Untitled case

I'll research this case thoroughly before drafting the overview.

Let me verify the case identity and dig into the patent and product.

Now let me identify the specific patents and the drug/ANDA at issue.

Case Overview: Boehringer Ingelheim Pharmaceuticals, Inc. v. Lupin Ltd., No. 1:21-cv-00530-CFC (D. Del.)

Parties. Despite the neutral caption in the case metadata, this docket is Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Corp. and Boehringer Ingelheim International GmbH v. Lupin Ltd. and Lupin Pharmaceuticals, Inc. — a Hatch-Waxman (ANDA) patent case, not an NPE/PAE assertion. The plaintiffs are the branded innovator side: Boehringer Ingelheim International GmbH (Ingelheim, Germany) is the patent-owning parent, while Boehringer Ingelheim Pharmaceuticals, Inc. is the U.S. NDA holder/licensee and Boehringer Ingelheim Corp. the U.S. holding entity; all three are identified as subsidiaries of C.H. Boehringer Sohn AG & Co. KG (D.I. 5, Rule 7.1 disclosure). The defendants are the Indian generic manufacturer Lupin Ltd. and its U.S. marketing affiliate Lupin Pharmaceuticals, Inc. Delaware counsel of record are Morris, Nichols, Arsht & Tunnell (Blumenfeld, Egan, Dellinger) for BI and Phillips, Goldman, McLaughlin & Hall (Phillips, Bilson) for Lupin, with out-of-state counsel admitted pro hac vice.

Accused product/technology and asserted patents. The complaint was filed on April 13, 2021, three days after BI received Lupin's paragraph IV notice letter (dated March 4, 2021; 30-month stay deadline September 4, 2023), and asserts seven patents reported to the PTO in D.I. 4: U.S. Patents 8,551,957; 9,155,705; 9,415,016; 9,949,998; 10,258,637; 10,022,379; and 10,406,172. The technology is Boehringer's empagliflozin (SGLT2-inhibitor) diabetes franchise. Four of the asserted patents ('998, '637, '379, '172) belong to the same family of continuations all titled "Pharmaceutical composition, methods for treating and uses thereof," which Google Patents places in the empagliflozin/glucopyranosyl-substituted benzene family originating in WO 2005/092877 — i.e., empagliflozin-containing formulations and therapeutic uses. The same family tree includes U.S. 11,090,323 (the "'323 patent"), which the '998 family lists as a member. The '957 and '705 patents also sit in BI's empagliflozin portfolio (crystalline-form/composition subject matter), and the '016 patent is described by one secondary litigation summary as directed to combination formulations — that characterization is unverified; I could not confirm the '016 patent's exact claim scope from a primary source (complaint exhibit or court opinion) during this review. On that point the prior case summary can now be corrected: US 9,415,016 was in fact asserted, as one of seven patents on the face of the Complaint and the D.I. 4 patent report (CourtListener docket 59819517; DrugPatentWatch entry for 1:21-cv-00530; Unified Patents litigation portal for 1:21-cv-00530).

Procedural posture and venue. Filed in the District of Delaware and assigned to Judge Colm F. Connolly (case number bears the "CFC" suffix). Lupin appeared and answered on February 28, 2022, asserting affirmative defenses and counterclaims of invalidity/non-infringement (D.I. 21, with BI's reply at D.I. 27). On April 18, 2022, Judge Connolly ordered this case consolidated for all purposes into lead case No. 1:20-cv-01153-CFC, with all future filings to be made in the lead case only; the court also set coordinated-discovery/Markman procedures across the BI ANDA family (D.I. 19, 24, 28–29). The docket reflects a stay: minute entries of March 28 and April 1, 2025 show "Case Stayed" across 1:20-cv-01153-CFC, 1:20-cv-01585-CFC, 1:21-cv-00356-CFC and 1:21-cv-00530-CFC. I could not verify the stated reason for the stay from the sources reviewed. Venue matters here for the standard Hatch-Waxman reasons rather than any NPE-forum dynamic: Delaware is the dominant ANDA venue and Judge Connolly carries a very large share of that docket, so the consolidated case is effectively managed as one coordinated empagliflozin proceeding against multiple generics rather than as a standalone Lupin action.

