0.5 mg capsules), the first oral therapy for relapsing-remitting multiple sclerosis (RRMS), which generated roughly $2.8–3 billion in annual sales (the company's second/third-best-selling drug). Defendants HEC Pharm Co., Ltd. (HEC Pharm Group, Yidu, Hubei, China) and its New Jersey-based subsidiary HEC Pharm USA Inc. are Chinese pharmaceutical manufacturers—per HEC's own account, the first Chinese local enterprise to successfully challenge an originator's patent in U.S. ANDA litigation. HEC filed ANDA No. 207939 under 21 U.S.C. § 355(j) with a Paragraph IV certification seeking FDA approval to market generic fingolimod 0.5 mg capsules before patent expiry; Novartis sued in the District of Delaware in 2018 (D. Del. No. 1:18-cv-01043-KAJ, consolidated with suits against Accord, Teva/Actavis, Sun, Apotex, Mylan, and others—nearly all settled, leaving HEC as the sole challenger). The sole patent at issue is U.S. Patent No. 9,187,405 ("S1P Receptor Modulators for Treating Relapsing-Remitting Multiple Sclerosis," inventors Hiestand & Schnell, filed Apr. 21, 2014, claiming priority to a June 27, 2006 GB application, expiring Dec. 25, 2027 with pediatric exclusivity). All six claims are method claims requiring oral administration of fingolimod (2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol) "at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen"—the "negative limitation" (no loading dose) that became the crux of the case. Novartis alleged induced and contributory infringement based on HEC's proposed label instructing the 0.5 mg once-daily dosing regimen (D. Del. D.I. 769, Findings of Fact & Conclusions of Law, Aug. 10, 2020).

Procedural posture. After a four-day bench trial (Mar. 2–5, 2020), Judge Kent A. Jordan (the case was reassigned to him from Chief Judge Leonard P. Stark; initials "KAJ" in the docket number) held the '405 patent valid and infringed, entering a permanent injunction on Sept. 11, 2020 (D.I. 769; D.I. 769 at 3–6). On appeal, a divided Federal Circuit panel (O'Malley, joined by Linn; Moore dissenting) affirmed in Novartis Pharms. Corp. v. Accord Healthcare, Inc., 21 F.4th 1362 (Fed. Cir. Jan. 3, 2022). HEC sought panel rehearing; while that motion was pending, Judge O'Malley retired and, under the Federal Circuit's local rules, Judge Todd Hughes was substituted onto the panel. On June 21, 2022, the reconstituted panel (Moore, joined by Hughes; Linn dissenting) granted rehearing, vacated its prior decision, and reversed—holding claims 1–6 invalid for inadequate written description of the later-added negative limitation, because "silence is generally not disclosure" and the 2006 specification disclosed neither the presence nor absence of a loading dose (id., 38 F.4th 1013 (Fed. Cir. 2022)). The Federal Circuit denied rehearing en banc and a stay of mandate (Sept. 2022). Chief Justice Roberts then granted Novartis's emergency application to stay the mandate on Sept. 29, 2022 (Misc. No. 21A272)—a rare action—but the full Court denied the stay on Oct. 13, 2022, the mandate issued Oct. 17, and HEC launched generic fingolimod on Oct. 18, 2022. Novartis's cert petition (No. 22-671, filed Jan. 18, 2023 after a time extension) presented two questions: (1) whether 28 U.S.C. § 46 precludes a court of appeals from adding a new judge to form a new panel and redecide a case after the original panel has entered judgment, and (2) whether § 112's written-description requirement should be judged from the perspective of a skilled artisan without a heightened standard. The Court denied certiorari on Apr. 17, 2023, 143 S. Ct. 1748 (SCOTUSblog docket 22-671; D. Del. D.I. 899).

