Litigation

Boehringer Ingelheim Pharmaceuticals Inc. et al. v. Granules India Limited

dismissed

1:24-cv-01091

Patents at issue (5)

9415016
10022379
11911388
10973827
9155705

Summary

Hatch-Waxman ANDA-style action brought by Boehringer Ingelheim entities against Granules India Limited over JENTADUETO (linagliptin/metformin HCl). The suit asserted US 9,415,016 B2 plus US 10,022,379 B2, US 11,911,388 B2, US 10,973,827 B2, and US 9,155,705 B2. It was voluntarily dismissed without prejudice under Fed. R. Civ. P. 41(a)(1)(A)(i), with plaintiffs preserving the right to re-assert.

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 thoroughly before drafting the overview.

Now let me dig into the specific patents, the parallel litigation, and IPR activity.

Key legal developments & outcome

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

I'll research the procedural history, PTAB activity, and related dispositions for this case and its asserted patents.

Let me research PTAB proceedings on the asserted patents and the parallel JENTADUETO/TRADJENTA litigation landscape.

Let me check PTAB activity on the specific asserted patents and the related Granules cases.

Key Legal Developments & Outcome — Boehringer Ingelheim Pharms. Inc. v. Granules India Ltd., 1:24-cv-01091 (D. Del.)

Bottom line

This case has no merits developments to report — no answer, no counterclaims, no motions practice, no Markman, no discovery, no trial, no judgment, and no appeal. It was a complaint-to-dismissal case that lasted 17 days of docket life (filed 2024-09-30; voluntarily dismissed 2024-10-07; closed 2024-10-16). Every item in the task list that presupposes an actively litigated case (transfer/stay motions, claim construction, JMOL, fees) is inapplicable, and I flag that rather than manufacture entries. The only substantive legal events are the filing of the ANDA complaint and the Rule 41(a)(1)(A)(i) notice of voluntary dismissal without prejudice.

The real legal "activity" for these patents sits outside this docket — in consent judgments entered in the companion Granules cases and in earlier Mylan/Aurobindo litigation over the same linagliptin family.

Chronological events on this docket

Date (YYYY-MM-DD) Event D.I. Substantive significance
2024-08-16 Date patentee received Granules' Paragraph IV notice (per ANDA supplemental information) 3 Starts the 45-day § 355(j)(5)(B)(iii) window; sets 30-month stay clock
2024-09-30 Complaint for ANDA/patent infringement filed; magistrate-consent forms; Rule 7.1 disclosure (corporate parent C.H. Boehringer Sohn AG & Co. KG); patent report to Commissioner; summons issued 1–6 Asserted five patents: US 9,155,705; 9,415,016; 10,022,379; 10,973,827; 11,911,388. § 271(e)(2) ANDA action; no jury demand
2024-09-30 ANDA supplemental statement: 30-month stay deadline 2027-02-16 3 Would have governed FDA approval timing absent dismissal
2024-10-02 Case assigned to Judge Colm F. Connolly; Standing Order re briefing 7 —
2024-10-07 Notice of Voluntary Dismissal under Rule 41(a)(1)(A)(i), without prejudice, as to all claims and all three BI plaintiffs (Dellinger) 8 Operative dispositive event
2024-10-16 Report to Commissioner of Patents (listing all five patents); CASE CLOSED per D.I. 8 9 Docket terminated

Sources: Justia docket; CourtListener docket feed; DrugPatentWatch litigation record. CourtListener's docket feed confirms the sequence verbatim (D.I. 8 entered 10/07/2024; "CASE CLOSED per 8 NOTICE of Voluntary Dismissal").

