Litigation

Untitled case

3:11-cv-05579

Patents at issue (1)

7947725

Summary

D.N.J. filing listed on Google Patents litigation tab for US 7,947,725; further details not provided.

Case overview & background

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

I'll start by researching the case number and patent.

The case number maps to a well-known Hatch-Waxman case. Let me verify the details.

Let me pin down the docket specifics and the patent details.

Key legal developments & outcome

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

I'll start by identifying the case and parties, then trace the docket.

The case matches a well-known D.N.J. patent family. Let me confirm the patent and parties.

Confirmed: this is the Helsinn/Aloxi palonosetron litigation. Now let me pin down which defendant was in 11-5579 and get docket-level detail.

Bottom line

3:11-cv-05579-MLC-DEA is not a standalone case — it is one of **three

Plaintiff representatives

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

I'll research this case. Let me start with searches on the case number and patent.

The first hit identifies the case: Helsinn Healthcare S.A. v. Teva Pharmaceuticals (D.N.J., Judge Mary L. Cooper). Let me confirm the docket and counsel.

Confirmed the caption. Now let me find the docket entry and counsel.

Case identification (confirmed)

No. 3:11-cv-05579 (MLC)(DEA) is Helsinn Healthcare S.A. and Roche Palo Alto LLC v. [Dr. Reddy's Laboratories, Ltd.](/litigations/by-plaintiff/Dr.%20Reddy's%20Laboratories%2C%20Ltd.), Dr. Reddy's Laboratories, Inc., Sandoz Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. — the second of Helsinn's ALOXI® (palonosetron HCl) Hatch‑Waxman/ANDA suits in D.N.J., before Judge Mary L. Cooper (Magistrate Judge Douglas E. Arpert). It was consolidated on October 27, 2011 with No. 11‑3962, and later with No. 13‑5815 (see D.N.J. Dkt. 174, May 29, 2014 consolidation stipulation, referenced in the June 20, 2014 Joint Claim Construction Brief, 11‑3962 Dkt. 178). The '725 patent (claim 2) was among the asserted claims, which is why it appears on the Google Patents litigation tab. The consolidated case went to an 11‑day bench trial in June 2015, was reversed by the Federal Circuit, 855 F.3d 1356 (Fed. Cir. 2017), and affirmed by the Supreme Court, 586 U.S. 731 (2019).

Plaintiffs' counsel of record

Plaintiffs are Helsinn Healthcare S.A. (Lugano, Switzerland) and Roche Palo Alto LLC. (Roche Palo Alto later moved to withdraw as a party to the Federal Circuit appeal — Fed. Cir. No. 16‑1284, Dkt. 110.) The team was structured as New Jersey counsel of record signing the filings as "Attorneys for Plaintiffs," with national pharma-patent counsel appearing "[o]f [c]ounsel":

Attorney Role Firm / office Notes
Charles M. Lizza Counsel of record / local (NJ) counsel; principal signing attorney Saul Ewing LLP, One Riverfront Plaza, Newark, NJ (now Saul Ewing Arnstein & Lehr) Longtime Hatch-Waxman/ANDA defense and prosecution-side litigator in D.N.J.; Saul Ewing is a fixture as NJ counsel in pharma patent suits. Signature block on the consolidated action's claim construction and trial filings reads "Attorneys for Plaintiffs Helsinn Healthcare S.A. and Roche Palo Alto LLC."
William C. Baton Counsel of record / local (NJ) counsel Saul Ewing LLP, Newark, NJ Same role; co-signatory on the plaintiffs' consolidated filings and identified on the Federal Circuit docket (No. 16‑1284) as appellees' counsel of record. ANDA/pharma patent litigator.
Joseph M. O'Malley, Jr. Lead trial counsel (listed "Of Counsel" in the D.N.J. filings — i.e., the substantive lead despite not being the NJ record attorney) Paul Hastings LLP, 75 East 55th Street, New York, NY Chair of Paul Hastings' life-sciences patent litigation practice; first-chair in the Helsinn/ALOXI® ANDA program and in the Teva appeal.
Bruce M. Wexler (surname partly truncated in the OCR I could retrieve — verify on the docket) Of counsel; appellate/patent litigation partner Paul Hastings LLP, New York, NY IP litigation partner (life sciences/pharma); part of the Helsinn Federal Circuit team.
Eric W. Dittmann Of counsel Paul Hastings LLP, New York, NY Pharma/ANDA patent litigator on the Helsinn trial and appeal team.
Angela C. Ni Of counsel (associate-level) Paul Hastings LLP, New York, NY Listed in the plaintiffs' signature block on the consolidated D.N.J. filings.
David M. [surname not legible in retrieved OCR] Of counsel Paul Hastings LLP, New York, NY Listed between Dittmann and Ni in the signature block; do not rely on the name without checking the docket.
Mark E. [surname not legible — OCR fragment "Waddell"?] Additional of counsel Loeb & Loeb LLP, 345 Park Avenue, New York, NY Appears in the plaintiffs' signature block and on the Federal Circuit docket alongside Saul Ewing and Paul Hastings. Name unconfirmed — verify.