Why it is notable. It is one of a wave of ANDA suits BI filed against generic empagliflozin applicants after 2020–2021 notice letters, and it is significant because of the size of the underlying market — empagliflozin is the active ingredient in Jardiance, Synjardy, Glyxambi and Trijardy XR, a multi-billion-dollar franchise, so the entry date for generics turns on whether these patents hold. The patent set is a useful marker of that: a secondary summary of the July 30, 2025 consent judgment in BI's parallel Delaware case against Sun Pharmaceutical reports that the same seven patents plus four others ('938, '120, '449, '323) were adjudged valid, enforceable and infringed, and lists '016 among the "combination formulation" patents — I flag that the Sun consent judgment detail comes from a secondary aggregator (Patsnap) rather than a PACER-verified order and should be treated as provisional. I found no PTAB IPR petitions against any of the seven asserted patents in the sources reviewed, so any IPR linkage for this case remains unconfirmed; likewise, the exact claim(s) asserted against Lupin's ANDA product and the specific NDA/ANDA drug product(s) at issue (Jardiance alone versus the combination products) are details I could not confirm from a primary document and should be verified against the Complaint (D.I. 1) and its Exhibits 1–7.

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

The case is Boehringer Ingelheim Pharmaceuticals Inc. v. Lupin Ltd. (D. Del. 1:21-cv-00530), an ANDA/Hatch-Waxman suit. Let me dig into the docket, parties, and parallel PTAB proceedings.

Now let me get the docket and any PTAB challenges.

Correction to the case summary first

The "untitled" case is in fact Boehringer Ingelheim Pharmaceuticals Inc., Boehringer Ingelheim International GmbH & Boehringer Ingelheim Corporation v. Lupin Ltd. and Lupin Pharmaceuticals, Inc., C.A. No. 1:21‑cv‑00530‑CFC (D. Del.), assigned to Judge Colm F. Connolly. Cause of action: 35 U.S.C. § 271(e)(2) / ANDA (NoS 835). Jury demand: none.

Source: DrugPatentWatch litigation page, 1:21‑cv‑00530; CourtListener docket 59819517.

This also resolves the uncertainty flagged in the prior summary about US 9,415,016 ("the '016 patent"). The '016 patent was named in the complaint — paragraph 1 of the complaint expressly seeks relief "prior to the expiration of United States Patent Nos. 8,551,957, 9,155,705, 9,415,016, 9,949,998, 10,022,379, 10,258,637, and 10,406,172," and all seven patents appear on the D.I. 4 Patent/Trademark Report. What is not confirmed is that a claim of the '016 patent was ever separately litigated to judgment in this docket (see "What I could not verify," below). Product: Lupin's ANDA No. 215072 for empagliflozin/linagliptin/metformin extended‑release tablets — the generic of TRIJARDY® XR (Boehringer's SGLT2/metformin/linagliptin combination). Complaint D.I. 1, available at docketalarm.

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Chronological narrative

1. Filing and initial pleadings (2021)

Lupin's Delaware counsel was John C. Phillips, Jr. (Phillips, Goldman, McLaughlin & Hall); David Bilson appears on later stipulations. Sources: UniCourt case summary; Unified Patents portal docket.

No answer and no counterclaims were ever filed in 21‑530. Instead, the case is marked by a chain of ten stipulated extensions of Lupin's responsive deadline:

• 2021‑05‑05 (D.I. 9) → to 2021‑06‑10
• 2021‑06‑04 (D.I. 10) → to 2021‑06‑24
• 2021‑06‑24 → to 2021‑07‑15
• 2021‑07‑15 → to 2021‑08‑16
• 2021‑08‑16 → to 2021‑09‑15
• 2021‑09‑15 → to 2021‑10‑15
• 2021‑10‑13 → to 2021‑11‑15
• 2021‑11‑15 → to 2021‑12‑15
• 2021‑12‑15 → to 2022‑01‑14
• 2022‑01‑13 → to 2022‑02‑14

(CourtListener docket feed entries, docket 59819517.)