Filing & initial pleadings

  • Complaint (D.I. 1, 2024-09-30). A § 271(e)(2) ANDA action over Granules' proposed generic linagliptin/metformin HCl tablets (ANDA No. 219778) in 2.5/500, 2.5/850, and 2.5/1000 mg strengths — the JENTADUETO® product. Per the complaint analysis, BI pleaded the composition patents (’016, ’827) as necessarily infringed because a bioequivalent generic tablet would practice the claimed linagliptin + metformin + basic amino acid (L-arginine) film-coated formulation, and pleaded the method patent (’388) on inducement through Granules' proposed label for renally impaired patients at 5 mg linagliptin. BI expressly pleaded it had no access to Granules' confidential ANDA and alleged infringement "on information and belief." (Complaint analysis, Ex Parte)
  • Answer / counterclaims: None filed. Granules never appeared or responded.
  • Rule 7.1 disclosure (D.I. 5) was plaintiff-side only.

Pre-trial motions of substance

  • None. No motion to dismiss, transfer, stay pending IPR, preliminary injunction, or summary judgment was filed by any party. The § 41 notice represents that Granules "has not served an answer or motion for summary judgment," which is the condition precedent to a unilateral 41(a)(1)(A)(i) dismissal.

Claim construction (Markman)

  • None. The case never reached the scheduling-order or claim-construction stage. (For contrast, the same patent family did get construed in Boehringer v. Mylan, N.D. W. Va. 1:20-cv-00019, where Judge Keeley adopted BI's proposed constructions of two '526 terms at the Feb. 10, 2021 Markman — see D.I. 160 opinion, Justia.)

Discovery

  • None. No Rule 26 conference, no protective order, no ESI or expert activity appears. The case closed ~7 days after the complaint and well inside any answer deadline.

Trial / verdict / post-trial motions

  • None. No trial date, verdict, JMOL, new-trial motion, or fee motion. No fees were awarded or requested.

Final disposition

  • Voluntary dismissal without prejudice under Fed. R. Civ. P. 41(a)(1)(A)(i) (D.I. 8, 2024-10-07), effective without court order (a 41(a)(1)(A)(i) dismissal is self-executing). Closing on 2024-10-16 with the § 290 report to the Patent Office.
  • Legal effect: Dismissal is without prejudice, so BI's five patents were never adjudicated on validity, enforceability, or infringement in this action, and BI retained (and retains) the right to re-assert all five. The 30-month stay that would have run to 2027-02-16 was never triggered into force in this case.
  • Appeal: None. No notice of appeal; the dismissal was not appealable by BI as the dismissing plaintiff.
  • Caveat (from the PatSnap summary): The public record does not disclose whether the withdrawal was tied to a settlement, license, or consent decree. The docket shows no such agreement in 1:24-cv-01091. (PatSnap)

Parallel PTAB (IPR/PGR) proceedings — what exists and what doesn't

On the five patents asserted here (’705, ’016, ’379, ’827, ’388): I found no IPR, PGR, or CBM proceeding naming any of them as the challenged patent. DrugPatentWatch's drug-level PTAB listing for JENTADUETO/linagliptin-metformin returns only different patents in the family — US 8,673,927, US 8,846,695, and US 9,173,859, all challenged by Mylan in 2016 IPRs (e.g., IPR2016-01563 on the ’927 patent and IPR2016-01566 on the ’859 patent). (DrugPatentWatch JENTADUETO litigation/PTAB page)

  • IPR2016-01566 (Mylan v. Boehringer, ’859) was denied institution in part because Mylan failed to authenticate an old Glucophage® drug label as a prior-art printed publication. (PTAB Litigation Blog)
  • The ’927- and ’859-family method patents were instead invalidated in district court — obviousness-type double patenting as to the ’927/’859 dosages, from the D.N.J. consolidated litigation (Boehringer v. Mylan/Aurobindo, Nos. 3:15-cv-05982 etc.), which went up on appeal as Fed. Cir. No. 19-1172. (Fed. Cir. briefing, CourtListener RECAP)
  • Effect on this litigation: none. Because Granules never filed (or was never served beyond the summons before dismissal), there was no motion to stay pending IPR, and no PTAB proceeding on the asserted formulation/composition patents existed to stay for.

