Helsinn-related family appeal

I'll start by pinning down what Federal Circuit case 17-1746 actually is, since the metadata is thin.

Now let me pin down the specific docket number 17-1746 and how it relates to the main Helsinn appeal.

Case overview — Helsinn v. Teva (Fed. Cir., palonosetron / Aloxi®)

A note on the docket number first. The metadata I was given labels this as "Helsinn-related family appeal," Fed. Cir. No. 17-1746, patent 7,947,724. In my searches I could not retrieve a docket sheet, opinion, or news item keyed to 17-1746 specifically, so I cannot confirm what that particular docket number covers; Google Patents' litigation tables sometimes carry family/companion entries that do not map one-to-one to a published opinion. What is thoroughly documented — and what any 17-1746 entry in this family must relate to — is the Helsinn v. Teva appeal decided as Nos. 2016-1284, 2016-1787, 855 F.3d 1356 (Fed. Cir. May 1, 2017), which invalidated the '724 patent along with three siblings and went up to the Supreme Court. The overview below describes that dispute and flags where the docket-number identification remains unsourced.

Parties and what they do. Plaintiff-appellee Helsinn Healthcare S.A. is a privately held Swiss pharmaceutical group headquartered in Lugano (founded 1976), which in-licenses, develops and registers oncology-supportive-care compounds and out-licenses them to marketing partners; by the time of the appeal, Reuters reported that roughly 90% of Helsinn's annual revenue came from Aloxi® (palonosetron hydrochloride) injection, the product at issue. Co-plaintiff Roche Palo Alto LLC (successor to Syntex) was the assignee/licensor of the underlying palonosetron patent estate. Defendants were generic filers Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. (the sole remaining defendant by trial), with Dr. Reddy's Laboratories and Sandoz Inc. originally consolidated in and dismissed by consent/stipulation in Dec. 2014 and Oct. 2015 respectively. This is a classic operating-company vs. generic-company Hatch-Waxman conflict — no NPE/PAE or university plaintiff is involved, and Helsinn commercializes (through U.S. partner Eisai, which acquired original licensee MGI Pharma) rather than merely licensing.

Accused product and patents. The accused conduct is Teva's submission of a consolidated ANDA under 35 U.S.C. § 271(e)(2)(A) with Paragraph IV certifications, seeking approval for generic palonosetron HCl IV solutions at 0.25 mg/5 mL (CINV indication) and 0.075 mg/1.5 mL (PONV indication) before the patents expired — i.e., a generic version of Aloxi. The asserted claims were claims 2 and 9 of the '724 patent, claim 2 of the '725 patent, claim 6 of the '424 patent, and claims 1, 2 and 6 of the '219 patent. One-line sketches:

All four claim priority to a Jan. 30, 2003 provisional, making the

I'll research this docket across Federal Circuit, district court, and PTAB sources.

I'll research the counsel of record, starting with the docket and opinions for this appeal.

Let me pin down the docket number and the counsel roster on the briefs.

Counsel of record for the plaintiff(s) — Helsinn Healthcare S.A. (and Roche Palo Alto LLC)

Threshold caveat, carried forward from the overview. I again could not retrieve a docket sheet, opinion, or press item keyed to Fed. Cir. No. 17-1746 itself (a search for "2017-1746" returned nothing usable before my research budget ran out). The attorney roster below is therefore drawn from the documented Helsinn appeals in this family — Nos. 2016-1284, -1787, 855 F.3d 1356 (Fed. Cir. May 1, 2017) — and from the underlying D.N.J. record, on the assumption that any 17-1746 entry in this family would be staffed by the same Paul Hastings team. If 17-1746 is in fact a different Helsinn-family appeal (e.g., a later appeal involving the '094 patent or a preliminary-injunction ruling), the roster could differ; that must be confirmed on PACER.

Plaintiffs' appellate team — Paul Hastings LLP (New York)

The certificate of service in the en banc amicus filings in Nos. 2016-1284, -1787 lists "principal counsel for the parties," and the appellee-side name given is Joseph M. O'Malley, Jr. of Paul Hastings; Reuters' summary of the decision likewise lists "Appellee: Joseph M. O'Malley Jr., Paul Hastings LLP, New York, NY."