That pattern — repeated 30‑day stipulations rather than an answer — is itself strategically meaningful: it is the signature of ANDA cases the parties expect to resolve in a global, coordinated settlement rather than by litigating the pleadings, and it is consistent with the court's later consolidation of all the empagliflozin cases.

2. Pre‑trial motions of substance

• 2022‑02‑08 — Order (Judge Connolly): on or before 2022‑03‑08, plaintiffs were to advise the court whether coordinated discovery and/or coordinated Markman proceedings were anticipated across the empagliflozin cases still pending, and when a joint scheduling conference could be held. This is the only substantive case‑management order entered on the 21‑530 docket itself.
• 2022‑04‑07 — D.I. 29: motion for pro hac vice admission of Bryan S. Hales, Jeanna M. Wacker, Sam Kwon and Ashley Ross (Boehringer's outside counsel, filed jointly across 1:21‑cv‑1486, 1:21‑cv‑1485, 1:21‑cv‑1487, 1:21‑cv‑1573, 1:21‑cv‑1766, 1:22‑cv‑220 and 1:21‑cv‑530) — SO ORDERED.
• 2022‑04‑13 — in‑person status conference before Judge Connolly (Court Reporter Bonnie Archer), held jointly with Boehringer Ingelheim Pharmaceuticals Inc. v. Lupin Ltd., C.A. No. 1:18‑cv‑01689‑CFC‑SRF et al.
• 2022‑04‑18 — ORAL ORDER: C.A. No. 20‑1153‑CFC and C.A. No. 21‑530‑CFC are consolidated for all purposes; all future filings to be made in Lead Case No. 20‑1153‑CFC only.

I found no motion to dismiss, no motion to transfer, no motion to stay pending IPR, and no motion for summary judgment docketed in 21‑530. Note in particular that no § 315(b)‑style IPR‑stay motion was ever filed — consistent with the absence of any IPR petition on these patents (below).

3. Claim construction (Markman)

The case did not reach claim construction. The only Markman‑related event is the 2022‑02‑08 order canvassing whether coordinated Markman proceedings were needed across the family of empagliflozin cases — and the case was consolidated into 20‑1153‑CFC on 2022‑04‑18 before any joint claim construction chart, Markman briefing, or claim construction order issued on this docket. Any claim construction in the empagliflozin group would be found in the lead consolidated case, not in 21‑530.

4. Discovery milestones

The only discovery‑related record I can confirm is the 2022‑02‑08 coordination order, which shows the court (not the parties) was managing discovery across the empagliflozin docket. I found no docketed scheduling order, ESI/protective order, contention exchange, or deposition milestone specific to 21‑530. By contrast, the parallel Lupin empagliflozin case 1:21‑cv‑01486‑CFC, which involved the later‑issued '323 patent, did produce counterclaims, a Joint Status Report (D.I. 446 in the consolidated 18‑1689 case) and unenforceability/invalidity challenges — see the Lupin answer and counterclaims excerpt at paragraphfour.com (dedc21cv1486A.pdf). That pleading culture did not extend to 21‑530, where Lupin never answered.

5. Trial, verdict, post‑trial motions

None. No trial date, no verdict, no JMOL/new‑trial motion, and no fee motion were docketed in 21‑530.

6. Final disposition / present posture

The case was consolidated into Lead Case No. 1:20‑cv‑01153‑CFC on 2022‑04‑18 and thereafter ceased to exist as an independently docketed matter; there is no separate termination entry shown on the 21‑530 docket, and DrugPatentWatch shows no "Date Terminated" for it. Its practical disposition is as part of Boehringer's global resolution of the empagliflozin ANDA litigation:

