Litigation

Sun Pharma Global FZE v. Lupin Ltd.

18-2213

Patents at issue (2)

6030999
8778999

Defendants (1)

Summary

Case noted for disambiguation because it involved U.S. 8,778,999, a bromfenac/Bromsite patent different from 6,030,999.

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 before drafting. Let me run several searches in parallel.

Now let me verify the second patent and the case's ultimate resolution.

Let me identify the '999 vs. 6,030,999 patents and check the PTAB/Federal Circuit angles.

Case Overview — Sun Pharma Global FZE v. Lupin Ltd., No. 3:18-cv-02213-FLW-TJB (D.N.J.)

Parties. This is a Hatch-Waxman (ANDA) infringement action between two operating pharmaceutical companies — no NPE/PAE is involved on either side, though the asserted patent reached the plaintiff through acquisition rather than in-house invention. Plaintiffs are Sun Pharma Global FZE (a Sun Pharma group holding entity) and Sun Pharmaceutical Industries, Inc. (the group's U.S. arm, based in Cranbury, New Jersey), affiliates of India's Sun Pharmaceutical Industries Ltd. Sun acquired InSite Vision Inc. (Alameda, CA) in 2015, and the patent-in-suit was formally assigned to Sun under a March 2016 agreement with InSite. Defendants are Lupin Ltd. (Mumbai) and its U.S. subsidiary Lupin Pharmaceuticals, Inc. — one of the larger Indian generic manufacturers and, here, the paragraph IV ANDA filer. Sun was represented by Betty Chen (Fish & Richardson) with Gregory D. Miller (Rivkin Radler) as local counsel; Lupin by William A. Rakoczy (Rakoczy Molino Mazzochi Siwik) with Eric I. Abraham (Hill Wallack). (D.E. 99)

Accused product and patent. Lupin filed ANDA No. 211239 seeking to market a bioequivalent generic of BromSite® (bromfenac ophthalmic solution 0.075%, NDA No. 206911, approved 2016), a topical NSAID indicated for postoperative inflammation and the prevention of ocular pain in cataract-surgery patients. BromSite is a reformulation of bromfenac (commercialized

Key legal developments & outcome

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

I'll research this case systematically. Let me start with searches on the docket and patents.

Let me dig into the docket, the February 2020 dismissal, and any appeal or PTAB proceedings.

Several new threads to verify: a February 2020 dismissal, a reissue patent RE50,218, and possible appeals/PTAB activity. Let me check the docket and these items.

Bottom line

The case caption in the metadata is slightly off from what the record shows: the docket is Sun Pharmaceutical Industries Ltd., et al. v. Lupin Ltd., et al., No. 3:18-cv-02213-FLW-TJB (D.N.J.) (Sun Pharma Global FZE was the named plaintiff and patent owner of record at filing; it later merged into Sun Pharmaceutical Industries Ltd.). Only U.S. Patent No. 8,778,999 was asserted — I found no record of 6,030,999 in any filing, opinion, FDA letter, or docket summary for this case, and I could not verify that patent's relevance at all. Treat the "6,030,999" entry as unsourced metadata (see caveats at the end).

On the merits, Sun lost at a five-day remote bench trial: the court held the '999 patent not literally infringed, obvious, and indefinite, but found no inequitable conduct. That September 30, 2021 opinion, however, was later vacated in February 2022 as part of a negotiated dismissal — so the invalidity ruling never became a final, appealable, preclusive judgment.

