US 9415016

I'll search for authoritative information on US 9415016, including its claims and any 2026 CAFC docket activity.

Let me look for the claim text of US 9415016 and any Federal Circuit activity.

Let me try to retrieve the actual claim set from a patent-claims database, and check for any CAFC docket.

US 9,415,016 B2 — Summary

A note on scope/uncertainty up front: I was able to verify the bibliographic data, abstract, and specification content from the patent text and confirmed bibliographic sources. I was not able to retrieve the verbatim granted claim set (the claims section did not load from the sources I reached). The claim overview below is therefore inferred from the specification, the Orange Book listing, and the Google Patents claim-term data, and should be treated as provisional rather than authoritative. I also found no Federal Circuit 2026 docket activity for this patent.

Bibliographic data (verified)

Caveat on dates: The filing date (2015) is later than the 2008 priority date because this is a continuation in a family descending from the 2008 priority application (via US 12/935,634, which issued as US 9,155,705). That is consistent with the Google Patents "Application filed by Boehringer Ingelheim" event dated 2015-08-27.

Abstract (verbatim)

"The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases."

Plain-language overview of the invention

The patent describes fixed-dose combination (FDC) tablet formulations combining a DPP-4 inhibitor with a second antidiabetic ("partner") drug. Its central technical problem is chemical incompatibility: DPP-4 inhibitors bearing a free primary/secondary amino group (e.g., linagliptin, internally called BI 1356) degrade in the presence of metformin HCl and various excipients, forming N-acetyl and N-carbamoyl degradation products. The claimed solution is to include a nucleophilic/basic stabilizer — specifically the basic amino acid L-arginine — in the formulation.

Preferred embodiments throughout the specification:

• DPP-4 inhibitor: 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine free base (BI 1356 / linagliptin)
• Partner drug: metformin hydrochloride (also lists pioglitazone, atorvastatin, telmisartan)
• Stabilizer: L-arginine
• Dosage forms covered: mono-layer tablets, bi-layer tablets, tri-layer tablets, press-coated tablets (tablet-in-tablet and "bull's eye"), and film-coated tablets with the DPP-4 inhibitor applied as a drug layer.

Claim overview — inferred, not verbatim-verified

Based on the specification and the Google Patents claim-term frequency data (metformin hydrochloride, linagliptin, L-arginine, magnesium stearate, colloidal silica appear heavily in claim-linked text), the independent claims appear to be directed to pharmaceutical compositions / oral solid dosage forms (tablets) rather than methods of treatment, roughly as follows:

1. A pharmaceutical composition (tablet) comprising a DPP-4 inhibitor (linagliptin/BI 1356, optionally its salt), metformin hydrochloride, L-arginine, and one or more pharmaceutically acceptable excipients. The L-arginine is the distinguishing stabilizing feature.

2. Dependent claims likely add: the specific DPP-4 inhibitor identity; amounts (e.g., linagliptin 2.5 mg with metformin HCl 500/850/1000 mg and L-arginine ~1.0–25 mg); specific excipients (corn starch, pregelatinized starch, D-mannitol, copovidone, magnesium stearate, colloidal anhydrous silica); the tablet architecture (mono-layer, bi-layer, press-coated/tablet-in-tablet/bull's eye, or film-coated with drug layering); and the weight ratios disclosed (DPP-4 inhibitor : L-arginine ~1:20 to 10:1; metformin HCl : L-arginine ~40:1 to 1000:1).

I could not confirm whether the granted claims also include an independent process claim (e.g., for making the granules/tablet) or a use/indication claim (treatment of type 2 diabetes). The specification contemplates both, but I cannot verify their presence in the granted claims without the verbatim claim text.

Litigation / regulatory context (verified)

• Orange Book: US 9,415,016 is listed for Trijardy XR (empagliflozin / linagliptin / metformin HCl) with expiration Apr 2, 2029 (patent use code DP).
• US district court cases associated with this patent family (per Google Patents/Unified Patents): D. Del. 1:21-cv-00530; N.D. W. Va. 1:20-cv-00090; E.D. Pa. 2:20-cv-02545; D. Del. 1:24-cv-01091; D. Del. 1:20-cv-01153.
• Federal Circuit 2026: I found no CAFC docket naming 9,415,016. Searches returned (a) a Canadian Federal Court statement of defence involving Ascend and Boehringer Ingelheim Canada (April 2026) concerning unrelated Canadian patents, and (b) Japanese IP High Court decisions dated 2026-04-22 involving linagliptin combination-therapy patents (Nipro v. Boehringer Ingelheim). Neither involves US 9,415,016, so I am flagging them as tangential, not evidence of CAFC activity.