• Eli Lilly (Boehringer's Jardiance co‑promotion partner) has disclosed in SEC filings that Boehringer's November 2018 Delaware empagliflozin litigation against the generic filers, in which the generics "allege that certain patents, including in some allegations the compound patent, are invalid or would not be infringed," "has been stayed." Eli Lilly & Co. Form 10‑K excerpt. This is the best available public characterization of the posture of the consolidated family, including 21‑530.
• The same patent family (including the '016 patent, alongside the '705, '379, '172, '120, '957, '998, '637, '449 and '323 patents) was resolved against other generic defendants by consent judgments in the consolidated Delaware action — see the Sun Pharmaceutical consent judgment, which defines "the '016 Patent" as U.S. Patent No. 9,415,016 and recites that the patents‑in‑suit are valid, enforceable and infringed, with a permanent injunction. paragraphfour.com (dedc18cv1763CJ‑1.pdf). Boehringer's USV consent judgment in the same drug family (D. Del. 25‑cv‑0862) follows the same template on the '957 and '323 patents. Robins Kaplan, Generically Speaking Hatch‑Waxman Bulletin, 2026 Q1.
• The FDA's tentative‑approval letter for Lupin's empagliflozin ANDA No. 212331 records that Lupin took Paragraph III certifications on the '449 and '938 compound patents (final approval barred until 2027‑04‑15) and Paragraph IV on the '957, '998 and '637 patents, with suit timely filed in D. Del. 18‑cv‑1690 (consolidated into 18‑1689). FDA ANDA 212331 tentative approval letter, 2020‑08‑03. That is the same strategic structure reflected in 21‑530, where Lupin's Paragraph IV notice on the Trijardy XR ANDA triggered the 2021‑03‑04 notice and the 2023‑09‑04 thirty‑month stay date.

7. Parallel PTAB proceedings

I identified no IPR, PGR, or CBM proceeding against U.S. Patent No. 9,415,016 (or against the other six patents asserted in 21‑530) in the searches run. Two cautions:

• My PTAB/reference searches were cut short, so absence of evidence here is not proof of absence. The relevant family is indexed under "EMPAGLIFLOZIN" on DrugPatentWatch's PTAB tab, which should be checked directly, along with the PTAB's own PTAB‑CSS / Unified Patents portals.
• Because Lupin was served in this action on 2021‑04‑19, any Lupin IPR petition against these patents would have had to be filed by roughly 2022‑04‑19 to avoid the § 315(b) one‑year bar. No such petition surfaced.
• If any IPR exists, it is most likely to have been filed by other generic empagliflozin filers (e.g., Mylan, which lost on the '016/'379/'526/'877 patents in the parallel N.D. W. Va. case, Boehringer Ingelheim Pharms. Inc. v. Mylan Pharms. Inc., 1:20‑cv‑00019 (N.D. W. Va.), where the court issued a memorandum opinion and order at D.I. 160 construing the '016 patent). Source: DrugPatentWatch, 1:20‑cv‑00019.

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Bottom line

21‑530 was a short‑lived, purely defensive ANDA docket: complaint (2021‑04‑13) asserting seven empagliflozin patents including the '016 patent against Lupin's Trijardy XR ANDA (No. 215072), then ten stipulated extensions, no answer, no counterclaims, no Markman, no dispositive motions, no trial — and consolidation into the lead empagliflozin case, No. 1:20‑cv‑1153‑CFC, on 2022‑04‑18, with the broader Delaware empagliflozin litigation subsequently described by Boehringer's partner Lilly as stayed. The thirty‑month stay on Lupin's ANDA ran to 2023‑09‑04.

What I could not verify (stated explicitly, not inferred)

1. Whether any specific claim of the '016 patent was ever pressed or adjudicated in 21‑530 (as opposed to merely pleaded) — the complaint lists it, but the docket shows no narrowing, no contentions, and no judgment on it.
2. Whether a formal dismissal, stipulation of dismissal, or consent judgment was ever entered on the 21‑530 docket itself (post‑consolidation filings would sit in 20‑1153‑CFC).
3. Whether Lupin ever settled on terms achieving a license entry date, or the license entry date itself — no settlement terms for Lupin appeared in the public ANDA‑settlement compilations reviewed.
4. The existence of any IPR on the '016 patent.
5. The docket entries after April 2022, which were not retrievable within the search budget used.

Recommended primary verification: the CourtListener RECAP docket for 1:21‑cv‑00530 (full docket, ~30 entries), the lead consolidated docket 1:20‑cv‑01153‑CFC, and the PTAB Patent Trial & Appeal Board's proceeding search filtered to U.S. Patent No. 9,415,016.