Confidence note: This is a negative finding derived from aggregator PTAB lists (DrugPatentWatch) rather than a full PTAB/PTActs patent-by-patent query. I could not confirm the absence of a filing by direct USPTO PTAB search within this session, so treat "no IPR on the five asserted patents" as well supported but not airtight; a PTAB API/PTActs check keyed to each patent number would be the definitive verification.

Related dockets that supply the "real" disposition for this product line

Because 1:24-cv-01091 resolved without a merits outcome, the substantive results for Granules and for these JENTADUETO patents come from adjacent cases:

  1. 1:24-cv-00753 (D. Del.) — consent judgment, Q4 2024. Companion BI/Granules ANDA case over US 9,486,526 and US 10,034,877 (ANDA No. 219466; TRADJENTA®). The Q4 2024 Generically Speaking Hatch-Waxman bulletin reports the resolution: the patents-in-suit are valid and enforceable; unless authorized, Granules is enjoined from infringing until expiration; Granules may maintain its Paragraph IV certification; and all claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs or fees. ([Robins Kaplan ANDA Litigation

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 the plaintiffs in this Delaware ANDA action.

Let me pull the full docket and parties pages to confirm exactly who entered an appearance.

I need the actual complaint and dismissal signature blocks. Let me try to retrieve the filed documents.

Counsel of Record — Plaintiffs (as reflected on the public docket)

Bottom line: The only attorneys tied to the three Boehringer plaintiffs on the public docket are two Morris, Nichols, Arsht & Tunnell LLP attorneys in Wilmington, Delaware: Megan E. Dellinger (flagged by CourtListener as lead attorney) and Brian P. Egan. Both are Delaware/local counsel. No out-of-state or in-house attorney appears on the docket — and, importantly, the case was on file for only 17 days (complaint filed 9/30/2024; voluntary dismissal 10/7/2024; case closed 10/16/2024), so no pro hac vice motions, notices of appearance, or expert/litigation teams ever materialized. The counsel record here is therefore unusually thin.

Name Role Firm / Office Notes
Megan E. Dellinger Delaware counsel; flagged "LEAD ATTORNEY" for all three plaintiffs on the CourtListener party record. She is also the ECF filer of the Rule 41(a)(1)(A)(i) Notice of Voluntary Dismissal (D.I. 8, Oct. 7, 2024). Morris, Nichols, Arsht & Tunnell LLP, 1201 N. Market St., Wilmington, DE 19899; (302) 351-9366 Morris Nichols IP Litigation partner; Delaware bar #5739. IAM Patent 1000–ranked Delaware patent litigator; recurring Delaware counsel for Boehringer in its ANDA/Hatch-Waxman docket and, e.g., for Pfizer/BMS in Pfizer v. Natco (C.A. 24-621-CFC).
Brian P. Egan Delaware counsel ("ATTORNEY TO BE NOTICED" on the party record); sole attorney listed in DrugPatentWatch's case record. Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE; (302) 351-9454; began@morrisnichols.com Morris Nichols IP Litigation partner; Delaware bar #6227. Chemical-engineering B.E. (Vanderbilt) and former USPTO patent examiner in the chemical arts — apt for a linagliptin/metformin formulation case. Representative matters include Edwards Lifesciences (heart valves + IPRs), Thermo Fisher (PCR), Viasat, Nichia, and Delaware counsel work for Google and J&J. IAM Patent 1000–ranked; clerked for Judge Cynthia M. Rufe (E.D. Pa.).
Jack B. Blumenfeld Not confirmed — listed as a plaintiff attorney for this case by the UniCourt aggregator, but he does not appear on the CourtListener party/attorney record for C.A. 24-1091 and did not sign the only substantive filing (D.I. 8). Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE Senior Morris Nichols IP litigation partner (Delaware bar #1014) and the firm's traditional lead name on Boehringer/Pfizer-style ANDA complaints. Treat his appearance in this docket as unverified; aggregator listings for short-lived cases frequently default to the firm's name partners.