Caveats

• I could not verify the verbatim independent claim language; the descriptions above are reconstructions from the specification and aggregated claim-term data.
• I found no 2026 Federal Circuit appeal for this patent; absence of a result is not proof that none exists.
• Dates and status fields come from Google Patents/Espacenet and are stated by those sources as assumptions, not legal conclusions.

I'll research litigation involving US patent 9415016. Let me search multiple sources.

Let me try more targeted searches on litigation databases.

I found key leads. Let me research the specific case numbers listed on the patent page.

Litigation Involving US Patent 9,415,016

Bottom line up front

US 9,415,016 ("DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation"), assigned to Boehringer Ingelheim International GmbH, is listed by Google Patents as being part of a patent family that has been litigated. The patent has a priority date of 2008‑04‑03, a filing date of 2015‑08‑27 (as a continuation/divisional‑type application, app. no. 14/836,996), and an anticipated expiration of 2029‑04‑02. It is Orange Book–listed for JENTADUETO XR (linagliptin/metformin HCl, NDA 208026).

I was able to confirm the full party/outcome details of one case directly. For the remaining cases listed on the patent record, I could not, within the search limits of this session, independently confirm plaintiff/defendant/outcome — so I flag those explicitly as unverified rather than guessing.

Confirmed case

• Plaintiff counsel: Brian P. Egan and Megan Elizabeth Dellinger, Morris, Nichols, Arsht & Tunnell LLP.
• Source: PACER docket for 1:24‑cv‑01091, as reported at https://www.patsnap.com/resources/blog/litigation/boehringer-ingelheim-v-granules-india-jentadueto-patent-suit-patsnap/

This is a Hatch‑Waxman ANDA‑style action (Granules is an Indian generics manufacturer seeking U.S. market entry for linagliptin/metformin tablets).

Additional cases listed on the patent record (details NOT independently verified)

The Google Patents page for US 9,415,016 (https://patents.google.com/patent/US9415016/en) lists the following additional U.S. litigation under "Family has litigation." I was unable to retrieve party names, filing dates, or outcomes for these in this session, and I will not speculate:

Important caveat: Google Patents labels these under "Family has litigation," which is a family‑level designation. That means these cases involve one or more patents in the same family; it does not necessarily guarantee that US 9,415,016 itself was asserted in every one of them. Confirming whether the '016 patent was a specifically asserted claim in cases 1:21‑cv‑00530, 1:20‑cv‑00090, 2:20‑cv‑02545, and 1:20‑cv‑01153 would require retrieving the individual complaints from PACER or the Unified Patents Portal.

Context that may help identify these (unconfirmed, offered only as leads): The co‑plaintiff structure in the confirmed Granules case (Boehringer Ingelheim Pharmaceuticals Inc. + Boehringer Ingelheim International GmbH + Boehringer Ingelheim Pharma GmbH & Co. KG) is the typical structure BI uses in its JENTADUETO/TRADJENTA ANDA litigation. The 2020 filings (1:20‑cv‑00090, 2:20‑cv‑02545, 1:20‑cv‑01153) are plausibly part of a wave of ANDA suits over linagliptin/metformin FDC products; the N.D. W. Va. venue in particular is consistent with a defendant with operations in that district. I have not confirmed any defendant names for these four cases.

Family‑level (non‑U.S.) litigation

Google Patents also flags "First worldwide family litigation filed" via Darts‑ip family 39714040 (https://patents.darts-ip.com/?family=39714040...). Separately, Boehringer Ingelheim has pursued extensive Indian litigation over its linagliptin patents (e.g., Macleods, Delhi High Court LPA 129/2025, involving IN'301). Those Indian proceedings concern Indian patent rights, not US 9,415,016, and should not be conflated with the U.S. cases above.

Reliability notes

• I did not auto‑correct any patent or case numbers; all identifiers above are reproduced exactly as they appeared in the sources.
• The confirmed Granules entry is sourced to PACER docket records for 1:24‑cv‑01091 as compiled by PatSnap. PACER itself is the authoritative primary source if you need certified docket copies.
• For the four unverified case numbers, you should pull the dockets directly from PACER (https://pacer.uscourts.gov) or the Unified Patents Portal case pages to obtain plaintiffs, defendants, filing dates, and dispositions. I could not do so within this session.
• US 9,415,016's Orange Book listing (product patent, expiration 2029‑04‑02) is corroborated by the FDA Orange Book cumulative supplement (Dec. 2020) and the NDA 208026 entry for JENTADUETO XR.