1. Filing and initial pleadings (2018)

  • 2018-02-14/15 — Complaint filed. Hatch-Waxman suit under 35 U.S.C. § 271(e)(2) in D.N.J., assigned to Chief Judge Freda L. Wolfson, with Magistrate Judge Tonianne J. Bongiovanni. The trigger was Lupin's ANDA No. 211239 for bromfenac ophthalmic solution 0.075%, a generic of Sun's BromSite®, with a Paragraph IV certification received by FDA 2017-10-25. Complaint sought to prevent approval/marketing before the '999 patent's expiry (2029-08-07, including PTE). See Sun Pharma Global FZE v. Lupin Ltd., 2021 WL 4473411, at *1 & n.2 (D.N.J. Sept. 30, 2021) (ECF No. 244); FDA ANDA 211239 approval letter, https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211239Orig1s000ltr.pdf.
  • Patent background: '999 patent filed 2009-03-05, issued 2014-07-15, originally assigned to InSite Vision Inc., acquired by Sun in November 2015 and formally assigned to Sun Pharma Global FZE in a March 2016 agreement. Named inventors: Hosseini, Bowman, Si, Pham. Claim 1 covers a topical ophthalmic composition of bromfenac with a crosslinked polycarbophil mucoadhesive polymer, viscosity ~1,000–3,400 cps, pH ~7.4–8.5.
  • Answer and counterclaims. Lupin (Lupin Ltd. and Lupin Pharmaceuticals, Inc.) denied infringement on viscosity grounds and counterclaimed for declaratory judgment of invalidity (obviousness and indefiniteness) and unenforceability for inequitable conduct — specifically Dr. Lyle Bowman's alleged failure to disclose his own earlier patent, U.S. 6,159,458 ("Bowman I"), during prosecution. ECF No. 244 at 1–3.
  • Counsel of record (secondary-source, not verified against PACER): Betty Chen / Fish & Richardson for Sun; William Rakoczy / Rakoczy Molino for Lupin (Paragraph Four case tracker, https://paragraphfour.com/members/gregoryglass/activity/11848/).

2. The February 2020 "dismissal" that did not end the case

Docket trackers report the case "Settled and dismissed 2/3/20," with DrugPatentWatch listing a termination date of 2020-02-02. That is corroborated by the court's own account: "The parties attempted to settle in 2020, ECF No. 145, but were unable to do so, ECF No. 155." ECF No. 244 at 2 n.5. In other words, a 2020 settlement-driven dismissal was entered and then undone when the deal collapsed, and the litigation resumed. (I could not retrieve the text of ECF 145/155 to confirm the precise mechanism — e.g., a vacated stipulation versus a conditional dismissal — so treat that detail as unconfirmed.)

3. Pre-trial motions of substance (2019–2021)

No motion to dismiss, transfer, or § 315 stay pending IPR appears in the record I could access. The substantive pretrial activity was a Daubert/expert-witness cluster, resolved in one opinion, ECF No. 185 (filed 2021-03-08; reported at Sun Pharma Global FZE v. Lupin Ltd., 2021 WL 1056556-ish per Law.com publication date 2021-03-19; full text at https

In the news

What the press has reported about this case, summarized with links to the source articles.

I'll search several angles to locate actual published coverage of this case.

Initial searches found docket materials but no mainstream press. Let me search more specific angles, including Law360/trade coverage and the second patent number.

Two leads: a Law360 piece republished elsewhere and a Life Sciences IP Review item. Let me pin those down and check the vacatur outcome.

Press coverage of Sun Pharma Global FZE v. Lupin Ltd., No. 18-2213 (D.N.J.)

What the trade press reported. Coverage of this ANDA/bromfenac case is thin and confined almost entirely to pharma-legal trade outlets; I found no reporting in Reuters, Bloomberg Law, Ars Technica, The Verge, IPWatchdog, Patently-O, or mainstream press. Law360, which maintains a dedicated case page for the docket, reported on 2021-09-30 ("Sun Pharma's Eye Pain Patent Invalidated") that Judge Freda L. Wolfson invalidated Sun's patent on a branded eye-surgery pain treatment, "finding on Thursday that the patent was obvious in light of an earlier patent." That aligns with the court record: the Sept. 30, 2021 findings of fact and conclusions of law after a five-day remote bench trial (ECF No. 244, 2021 WL 4473411) held that Lupin's ANDA did not literally infringe U.S. 8,778,999 and that the patent was invalid as obvious over Bowman I (U.S. 6,159,458 — the patent's own inventor's earlier patent) and indefinite for failing to specify a spin-time parameter for viscosity measurement. Life Sciences IP Review likewise carried an item dated 2021-10-05 stating that a New Jersey court "invalidated a Sun Pharmaceuticals patent related to its anti-inflammatory eye drops BromSite in an infringement suit against generic drug manufacturer Lupin Pharmaceuticals." Notably, the trial court's inequitable-conduct holding ran against Lupin: Judge Wolfson found Dr. Lyle Bowman did not commit inequitable conduct by withholding Bowman I from the PTO, a nuance the headline-level trade coverage did not capture.

