Litigation

Helsinn Healthcare S.A. et al. v. Actavis LLC

dismissed

2:16-cv-01683

Filed
2016-03-24
Terminated
2019-05-15

Patents at issue (2)

9066980
7947724

Defendants (1)

Summary

ANDA action asserting U.S. 7,947,724 and U.S. 9,066,980. Stayed pending resolution of Civil Action No. 14-4274; ended by stipulated dismissal without prejudice after Actavis withdrew its NDA.

Case overview & background

Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.

I'll research this case carefully before drafting.

Key legal developments & outcome

Major rulings, motions, claim construction, settlements, and the present posture or final disposition.

I'll research this case across PACER dockets, opinions, and PTAB records.

Bottom line

This was a short-lived, single-defendant Hatch‑Waxman track that never reached claim construction, summary

Plaintiff representatives

Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

I'll research the docket and counsel appearances for this case.

Let me pull the docket and complaint details directly.

Plaintiffs' counsel of record — Helsinn Healthcare S.A. et al. v. Actavis LLC, No. 2:16-cv-01683 (SRC)(CLW) (D.N.J.)

Sourcing note. The identity of plaintiffs' counsel here is unusually clean because the case never went to a merits ruling — it was filed 3/24/2016, stayed, and dismissed by stipulation on 5/15/2019 (D.E. 104, 105, 106). Counsel of record is therefore established primarily from the signature blocks of the complaint (D.E. 1) and the appearances recorded on the docket, as mirrored by CourtListener, Justia and Plainsite (PACER itself is paywalled; no filing in this case was sealed as to counsel identity). Docket: https://www.courtlistener.com/docket/[6127739](/patent/6127739)/helsinn-healthcare-sa-v-actavis-llc/ ; https://dockets.justia.com/docket/new-jersey/njdce/3:2016cv01683/[331270](/patent/331270) ; complaint text: https://www.courtlistener.com/docket/6127739/1/helsinn-healthcare-sa-v-actavis-llc/

Structural point. Plaintiffs used the same three-firm structure Helsinn used across its Aloxi®/palonosetron campaign (the Teva/Dr. Reddy's/Sandoz case, No. 11-3962, and the later Sagent, Zydus/Cadila actions): Paul Hastings as national lead for Helsinn; Loeb & Loeb for co-plaintiff Roche Palo Alto; Saul Ewing as New Jersey local counsel for both plaintiffs.

1. Local counsel — Saul Ewing LLP, Newark, NJ

One Riverfront Plaza, Suite 1520, Newark, NJ 07102-5426, (973) 286-6700. Listed on D.E. 1 as "Attorneys for Plaintiffs Helsinn Healthcare S.A. and Roche Palo Alto LLC."

Name Role Note
Charles M. Lizza Local counsel of record; the attorney who actually signed and e-filed the complaint (s/ Charles M. Lizza) and who filed the case-closing letter at D.E. 105 (5/14/2019) Saul Ewing partner and one of the most frequent D.N.J. local counsel in Hatch-Waxman/ANDA matters; also Helsinn's local counsel in No. 11-3962 (see, e.g., D.E. 178 there).
William C. Baton Local counsel of record Saul Ewing partner, ANDA/pharma patent litigator; appears in the Helsinn palonosetron litigations alongside Lizza.
Sarah Ann Sullivan Local counsel of record (associate-level appearance on D.E. 1) Saul Ewing; listed in the Justia docket's representation list for plaintiffs.
Sheila Raftery Wiggins Local counsel of record Saul Ewing; listed in the Justia docket's representation list for plaintiffs.

2. National/lead counsel for Helsinn — Paul Hastings LLP, New York, NY

75 East 55th Street, New York, NY 10022, (212) 318-6000. Listed on D.E. 1 as "Attorneys for Plaintiff Helsinn Healthcare S.A."

Name Role Note
Joseph M. O'Malley, Jr. Lead trial/lead national counsel for Helsinn Paul Hastings partner who led Helsinn's palonosetron program litigation, including the consolidated No. 11-3962/13-5815 case tried before Judge Cooper and the Federal Circuit appeal in Helsinn v. Teva (16-1284/16-1787), aff'd 586 U.S. ___ (2019) on the AIA on-sale bar — the very decision that drove the stay in this case.
Eric W. Dittmann National counsel (partner) Paul Hastings IP litigation partner; member of the Helsinn trial team in No. 11-3962.
Young J. Park National counsel Paul Hastings; member of the Helsinn palonosetron team.
Isaac S. Ashkenazi National counsel Paul Hastings; Helsinn team.
Gary Ji National counsel Paul Hastings; Helsinn team.
Angela C. Ni National counsel (associate) Paul Hastings; in No. 11-3962 she executed declarations as "an associate at the law firm of Paul Hastings LLP … counsel for Plaintiff Helsinn Healthcare S.A." (D.E. 178 in 11-3962).
Dana Weir National counsel Paul Hastings; Helsinn team.

