Sun Pharmaceutical Industries Ltd. et al. v. Solaris Pharma Corporation

I'll research the parties, product, and patents before drafting.

Important lead: there's prior D.N.J. litigation over the ’999 patent. Let me dig into that history and any PTAB proceedings.

Key finding: the ’999 patent was held invalid after a 2021 bench trial, and the reissue issued in 2024. Let me verify the vacatur, settlement, and any PTAB challenges to the reissue.

Case Overview and Background

The parties and the commercial stakes. This is a conventional, operating-company-versus-generic Hatch-Waxman case with no NPE or university involvement. Plaintiffs are Sun Pharmaceutical Industries Ltd. (Mumbai, India) and its U.S. subsidiary Sun Pharmaceutical Industries, Inc. (Princeton/Cranbury, NJ) — the plaintiffs' corporate structure, ownership chain, and the 2021 Sun Pharma Global FZE→Sun India merger that moved title to the patent are set out in the complaint (Compl. ¶¶ 19–22, ECF No. 1) and are not repeated here. Sun holds NDA No. 206911 for BromSite® (bromfenac ophthalmic solution) 0.075%, approved April 8, 2016, a once-daily topical NSAID indicated for post-operative inflammation and prevention of ocular pain in cataract surgery; BromSite uses InSite Vision's "DuraSite" mucoadhesive polycarbophil delivery vehicle, which Sun acquired with InSite in 2015. Defendant Solaris Pharma Corporation is a Somerset, New Jersey–based generics manufacturer (Compl. ¶¶ 6, 13) that filed ANDA No. 220440 for a generic bromfenac 0.075% product and sent Sun a Paragraph IV notice letter dated March 11, 2026, triggering this suit 42 days later (Compl. ¶¶ 2, 8, 23). Because Solaris manufactures in New Jersey and has previously consented to D.N.J. jurisdiction (Valeant Pharms. N. Am. LLC v. Solaris Pharma Corp., No. 3:18-cv-13695), personal jurisdiction and venue are pleaded almost as an afterthought (Compl. ¶¶ 12–18).

The patents and the technology. The single patent actually asserted is U.S. Reissue Patent No. RE50,218 ("Non-Steroidal Anti-Inflammatory Ophthalmic Compositions"), which issued November 26, 2024 to the same four InSite inventors (Hosseini, Bowman, Si, Pham) from reissue application No. 17/726,665. Claim 1 covers an aqueous topical ophthalmic composition of bromfenac plus a "flowable crosslinked carboxy-containing polycarbophil mucoadhesive polymer," with viscosity of about 1,000–3,400 cps and pH about 7.4–8.5; the reissue claim notably adds a specific measurement protocol — viscosity "measured with a Brookfield cone and plate viscosity DV-II+ with the spindle No. CP-52 at 6 rpm." The parent, U.S. Patent No. 8,778,999 (issued July 15, 2014; expired/would expire Aug. 7, 2029 with 155 days of PTE), used the same claim language without any measurement method — which is precisely why it failed. ⚠️ Metadata flag: the case metadata lists both patents as "at issue," but the complaint pleads the '999 only as background (the reissue lineage, Compl. ¶ 19) and all three counts (Counts I–III: § 271(e)(2) infringement, DJ of infringement, and inducement/contributory infringement) are directed solely to the '218. The '999 is not asserted. That matters because the '999 was held invalid — obvious over Bowman I (U.S. Pat. No. 6,159,458), indefinite for failing to specify a spin time in the viscosity test, and not literally infringed — after a five-day bench trial before Chief Judge Freda L. Wolfson, Sun Pharma Global FZE v. Lupin Ltd., No. 3:18-cv-02213-FLW-TJB, 2021 WL 4473411 (D.N.J. Sept. 30, 2021) (D.E. 244). Sun moved for reconsideration; before that was decided, the parties stipulated to vacatur of the opinion and order (D.E. 244/245) and to dismissal with prejudice with a mutual waiver of appeal (Stip. & Order, D.E. 261, signed Feb. 9, 2022; recon. motion denied as moot, Text Order, Mar. 31, 2022). The reissue application was filed April 22, 2022 — roughly ten weeks later — and the resulting RE50,218 effectively writes Judge Wolfson's indefiniteness holding into the claim. That is the analytic heart of this case: Solaris will presumably argue that a post-litigation reissue that adds the very parameter found missing cannot escape the same Bowman I obviousness attack (and may raise recapture, written-description, and intervening-rights issues), while Sun will argue the measured-viscosity limitation cures the § 112 problem and narrows the claim beyond the vacated judgment's reach. Because the 2021 judgment was vacated, it has no preclusive or precedential effect, but its 78-page findings read as a roadmap for any generic defendant. See CourtListener D.E. 244; Justia; Robbins Kaplan ANDA summary.