I'll start by searching for any PTAB proceedings on this patent, since the structured block indicates no AIA trials on file from ODP.

The first search surfaced a different patent ('941 = Ancora's 6,411,941), which is a false positive. Let me search more precisely for this patent and its family in PTAB.

Let me check the DrugPatentWatch PTAB case page for this specific patent and search for any IPR/petitioner against it.

Proceedings overview

Zero AIA trial proceedings on file for US 9,415,016. The canonical structured block from the USPTO Open Data Portal reports no IPR, PGR, or CBM proceeding for this patent, and my independent web searches (Google Patents family data, Unified Patents portal entries, DrugPatentWatch PTAB case listings, and general PTAB/CAFC queries) surfaced no petition, institution decision, or Final Written Decision naming US 9,415,016 as the challenged patent. The breakdown is therefore: 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denied. The bottom-line defensive posture for a defendant is not "the patent has survived IPRs and is hardened" — it is that the validity of the '016 claims has never been tested at the PTAB. The claims stand unadjudicated, which cuts both ways: no claim has been canceled for you to point to, but the patent owner also has no PTAB victory it can wave at the district court.

One false positive to flag and discard: search engines repeatedly return results for US 6,411,941 (Ancora Technologies — the Ancora v. Roku/VIZIO/Nintendo line of IPRs). That is a different patent in a different technology and has nothing to do with this case. I mention it only so the identifiers are not conflated.

A second adjacent-but-distinct item is worth flagging: IPR2016-01566 (Mylan Pharmaceuticals Inc. v. Boehringer Ingelheim International GmbH) challenged US 9,173,859 — a different linagliptin/metformin patent in BI's Orange Book stack, not the '016 patent. The Board denied institution, holding that Mylan failed to make the threshold showing that a Glucophage® drug label was a prior-art printed publication. This is a useful pattern signal (see below) but it is not a proceeding on US 9,415,016, and I am not counting it as one.

Per-proceeding detail

Not applicable — no proceedings to describe. Because there is no AIA trial on this patent, there is no proceeding number, petitioner, panel, institution decision, FWD, settlement, or appeal to report. I will not invent one.

For completeness, the verified public record establishes the following about the '016 patent:

• Patent identity: US 9,415,016 B2, "DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation," application 14/836,996, filed 2015-08-27, granted 2016-08-16, earliest priority 2008-04-03, assignee Boehringer Ingelheim International GmbH. Google Patents lists anticipated expiration 2029-04-02 and Active legal status. Family identifier 39714040 (shared with US 9,155,705, US 10,022,379, US 10,973,827).
• Orange Book listing: protects JENTADUETO, JENTADUETO XR, and TRIJARDY XR; patent expiration 2029-04-02 with pediatric exclusivity (PED) noted to 2029-10-02.
• Asserted claims: independent claim 1 is a composition claim (linagliptin at 2.5 mg or 5 mg; metformin HCl; one or more excipients; a basic amino acid such as L-arginine in a degradation-suppressing amount; film-coated tablet; 0.1–0.5% linagliptin and 47–85% metformin HCl by weight of total coated tablet mass). Dependent claims 2–11 (and beyond) recite stabilization, L-arginine/L-lysine/L-histidine, dosage strengths, metformin amounts, and L-arginine amounts.
• District court activity (not PTAB): The '016 patent has been asserted in Hatch-Waxman suits including Boehringer Ingelheim v. Lupin (D. Del., Trijardy XR — asserted alongside US 8,551,957; 9,155,705; 9,949,998; 10,022,379; 10,258,637; 10,406,172) and Boehringer Ingelheim Pharmaceuticals Inc. v. Granules India Ltd., No. 1:24-cv-01091 (D. Del.) — where, per the docket, BI voluntarily dismissed without prejudice under Rule 41(a)(1)(A)(i) before any answer or summary-judgment motion. The prompt's structured block also lists Delaware (1:21-cv-00530, 1:20-cv-01153, 1:24-cv-01091), W.D. Pa. (2:20-cv-02545), and N.D. W. Va. (1:20-cv-00090) cases in the family. Note the distinction that matters: a Rule 41(a)(1)(A)(i) dismissal is not a merits adjudication and is not a PTAB outcome — the '016 claims remain fully intact and unchallenged on the merits.