3. Counsel for co-plaintiff Roche Palo Alto LLC — Loeb & Loeb LLP, New York, NY

345 Park Avenue, New York, NY 10154, (212) 407-4127.

Name Role Note
Mark E. Waddell Counsel for Roche Palo Alto LLC (Roche was a co-owner/co-plaintiff on the '724 and '980 patents) Loeb & Loeb partner; appears in the separate Roche/caption block on D.E. 1 (the complaint's signature pages separately designate Saul Ewing for "Helsinn … and Roche Palo Alto LLC," Paul Hastings for "Helsinn Healthcare S.A.," and Waddell's Loeb & Loeb block). The precise "for Roche" designation is partially truncated in the text I could retrieve, so treat the role attribution as a strong inference rather than a verbatim quote.

Explicit gaps / cautions

  • Pro hac vice admissions: Paul Hastings and Loeb & Loeb attorneys practicing in D.N.J. would have been admitted PHV, but I could not verify individual PHV order entry numbers from the free mirrors. The docket does contain a PHV application by Actavis, and Plainsite reports PHV counsel Jovial Wong, Samuel S. Park, David W. Creasey and Alyssa E. Ramirez added to the NEF list (https://www.plainsite.law/courts/new-jersey-district-court/helsinn-healthcare-sa-v-actavis-llc/361n6r1g2/). Those four are Winston & Strawn lawyers — the firm that represented Teva against Helsinn in No. 11-3962 — so they are almost certainly defendant-side (Teva acquired Actavis's generics business in 2016), not plaintiffs' counsel. I flag this because a careless reading of the docket feed could misattribute them to plaintiffs.
  • Defendant side, for contrast (not responsive): Actavis LLC was represented by James S. Richter and Keiyana B. Fordham (Dughi, Hewit & Domalewski, Cranford, NJ) as local counsel, plus PHV counsel.
  • No in-house counsel for Helsinn or Roche appears of record in this docket.
  • I did not find any Rule 83.1/PHV or substitution entry changing plaintiffs' counsel before dismissal; Lizza signed the closing letter (D.E. 105) and the dismissal (D.E. 106), consistent with Saul Ewing remaining local counsel through the end.
  • Current firm/office affiliations above reflect the record at the time of filing; several of these lawyers have since moved (e.g., the Paul Hastings and Saul Ewing rosters have changed since 2016–2019). I have not asserted current titles I could not verify.

Defendant representatives

Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

I'll research the docket and counsel appearances for this case.

Let me pull the docket detail and research each attorney's firm.

Counsel of Record for Actavis LLC — Helsinn Healthcare S.A. v. Actavis LLC, No. 2:16-cv-01683 (D.N.J.)

Actavis LLC was represented by a two-layer defense team: Duane Morris LLP (New Jersey local counsel + Boston PHV life-sciences partners) at the outset, and later a Winston & Strawn LLP patent-litigation team admitted pro hac vice alongside substituted New Jersey counsel. Below is what the docket supports, with verification flags where I could not confirm a firm affiliation.

1. Duane Morris LLP team (initial appearance, 2016)

Attorney Role Firm / Office Notes
Sheila Raftery Wiggins Local counsel of record (Notice of Appearance for Actavis LLC; later terminated by substitution of attorney) Duane Morris LLP, One Riverfront Plaza, 1037 Raymond Blvd., Suite 1800, Newark, NJ Career ANDA/Hatch-Waxman local counsel in D.N.J.; e.g., NJ local counsel for Wockhardt in Jazz Pharms. v. Amneal (2:13-cv-00391) and for Gavis in Helsinn v. Gavis Pharma (3:15-cv-01228) — same palonosetron/Aloxi® patent family.
Vincent L. Capuano Of counsel / PHV — defense-side life sciences partner (Consent Motion for Leave to Appear Pro Hac Vice, D.I. 14; granted 6/1/2016 by Mag. J. Douglas E. Arpert) Duane Morris LLP, Boston office IP partner focused on life sciences, generics/biosimilars and PTAB work; previously appeared PHV for Actavis in Millennium Pharms. v. Actavis (D. Del. 1:12-cv-01750) alongside Fitzpatrick. Named an LMG Life Sciences "Life Sciences Star."
Anthony J. Fitzpatrick Of counsel / PHV — same D.I. 14 application, granted 6/1/2016 Duane Morris LLP, Boston office Co-chair of Duane Morris' Patent Litigation division; first-chair federal/Federal Circuit and PTAB trial experience in Hatch-Waxman and biologics disputes; also appeared for Actavis in Millennium v. Actavis.