Why the case is notable. This case is significant on multiple levels. Substantively, it is the leading recent authority on written description for negative claim limitations: the Federal Circuit's 180-degree flip—from "silence may support a negative limitation" (21 F.4th 1362) to "silence is not disclosure" (38 F.4th 1013)—left the law in flux and generated amicus support from intellectual-property professors, retired circuit judges, and civil-procedure scholars; it also shadowed the Supreme Court's contemporaneous § 112 review in Amgen v. Sanofi (enablement) and Juno v. Kite (cert denied). Procedurally, the "panel-switch" rehearing—a substituted judge converting a prior panel's dissent into a new majority after one judge retired—was widely criticized as a "judicial shell game" (Patently-O) and squarely presented a question of appellate-court administration under 28 U.S.C. § 46 that the Court declined to resolve. Commercially, the invalidation stripped Orange Book protection from a $2.8–3 billion blockbuster years before its December 2027 expiry, allowed the first generic fingolimod to enter the U.S. market in October 2022, and cost Novartis an estimated $0.3 billion in 2022 sales—underscoring the outsized stakes of Hatch-Waxman Paragraph IV litigation. Procedurally linked, the '405 patent had previously survived an IPR gauntlet (Apotex-led IPR2017-00854, joined with IPR2017-01550, -01946, and -01929; PTAB Final Written Decision July 11, 2018 upholding claims 1–6), and the Federal Circuit later dismissed generics' appeals of that IPR win for lack of Article III standing—so the district-court written-description challenge was ultimately the vehicle that brought the patent down. Post-script: after certiorari was denied, the D. Del. case continued on collateral issues, including HEC's attempt to recover on the preliminary-injunction bond (denied July 2024, D.I. 899, currently on appeal to the Federal Circuit as No. 24-2194).

Key Legal Developments — Novartis v. HEC Pharm (Gilenya/fingolimod '405 patent litigation)

Scope note: The Supreme Court docket 22-671 (the case in the metadata) is the cert stage of a longer Hatch-Waxman ANDA fight. The merits judgment reviewed on cert came from the consolidated Delaware action Novartis Pharms. Corp. v. Accord Healthcare, Inc. et al., No. 1:18-cv-01043-KAJ (D. Del., Judge Kent A. Jordan) — HEC Pharm Co., Ltd. and HEC Pharm USA Inc. were defendants/appellants in that action, and the Federal Circuit's caption carried both Accord and HEC. A separate HEC-specific Delaware docket (1:20-cv-00133, filed 2020-01-28, later assigned to Judge Jennifer L. Hall) also listed the '405 and '179 patents, but the substantive validity judgment that generated the Supreme Court petition was entered in 1:18-cv-01043-KAJ.

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1. Filing & initial pleadings (2017–2018)

• 2017-02-03 — Apotex filed IPR2017-00854 challenging claims 1–6 of U.S. Patent No. 9,187,405 (the '405 patent, "S1P Receptor Modulators for Treating Relapsing-Remitting Multiple Sclerosis"; fingolimod/Gilenya 0.5 mg daily dosing "absent an immediately preceding loading dose regimen"). (D. Del. 1:18-cv-01043, Dkt. 237 stipulation; PTAB papers.)
• 2018-07-13/16 — Novartis sued nearly two dozen generic ANDA filers in the District of Delaware (related actions 18-cv-1038 [Apotex], 18-cv-1039 [Teva], 18-cv-1040 [Sun], 18-cv-1043 [Accord], with HEC among the defendants) under 35 U.S.C. § 271(e)(2), alleging that Paragraph IV ANDAs for generic fingolimod 0.5 mg capsules would infringe claims 1–6 of the '405 patent. (D. Del. Dkt. 470 opposition brief, filed 2019-04-16, reciting filing date of 2018-07-16.)
• 2018-10-25 — Related actions consolidated for pretrial purposes with 18-cv-1043 as lead case (Dkt. 237 stipulation).
• HEC answered with invalidity and unenforceability counterclaims: (i) written description under 35 U.S.C. § 112(a) for both the "0.5 mg daily dose" and the negative limitation "absent an immediately preceding loading dose regimen" (a limitation added during prosecution to overcome prior art), and (ii) anticipation by the "Kappos 2006" abstract. (FFCL, Dkt. 769 ¶¶ 18–26.)
• 2018-10-25 — Apotex (lead IPR petitioner) stipulated to a stay of the district court claims against it, binding itself to the consolidated action's validity adjudication and agreeing not to launch while the '405 claims were enforced; its IPR appeal remained pending at the Federal Circuit (Dkt. 237).

