Litigation
Apotex Inc. et al. v. Novartis AG
Final written decision; claims upheldIPR2017-00854
- Filed
- 2017-02-03
- Terminated
- 2018-07-11
Patents at issue (1)
Plaintiffs (3)
Defendants (1)
Summary
Case overview & background
Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.
Case Overview: Apotex Inc. et al. v. Novartis AG, IPR2017-00854
Parties and accused technology. This docket is an inter partes review (IPR) at the USPTO Patent Trial and Appeal Board—the validity half of a broader Hatch-Waxman ANDA fight over Novartis's Gilenya® (fingolimod 0.5 mg capsules), the first oral disease-modifying therapy approved for relapsing-remitting multiple sclerosis (RRMS). The petitioners are generic drug manufacturers: lead petitioner Apotex Inc. and Apotex Corp. (who filed the original petition on February 3, 2017), joined by Argentum Pharmaceuticals LLC (IPR2017-01550), Actavis Elizabeth LLC and Teva Pharmaceuticals USA, Inc. (IPR2017-01946), and Sun Pharmaceutical Industries entities (IPR2017-01929), all of whose substantially identical petitions were joined into IPR2017-00854 with Apotex as lead (Final Written Decision, Paper 109, at 4–5). Patent owner Novartis AG (whose rights had been assigned to Novartis Pharmaceuticals Corp., the real party in interest, per Paper 22) is the innovator operating company and markets Gilenya. The "accused product" is generic fingolimod 0.5 mg capsules—for Apotex, ANDA No. 207993 (see Stipulation, Novartis Pharms. Corp. v. Apotex Inc., C.A. No. 18-1038-LPS, D. Del., Dkt. 237)—which would practice the claimed method of administering fingolimod at 0.5 mg/day without a loading dose.
Patent and asserted claims. The sole patent at issue is U.S. Patent No. 9,187,405 B2, "S1P Receptor Modulators for Treating Relapsing-Remitting Multiple Sclerosis," invented by Peter C. Hiestand and Christian Schnell, assigned to Novartis Pharmaceuticals Corp., claiming priority to a June 27, 2006 UK application and Orange Book-listed for Gilenya. Claims 1–6 cover methods of treating RRMS (reducing/preventing/alleviating relapses; treating; or slowing progression) by orally administering fingolimod (2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol), free form or pharmaceutically acceptable salt, "at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen," with dependent claims 2, 4, and 6 limited to the hydrochloride salt. Petitioners challenged all six claims on three grounds: (1) obviousness over Kovarik (WO 2006/058316) in view of Thomson; (2) obviousness over Chiba (U.S. 6,004,565), Kappos 2005, and Budde; and (3) anticipation by the 2010 Kappos NEJM article (Paper 109 at 10).
Procedural posture and outcome. The PTAB instituted review on July 18, 2017, held oral argument on May 11, 2018, and issued its Final Written Decision on July 11, 2018 (Paper 109) before a panel of Administrative Patent Judges Christopher M. Kaiser, Robert A. Pollock, and Kristi L. R. Sawert (replacing Lora M. Green), holding that petitioners failed to show claims 1–6 unpatentable on any ground. The Board found no prior art disclosed 0.5 mg daily fingolimod without a loading dose, credited Novartis's evidence that the art taught away from such low-dose, no-loading-dose administration, and found the Kappos 2010 reference was not prior art because the '405 patent's priority date (June 2006) predated it; Novartis's contingent motion to amend was rendered moot. The case terminated July 11, 2018, with the IPR certificate issued February 10, 2020. Petitioners appealed to the Federal Circuit (Nos. 18-2209, 18-2230, 18-2260, 18-2273); Apotex settled after argument, and the remaining appeal was dismissed because Argentum, the last appellant, lacked Article III standing absent a filed ANDA (Argentum Pharms. LLC v. Novartis Pharms. Corp., 956 F.3d 1374 (Fed. Cir. 2020)). The venue here is the PTAB (Alexandria, VA), whose estoppel and final-decision consequences directly shaped the parallel infringement suits Novartis filed in the District of Delaware immediately after the FWD (18-cv-1038 against Apotex, 18-cv-1039 against Teva, 18-cv-1040 against Sun, 18-cv-1043 against Accord), consolidated before Judge Leonard P. Stark.