Procedural posture and why it matters. Filed April 22, 2026 in the District of New Jersey, Newark vicinage, before Judge Evelyn Padin with Magistrate Judge Stacey D. Adams (2:26-cv-04286-EP-SDA); the case is at the pleading stage, with Solaris's response deadline extended to July 7, 2026 and a Rule 7.1 disclosure deficiency flagged by the clerk (see the Defendant Representatives section above for the Hill Wallack defense team and the status caveats). D.N.J. is the preferred venue for both sides here for reasons beyond the accident of Solaris's Somerset plant: it is the nation's highest-volume ANDA docket, its Local Patent Rules compress the pleadings-to-contentions timeline, and both the '999 merits trial and Solaris's prior ANDA defense work are already in that courthouse. Two features make the case notable. First, the generic is already on the market: FDA approved Lupin's ANDA No. 211239 for bromfenac 0.075% (see FDA approval letter), and the Agency's letter records that the '999 patent carried an August 7, 2029 expiry while noting the earlier suit was dismissed — so the reissue is Sun's attempt to reset the exclusivity clock on a product whose prior patent already lost on the merits. Second, the reissue is an unusual, litigation-driven asset: post-grant reissue is the mirror image of the IPR-heavy dynamic in bromfenac/ophthalmic NSAID art (Bausch/Senju's '606 patent, for example, has been through contested PTAB proceedings), and a reissue issued from an application filed after an adverse trial judgment invites both a fresh § 282 invalidity case and a potential IPR/PGR by Solaris or a third party. I could not locate any PTAB proceeding against RE50,218 as of today; treat that as "none found," not "none filed," since my search of PTAB dockets was not exhaustive. Other sourcing limits worth noting: publicly reported expiration data for the '218 lists March 5, 2029 (DrugPatentWatch/Paragraph IV databases, example) — i.e., the original 20-year term without the 155-day PTE reflected in the '999 — and the current BromSite labeling still recites "US Patent No. 8,778,999"; whether the PTE carried over to the reissue, and why the listed date differs, is a point to verify against the Orange Book and the reissue file rather than assume. Market-size figures for BromSite are not well sourced in what I could reach, and I have not estimated them.

I'll research this case systematically. Let me start with several parallel searches.

Let me pull the full docket and check for later events.

I'll research the counsel of record for Sun Pharmaceutical in this case.

I have the docket. Now let me confirm firm affiliations and roles for each plaintiff-side attorney.

Counsel of Record for Plaintiffs (Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc.)

All five plaintiff-side appearances are from a single firm: Rivkin Radler LLP, New Jersey office. The complaint (ECF No. 1, filed 4/22/2026) was signed and electronically filed by Gregory D. Miller, and Notices of Appearance were docketed the same day as ECF Nos. 3–6.