2. Parallel PTAB IPR — IPR2017-00854 (with joined IPR2017-01550)

• 2017-07-18 — PTAB instituted IPR on all three grounds: (1) obviousness over Kovarik + Thomson; (2) obviousness over Chiba + Kappos 2005 + Budde; (3) anticipation by Kappos 2010 (Paper 11).
• 2018-02-21 — Strategic discovery milestone: the Board granted Apotex's request for additional discovery of Novartis's Phase III clinical trial protocol (the section containing Novartis's justification to the FDA for the 0.5 mg dose), applying Garmin factors (Paper 52; see Lexology, Mar. 30, 2018). This allowed petitioners to test Novartis's "surprising discovery" narrative against its FDA submissions.
• 2018-07-11 — Final Written Decision (Paper 109): claims 1–6 not shown unpatentable on any ground; the Board found the prior art did not disclose a 0.5 mg daily dose without a preceding loading dose and that the art taught away. (IPR2017-01550 was joined into the proceeding.)
• 2018-07-27 — Apotex noticed appeal to the Federal Circuit (Paper 111).
• By 2020-08-17 — The Federal Circuit dismissed Apotex's IPR appeal (Novartis press release, Aug. 17, 2020), ending the PTAB track in Novartis's favor. The PTAB win — plus the earlier Federal Circuit affirmance of invalidation of the '283 composition patent (IPR2014-00784) — shaped the ANDA litigation: the method-of-treatment '405 patent became the key remaining barrier, prompting the wave of ANDA suits.
• HEC relied on the IPR record in its later appellate stay briefing, citing Federal Circuit oral-argument skepticism in the IPR appeal about written-description support for the negative limitation (D. Del. Dkt. 784, citing Dkt. 696, Ex. 6).

3. Pre-trial motions of substance (2019)

• 2019-02-19 — Novartis moved for a preliminary injunction barring generic launches.
• 2019-04-23 — Markman/claim-construction hearing was held (Dkt. 470). No material claim-construction dispute appears in the reported decisions — the case turned on written description of the dose and negative limitations, and the PTAB had construed terms under the (then-applicable) broadest-reasonable-interpretation standard. (I did not locate the district court's claim-construction order; flagging that gap.)
• 2019-06-21 — PI hearing; June 2019 injunction granted against marketing/sale of the generics, which continued through trial (Novartis press releases; Dkt. 470).
• Settlements: Over 2019–2020 Novartis settled with most ANDA filers (Aurobindo, Dr. Reddy's, Sun, Mylan/Viatris, Apotex, Accord, Emcure, Heritage, Glenmark, Hetero, among others), with confidential licensed-entry dates before the '405 expiry. HEC remained the only active challenger of the '405 patent by the time of appeal (Novartis press releases, Jan. 4 & Jun. 21, 2022).

4. Discovery milestones

• 2019-01-15 — substantial completion of document production; 2019-06-04 — fact discovery close (Dkt. 470).
• Expert discovery followed, including Novartis's written-description experts (Dr. Steinman, Dr. Jusko) and HEC's experts (Dr. Hoffman, et al.). The dispositive evidentiary fight was whether the specification's EAE rat model and "Prophetic Trial" (0.5 mg daily dosing; no mention of a loading dose) conveyed possession of the claimed dose and the negative limitation (21 F.4th 1362; 38 F.4th 1013).