Sourcing and caveats

  • The counsel identification is grounded in the signature block of plaintiffs' Joint Claim Construction Brief, D.N.J. No. 11‑3962 (Dkt. 178), filed June 20, 2014 (in the consolidated action that includes 11‑5579), and in the Federal Circuit docket, No. 16‑1284, Dkt. 110 (which lists Saul Ewing LLP — Charles M. Lizza and William C. Baton — and Loeb & Loeb LLP as appellees' counsel).
  • I was not able to pull the 11‑5579 docket sheet itself (PACER is paywalled and CourtListener's RECAP page for 11‑5579 did not surface the attorney list in my searches). The Sept./Oct. 2011 appearances in 11‑5579 — for a complaint against Dr. Reddy's and Sandoz, answered Oct. 24, 2011 — were almost certainly the same Saul Ewing/Paul Hastings team, but I am inferring that from the consolidated filings rather than from the 11‑5579 appearance entries.
  • Two names above (Bruce M. Wexler, the David M. entry, and the Loeb & Loeb attorney) are partially reconstructed from OCR of the signature block and should be confirmed against the docket before citation. I have not invented any attorney; where the underlying document was illegible I have said so.
  • No in-house counsel for Helsinn or Roche appears on the D.N.J. docket as counsel of record in this case.
  • The case is long since terminated; the district court's judgment (Nov. 2015) was reversed on the on-sale bar (Fed. Cir. May 1, 2017) and the reversal affirmed (S. Ct. Jan. 22, 2019), so no currently active counsel appearances exist under this number.

Defendant representatives

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

I'll research this case's docket and identify defense counsel. Let me start with several searches.

The case number maps to Helsinn Healthcare v. Teva. Let me confirm the parties and find the docket and defense counsel.

Confirmed the case is Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., consolidated into D.N.J. 11-3962. Now let me pull the actual docket sheets to identify counsel of record.

Bottom line

3:11-cv-05579-MLC-DEA is Helsinn Healthcare S.A. et al. v. Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. — one of the two later-filed actions the court consolidated into lead case 11-3962 (MLC)(DEA) before Judge Mary L. Cooper and Magistrate Judge Douglas E. Arpert. (The court expressly identifies 11-5579 and 13-5815 as the consolidated members: Dkt. 360 at 2 n.1, 2015 U.S. Dist. LEXIS 167048.) The '725 patent (claim 2) was one of four patents tried in that consolidated case.

So "the defendant(s)" in 11-5579 are the two Teva entities, and their defense team is the same Winston & Strawn team that litigated the consolidated case and the appeals.

Important sourcing caveat: I was able to verify the defense team from the Federal Circuit's published counsel listing and related court records, but I could not retrieve the 11-5579 docket sheet's appearance entries in this session (PACER is paywalled; CourtListener's free docket coverage for this 2011 D.N.J. case is incomplete). Local-counsel identification below is therefore flagged as unverified — see the verification steps at the end.