What I could not verify

  • Complaint signature block (D.I. 1). I was unable to retrieve the filed PDF of the complaint, so I could not confirm whether it carried an "OF COUNSEL" line naming an out-of-state firm. Morris Nichols complaints in Boehringer's parallel Delaware ANDA suits typically include such an OF COUNSEL designation (usually the same firm handling the case nationally), but I will not name a firm here without the document. If you need this, the D.I. 1 PDF from PACER (or RECAP) is the definitive source.
  • In-house counsel. No Boehringer in-house attorney appears on the docket. Given the 17-day life of the case, that is expected, not a sign of sealed filings.
  • No sealed filings are indicated in this docket; nothing about counsel here is hidden by sealing — the thinness of the record is purely a function of the rapid voluntary dismissal.

Cross-check against the parallel/follow-on Granules matters

Worth noting for context (and consistent with the earlier sections): the representation lineup is stable across Boehringer's Granules filings. In Boehringer Ingelheim Pharmaceuticals Inc. v. Granules India Limited, 1:24-cv-00753 (D. Del.) (the '526/'877 suit, which ended in a consented judgment in October 2024) and 1:25-cv-00663 (D. Del.) (the '998/'637/'323/'166 suit, terminated by consent judgment signed by Judge Connolly on 9/2/2025), the same Morris Nichols attorneys appear — the proposed consent judgment and stipulations in 1:25-cv-00663 are attributed to Dellinger, and aggregator records for 1:24-cv-00753 list Blumenfeld, Egan, and Dellinger. That trio is effectively Boehringer's Delaware ANDA team at Morris Nichols.

Source notes

One flag: if you see the PatSnap-generated summary of this case (it circulates widely), note that it repeats name spellings as "Boehringer Ingleheim" and cites the PACER docket generically; it corroborates Dellinger/Egan/Morris Nichols but adds nothing beyond the aggregator record, so I've relied on CourtListener and the Justia/PACER-derived docket for the counsel determinations above.

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 the defendant in this case.

Let me examine the actual docket and check whether Granules appeared.

The docket suggests Granules may never have appeared. Let me verify and check the closely related Granules cases for defense counsel.

Counsel of Record for the Defendant — Boehringer Ingelheim Pharms. Inc. v. Granules India Ltd., 1:24-cv-01091 (D. Del.)

Bottom line

There is no counsel of record for Granules India Limited in this case. The action was voluntarily dismissed by the plaintiffs under Fed. R. Civ. P. 41(a)(1)(A)(i) before Granules was required to (and before it did) appear, answer, or move. Any list of "defense counsel" for this docket would necessarily be fabricated. I am flagging this rather than filling the gap, because the case metadata ("dismissed") and the docket both confirm the case closed at the pleading stage.

Docket evidence supporting that conclusion

The entire docket consists of nine entries, all plaintiff-side or court-generated:

D.I. Date Entry
1 09/30/2024 Complaint for ANDA/patent infringement (Dellinger, Morris Nichols)
— 10/01/2024 Summons issued as to Granules India Limited
— 10/02/2024 Case assigned to Judge Colm F. Connolly
7 10/02/2024 Standing Order Regarding Briefing in All Cases (Connolly, J.)
8 10/07/2024 Notice of Voluntary Dismissal (Dellinger, for all three BI plaintiffs)
9 10/16/2024 Report to Commissioner of Patents re: 9,155,705; 9,415,016; 10,022,379; 10,973,827; 11,911,388
— 10/16/2024 "CASE CLOSED per 8 Notice of Voluntary Dismissal"

Sources: CourtListener docket 69213886; CourtListener docket feed; DrugPatentWatch litigation page for 1:24-cv-01091.