Why the case is notable. This IPR is a landmark in the Gilenya patent thicket: while the PTAB in a separate proceeding had invalidated Novartis's fingolimod composition patent ('283), here the Board upheld the later-expiring method-of-treatment claims covering the commercially critical 0.5 mg no-loading-dose regimen for a multi-billion-dollar MS drug—prompting a wave of Delaware ANDA litigation and settlement-driven generic entry timing. The decision is also doctrinally significant for its "teaching away" analysis of low-dose fingolimod, and the saga continued in Novartis Pharms. Corp. v. Accord Healthcare, Inc. (No. 2021-1070), where a reshuffled Federal Circuit panel, on rehearing in June 2022, reversed course and held claims 1–6 of the '405 patent invalid for inadequate written description of the "absent an immediately preceding loading dose regimen" negative limitation—"silence is generally not disclosure"—a major development in the law of negative claim limitations that post-dates and, in practical terms, supersedes the IPR outcome the Board reached here.
Key legal developments & outcome
Major rulings, motions, claim construction, settlements, and the present posture or final disposition.
Apotex Inc. et al. v. Novartis AG — IPR2017-00854 and the Parallel Gilenya® ('405 Patent) Litigation
Scope note
The case in your metadata — IPR2017-00854 — is a PTAB inter partes review, not a district court infringement suit. The infringement litigation over U.S. Patent No. 9,187,405 ("the '405 patent," Gilenya®/fingolimod 0.5 mg daily-dosing method claims) ran in parallel in the District of Delaware, principally as Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 1:18-cv-01043-KAJ (D. Del.), with sister cases against Apotex, Teva, Sun, and other ANDA filers, followed by Federal Circuit appeals. Below is the full chronology across both fronts. Sources are public records and reporting (PTAB papers, CourtListener/docket entries, Jones Day, PTAB Litigation Blog, Robin Singer/Casetext, FindLaw, FiercePharma, Novartis press releases); I did not access PACER directly, so where a specific docket number or date is unconfirmed I flag it.
Part A — The PTAB IPR (the named case): IPR2017-00854
Patent and claims. The '405 patent claims methods of treating relapsing-remitting multiple sclerosis by oral fingolimod "at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen." Claims 1–6 were challenged. Priority date asserted: June 27, 2006 (predecessor applications). The '405 patent is Orange Book-listed for Gilenya. (FWD, Paper 109; Jones Day/Mondaq, Aug. 13, 2018.)
- 2017-02-03 — Apotex Inc. and Apotex Corp. filed the IPR petition (Paper 2), challenging claims 1–6 on three grounds: two obviousness combinations under § 103 and one anticipation ground under § 102 based on a 2010 publication (the phase III results article). (FWD, Paper 109; PTAB Litigation Blog.)
- 2017 (spring) — Novartis AG filed a Preliminary Response (Paper 8). Novartis's mandatory notices identified Novartis Pharmaceuticals Corp. as the real party in interest (the '405 patent had been assigned to NPC; Paper 22). (FWD, Paper 109.)
- 2017-07-18 — Institution decision (Paper 11): the Board instituted review of all challenged claims on all grounds. (RPX Insight; FWD.)
- 2017-06-09 / 2017-08-15 / 2017-08-16 — Three substantially identical petitions filed with joinder requests: Argentum Pharmaceuticals LLC (IPR2017-01550), Actavis Elizabeth LLC/Teva (IPR2017-01946), and Sun Pharma (IPR2017-01929). The Board granted each and joined them into IPR2017-00854 (joinder decisions: Teva 2017-09-11; Sun 2017-10-02; Argentum ~Sept.–Oct. 2017), with Apotex as lead petitioner. (FWD, Paper 109; PTAB Litigation Blog; ipverse docket.)
- 2017-10-06 — Board order revising due dates 1–7; later a stipulated protective order. (ipverse docket.)
- 2017-11 through 2018-04 — Discovery phase: expert declarations (Dr. Barbara Giesser for petitioners; Drs. Lublin, Steinman, Jusko, Schnell for patent owner); depositions (e.g., Schnell, Giesser, Lublin). Patent Owner Response (Paper 26), Petitioners' Reply (Paper 49), authorized Sur-Reply (Paper 63). (FWD; ipverse docket.)
- 2018-01-24/25 — Discovery dispute over petitioners' motion for additional discovery of the Phase III clinical trial protocol (Ex. 2065); the Board (Paper 41) allowed a limited supplemental brief, a supplemental Lublin declaration, and a ≤1-hour telephonic deposition. (Paper 41, entered 2018-01-25.)