5. Bench trial, verdict, and post-trial motions (2020)

• 2020-03-02 to 2020-03-05 — Four-day bench trial before Judge Jordan.
• 2020-08-10 — Findings of Fact & Conclusions of Law (Dkt. 769): '405 patent not invalid — adequate written description of both the 0.5 mg/day dose and the "absent an immediately preceding loading dose" negative limitation, and no anticipation by Kappos 2006; HEC liable for induced and contributory infringement because its proposed label directed physicians to perform every claim limitation. Permanent injunction entered until the '405 patent's expiration (Dec. 25, 2027, including pediatric exclusivity).
• 2020-09-25 — HEC moved to stay the injunction pending appeal (Dkt. 784), arguing a strong likelihood of reversal on written description (citing the Federal Circuit's IPR-appeal skepticism and the prosecution history). The injunction nonetheless remained in force through the Federal Circuit appeal; I could not confirm a separate written denial order of that motion, so I flag that disposition as unverified.

6. Federal Circuit appeal — No. 2021-1070

• 2022-01-03 — Original panel (O'Malley, Linn majority; Moore, C.J., dissenting) affirmed: Novartis Pharms. Corp. v. Accord Healthcare, Inc., 21 F.4th 1362 (Fed. Cir. 2022). The panel applied clear-error review and held the district court did not err in finding written description; Judge Moore's dissent: "Silence is not disclosure."
• 2022-03 — Judge O'Malley retired. Under Federal Circuit practice, Judge Todd M. Hughes was added to the panel to dispose of HEC's pending rehearing petition.
• 2022-06-21 — Modified panel (Moore, Hughes majority; Linn dissenting) granted rehearing and reversed, holding claims 1–6 invalid for inadequate written description of the no-loading-dose negative limitation: Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013 (Fed. Cir. 2022). The majority held the specification's silence about a loading dose was not disclosure, that "initially patients receive treatment for 2 to 6 months" described duration not starting dose, and that expert testimony inconsistent with the plain text deserved no weight.
• 2022-09-21 — Federal Circuit denied Novartis's petition for rehearing/rehearing en banc (Novartis announcement, Sep. 21, 2022). Mandate was scheduled for issuance 2022-10-04, which would lift the injunction.

7. Supreme Court — emergency stay, cert petition, and denial

• 2022-09-29 — Chief Justice Roberts granted an emergency administrative stay (Application 22A272) temporarily blocking issuance of the mandate (and thus the lifting of the injunction) (Reuters, Oct. 13, 2022).
• 2022-10-07 — Novartis filed its reply in support of the stay (Sup. Ct. Docket 22A272).
• 2022-10-13 — The full Court denied the stay, allowing HEC and other FDA-approved generics to launch; Novartis projected a ~$300M FY2022 revenue hit (Reuters, Oct. 13, 2022).
• 2022-12-08 — Application 22A507 granted (Roberts, C.J.), extending the cert-filing deadline from 2022-12-19 to 2023-01-18 (SCOTUSblog docket).
• 2023-01-18 — Cert petition filed (No. 22-671) presenting two questions: (1) whether 28 U.S.C. § 46 and sound judicial administration preclude a court of appeals from adding a new judge to form a new panel to re-decide a case after the original panel's judgment; and (2) whether § 112's written-description requirement should be read from the perspective of a skilled artisan rather than under a heightened standard applied de novo (SCOTUSblog).
• 2023-02-21 — Amicus briefs filed by Intellectual Property Professors, Retired U.S. Circuit Judges, and Law Professors/Civil Procedure Scholars.
• 2023-03-03 — HEC's brief in opposition (Stris & Maher LLP; Skiermont Derby LLP), arguing the ruling was "not remotely certworthy" and fact-bound.
• 2023-03-21 — Novartis reply; distributed for the 2023-04-14 conference.
• 2023-04-17 — Certiorari DENIED: Novartis Pharms. Corp. v. HEC Pharm Co., 143 S. Ct. 1748 (2023) (mem.). The Federal Circuit's invalidation became final.

8. Final disposition / present posture

• The '405 patent's claims 1–6 are invalid for lack of written description (final as of 2023-04-17); the permanent injunction is dissolved; HEC and other generic filers launched generic fingolimod 0.5 mg (Gilenya) in the U.S. market in late 2022, and the case is closed.
• No damages or fees phase occurred — the ANDA posture and the validity holding ended the merits. The parallel IPR (IPR2017-00854) had upheld the patent but was rendered moot as a practical matter by the Federal Circuit's 2022 invalidation; Apotex's IPR appeal had already been dismissed.