Sources: BIO amicus certificate of service, Nos. 2016-1284/-1787 (July 14, 2017), http://patentlyo.com/media/2017/09/BIO.pdf; Paul Hastings signature blocks reproduced in D.N.J. filings, e.g. https://storage.courtlistener.com/recap/gov.uscourts.njd.[327971](/patent/327971).25.0.pdf and https://patentdocs.typepad.com/files/helsinn-v-zydus.pdf; PTAB petition papers listing the same Paul Hastings group, https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1462972](/patent/1462972)/download-documents.

Note on the two addresses. The Paul Hastings New York office is given as 75 East 55th Street in the 2013–2015 papers and as 200 Park Avenue in 2016–2018 papers — that is an office relocation, not two firms. Both appear in Helsinn filings.

Local counsel (district court)

The D.N.J. filings in the related Helsinn actions carry a separate local-counsel signature block; the CourtListener copy of the Roche dismissal stipulation in No. 15-8663 (MLC)(DEA) is headed with the name Charles M. Lizza (Newark, N.J.). I could not verify his firm affiliation from the retrieved documents (my recollection is Saul Ewing, formerly Saiber LLC, but I have no source in hand — treat as unverified). Local counsel would normally appear in the Federal Circuit as well only if they entered an appearance there, which I could not confirm.

In-house counsel

No Helsinn or Roche in-house attorney is identified as counsel of record in any document I retrieved. Helsinn's public face in this litigation is CEO Riccardo Braglia (a business, not legal, officer) — not counsel of record. I found no sourced basis for naming any Helsinn legal-department attorney; I am not going to guess one.

Roche Palo Alto LLC

Roche Palo Alto was a named plaintiff-appellee on the appeal (the principal brief is captioned "Plaintiffs-Appellees Helsinn Healthcare S.A. & Roche Palo Alto LLC," 2016 WL 1698099), and it was represented by the same Paul Hastings team; it was dismissed from the parallel D.N.J. action in July 2016 by stipulation, with Helsinn expressly entitled to continue Roche's claims.

Supreme Court phase (for completeness — flag as unverified)

Before the Supreme Court in No. 17-1229 Helsinn's merits briefing was reportedly led by Supreme Court specialty counsel in addition to the Paul Hastings team. I did not retrieve the 17-1229 docket or briefs in these searches, so I am not naming that attorney; anyone needing it should pull the 17-1229 docket and the August 23, 2018 merits brief.

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What remains unsourced / recommended verification

1. The 17-1746 docket itself. Pull the Fed. Cir. docket and the "Attorney(s) of Record" / "Notice of Appearance" entries on PACER (or CourtListener RECAP) to confirm which Paul Hastings attorneys entered appearances in that docket and whether local counsel or additional appellate counsel appeared.
2. The plaintiffs' principal brief in 17-1746 — the cover page and signature block are the authoritative counsel list for that appeal.
3. Charles M. Lizza's firm — confirm from the D.N.J. ECF appearance form or a firm website.
4. Whether any Paul Hastings attorney has since moved firms — the roster above reflects the 2013–2018 filings; current affiliation should be checked on the firm site before relying on it for a present-day contact.

I have not invented any attorney, firm, or filing; every name above comes from a retrieved docket document, brief certificate of service, or contemporaneous report, with the three exceptions expressly flagged (Lizza's firm, any in-house lawyer, and Supreme Court merits counsel).

I'll research the docket and counsel for Fed. Cir. No. 17-1746.

Let me dig into whether 17-1746 corresponds to the DRL appeal, and search PACER-adjacent sources.

Let me check CourtListener's Federal Circuit docket records directly.

Counsel of record — bottom line first

I could not verify that Fed. Cir. No. 17-1746 is a case with its own retrievable docket, opinion, or briefing record. Searches across Google, CourtListener's RECAP index, firm client alerts, Law360/Reuters-derived summaries and the secondary literature on the Helsinn litigation returned nothing keyed to the number 17-1746. As flagged in the earlier overview section, Google Patents' litigation tables frequently carry family/companion rows that do not map one-to-one onto a published Federal Circuit appeal. I am therefore not going to name attorneys "for 17-1746" as if I had read that docket sheet. What follows separates (a) counsel I can source, in the Helsinn appellate proceedings that do exist, from (b) a reasoned but explicitly unverified hypothesis about what 17-1746 is, and (c) the verification steps needed to close the gap.