Strategic summary

Claim status: everything SUSTAINED-by-default; nothing CANCELED; nothing TESTED. No claim of US 9,415,016 has been canceled or narrowed by the PTAB, because no AIA trial has ever reached a Final Written Decision on this patent. All of claims 1–11+ (as issued, including independent composition claim 1 and its dependents) remain live and presumptively valid under § 282. Contrast this with the district court picture: even where BI's cases have ended, they ended by motion, not judgment — the Granules dismissal was expressly without prejudice and before defensive pleadings, so there is no invalidity or non-infringement ruling a defendant can borrow.

Estoppel landscape — there is none, and that is the opportunity. Because no petitioner has ever been through an IPR on this patent, § 315(e)(2) estoppel is a blank slate. No prior petitioner is barred from anything, and — critically — you are not constrained by anyone else's prior grounds either, because there is no prior IPR record to inherit. That means the full universe of § 102/§ 103 prior-art combinations remains available to a defendant who wants to file a fresh IPR, subject only to § 315(b)'s one-year bar from service of an infringement complaint and the Board's § 325(d) / General Plastic discretion. (A defendant served more than one year ago on this patent has forfeited the IPR route and would be confined to district-court invalidity, where the burden is clear-and-convincing rather than preponderance.)

Pattern signals. BI is a serial PTAB petitioner on other companies' patents (DrugPatentWatch lists BI as petitioner in IPRs against Genentech, Biogen, and others) but has never been a PTAB patent owner on this patent and, on the adjacent '859 patent, defeated a Mylan IPR at the institution stage on a printed-publication technicality (IPR2016-01566). The family has not attracted a defensive aggregator — I found no Unified Patents or other aggregator IPR on the '016 patent (Unified's portal merely lists the patent bibliographically). The litigation pattern — multiple generics (Lupin, Granules, Mylan, and the 2020–2021 Delaware/Pennsylvania/West Virginia cases) sending Paragraph IV notices and BI responding with serial district-court complaints rather than facing IPRs — suggests challengers have either chosen the ANDA/Paragraph IV track over AIA trials, settled, or been unable to assemble institution-quality art on the composition claims.

Recommended next steps

1. Do not expect a shortcut. There is no FWD to link to and no canceled claim to quote. Any demand-letter response premised on "the PTAB already killed this patent" would be unsupportable. The absence of PTAB activity is the signal: well-asserted Orange Book patents like this one are usually IPR targets, and this one has never been hit — so treat the claims as strong-until-proven-otherwise and build your own record.
2. Run a fresh prior-art / § 112 diligence pass before committing to an IPR. Given no prior petitioner has consumed any ground, an IPR remains fully available to a newly-served defendant (file within one year of service under § 315(b)). Target independent claim 1's core limitations — the "basic amino acid … in an amount sufficient to suppress degradation," the 0.1–0.5% linagliptin / 47–85% metformin HCl weight ranges, and the film-coat element — and confirm the priority date (2008-04-03) and the intervening prior art (e.g., the fixed-dose-combination and linagliptin formulation literature from 2007–2008).
3. Watch the co-family patents. The '016 patent shares family 39714040 with US 9,155,705, US 10,022,379, and US 10,973,827. An invalidity theory that lands on the '016 composition may also reach the siblings, and vice versa — but note that a win on a sibling is not a win here.
4. If you are a plaintiff-side or a defendant already past the § 315(b) window, the strategy space is district-court invalidity (clear-and-convincing) and inter partes or ex parte reexamination (no § 315(b) bar, lower estoppel exposure) rather than IPR. Consider that route deliberately; it is the only PTAB-adjacent channel still open to a time-barred party.

Caveat on sourcing: the conclusion "no AIA trial on US 9,415,016" rests on (a) the authoritative ODP structured block and (b) my searches of Google Patents, DrugPatentWatch, Unified Patents, and general PTAB/CAFC queries. If the ODP ingest lags a very recently filed petition, a brand-new proceeding could exist that neither source has indexed — I found no evidence of one, and I have not fabricated any proceeding number to fill the gap. For a definitive check, run the patent number directly through USPTO PTAB E2E / PatentCenter and the CourtListener docket search at the URLs below.

• USPTO PTAB E2E: https://ptacts.uspto.gov/ptacts/public-informations/patents/search
• USPTO PatentCenter for US 9,415,016: https://patentcenter.uspto.gov/ (application 14/836,996)
• Google Patents (authoritative text used here): https://patents.google.com/patent/US9415016/en
• CourtListener docket search: https://www.courtlistener.com/?q=%229415016%22

I'll research the assignment record and ownership chain for US 9415016 before writing up the analysis.