The 2022 dismissal and vacatur. The more consequential press item is the follow-on. Law360 reported on 2022-02-08 ("Sun Pharma, Lupin Agree To Drop Eye Pain Patent Dispute") that Sun agreed to drop the suit "while getting a New Jersey federal judge to toss an earlier ruling that invalidated Sun's patent at the heart of the case," adding that Sun had asked Judge Wolfson the day before to rescind her September ruling. A syndicated copy of that Law360 story carrying the byline Tiffany Hu and the timestamp "February 8, 2022, 7:33 PM EST" is mirrored on darik.news, though the machine-scraped text is garbled (Lupin appears as "Lupine," and "obvious" as "explicit"), so I would not quote it verbatim. Life Sciences IP Review framed the same event differently on 2022-02-10, describing the parties as having "decided to settle" and as "invalidating an opinion handed down by the US District Court for the District of New Jersey in September" — a characterization that treats the vacatur as part of a settlement, whereas Law360 described a voluntary dismissal plus vacatur. That is a genuine point of divergence in the reporting; neither account discloses any settlement terms, and I found no court filing or press report quantifying a payment or license date.

Numbers and significance. No outlet reported damages sought or awarded, and none plausibly could have: this was a bench-tried Hatch-Waxman declaratory case, and the docket reflects no damages phase. The only product/market detail in the coverage is BromSite (bromfenac ophthalmic solution 0.075%), the NDA product embodying the '999 patent — reported in the Robins Kaplan Hatch-Waxman bulletin, which is law-firm analysis rather than journalism but is the most substantive published commentary I found on the decision's reasoning (viscosity testing under a patent-specified method, Nautilus indefiniteness, and the "darling" of ophthalmic NSAIDs obviousness analysis). The practical significance the press emphasized was competitive rather than doctrinal: an early generic entry window for Lupin's bromfenac product, later undone procedurally by the vacatur.

Caveats. Two gaps worth flagging. First, the case metadata lists U.S. 6,030,999 among the patents at issue, but I found no press report, docket entry, or litigation database linking that patent to this case — DrugPatentWatch and the Robin Kaplan write-up list only 8,778,999, and the metadata's own case summary flags the '999 confusion. The 6,030,999 reference appears unsupported by anything I located, and I would verify it against the complaint before relying on it. Second, the Life Sciences IP Review items were surfaced only through the publication's paginated archive listings, not direct article URLs, so the links above point to archive pages rather than the individual stories; the Law360 pieces sit behind a paywall and I could only retrieve headlines and opening sentences from its case page, not full text.

Sources

Plaintiff representatives

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

I'll research the counsel of record for Sun Pharma Global FZE in this New Jersey patent case.

Let me pull the docket sheet and complaint to identify counsel entries.

Bottom line

Sun was represented by a two-firm team: Rivkin Radler LLP (Hackensack, N.J.) as New Jersey counsel of record on the ECF docket, and Fish & Richardson P.C. as lead patent trial counsel appearing pro hac vice from its Redwood City, Atlanta, Wilmington, and Houston offices. No in-house Sun attorney appears as counsel of record in the filings I could review.

One caution before the roster: the case caption in your metadata lists U.S. Patent Nos. 6,030,999 and 8,778,999, but every filing and opinion in D.N.J. No. 3:18-cv-02213-FLW-TJB that I located asserts only the '999 patent (8,778,999) (BromSite® bromfenac 0.075%). I found no reference to a 6,030,999 patent anywhere in this docket. The counsel identified below are those who appeared in 18-2213; if there is a second, related Sun–Lupin matter involving 6,030,999, its appearance list would need to be checked separately. Flagging rather than guessing.

Counsel of record for Plaintiffs Sun Pharma Global FZE and Sun Pharmaceutical Industries, Inc.

# Attorney Role Firm / office
1 Gregory D. Miller N.J. counsel of record (local); filed the complaint Rivkin Radler LLP, Hackensack, NJ
2 Betty Chen Lead patent/trial counsel (PHV) Fish & Richardson P.C., Redwood City, CA
3 Christopher O. Green Trial team; expert/Daubert briefing (PHV) Fish & Richardson P.C., Atlanta, GA
4 Sara C. Fish Trial team; discovery correspondence (PHV) Fish & Richardson P.C., Atlanta, GA
5 Susan E. Morrison Of counsel (PHV) Fish & Richardson P.C., Wilmington, DE
6 Karrie E. Wheatley Of counsel (PHV) Fish & Richardson P.C., Houston, TX
7 Gene Y. Kang N.J. team (Rivkin Radler) Rivkin Radler LLP, Hackensack, NJ
8 Jenna Z. Gabay N.J. team (Rivkin Radler) Rivkin Radler LLP, Hackensack, NJ