- 2018 — Novartis filed a Corrected Contingent Motion to Amend (Paper 61); petitioners opposed (Paper 51); Novartis replied (Paper 64); petitioners sur-replied (Paper 85, 2018-04-19).
- 2018-07-11 — Final Written Decision (Paper 109): claims 1–6 not shown unpatentable. The Board found the prior art did not disclose 0.5 mg daily fingolimod without a preceding loading dose; the art (per Novartis's evidence) taught away from low daily dosing, and the asserted 2010 reference was not prior art because the claims were entitled to the 2006 priority date. The contingent motion to amend was not granted (claims upheld as issued). (Paper 109; PTAB Litigation Blog, July/Aug. 2018.)
- 2020-02-10 — IPR certificate issued confirming claims 1–6 (per your case metadata).
Appeals from the IPR (Federal Circuit):
- No. 18-2209, Apotex Inc. v. Novartis Pharms. Corp. — Apotex appealed the FWD; after oral argument, Apotex settled with Novartis and the appeal was dismissed. (Argentum Pharms. LLC v. Novartis Pharms. Corp., No. 18-2273 (Fed. Cir. 2020), slip op. at 2 n.2.)
- No. 18-2273, Argentum Pharms. LLC v. Novartis Pharms. Corp. — Teva and Sun appeals were dismissed after their settlements; the Federal Circuit dismissed Argentum's appeal for lack of Article III standing (Argentum had no concrete injury from the PTAB decision), without reaching the merits (opinion issued 2020). (CourtListener, opinion 4747918.)
Part B — The district court ANDA infringement litigation (D. Del.)
Filing and pleadings.
- 2018-07-13 (immediately after the IPR FWD) — Novartis Pharmaceuticals Corp. sued numerous generic filers in the District of Delaware asserting the '405 patent against their fingolimod ANDAs, including 1:18-cv-01038 (Apotex), 1:18-cv-01039 (Teva/Actavis), 1:18-cv-01040 (Sun), and 1:18-cv-01043 (Accord Healthcare/HEC Pharm). (Jones Day/Mondaq, Aug. 13, 2018; Stanford NPE Litigation Database; CourtListener docket 7445353.)
- The cases were coordinated/consolidated before Judge Kent A. Jordan (Third Circuit judge sitting by designation; case no. 1:18-cv-01043-KAJ). Roughly twenty ANDA filers were involved (Apotex, Teva, Sun, Accord/HEC, Mylan, Alkem, Dr. Reddy's, Aurobindo, Bionpharma, Ezra, and others). (ParagraphFour docket summary; Studicata summaries.)
- Defendants answered with non-infringement and invalidity counterclaims (lack of written description of the "absent an immediately preceding loading dose" negative limitation and of the 0.5 mg daily dose; anticipation by a 2006 European Neurological Society abstract). (D.I. 769, FFCL, Aug. 10, 2020.)
Pre-trial motions of substance.
- 2019-02 — Novartis moved for a preliminary injunction against certain defendants (including HEC) planning at-risk launches. (Studicata summary.)
- 2019-08 — Preliminary injunction granted; Novartis posted a $50 million bond. (Studicata; later bond-release opinion.)
- 2019–2020 — The court resolved claim-construction/validity framing; the dispositive question became whether the specification supports the negative loading-dose limitation — the issue that defined both the bench trial and appeal. (I did not locate a separately published Markman opinion; the record suggests the claims were applied essentially on their plain meaning, with "absent an immediately preceding loading dose regimen" as the battleground.) Flag: no standalone claim-construction order was confirmed in my sources.
- Settlements — All defendants except HEC settled before or during the case: Apotex, Teva, Sun, Mylan, Alkem, Dr. Reddy's, Aurobindo, Bionpharma, Ezra, and others. Under the confidential settlements, settling filers could launch generics only on agreed dates before the '405 patent's December 2027 expiry (including pediatric exclusivity). (Novartis press releases, Jan. 4, 2022 & Sept. 21, 2022; ParagraphFour summary.)
Trial and verdict (bench trial).
- 2020-03-02 to 2020-03-05 — Four-day bench trial before Judge Jordan, HEC (Accord) as the sole remaining defendant. (D.I. 769; CourtListener docket entries, trial transcripts Vols. 1–4.)