Docket support: CourtListener docket for 2:16-cv-01683 (entries for Wiggins' Notice of Appearance; Consent Motion for PHV of Capuano and Fitzpatrick; Order of 6/1/2016; "Substitution of Attorney — Attorney SHEILA RAFTERY WIGGINS terminated. Attorney JAMES S. RICHTER … added"), https://www.courtlistener.com/docket/6127739/helsinn-healthcare-sa-v-actavis-llc/; Justia docket listing Wiggins as defendant's counsel, https://dockets.justia.com/docket/new-jersey/njdce/3:2016cv01683/331270.

2. Winston & Strawn LLP team (later PHV admissions)

Attorney Role Firm / Office Notes
Jovial Wong PHV — appears to have been the primary/lead defense attorney on the later team (admitted under the same D.I. 38 application; Actavis/Teva's Helsinn-side counsel) Winston & Strawn LLP, Washington, D.C. (1901 L St. N.W. / 1700 K St. N.W.) One of the most active ANDA litigators in the country (Patexia top-10/top-15 ANDA rankings; IAM Patent 1000; Legal 500). His Winston bio expressly lists palonosetron among the products he has litigated — i.e., he was Teva/Actavis' counsel in the parallel Helsinn palonosetron matters.
Samuel S. Park PHV — Winston patent litigator, frequent PTAB lead counsel (D.I. 38) Winston & Strawn LLP, Chicago (312-558-5700) Registered patent attorney; lead counsel on IPR petitions for generic/pharma clients (e.g., petitions naming him as lead counsel with Wong as backup).
David W. Creasey PHV (named in the same D.I. 38 application for Actavis) Believed Winston & Strawn LLP — not independently confirmed Listed in the Actavis PHV application ordered by the Court; I could not verify his firm/office from a firm page or opinion within this research.
Alyssa E. Ramirez PHV (named in the same D.I. 38 application for Actavis) Believed Winston & Strawn LLP — not independently confirmed Same caveat as Creasey; docket confirms admission and ECF noticing only.

Docket support: "ORDER Granting 38 Application for leave to appear Pro Hac Vice as to Jovial Wong, Samuel S. Park, David W. Creasey, and Alyssa E. Ramirez"; corresponding notices of request for NEFs (CourtListener docket, supra). Wong/Park's Winston affiliation is confirmed independently (firm bios and PTAB powers of attorney, e.g., https://www.winston.com/en/professionals/wong-jovial).

3. Substituted New Jersey counsel (2017)

  • James S. Richter — substituted in as counsel of record for Actavis LLC when Duane Morris' Sheila Raftery Wiggins was terminated (docket: "Substitution of Attorney … JAMES S. RICHTER for ACTAVIS LLC … added"). He is the NJ attorney of record for defendant after that substitution, likely serving as local counsel to the Winston & Strawn team. Firm/office not verified — I did not locate a reliable firm page or opinion placing him, so I am not attributing a firm.
  • Keiyana B. Fordham — filed a Notice of Appearance on behalf of Actavis LLC in this action (per the Plainsite docket mirror of the D.N.J. docket, https://www.plainsite.law/courts/new-jersey-district-court/helsinn-healthcare-sa-v-actavis-llc/361n6r1g2/). Firm and role unverified; no firm page, opinion, or PHV order located in this research.

4. In-house counsel

No in-house Actavis/Teva attorney appears on the docket as counsel of record; the defense was handled entirely through outside counsel. (Actavis LLC was, by this period, part of the Teva group — which explains the overlap between the Duane Morris and Winston & Strawn teams here and the Teva-side teams in the related Helsinn palonosetron litigation.)

Verification notes / gaps

  • Well sourced: Wiggins (Duane Morris, Newark), Capuano and Fitzpatrick (Duane Morris, Boston, PHV granted 6/1/2016), Wong and Park (Winston & Strawn, PHV under D.I. 38), Richter (substituted NJ counsel of record), Fordham (notice of appearance).
  • Not confirmed: firms/offices for Creasey, Ramirez, Richter, and Fordham; whether Wong was formally designated "lead" (the docket reflects PHV admission, not a formal lead-counsel designation, and the case was stayed and then dismissed without prejudice, so no trial-lead record exists).
  • No sealing issue affected the counsel records here — appearances and PHV orders are public; the substantive filings were largely stayed pending the related action (Civil Action No. 14-4274), and the case ended by stipulated dismissal without prejudice on May 15, 2019 after Actavis withdrew its NDA.