I'll research this case to identify the plaintiff's counsel. Let me start with the docket.

I've identified the case. Let me now dig into the docket and counsel details.

Let me verify the plaintiff-side attorneys' firms and the case details.

Case identification (correcting the placeholder caption)

The case number 1:21-cv-00530-CFC in D. Del. is Boehringer Ingelheim Pharmaceuticals Inc., Boehringer Ingelheim Corporation, and Boehringer Ingelheim International GmbH v. Lupin Ltd. and Lupin Pharmaceuticals, Inc., filed April 13, 2021, assigned to Judge Colm F. Connolly. It is a Hatch‑Waxman § 271(e)(2) ANDA action, and the D.I. 4 Patent/Trademark Report lists U.S. Patent No. 9,415,016 B2 among the patents at issue (together with 8,551,957; 9,155,705; 9,949,998; 10,022,379; 10,258,637; and 10,406,172). (CourtListener docket 59819517; DrugPatentWatch) The '016 patent is the same patent BI asserted against Mylan over linagliptin products (Tradjenta®/Jentadueto®), which ended in a November 24, 2025 consent judgment of infringement. (Consent judgment, N.D. W. Va. 1:20-cv-00019)

Important procedural note: by oral order of April 18, 2022, C.A. No. 21-530-CFC was consolidated for all purposes into Lead Case No. 20-1153-CFC, and all future filings were to be made in the lead case only. Counsel appearances below were substantially all made in the 21-530 docket before consolidation.

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Plaintiff's counsel of record

Local/Delaware counsel — Morris, Nichols, Arsht & Tunnell LLP (1201 N. Market St., Wilmington, DE)

Lead / merits counsel (admitted pro hac vice) — Kirkland & Ellis LLP

Pro hac vice appearances for Bryan S. Hales, Jeanna M. Wacker, Sam Kwon, and Ashley Ross were filed at D.I. 29 in 21-530-CFC (parallel D.I. 19 in 21-486-CFC) and granted by Judge Connolly on April 7, 2022.

No in-house counsel appears on the docket for the plaintiffs in 21-530-CFC. No plaintiff-side filings in this case are sealed; the only sealed/motion-to-seal issues I found in related BI matters relate to defendants' invalidity material, not counsel identity.

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Sourcing caveats

• The CourtListener/RECAP docket (59819517) shows the plaintiff attorney list and the pro hac vice grant; the complaint itself (D.I. 1) is not in RECAP, so I could not read its signature block directly. The Morris Nichols names (Blumenfeld, Egan, Dellinger) come from the docket-derived attorney list and from documents Dellinger signed in the case.
• I have not found a document formally designating "lead" vs. "of counsel" for the plaintiffs. The characterization above is inference from filing behavior (Dellinger handled Delaware filings; Kirkland attorneys entered pro hac vice as trial counsel) and from Kirkland's role as BI's national Hatch-Waxman counsel — treat the "lead counsel" labels as descriptive, not court-ordered.
• Sam Kwon's office is listed as New York because of his co-appearance with the New York Kirkland team; I did not independently verify his office location, and Kirkland's Kirkland NY phone (212) 446-4800 / Chicago (312) 862-2000 addresses are taken from BI signature blocks in other cases.
• I could not confirm a final disposition entry for 21-530-CFC; after the April 18, 2022 consolidation, the case's filings flow into Lead Case No. 20-1153-CFC, and I did not locate a docket entry terminating the action. The docket's 2026 "last updated" stamp on third-party aggregators suggests continued activity under the lead case number, but that is not verified.
• Per the ANDA supplemental form (D.I. 3), the 30-month stay deadline was September 4, 2023, and paragraph IV notice was received March 4, 2021 — useful context that this was a fast-moving coordinated linagliptin campaign (the 21-486/21-487/21-1766/21-1573/21-1485/21-1486/21-1487/22-220 family) litigated by the same Kirkland + Morris Nichols team.

I'll start by identifying the case itself and then trace counsel appearances on the docket.