- 2020-08-10 — Findings of Fact and Conclusions of Law (D.I. 769) : HEC liable for induced and contributory infringement (its label instructed physicians to administer 0.5 mg daily with no loading dose — i.e., each claim limitation); the '405 patent not invalid — adequate written description of the no-loading-dose limitation and of the 0.5 mg daily dose, and no anticipation by the 2006 abstract. (D.I. 769; unsealed per D.I. 773 on 2020-08-17.)
- 2020-09-11 — Final judgment and permanent injunction against HEC (through December 2027, including pediatric exclusivity). Additional final judgments entered as settlements concluded: Alkem 2020-09-23; Dr. Reddy's and Sun 2020-10-21; Mylan 2020-10-27; Aurobindo 2021-01-21. (ParagraphFour summary; Novartis press release Jan. 4, 2022.)
- Post-trial — On Novartis's motion, the court released Novartis from claims against the $50M preliminary-injunction bond, holding the bond merged into the permanent injunction (post-trial opinion; Studicata summary). No damages award was necessary (injunctive relief for a pre-expiry ANDA case).
Part C — Federal Circuit appeal: the flip-flop (No. 2021-1070)
- 2021 — HEC appealed (Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070). Oral argument 2021-07-08; briefing through spring 2021.
- 2022-01-03 — Panel (Moore, Linn, O'Malley) affirmed the district court: 21 F.4th 1362 (Fed. Cir. 2022). The majority held written description did not require the specification to describe a reason to exclude a loading dose; Chief Judge Moore dissented ("silence is not disclosure"). (Novartis press release Jan. 4, 2022; IPWatchdog; GDB Law; Fitch Even.)
- 2022-06-21 — HEC's panel rehearing granted; with Judge O'Malley retired (effective 2022-03-11) and Judge Hughes on the modified panel, the court vacated its January decision and reversed — 2022 WL 2204163 (Fed. Cir. June 21, 2022) (Moore & Hughes majority; Linn dissenting). Holding: the district court clearly erred; the specification never mentions loading doses, "initially" in the specification refers to duration of treatment, not starting dose, and the later-added negative limitation "absent an immediately preceding loading dose regimen" lacks written description support → claims 1–6 invalid under 35 U.S.C. § 112(a). (Casetext; FindLaw; Robin Kaplan Generically Speaking Q2 2022; FiercePharma, June 2022; IPWatchdog, June 21, 2022.)
- 2022-09-21 — Federal Circuit denied Novartis's petition for rehearing/rehearing en banc; Novartis announced it would petition the U.S. Supreme Court. (Novartis press release, Sept. 21, 2022.)
- Late 2022 — Novartis sought certiorari (Supreme Court No. 22-671, with a time-extension filing dated 2022-12-06). Disposition of the cert petition is not confirmed in the sources I reviewed — flag as unverified.
Part D — Effect of the parallel IPR on the litigation, and final posture
- The IPR cleared the way for the litigation. The PTAB's 2018-07-11 FWD upholding claims 1–6 (and the 2020-02-10 certificate) is precisely why Novartis filed the D. Del. ANDA wave days after the FWD (2018-07-13). The IPR addressed only §§ 102/103 (anticipation/obviousness); it never reached § 112 written description, so it did not estop or preclude the later invalidity ruling.
- Settlements largely mooted the IPR appeals. Apotex settled post-argument (18-2209 dismissed); Teva and Sun appeals were dismissed after settlement; Argentum's appeal was dismissed for lack of standing (18-2273, 2020) — so the PTAB's merits ruling on the '405 patent was never reviewed on appeal.
- The 2022 Federal Circuit reversal effectively superseded the IPR outcome. Although the PTAB (and the D. Del. bench trial) upheld the '405 claims, the June 21, 2022 panel-rehearing decision invalidated claims 1–6 for inadequate written description, reversing the HEC judgment and vacating the permanent injunction against HEC (Novartis stated the injunction remained technically in place pending further review).
- Present posture (as of the sources reviewed): The IPR case itself is closed (FWD 2018-07-11; certificate 2020-02-10). The Delaware ANDA litigation is largely resolved — all defendants settled except HEC, whose case ended in a judgment that was reversed on rehearing (2022-06-21). The final chapter (Supreme Court certiorari in No. 22-671, and any impact of the invalidity holding on the settling parties' agreed entry dates) was still unfolding as of the most recent sources; I could not confirm the Supreme Court's disposition.