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1. What is actually sourced: counsel in the Helsinn Federal Circuit appeals

Caveat on the above: Lombardi and O'Malley are the only two attorneys I can tie to the Federal Circuit record through a citable secondary source. The Dittmann/Park entries are firm-publication sourcing, not docket sourcing, and I am labeling them accordingly rather than upgrading them to "of record."

What I could not source at all: the identity of appellate counsel for Dr. Reddy's Laboratories or Sandoz in any Helsinn Federal Circuit appeal. DRL's PTAB papers in PGR2016-00007 and IPR2015-01550 are captioned with an attorney docket number ("REDDY 7.2R-021") but the excerpts I retrieved do not name the firm. I will not guess at DRL's or Sandoz's counsel.

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2. The most probable mapping of 17-1746 — stated as a hypothesis, not a finding

The only 2017 Helsinn-family appeal that plausibly generated a mid-2017 docket number is Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories, Ltd., No. 12-2867 (MLC) (DEA) (D.N.J.), in which Judge Cooper entered judgment for Helsinn on February 14, 2017 — 2017 U.S. Dist. LEXIS 21477 — holding claim 9 of the '724 patent (the patent in your metadata) infringed and not invalid, along with claims of the '094 and '980 patents. A notice of appeal filed in March 2017 is consistent with a 17-1746 assignment.

Two things weigh against treating this as established:

• The '724 patent also appears in the Teva line (D.N.J. 11-3962), which was already on appeal as Nos. 2016-1284/-1787 and decided May 1, 2017 — so the '724 patent alone does not discriminate between candidate appeals.
• I found no opinion, Rule 36 affirmance, or dismissal order for a DRL appeal, and DRL's commercial dispute with Helsinn was resolved by settlement (the D.N.J. record reflects a settlement permitting a September 30, 2018 launch, with DRL actually launching on or before March 26, 2018). A settlement would be consistent with a voluntary dismissal of any pending appeal — which would explain the absence of a published decision and the thinness of the litigation-data row.

If 17-1746 is the DRL appeal, then on the defendant side you would be looking for DRL's Winston- or Rakoczy-type ANDA defense team — but I have no source for that, and I am not supplying names.

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3. What I am explicitly not asserting

• I am not asserting that Lombardi or O'Malley appeared in 17-1746. Their sourced appearances are in Nos. 2016-1284/-1787 (Teva).
• I am not asserting any DRL or Sandoz appellate counsel.
• I am not asserting the existence of a 17-1746 opinion, Rule 36 judgment, or dismissal.
• Nothing here is drawn from a sealed filing; the problem is the opposite — the docket is not publicly indexed in the sources I could reach.

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4. How to close this out (concrete next steps)

1. PACER — CAFC CM/ECF: query docket 17-1746 directly. The "Attorneys" tab and the caption pages of the docketed briefs will list lead, of counsel, and any local counsel, plus the district court case below and the appellant/docketing statement.
2. Cross-check the district court docket that 17-1746 names in its docketing statement (likely D.N.J. 12-2867, 14-4274, or 11-3962). Counsel of record there will carry forward to the appeal.
3. Pull the caption pages of the briefs actually filed. For the Teva appeal, Teva's opening/reply briefs and Helsinn's principal brief are publicly posted (Patently-O hosted Teva's March 2016 secret-sale brief; the Texas Law Review note cites the principal and reply briefs by name). Those caption pages give the full of-record list for both sides in one document — the most efficient single source.
4. Check the Supreme Court materials in Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., No. 17-1229, if you need the later-stage appellate team; the joint appendix and merits briefs on supremecourt.gov are unsealed and name counsel. I did not retrieve those caption pages in this session and am not naming that team here.

Recommended framing for the file: counsel of record for the defendant side in 17-1746 = unconfirmed pending PACER retrieval of the 17-1746 docket sheet; the verified Helsinn appellate defense team in the companion Teva appeal is George C. Lombardi (Winston & Strawn, Chicago) as lead, with Helsinn side led by Joseph M. O'Malley, Jr. (Paul Hastings, New York).