Appearance block relied on: Sun's/Defendants' joint motion to seal, ECF No. 99 (filed 8/16/2019), which lists all eight above under "Attorneys for Plaintiffs/Counterclaim-Defendants, Sun Pharma Global FZE and Sun Pharmaceutical Industries, Inc." — https://storage.courtlistener.com/recap/gov.uscourts.njd.[366742](/patent/366742)/gov.uscourts.njd.366742.99.0.pdf

1. Gregory D. Miller — Rivkin Radler LLP (New Jersey counsel of record)

  • Firm/office: Rivkin Radler LLP, 21 Main Street, Suite 158, Court Plaza South – West Wing, Hackensack, NJ 07601-7021 (the firm has since used 25 Main Street, Court Plaza North, Suite 501, Hackensack).
  • Role/evidence: ECF-filing attorney for essentially every Sun paper in the case, beginning with the complaint (filed 2/14/2018) and Sun's corporate disclosure statement, and including the 8/16/2019 seal motion ("MILLER, GREGORY"). He submitted the declaration supporting the joint sealing motion and signed Sun's discovery letters (e.g., the 7/15/2019 letter to Mag. J. Bongiovanni re Lupin's document production).
  • Experience note: Rivkin Radler's Hackensack-based IP group is a regular New Jersey local-counsel shop in ANDA/Hatch-Waxman matters; Miller also later appeared for Sun as defendant in the consolidated D.N.J. Sun Pharmaceutical matters (C.A. No. 2:24-cv-7791), alongside Carlson Caspers.

2. Betty Chen — Fish & Richardson P.C. (lead trial counsel, admitted pro hac vice)

  • Firm/office: Fish & Richardson P.C., 500 Arguello Street, Suite 500, Redwood City, CA 94063.
  • Role: First-listed plaintiff-side attorney in the case's caption block and identified in Paragraph IV litigation trackers as Sun's lead lawyer for this Bromsite case (ParagraphFour lists "Plaintiff Lawyer/Firm: Betty Chen / Fish Richardson" for 3:18-cv-02213). She was admitted pro hac vice and was on the trial team for the five-day remote bench trial held in March 2021 before Chief Judge Wolfson.
  • Experience note: Fish & Richardson is one of the highest-volume Hatch-Waxman plaintiff firms; Chen's practice is ANDA/pharmaceutical patent litigation. (I did not independently verify her full case list — treat this as firm-level context.)

3. Christopher O. Green — Fish & Richardson P.C., Atlanta (pro hac vice)

4. Sara C. Fish — Fish & Richardson P.C., Atlanta (pro hac vice)

  • Firm/office: Same Atlanta address as Green.
  • Role: Trial team; the discovery record shows her as Sun's correspondence contact — e.g., Lupin's counsel's July 2, 2019 letter was addressed to "S. Fish," and Sun's July 15, 2019 motion-to-compel letter (Rivkin Radler letterhead) recounts that correspondence. See https://archive.org/download/gov.uscourts.njd.366742/gov.uscourts.njd.366742.77.0.pdf
  • Experience note: Not independently verified beyond this docket.

5. Susan E. Morrison — Fish & Richardson P.C., Wilmington, DE (pro hac vice, of-counsel listing)

  • Firm/office: Fish & Richardson P.C., 222 Delaware Avenue, 17th Floor, P.O. Box 1114, Wilmington, DE 19801.
  • Role: Listed in the plaintiffs' caption block as part of the Sun team; Delaware-based, likely supporting the parallel Delaware Hatch-Waxman track (Sun Pharma entities were defendants in the Delaware Bromsite/injectable litigation handled by Richards, Layton & Finger and Carlson Caspers).
  • Experience note: Not independently verified beyond this docket.

6. Karrie E. Wheatley — Fish & Richardson P.C., Houston (pro hac vice)

  • Firm/office: Fish & Richardson P.C., 1221 McKinney Street, Suite 2800, Houston, TX 77010.
  • Role: Listed in plaintiffs' caption block as part of the Sun team. No separate substantive filing by her located.
  • Experience note: Not independently verified beyond this docket.