Key dates at a glance
| Date | Event |
|---|---|
| 2017-02-03 | IPR2017-00854 petition filed (Apotex) |
| 2017-07-18 | PTAB institution decision (all claims, all grounds) |
| 2017-09-11 / 2017-10-02 | Teva and Sun IPRs joined; Argentum joined shortly before/after |
| 2018-07-11 | PTAB FWD: claims 1–6 not unpatentable (Paper 109) |
| 2018-07-13 | Novartis D. Del. ANDA suits filed (incl. 18-cv-1038 Apotex; 18-cv-1043 Accord/HEC) |
| 2019-02 / 2019-08 | Preliminary injunction motion / granted ($50M bond) |
| 2020-03-02 – 03-05 | Bench trial (HEC sole remaining defendant) |
| 2020-08-10 | FFCL: infringement; patent valid (D.I. 769) |
| 2020-09-11 | Final judgment + permanent injunction v. HEC (through Dec. 2027) |
| 2020-02-10 | IPR certificate issued (claims confirmed) |
| 2020 (mid) | IPR appeals resolved: 18-2209 dismissed (settlement); 18-2273 dismissed (standing) |
| 2022-01-03 | Fed. Cir. affirms (21 F.4th 1362); Moore dissent |
| 2022-06-21 | Fed. Cir. on rehearing reverses — claims 1–6 invalid (no written description) |
| 2022-09-21 | Rehearing en banc denied; cert petition planned (No. 22-671 filed late 2022) |
Caveat: settlement terms (generic entry dates) are confidential; cert-petition disposition and any post-2022 district court activity (e.g., vacatur mechanics, bond, fees motions) were not verified in the sources used here.
Plaintiff representatives
Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- Wilson Sonsini Goodrich & Rosati
- Steven W. Parmelee · lead counsel
- Michael T. Rosato · back-up counsel
- Jad A. Mills · back-up counsel
I'll research this case. Note first that IPR2017-00854 is an inter partes review before the PTAB, so there are no traditional "plaintiffs/defendants"—Apotex is the petitioner (challenger) and Novartis is the patent owner. I'll identify the counsel of record for Apotex (the petitioner side) as the analog to "plaintiffs."
I have strong primary sources already (the Power of Attorney, hearing transcript, and Board orders). Let me verify the full counsel list on the PTAB docket and check the underlying Hatch-Waxman district court case (where Apotex would be a defendant/counterclaimant), plus attorney backgrounds.
The core counsel list is confirmed from primary docket documents. Let me verify the lead/back-up designations via the USPTO PTACTS docket and get attorney background details.
Threshold note on posture
IPR2017-00854 is not a district-court patent infringement suit—it is an inter partes review before the PTAB. The metadata's "plaintiffs" (Apotex Inc., Apotex Corp.) are the petitioners (challengers of U.S. Patent No. 9,187,405), and Novartis AG is the patent owner. Below is the counsel of record for the Apotex side in the IPR, drawn from the PTAB record. (Separately, Novartis later filed Hatch-Waxman infringement suits in D. Del. against Apotex—e.g., Novartis Pharms. Corp. v. Apotex Inc., No. 18-cv-1038 (D. Del.)—but the case you've identified is the PTAB proceeding, so the IPR counsel of record is the operative answer.)
Counsel of record for Apotex (petitioner side) — all Wilson Sonsini Goodrich & Rosati
| Name | Role | Firm / Office | Note |
|---|---|---|---|
| Steven W. Parmelee (USPTO Reg. No. 31,990) | Lead counsel | Wilson Sonsini Goodrich & Rosati, 701 Fifth Avenue, Suite 5100, Seattle, WA 98104-7036 | Signatory of the Petition and Power of Attorney (Paper 1, Feb. 3, 2017); self-identified as "Lead Counsel for Petitioner Apotex" in correspondence to the Board (Ex. 3008, Mar. 9, 2018); argued/appeared at the June 4, 2018 oral hearing (Paper 108). Longtime WSGR IPR/patent-litigation partner; previously led Apotex's and other generics' challenges to Novartis's Gilenya composition patent (IPR2014-00784/IPR2015-00518). |
| Michael T. Rosato (Reg. No. 52,182) | Back-up counsel | Wilson Sonsini, Seattle (same address) | Listed as back-up counsel in the POA and on every Board order (Papers 16, 41); argued the expert-deposition scheduling dispute before the panel on Aug. 10, 2017 (Paper 16). WSGR PTAB litigator with extensive pharma IPR experience. |
| Jad A. Mills (Reg. No. 63,344) | Back-up counsel | Wilson Sonsini, Seattle (same address) | Listed as back-up counsel in the POA and Board orders; appeared on behalf of petitioner at the June 4, 2018 oral hearing (Paper 108). WSGR partner focused on PTAB and patent litigation. |
Sources: Power of Attorney, Paper 1 (PTAB Feb. 3, 2017); Petition for IPR, Paper 2 (Feb. 3, 2017); Order – Conduct of Proceeding, Paper 16 (Aug. 11, 2017); Order – Conduct of Proceeding, Paper 41 (Jan. 25, 2018); Hearing Transcript, Paper 108 (June 4, 2018); Ex. 3008 (Mar. 9, 2018).