Let me dig into the litigation history and any recorded assignments.

Let me check for recorded assignment data and the Google Patents legal events page.

Ownership & Assignment Analysis — US 9,415,016 B2

Patent: US 9,415,016 B2 — "DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation"
Application: 14/836,996 · filed 2015-08-27 · granted 2016-08-16 · priority 2008-04-03
Source of record: https://patents.google.com/patent/US9415016/en

Data-access note up front. I attempted to pull live records from the USPTO Patent Assignment Search (assignmentcenter.uspto.gov / assignment.uspto.gov) and could not retrieve reel/frame-level entries for this patent through the tools available in this session. I therefore will not invent reel/frame numbers or correspondents. What follows is grounded in the sources I could reach: Google Patents legal events, Espacenet bibliographic data, FDA Orange Book listings, and federal court dockets. Where a datum is unverified, I say so. This is itself a caveat to the confidence of the verdict below.

Inventors

Employer attribution caveat: The residence data above comes from Espacenet's bibliographic record (inventors listed as DE and JP). Employer is inferred from the corporate-affiliation pattern typical of BI's German and Japanese formulation-development sites; I have not independently confirmed employment contracts or inventor assignment agreements. Treat the "employer" column as reasonable inference, not a documented record.

Unusual-pattern check — negative. There is no evidence of the pre-fire-sale tell described in the brief (all inventors departing the assignee within 12 months of filing). The inventor team is a mixed German/Japanese formulation-development group, wholly consistent with a large-cap pharma R&D collaboration between BI's German and Japanese affiliates. The subsequent chain of continuations (see timeline) shows sustained prosecution by the same corporate applicant, not abandonment.

Original assignee

Boehringer Ingelheim International GmbH (Ingelheim am Rhein, Germany) — named as original assignee on the issued patent and still shown as current assignee in Google Patents' legal-events block.

• Business: Privately held, family-owned multinational pharmaceutical company (not publicly traded). DPP-4/metformin franchise is a core metabolic-disease asset.
• Product embodying the claims: Yes, unambiguously. US 9,415,016 is listed in the FDA Orange Book as a product patent (Y) for JENTADUETO® (linagliptin/metformin HCl, NDA 201281; approved 2012-01-30 in 2.5/500, 2.5/850 and 2.5/1000 mg strengths) and for JENTADUETO XR® (NDA 208026; approved 2016-05-27). Listed expiration 2029-04-02; with pediatric exclusivity, 2029-10-02.
• Current status: Operating. BI is an active commercially selling entity, not acquired, dissolved, or in bankruptcy. It is asserting this patent itself in litigation (see below).

Assignment timeline

Plain finding: I found no evidence of any recorded assignment of US 9,415,016 away from the Boehringer Ingelheim group — no transfer to a shell entity, licensing LLC, aggregator, or any third party. The patent is a continuation in a family that BI has held continuously since the 2008 priority filing.

Two honest limitations on this finding:

1. I could not verify the reel/frame-level record for this patent in the Assignment Center during this session. It is normal for a corporate family like this to carry one or more routine "Assignment" records (inventor → BI operating entity) and possibly a "Change of Name" or intra-group record (e.g., Boehringer Ingelheim Pharma GmbH & Co. KG → Boehringer Ingelheim International GmbH). I cannot confirm or date those entries and will not fabricate them.
2. Google Patents' legal-events block for this patent shows no assignment events at all — only prosecution milestones (priority to continuations, publication, grant). That is consistent with the applicant of record having been the assignee from the outset (a 37 CFR 1.46/1.47-type corporate filing), leaving nothing to record post-issuance.

Ownership-adjacent events from non-assignment sources (for context, not substitutes for reel/frame records):

• 2008-04-03 — Priority filing (EP 08154039) by the Boehringer Ingelheim group. Context: original corporate filing.
• 2009-04-02 — PCT application filed (WO 2009/EP53978). Context: international phase.
• 2010-12-03 — US national phase entered (12/935,634 → later US 9,155,705). Context: US prosecution.
• 2015-08-27 — Continuation application 14/836,996 filed; grants as US 9,415,016. Context: internal continuation strategy within the same assignee — not a transfer.
• 2020–2024 — BI (as plaintiff) files ANDA infringement suits naming this patent. Context: enforcement by the owner, not a transfer-to-asserter.

If the Assignment Center shows records I could not reach, the expected entries would be ordinary inventor-to-employer assignments and possibly an intra-BI change-of-name. Neither pattern is an NPE signal.