7–8. Gene Y. Kang and Jenna Z. Gabay — Rivkin Radler LLP, Hackensack, NJ

  • Role: New Jersey-side team members listed on Sun's caption block (ECF No. 99). Neither appears as the ECF filer of a substantive motion in the materials I reviewed; Miller was the filing/signing attorney.
  • Experience note: Not independently verified.

Things worth flagging (do not conflate)

  1. Hill Wallack LLP is Lupin's local counsel, not Sun's. ECF No. 99's caption block pairs Eric I. Abraham (Hill Wallack LLP, Princeton, NJ) with Rakoczy Molino Mazzochi Siwik LLP (William A. Rakoczy, Paul J. Molino, Rachel P. Waldron, Conly S. Wythers, Katie A. Boda — Chicago) as "Attorneys for Defendants/Counterclaim-Plaintiffs, Lupin Ltd. and Lupin Pharmaceuticals, Inc." Because ECF No. 99's docket description reads "Joint MOTION to Seal ... by SUN PHARMA GLOBAL FZE..." and includes a "Declaration of Eric I. Abraham," database entries can misattribute Abraham to Sun. He was Lupin's counsel. Lupin's earlier appearances were by Abraham and Christina Lynn Saveriano (5/14/2018).
  2. Pro hac vice status: the filings contemporaneously caption Chen, Green, Fish, Morrison, and Wheatley as "(admitted pro hac vice)," which is strong but secondary evidence of admission; I did not pull the individual PHV orders from PACER.
  3. No withdrawal of Fish & Richardson found. Fish and Rivkin Radler counsel remain on the papers through post-trial briefing (e.g., Sun's post-trial proposed findings of fact and post-trial brief, and Sun's Rule 7.1.1 third-party litigation funding disclosure). The case ended by stipulation and order of dismissal with prejudice signed by Chief Judge Wolfson on 2/9/2022 (CourtListener docket 6668689, entry following ECF 249/261), with Sun's motion for reconsideration of the Sept. 30, 2021 opinion (ECF No. 244, later vacated) terminated as moot on 3/31/2022. So: no sealed-counsel problem — but also no later substitution of counsel.
  4. No in-house counsel of record identified. Sun's legal department did not enter an appearance on this docket in any document I reviewed.
  5. Docket naming inconsistency: CourtListener re-captioned the case "SUN PHARMACEUTICAL INDUSTRIES LTD. v. LUPIN LIMITED," but the operative caption in the Court's own opinions is "Sun Pharma Global FZE and Sun Pharmaceutical Industries, Inc. v. Lupin Ltd. and Lupin Pharmaceuticals, Inc." Sun Pharmaceutical Industries Ltd. (the Indian parent) was not a plaintiff in 18-2213.

Sources

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 of record for this case.

I have a strong lead (D.E. 99 signature block). Let me verify against the docket and other filings.

Now let me pull the docket sheet and appearance entries to confirm the full defense team.

Counsel of Record for Defendants (Lupin Ltd. and Lupin Pharmaceuticals, Inc.)

Sourcing note up front: The defense teams' identities are grounded in the signature blocks and declarations attached to the parties' Joint Motion to Seal, D.E. 99 (filed Aug. 16, 2019) — available in full text via RECAP/CourtListener — and are consistent with the counsel listed in the Daubert opinion, D.E. 185 (Mar. 8, 2021), and the bench-trial opinion, D.E. 244 (Sept. 30, 2021). I was not able to pull a live PACER docket report or the individual Notice of Appearance entries (D.E. 2–20 range), so this list reflects the complete defense roster as it appears in the record I could verify. Additional Rakoczy Molino associates may have appeared on later filings without being captured here.