Additional notes
- In-house signatory: The POA was executed on behalf of Apotex by Omar Jabri, Senior Patent Attorney (Apotex's in-house patent department), dated February 3, 2017. He signed the appointment but was not counsel of record before the Board.
- No local counsel / pro hac vice for Apotex: In IPRs, all practitioners appear before the PTAB; WSGR's Seattle team served as both lead and back-up counsel, and no pro hac vice admissions for Apotex's counsel appear in the docket (the only pro hac vice motion in the case was Novartis's, for Robert W. Trenchard of Gibson Dunn, Paper 6).
- Joined petitioners had separate counsel: IPR2017-01550 (Argentum) was joined as co-petitioner, represented by Crowell & Moring (T. "Trea" et al.), and IPR2017-01929 (Sun Pharma) was also joined; the email record (Ex. 3008) shows Kirkland & Ellis and Winston & Strawn counsel on the joined cases. Those are not Apotex's counsel, but they are why you may see other firm names on later docket entries after joinder.
- Attorney bio caveat: The role designations, addresses, registration numbers, and appearances above are all documented in the PTAB record cited. The one-line "experience" notes are based on the WSGR attorney's public reputation and their appearances in related Gilenya IPRs (e.g., IPR2014-00784, IPR2015-00518) reflected in the record; I did not locate a separate verified bio page in this search, so treat those as general context rather than docket-confirmed facts.
- Outcome for context: The Board issued its Final Written Decision (Paper 109, July 11, 2018) holding claims 1–6 not shown unpatentable; an IPR certificate issued February 10, 2020. Apotex's Federal Circuit appeal (No. 2018-2209) was dismissed after settlement.
Defendant representatives
Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- Gibson, Dunn & Crutcher
- Jane M. Love · lead counsel
- Robert W. Trenchard · back-up counsel
- Andrew P. Blythe · trial counsel
Threshold clarification
The matter in your metadata — IPR2017-00854, Apotex Inc. et al. v. Novartis AG — is a PTAB inter partes review, not a district court patent infringement case. The parties are Petitioner (Apotex Inc., Apotex Corp.) and Patent Owner (Novartis AG). There is no "defendant" in the docket sense; the party defending the '405 patent against Apotex's validity challenge is Novartis AG (with Novartis Pharmaceuticals Corporation designated the real party in interest after an August 16, 2017 assignment, per the PO's Updated Mandatory Notice, Paper 22). I therefore identify the counsel of record for the defending party, Novartis, in the IPR, and flag the related Delaware ANDA litigation where the defendant/plaintiff roles differ.
Counsel of record for Novartis (patent owner) in IPR2017-00854
Lead counsel — Jane M. Love, Ph.D.
- Role: Lead counsel for Patent Owner (Reg. No. 42,812), designated in the Patent Owner Mandatory Notice (Paper 4, Apr. 11, 2017) and Power of Attorney (Paper 5).
- Firm/office: Gibson, Dunn & Crutcher LLP, 200 Park Avenue, 47th Floor, New York, NY 10166 (jlove@gibsondunn.com).
- Notable experience: A Ph.D. biochemist and veteran life-sciences/PTAB litigator at Gibson Dunn; she argued and won the appeal for Novartis before the Federal Circuit in the related appeal from these IPRs, Argentum Pharms. LLC v. Novartis Pharms. Corp., 956 F.3d 1374 (Fed. Cir. 2020) (oral argument by Love; also represented by Trenchard), and she signed virtually every substantive Patent Owner filing in IPR2017-00854 (e.g., Joint Stipulation, Paper 58).