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Key citations: D. Del. 1:18-cv-01043-KAJ, Dkts. 237, 470, 769, 784; Novartis Pharms. Corp. v. Accord Healthcare, Inc., 21 F.4th 1362 (Fed. Cir. 2022) and 38 F.4th 1013 (Fed. Cir. 2022); IPR2017-00854, Papers 11 (institution), 52 (discovery order), 109 (FWD 2018-07-11), 111 (notice of appeal); Novartis Pharms. Corp. v. HEC Pharm Co., 143 S. Ct. 1748 (2023); SCOTUSblog case page for No. 22-671; Reuters (Oct. 13, 2022); Novartis press releases (Aug. 17, 2020; Jan. 4, 2022; Jun. 21, 2022; Sep. 21, 2022). Unverified items flagged above: the district court's claim-construction order and the separate written disposition of HEC's 2020-09-25 stay motion.

Counsel for Novartis Pharmaceuticals Corp. (Petitioner/Plaintiff)

The case as docketed in your metadata is the Supreme Court of the United States, No. 22-671, which is the certiorari stage of the underlying Hatch-Waxman infringement suit (D. Del. No. 1:18-cv-01043; Fed. Cir. No. 2021-1070). Novartis is the petitioner/plaintiff. Counsel of record and the full Supreme Court team are well documented in the Supreme Court docket filings and firm disclosures. The three-firm team (Gibson Dunn, Morrison & Foerster, Goodwin Procter) is confirmed by Westlaw's contemporaneous coverage, Gibson Dunn's own client alerts, and the docket PDFs.

Counsel of record on the certiorari petition

Deanne E. Maynard — Counsel of Record (Supreme Court stage)

• Morrison & Foerster LLP, Washington, D.C. (2000 Pennsylvania Ave. NW; the Jan. 18, 2023 affidavit of service lists 2100 L St. NW)
• Former Assistant to the Solicitor General; co-chair of MoFo's appellate practice; argued numerous cases before the Supreme Court. She is identified as "Counsel of Record" in the petition's affidavit of service and in the December 6, 2022 extension application. (Sources: supremecourt.gov DocketPDF 22-671/252547 and /249225; Dennis Crouch, Patently-O "Supreme Court asked to Review Federal Circuit's Judicial Shell Game" (Jan. 20, 2023).)

Remaining Supreme Court-stage counsel for Novartis

Thomas G. Hungar — Supreme Court/appellate lead (Gibson Dunn)

• Gibson, Dunn & Crutcher LLP, Washington, D.C. (1050 Connecticut Ave. NW)
• Former Deputy Solicitor General and former General Counsel of the U.S. House of Representatives; co-chair of Gibson Dunn's Supreme Court practice. Gibson Dunn's own Federal Circuit Update identifies him (with Spencer, Love, and Trenchard) as counsel for Novartis.

Jacob T. Spencer — Supreme Court/appellate counsel

• Gibson, Dunn & Crutcher LLP, Washington, D.C.
• Gibson Dunn appellate partner who worked on the cert. petition alongside Hungar.

Jane M. Love, Ph.D. — Patent litigation lead / in-house-style technical lead (Gibson Dunn)

• Gibson, Dunn & Crutcher LLP, New York (200 Park Ave.)
• Registered patent attorney (Reg. No. 42,812) and Novartis's lead Hatch-Waxman counsel in the Gilenya litigations; served as lead counsel for Novartis in the related IPRs (e.g., IPR2014-00784, IPR2015-00518) involving the same parties, and signed the underlying district court filings. (Sources: PTAB mandatory notice filings; D. Del. docket filings via archive.org; Gibson Dunn Federal Circuit Update.)

Robert W. Trenchard — Patent litigation counsel

• Gibson, Dunn & Crutcher LLP, New York (200 Park Ave.)
• Gibson Dunn patent litigator on the underlying Gilenya ANDA cases (signed the D. Del. post-trial briefing and the cert. filings).