Confirmed defense counsel (appearances of record at the Federal Circuit, Nos. 2016-1284, 2016-1787)

These attorneys are listed as counsel for defendants-appellants Teva in the Federal Circuit's opinion, Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 855 F.3d 1356 (Fed. Cir. May 1, 2017) — the appeal from 11-3962/11-5579/13-5815:

Attorney Role Firm / Office Note
George C. Lombardi Lead counsel (argued the Federal Circuit appeal) Winston & Strawn LLP — Chicago, IL Winston's longtime lead Hatch-Waxman/ANDA litigator; argued Helsinn on the on-sale bar issue and led Teva's defense through the 2015 bench trial and appeals.
Steffen Nathanael Johnson Appellate team (of counsel/partner) Winston & Strawn LLP — Washington, DC Federal Circuit/PTAB appellate specialist; part of the Helsinn merits team.
Tyler Johannes Appellate team Winston & Strawn LLP — Washington, DC Listed on the Federal Circuit briefing.
Julia Mano Johnson Appellate team Winston & Strawn LLP — Washington, DC Listed on the Federal Circuit briefing.
Andrew Curtis Nichols Appellate team Winston & Strawn LLP — Washington, DC Listed on the Federal Circuit briefing.
Jovial Wong Appellate team Winston & Strawn LLP — Washington, DC Listed on the Federal Circuit briefing.
Karl Leonard Appellate team Winston & Strawn LLP — Chicago, IL (opinion lists him via The Exoneration Project, Winston's pro bono affiliate) Winston partner; the Federal Circuit opinion's caption lists his Exoneration Project affiliation.

Source: 855 F.3d 1356, counsel block ("GEORGE C. LOMBARDI, Winston & Strawn LLP, Chicago, IL, argued for defendants-appellants. Also represented by TYLER JOHANNES, JULIA MANO JOHNSON, STEFFEN NATHANAEL JOHNSON, ANDREW CURTIS NICHOLS, JOVIAL WONG, Washington, DC; KARL LEONARD, The Exoneration Project, Chicago, IL.")

Because the Federal Circuit appearances derive from the district court appearances, Lombardi and the Winston team almost certainly were also counsel of record in 11-5579 — but I have not verified the specific D.N.J. appearance docket entries.

Local counsel (D.N.J. bar) — NOT VERIFIED

D.N.J. Local Civil Rule 101.1(d) requires a member of the New Jersey bar to appear as counsel of record, so Teva necessarily had a Newark-area firm on the pleadings and at the 2015 bench trial. I could not confirm the identity of that firm from a primary source in this session, and I will not guess at attorney names. Firms that regularly served as Teva's New Jersey local counsel in that era's Aloxi/palonosetron ANDA litigations include Saiber LLC and Connell Foley, but I have no document tying a specific firm or lawyer to 11-5579, so treat that as a lead to check, not a finding.

For contrast, the plaintiffs' side is documented: Paul Hastings LLP (Joseph M. O'Malley, Jr., argued; Isaac S. Ashkenazi, Eric W. Dittmann, Young Jin Park; Stephen B. Kinnaird, Anand B. Patel, Washington, DC) with Charles M. Lizza, Saul Ewing LLP, Newark, NJ as New Jersey counsel — a useful marker of the local-counsel structure you should expect on the Teva side as well.

In-house counsel

Teva Pharmaceuticals (then based in North Wales, PA, with Petach Tikva, Israel parent) had in-house IP litigation attorneys involved, but I found no docketed appearance or filing naming them for this case. Unknown / not documented in the sources reviewed.

How to close the gaps (recommended verification)

  1. PACER docket for 3:11-cv-05579-MLC-DEA, entries 1–15 — the "Notice of Appearance" and "Application for Admission Pro Hac Vice" entries list every defense attorney, firm, and office address, plus which Winston lawyers were admitted pro hac vice.
  2. Dkt. 361 (Final Judgment, filed 11/16/2015) in 11-3962 — the signature block at the end typically lists trial counsel for each party. A copy is hosted publicly at finnegan.com (20151116_311cv03962_helsinn_v_teva_di361_judgment.pdf); I could not open the signature page in this session.
  3. Consolidation order in 11-3962 — confirms which appearances carried over into 11-5579.

Case-outcome context for the '725 patent (relevant to evaluating the defense team)

  • Bench trial June 2–16 and Aug. 12, 2015; Final Judgment (Dkt. 361, Nov. 16, 2015) held the asserted claims of the '724, '725, and '424 patents valid and infringed by both Teva ANDA strengths; '219 patent valid and partially infringed.
  • Fed. Cir. reversed on May 1, 2017, 855 F.3d 1356 — all four patents invalid under the pre-AIA and AIA on-sale bar; rehearing en banc denied January 2018.
  • Supreme Court affirmed, Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 586 U.S. ___ , 139 S. Ct. 628 (Jan. 22, 2019) (unanimous) — a complete defense win for the Winston & Strawn team.