# Attorney Role Firm & Office Note
1 William A. Rakoczy (admitted pro hac vice) Lead / national trial counsel Rakoczy Molino Mazzochi Siwik LLP, 6 W. Hubbard St., Suite 500, Chicago, IL 60654 Founding name partner of the leading Hatch‑Waxman/ANDA boutique; one of the most frequent defense counsel in Paragraph IV cases nationwide.
2 Paul J. Molino (PHV) Of counsel / trial team Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL Partner in the same ANDA-focused boutique; co-signed the defense pleadings and sealing papers with Mr. Rakoczy.
3 Eric I. Abraham Local counsel (D.N.J.) Hill Wallack LLP, 21 Roszel Road, Princeton, NJ 08540 (firm also has a Red Bank, NJ office) Hill Wallack's Complex Litigation group leader; a go-to D.N.J. local counsel in ANDA matters — author of "A Practitioner's Guide to the Local Patent Rules," N.J. Lawyer (Aug. 2015); named in the 2023 ANDA Litigation Intelligence Report. Filed the defense declaration in support of the joint sealing motion (D.E. 99‑5).
4 Rachel P. Waldron (PHV) Associate / of counsel, trial team Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL Listed as counsel for Lupin on the sealing motion and case filings.
5 Conly S. Wythers (PHV) Associate, trial team Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL Listed as Lupin counsel on the sealing motion. Caveat: the RECAP OCR renders this name inconsistently ("Wythens" in one instance, "Wythers" in another); "Wythers" appears to be correct, but I could not confirm against a PACER appearance entry.
6 Katie A. Boda (PHV) Associate, trial team Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL Listed as Lupin counsel on the sealing motion.

In-house counsel: No Lupin in-house attorney appeared on the docket in the filings I reviewed. Lupin's U.S. regulatory agent for the ANDA (No. 211239) was Lupin Pharmaceuticals, Inc., Harborplace Tower, Baltimore, MD, but no company lawyer entered an appearance.

Verification excerpts

From D.E. 99 (Joint Motion to Seal), CourtListener/RECAP:

"Eric I. Abraham — HILL WALLACK LLP — 21 Roszel Road, Princeton, New Jersey 08540 … William A. Rakoczy (admitted pro hac vice), Paul J. Molino (admitted pro hac vice), Rachel P. Waldron (admitted pro hac vice), Conly S. Wythers (admitted pro hac vice), Katie A. Boda (admitted pro hac vice) — RAKOCZY MOLINO MAZZOCHI SIWIK LLP — 6 West Hubbard Street, Suite 500, Chicago, Illinois 60654 … Attorneys for Defendants/Counterclaim-Plaintiffs, Lupin Ltd. and Lupin Pharmaceuticals, Inc."

From the same document, the caption confirms the party alignment:

"SUN PHARMA GLOBAL FZE and SUN PHARMACEUTICAL INDUSTRIES, INC., Plaintiffs/Counterclaim-Defendants, v. LUPIN LTD. and LUPIN PHARMACEUTICALS, INC., Defendants/Counterclaim-Plaintiffs. Civil Action No. 3:18-cv-02213-FLW-TJB."

Corroborating third-party docket summary (ParagraphFour): "Defendant Lawyer/Firm: William Rakoczy / Rakoczy Molino." (Plaintiffs' side, for contrast, was Betty Chen of Fish & Richardson with Gregory D. Miller of Rivkin Radler as local counsel — useful to avoid conflating the two teams, since both firms appear in the same signature blocks.)

What this team accomplished (context for the counsel identification)

  • The defense won a five-day remote bench trial held in March 2021 before Chief Judge Freda L. Wolfson. In D.E. 244 (Sept. 30, 2021), 2021 WL 4473411, the court found Lupin's ANDA product does not literally infringe the '999 patent, and that the patent was obvious over U.S. Patent No. 6,159,458 ("Bowman I") and indefinite for failing to specify spin time in its viscosity-measurement protocol — while rejecting Sun's inequitable-conduct theory.
  • Sun moved for reconsideration (D.E. 249); the parties then stipulated to dismissal with prejudice (D.E. 261, Feb. 9, 2022), and the reconsideration motion was denied as moot (D.E. 262, Mar. 31, 2022). The FDA's 2024 approval letter for Lupin's ANDA 211239 expressly notes that the New Jersey action "was dismissed." (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211239Orig1s000ltr.pdf)
  • I found no parallel PTAB IPR filed by Lupin against the '999 patent.

Two flags on the case metadata

  1. Patent list discrepancy. The metadata lists 6,030,999, but the complaint, both opinions (D.E. 185, D.E. 244), the FDA approval letter, and DrugPatentWatch all reflect only U.S. 8,778,999. I found no appearance of 6,030,999 anywhere in this docket — consistent with the existing disambiguation note, and worth confirming the metadata field before relying on it.
  2. Firm-name currency. Rakoczy Molino Mazzochi Siwik LLP is the firm of record during 2018–2022. I could not verify (and therefore do not assert) any subsequent firm-name change or lateral move by Messrs. Rakoczy or Molino; any current-firm attribution should be checked against the Illinois/current firm websites rather than assumed from this docket.