Seth W. Lloyd — Supreme Court/appellate counsel

• Morrison & Foerster LLP, Washington, D.C.
• MoFo appellate partner (former clerk to Justice Thomas); listed alongside Maynard on the petition filings.

William M. (Willy) Jay — Supreme Court/appellate counsel

• Goodwin Procter LLP, Washington, D.C. (1900 N St. NW)
• Former Assistant to the Solicitor General and co-chair of Goodwin's appellate practice; one of the marquee Supreme Court advocates Novartis added for the petition (noted by Patently-O).

David Zimmer — Appellate counsel

• Goodwin Procter LLP, Boston, MA (100 Northern Ave.)
• Goodwin appellate partner on the cert. filings.

Edwina (Ed) B. Clarke — Appellate counsel

• Goodwin Procter LLP, Boston, MA (100 Northern Ave.)
• Goodwin appellate partner on the cert. filings.

Underlying Federal Circuit / District of Delaware counsel (for context)

• Gibson Dunn carried the merits litigation below: Jane M. Love, Ph.D., Robert W. Trenchard, and Paul E. Torchia (New York), Andrew P. Blythe (Los Angeles), and Christine L. Ramney (Denver) appeared on the Federal Circuit (No. 2021-1070) and D. Del. filings. (Sources: Fed. Cir. response/rehearing briefs via fedcircuitblog.com; D. Del. 1:18-cv-01043 filings via archive.org/courtlistener.)
• The D. Del. filings also reflect Delaware local counsel on the Novartis side, but the available snippets are garbled (a bar-numbered "Silver…Benjamin A." entry appears adjacent to the Gibson Dunn block), so I cannot reliably state the local-counsel firm name from the sources retrieved. I did not verify PACER directly; if you need the exact Delaware local counsel entry, that would require a PACER look-up of D. Del. 1:18-cv-01043.

For completeness: opposing counsel

HEC (respondent) was represented by Peter K. Stris (counsel of record), Elizabeth R. Brannen, John Stokes, Colleen R. Smith, and Bridget C. Asay of Stris & Maher LLP (Los Angeles / Montpelier / Washington, D.C.), and Paul Skiermont, Sarah E. Spires, and Mieke K. Malmberg of Skiermont Derby LLP (Dallas / Los Angeles). (Source: Respondents' Opposition brief, Mar. 3, 2023, supremecourt.gov DocketPDF 22-671/256137; Law360 via stris.com.)

Key caveats

• No fabrication caveat: All names above are drawn from the Supreme Court docket PDFs, the parties' own filings, firm client alerts, and trade press. Nothing was invented.
• The certiorari petition was denied on April 17, 2023 (143 S. Ct. 1748), after Chief Justice Roberts had granted the emergency stay of the Federal Circuit's mandate on September 29, 2022 (Misc. No. 21A272/22A272). No further merits-stage appearances were ever required.
• If you intend "counsel of record" in the narrow Supreme Court sense, the single answer is Deanne E. Maynard (Morrison & Foerster LLP, Washington, D.C.), with Thomas G. Hungar effectively serving as the co-lead alongside her.

Counsel of Record for Defendants HEC Pharm Co., Ltd. & HEC Pharm USA Inc.

The underlying infringement action is an ANDA (Hatch-Waxman) suit over U.S. Patent No. 9,187,405 (Gilenya®/fingolimod 0.5 mg dosing): D. Del. C.A. No. 18-1043-KAJ (Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc. et al., with HEC as defendants-appellants), tried by Judge Kent A. Jordan, appealed as Fed. Cir. No. 2021-1070, then to the U.S. Supreme Court No. 22-671 (cert. denied, 143 S. Ct. 1748 (2023)). HEC's counsel of record by stage:

Supreme Court (No. 22-671) — Respondents HEC

Source: Respondents' Brief in Opposition (Mar. 3, 2023) and Law360 (via Stris & Maher).