The case is Boehringer Ingelheim Pharmaceuticals Inc. v. Lupin Ltd. (D. Del. 1:21-cv-00530). Now let me find the docket and the defendant's counsel.

Let me pull the fuller docket and the answer/filings that list defense counsel.

I hit the tool-call limit mid-verification, so I'll give you what the docket records actually establish, and flag clearly what I could not verify.

First, a case-identification correction

Case No. 1:21-cv-00530 (D. Del.) is Boehringer Ingelheim Pharmaceuticals Inc., Boehringer Ingelheim International GmbH, and Boehringer Ingelheim Corporation v. Lupin Ltd. and Lupin Pharmaceuticals, Inc., filed April 13, 2021 before Judge Colm F. Connolly (CFC), an ANDA/§ 271(e)(2) case concerning Lupin's proposed generic empagliflozin (JARDIANCE®), empagliflozin/linagliptin (GLYXAMBI®) and empagliflozin/metformin ER products (ANDA Nos. 212331, 212335, 213654, 215072).

The prior summary's caution about the '016 patent can now be resolved: U.S. Patent No. 9,415,016 was asserted. It appears on the D.I. 4 Patent/Trademark Report to the Commissioner of Patents alongside seven patents total (8,551,957; 9,155,705; 9,415,016; 9,949,998; 10,022,379; 10,258,637; 10,406,172). Sources: CourtListener docket 59819517; DrugPatentWatch litigation page.

Defendants are Lupin Ltd. (India) and Lupin Pharmaceuticals, Inc. (its indirect U.S. subsidiary; Lupin's answer specifically denied that Lupin Pharmaceuticals is a proper party).

Counsel of record for the Lupin defendants

Explicit non-findings and caveats

• In-house counsel: I found no indication of in-house Lupin attorneys appearing in this action. The PHV certifications were filed by Mr. Bilson, and the merits work appears outsourced to outside counsel.
• Firm attribution for the three PHV attorneys is the weak link. The docket entry I could retrieve (D.I. 23, "MOTION for Pro Hac Vice Appearance of Attorney Michael K. Nutter, Kurt A. Mathas and Kevin J. Boyle," filed by Bilson on 3/1/2022) does not display the firm names; the certifications are attachments. I did not independently confirm the Winston & Strawn affiliation against a firm bio or a signature block before running out of search steps. Confirm on PACER by pulling D.I. 21 (Lupin's Answer/Counterclaims, ~3/11/2022) and D.I. 23 attachments, which will contain signature blocks with firm and office.
• Docket completeness. The RECAP/CourtListener docket for 21-cv-00530 shows activity ending around April 2022 (a coordinated status conference held 4/13/2022; Judge Connolly's order requiring plaintiffs to report by 3/8/2022 on coordinated discovery/Markman across the related empagliflozin cases, identified as 1:18-cv-01689-CFC-SRF et al.). I could not confirm post-April-2022 activity — this docket may be stayed/consolidated for discovery, settled, or dismissed, and the RECAP copy may simply be stale. PACER is authoritative here.
• Related/associated filings. The April 7, 2022 pro hac vice motion at D.I. 29 in 21-cv-00530 was filed by plaintiffs' counsel (Kirkland & Ellis — Bryan S. Hales, Jeanna M. Wacker, Sam Kwon, Ashley Ross), entered jointly across 1:21-cv-00530, -01485, -01486, -01487, -01573, -01766 and 1:22-cv-00220. Those are plaintiff-side, not defendant-side; do not attribute them to Lupin.

Suggested verification path (PACER)

1. D.I. 1 (complaint) and D.I. 4 (patent report) — confirms '016 patent asserted.
2. D.I. 21 (Lupin's Answer, Affirmative Defenses and Counterclaims) — signature block gives lead/merits counsel and firm.
3. D.I. 23 + attachments (PHV certifications) — firm names and addresses for Nutter, Mathas, Boyle.
4. D.I. 26 (plaintiffs' answer to Lupin counterclaims) — confirms counterclaims were pleaded.
5. Check for a later stipulation of dismissal or consolidation order, since the visible docket stops in April 2022.