Two independent confirmations that no defense appearance occurred:

  1. The dismissal notice itself. As quoted from the PACER docket, the Rule 41(a)(1)(A)(i) notice recited: "At the time of filing this Notice of Dismissal, defendant Granules India Limited has not served an answer or motion for summary judgment in this matter." That is the classic § 41(a)(1)(A)(i) formula used when no responsive pleading or motion has been served. (PatSnap litigation summary, citing PACER for 1:24-cv-01091)
  2. The CourtListener parties page. The "Parties" tab shows Granules India Limited as defendant with no counsel block, while the three BI plaintiffs are listed with Brian P. Egan and Megan Elizabeth Dellinger of Morris, Nichols, Arsht & Tunnell LLP (Wilmington, DE). (CourtListener parties page)

The only attorneys associated with this docket in aggregator records (DrugPatentWatch, UniCourt, CourtListener) are plaintiff-side: Jack B. Blumenfeld, Brian P. Egan, and Megan E. Dellinger of Morris Nichols. Nothing in the public record identifies a Delaware local counsel, national lead counsel, or in-house attorney for Granules in 1:24-cv-01091.

Caveat

I cannot rule out a sealed or non-public filing, but (a) appearances and Rule 7.1/corporate disclosure statements are not typically sealed, (b) the case was terminated only seven days after the complaint was filed and about nine days after service of the summons, well inside any answer deadline, and (c) the § 41(a)(1)(A)(i) dismissal would have been unavailable had Granules served an answer or a motion for summary judgment. On the current record, the conclusion that no defense counsel of record ever existed is well supported.

Related-case context (expressly NOT counsel of record in 1:24-cv-01091)

Because the requested "counsel for Granules" list cannot be populated from this docket, below is what the public record shows for the same defendant in adjacent matters — offered only as background, with the caveat that I have not confirmed each entry against a primary PACER docket page:

  • Boehringer Ingelheim Pharms. Inc. v. Granules India Ltd., 1:24-cv-00753 (D. Del.) — a companion ANDA case against the same defendant concerning the linagliptin formulation patents US 9,486,526 and US 10,034,877 (ANDA No. 219466), resolved by consent judgment and injunction. The PatSnap PACER-derived summary describes Granules as "an Indian generics manufacturer," but I did not locate a named defense attorney for that docket in my searches. (PatSnap, Linagliptin ANDA consent judgment)
  • Boehringer Ingelheim Pharms. Inc. v. Granules India Ltd. and Granules Pharmaceuticals, Inc., 1:25-cv-00663 (D. Del.) — a later BI/Granules ANDA case (US 9,949,998; 10,258,637; 11,090,323; 11,833,166) also before Judge Connolly; the docket shows waivers of service and a consent judgment entered 09/02/2025 (D.I. 12), again with appearances not reflected in the aggregator listing I retrieved. (Justia docket)
  • Incyte Corp. v. Granules India Ltd., No. 1:25-cv-13227 (D.N.J.) — consent judgment signed by R. Touhey Myer, Kratz & Barry LLP (800 N. King St., Wilmington, DE) as "Attorneys for Defendant Granules India Ltd." (paragraphfour.com PDF of the consent judgment)
  • Granules USA, Inc. / Granules India Ltd., 11th Cir. No. 21-12618 — Robert F. Elgidely, Fox Rothschild LLP (One Biscayne Tower, Miami, FL) listed as "Counsel for Granules USA, Inc. and Granules India Ltd." (CourtListener RECAP PDF)

These names show who Granules has retained in other Hatch-Waxman matters; none of them is confirmed as having appeared in 1:24-cv-01091.

Suggested verification steps

  1. Pull the PACER docket sheet for 1:24-cv-01091 directly (D. Del.) and check the "Attorneys" tab and any "Notice of Appearance" entries — my aggregator data show entries 1–9 only, with no appearance.
  2. If a Rule 41(a)(1)(A)(i) dismissal is at issue, confirm via PACER whether any defendant responsive pleading was ever filed; the docket and the dismissal text indicate none.
  3. For the operative defense-side representation on this product family, review the 1:24-cv-00753 and 1:25-cv-00663 dockets (same court, same judge, same defendant), where Granules actually litigated and signed settlement papers.

Confidence: High that no defense counsel of record exists for Granules in 1:24-cv-01091. Moderate on the related-case counsel names above, which come from secondary aggregators or single-document PDFs rather than a full docket review; treat them as leads to confirm, not as verified appearances in this case.