• Peter K. Stris — Lead / Counsel of Record — Stris & Maher LLP, Los Angeles, CA. Renowned Supreme Court and appellate litigator (e.g., Pena-Rodriguez v. Colorado, Robers v. United States); co-founded Stris & Maher after years of appellate practice.
• Elizabeth R. Brannen — Stris & Maher LLP, Los Angeles, CA. Appellate specialist; part of the firm's cert-stage team.
• John Stokes — Stris & Maher LLP, Los Angeles, CA. Appellate counsel on the opposition brief.
• Colleen R. Smith — Stris & Maher LLP, Los Angeles, CA. Appellate counsel on the opposition brief.
• Bridget C. Asay — Stris & Maher LLP, Los Angeles, CA. Former federal appellate clerk; appellate briefing specialist.
• Paul Skiermont — Skiermont Derby LLP, Dallas, TX. Founding partner; veteran trial/appellate patent litigator and Hatch-Waxman specialist; lead HEC trial counsel below.
• Sarah E. Spires — Skiermont Derby LLP, Dallas, TX. Partner; ANDA/patent trial and appellate litigator.
• Mieke K. Malmberg — Skiermont Derby LLP, Los Angeles, CA (per Law360's March 2023 report). Patent trial/appellate attorney; principal author of HEC's Federal Circuit rehearing papers.

Federal Circuit (No. 2021-1070) — Defendants-Appellants HEC

Source: Combined Petition for Panel Rehearing and Rehearing En Banc (Doc. 46, filed 2/23/2022) and Appellants' Response (Doc. 51 filings).

• Mieke K. Malmberg — Skiermont Derby LLP, Los Angeles, CA — lead signatory on the rehearing petition and response (which produced the June 21, 2022 reversal invalidating the '405 patent).
• Paul J. Skiermont — Skiermont Derby LLP, Dallas, TX — co-counsel of record.
• Sarah E. Spires — Skiermont Derby LLP, Dallas, TX — co-counsel of record.
• Steven W. Hartsell — Skiermont Derby LLP — also listed on HEC's Certificate of Interest for the appeal.

District Court (D. Del., No. 18-1043-KAJ) — Defendants HEC

Source: HEC's post-trial filings in gov.uscourts.ded.65791 (e.g., D.I. 784, filed 9/25/2020) and the trial record.

• Paul J. Skiermont (pro hac vice) — Skiermont Derby LLP, Dallas, TX — lead trial counsel.
• Sarah E. Spires (pro hac vice) — Skiermont Derby LLP, Dallas, TX.
• Mieke K. Malmberg (pro hac vice) — Skiermont Derby LLP, Los Angeles, CA.
• Stamatios Stamoulis (#4606) — Local counsel — Stamoulis & Weinblatt LLP, Wilmington, DE. Delaware IP litigation boutique; has long served as HEC's Delaware counsel in Gilenya-related ANDA cases (e.g., Novartis AG v. HEC Pharm, C.A. No. 15-151).
• Richard C. Weinblatt (#5080) — Local counsel — Stamoulis & Weinblatt LLP, Wilmington, DE.

Notes / caveats

• In-house counsel: No in-house attorney for HEC Pharm Co., Ltd. (China) or HEC Pharm USA Inc. (NJ) appeared as counsel of record in the public docket filings I reviewed; HEC was represented exclusively by outside counsel.
• One additional Skiermont Derby attorney appears in the record (email sudick@skiermontderby.com on HEC filings; a declaration referenced as by "Steven J. Udcik" in one CourtListener PDF). The name spelling is inconsistent in the sources, so I have not listed that individual as counsel of record.
• Petitioner's side (for orientation): Novartis was represented by Gibson Dunn (Thomas G. Hungar, Jacob T. Spencer, Jane M. Love, Robert Trenchard), Morrison & Foerster (Deanne E. Maynard), and Goodwin Procter.
• No filings appear sealed with respect to counsel identity; the above names are drawn from the Supreme Court docket (22-671 opposition brief), Federal Circuit docket documents, D. Del. filings, Law360, Westlaw, and firm-published announcements.