Back-up counsel — Robert W. Trenchard
- Role: Back-up counsel (pro hac vice), designated in the Mandatory Notice and Power of Attorney (Papers 4–5, Apr. 11, 2017).
- Firm/office: Gibson, Dunn & Crutcher LLP, 200 Park Avenue, 47th Floor, New York, NY 10166 (rtrenchard@gibsondunn.com).
- Notable experience: Gibson Dunn IP litigation partner; appeared with Love on the June 4, 2018 oral-hearing transcript and on the Federal Circuit appellee brief in Argentum, 956 F.3d 1374; also listed of counsel for Novartis in the parallel Delaware ANDA actions.
Additional Gibson Dunn attorney appearing — Andrew P. Blythe
- Role: Appeared at the PTAB oral hearing on Novartis's behalf: "I'm Jane Love, and with me is Robert Trenchard and Andrew Blythe. We are from Gibson, Dunn & Crutcher representing Novartis" (Hearing Transcript, Paper 108, June 4, 2018).
- Firm/office: Gibson, Dunn & Crutcher LLP, 333 South Grand Avenue, Los Angeles, CA 90071 (per the D. Del. stipulation, 18-cv-1043-LPS Doc. 237).
- Note: He was not designated in the PTAB mandatory notices as lead/back-up counsel, but was part of the trial team; he is also listed of counsel for Novartis in the related ANDA litigation.
In-house counsel: None designated as counsel of record before the PTAB. The Power of Attorney (Paper 5) was executed on behalf of Novartis AG by signatory Gregory Ferraro (and a second signatory for Novartis Pharmaceuticals Corporation), but no Novartis in-house attorney appears as counsel of record on the PTAB docket.
Related district court context (if "infringement case" is what you meant)
The IPR's final written decision (Paper 109, July 11, 2018) upholding claims 1–6 prompted Novartis to sue generic companies in the District of Delaware on the '405 patent, including Novartis Pharmaceuticals Corp. v. Apotex Inc. et al., C.A. No. 18-1038-LPS (consolidated with 18-1043-LPS, etc.). There, Novartis is the plaintiff and Apotex is the defendant. Counsel of record per the parties' stay stipulation (D. Del. 18-1043-LPS Doc. 237):
- Novartis (plaintiff): of counsel — Jane M. Love, Robert Trenchard, Paul E. Torchia (Gibson Dunn, New York), Andrew P. Blythe (Gibson Dunn, Los Angeles); local counsel — McCarter & English (Daniel M. Silver, Michael P. Kelly, Benjamin A. Smyth, Wilmington, DE).
- Apotex (defendant): of counsel — Tung-On Kong, Dennis Gregory, Mary Procaccio-Flowers, Diyang Liu (Wilson Sonsini Goodrich & Rosati, various offices); local counsel — Potter Anderson & Corroon (David E. Moore, Bindu A. Palapura, Wilmington, DE).
Sources
- PO Mandatory Notice, IPR2017-00854, Paper 4 (Apr. 11, 2017); PO Power of Attorney, Paper 5 — designation of Love (lead) and Trenchard (back-up).
- PO Updated Mandatory Notice, Paper 22 (Sept. 5, 2017) — real party in interest changed to Novartis Pharmaceuticals Corp.; Love remains lead counsel.
- Oral Hearing Transcript, Paper 108 (June 4, 2018) — Love, Trenchard, and Blythe appearing for Novartis.
- Joint Stipulation to Modify Scheduling Order, Paper 58 (Mar. 2, 2018) — Love signing as "Lead Counsel for Patent Owners."
- Argentum Pharms. LLC v. Novartis Pharms. Corp., 956 F.3d 1374 (Fed. Cir. 2020) — Love argued for Novartis; Trenchard also of record.
- D. Del. 18-cv-1043-LPS, Doc. 237 (stay stipulation, Nov. 5, 2018) — Gibson Dunn/McCarter & English for Novartis; Wilson Sonsini/Potter Anderson for Apotex.
If you intended a different "patent infringement case" (e.g., a specific district court docket number or the HEC/Accord litigation that reached the Federal Circuit in Novartis Pharms. Corp. v. Accord Healthcare, No. 2021-1070), let me know and I can pull that docket's counsel separately.