Procedural notes and caveats

• No pro hac vice activity yet. As of the most recent docket snapshot available (CourtListener/PACER Monitor, reflecting events through roughly August 2026), the only plaintiff-side appearances are the five above — all D.N.J.-admitted. No admission motions for out-of-state or in-house Sun counsel appear. That is consistent with Sun using Rivkin Radler as its sole, New Jersey-based ANDA counsel in this District (the pattern in Selenious Acid and other Sun matters), rather than a two-tier national/local-counsel structure. The transcript-based record could change if Solaris's invalidity case prompts Sun to add Federal Circuit–level patent trial counsel.
• In-house counsel not identified. The complaint identifies Sun's corporate parties (Sun India, Mumbai; Sun USA, 2 Independence Way, Princeton, NJ) but no Sun legal-department attorney has entered an appearance.
• Docket number discrepancy to flag. The case is indexed under both 2:26-cv-04286 and 3:26-cv-04286 (Justia/DrugPatentWatch report "3:26cv04286"; CourtListener and the ECF headers on the complaint read "2:26-cv-04286-EP-SDA"). Per your standing instruction, I am treating the metadata number 2:26-cv-04286 as authoritative. Judge: Evelyn Padin; Magistrate: Stacey D. Adams.
• Defendant's side (for contrast, not requested): Solaris is represented by Eric I. Abraham, Kristine L. Butler and Olivia R. Meadows (appearances 6/18/2026, ECF Nos. 11–12 and later).
• Sourcing limits. The attorney/firm attributions above rest on the docket entries (ECF Nos. 1–6) and law-firm/Law360/Justia profiles, not on the notice-of-appearance signature blocks themselves, which are not in the RECAP collection. If you need courtroom-grade verification (bar number, firm address as stated in the filing, and any withdrawn appearances), pull ECF Nos. 3–6 directly from PACER — the Rivkin Radler address in recent D.N.J. filings is 25 Main Street, Court Plaza North, Suite 501, Hackensack, NJ 07601 (older filings show 21 Main Street, Court Plaza South, Suite 158).

I'll research Solaris Pharma's defense team, starting with docket entries and firm affiliations.

Confirmed Eric Abraham at Hill Wallack. Now let me verify the other two attorneys and check for later appearances or pro hac vice motions.

Let me dig further on Olivia Meadows and check for any later docket activity or pro hac vice admissions.

Counsel of Record for Defendant Solaris Pharma Corporation

Solaris's defense team entered uniformly on June 18, 2026 — roughly two months after the 4/22/2026 complaint and after a waiver of service (waiver sent 4/24/2026, original answer due 6/23/2026; extended to 7/7/2026). All appearances run to a single New Jersey firm, Hill Wallack LLP — the same firm that has built one of the largest ANDA-defense practices in the District of New Jersey.

Procedural and sourcing notes

• No pro hac vice admissions and no national trial counsel yet. As of the most recent docket snapshot I could reach (CourtListener/PACER Monitor, events into August 2026), the only defendant-side appearances are the three above. Unlike the typical two-tier structure (out-of-state patent trial counsel + D.N.J. local counsel), Solaris is running the defense entirely through Hill Wallack — consistent with that firm's model of serving as both lead and local ANDA counsel for generic-drug defendants. That could change once invalidity contentions and expert discovery begin.
• No in-house Solaris counsel identified on the docket. Solaris's principal place of business is 49 Napoleon Court, Somerset, NJ (Compl. ¶ 6), so no in-house admission would be expected.
• Answer/counterclaim status not confirmed. ECF No. 13 (Application for Clerk's Order to extend time to answer) was granted by text order, setting the answer due 7/7/2026; a further stipulation to update the answer due deadline was filed 7/6/2026 (signed by Abraham). I could not verify from the excerpt available whether Solaris's answer and counterclaims (non-infringement / invalidity of RE50,218) have since been docketed, or whether a further extension is outstanding. Likewise, the docket shows a clerk's quality-control message flagging Solaris's failure to file a Rule 7.1 corporate disclosure statement — worth checking whether that was cured.
• Docket-number discrepancy carried forward. Justia indexes this case as 3:26-cv-04286; the ECF headers on the complaint read 2:26-cv-04286-EP-SDA. Per your standing instruction, I treat 2:26-cv-04286 as authoritative (Judge Evelyn Padin; Magistrate Judge Stacey D. Adams). The CourtListener docket for the 2:26 number is here.

For courtroom-grade verification

Pull from PACER: ECF Nos. 11, 12, 13, 14/15 (Meadows notice), and 16+ to confirm (i) Meadows's firm and bar number from the signature block, (ii) whether additional Hill Wallack attorneys (e.g., William P. Murtha, Abraham's frequent co-counsel in RK Pharma and Sandoz matters) have appeared, and (iii) whether any out-of-state patent counsel has moved pro hac vice. I cannot confirm any of those three points from the sources I was able to reach.