Timeline diagram

timeline
    title Ownership of US 9415016
    2008 : Priority filing by Boehringer Ingelheim
    2009 : PCT application filed
    2010 : US national phase entered
    2012 : Jentadueto approved in the US
    2015 : Continuation application 14836996 filed
    2016 : US 9415016 granted to BI International
         : Jentadueto XR approved
    2020 : First ANDA suits filed by BI
    2021 : Additional ANDA suits filed
    2024 : Granules India suit dismissed

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. No transfer of this patent from BI to any "IP / Holdings / Licensing / Ventures" style entity appears in any source I reached. Current assignee remains Boehringer Ingelheim International GmbH. No single-purpose Delaware/Texas LLC is in the chain.

2. Known asserter in the chain — NOT PRESENT. No assignee in the record matches the NPE directory entries in the brief (Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant, Vringo, Pendrell, Innovatio, Round Rock, etc.). The asserting party is BI itself. Unified Patents' portal lists this patent under Boehringer Ingelheim International GmbH as assignee (https://portal.unifiedpatents.com/patents/patent/US-[7838529](/patent/7838529)-B2), i.e., the operating company — the opposite of the pattern the directory is designed to surface.

3. Repeat correspondent across the chain — NOT PRESENT / UNVERIFIED. Because I could not pull the recorded assignment entries, I cannot name a correspondent of record or test for recurrence. Nothing in the litigation record suggests an NPE-side filing agent; plaintiff counsel of record in the ANDA suits are BI's outside litigation firms (e.g., Morris, Nichols, Arsht & Tunnell LLP in D. Del.; Kirkland & Ellis for the broader Tradjenta/Jentadueto campaign) — that is operating-company litigation counsel, not a recording agent for shell LLCs. Not a finding, and I flag it as unverified rather than claim a negative I cannot support.

4. Cascading transfers — NOT PRESENT. The only "chain" here is a chain of continuations within one owner (14/836,996 → 15/203,906 → 15/403,705 → 16/007,047 → 16/676,643 → 17/199,569 → 17/876,700 → 18/345,029 → 18/666,901). These are same-assignee divisional/continuation filings tracked by Google Patents as "priority to," not a cascade of LLC-to-LLC assignments. Do not mistake the continuation chain for an ownership cascade.

5. Pre-litigation transfer — NOT PRESENT. No assignment is dated within 6 months before the first suit. The first relevant suit (Boehringer Ingelheim Pharmaceuticals Inc. v. Lupin Ltd., D. Del. 1:21-cv-00530, filed 2021-04-13) was brought by BI entities that had owned the family since 2008. Assertion was enabled by the owner's own long-held rights, not by a freshly recorded transfer.

6. Bankruptcy fire-sale — NOT PRESENT. BI is a profitable, family-owned operating company; no Chapter 7/11 proceeding is implicated for this patent.

7. Privateering — NOT PRESENT. This is the opposite configuration: BI asserts directly, in its own name, against generic competitors. There is no operating-company-to-NPE transfer with BI asserting behind a proxy.

8. Defensive aggregator — NOT PRESENT. The chain does not terminate at RPX, AST, LOT, or OIN. No neutralization signal.

Verdict

Operating-company assertion.

Boehringer Ingelheim International GmbH is the original and current assignee of US 9,415,016 (Google Patents legal events show no assignment events; Unified Patents lists BI as assignee), and the patent is Orange Book-listed as a product patent for JENTADUETO / JENTADUETO XR — a product BI actually manufactures and sells. BI asserts the patent in its own name against generic ANDA filers (D. Del. 1:21-cv-00530, filed 2021-04-13; N.D. W. Va. 1:20-cv-00090; E.D. Pa. 2:20-cv-02545; D. Del. 1:24-cv-01091), which is the textbook profile of a brand-owner enforcing against actual competitors rather than an NPE monetizing a bought patent.

Confidence caveat: This is a strong negative on NPE signals, but it rests on secondary sources (Orange Book, court dockets, Google Patents, Unified Patents) rather than on first-hand reel/frame records, which I could not retrieve this session. To close the loop, verify directly here: https://assignment.uspto.gov/patent/index.html (search "9415016") and https://assignmentcenter.uspto.gov/. Expect only routine inventor-to-employer and/or intra-BI records — anything transferring this patent outside the Boehringer Ingelheim group would contradict every other source consulted and should be treated as a red flag warranting re-analysis.

I'll search for the prior art citations on US 9,415,016. Let me run several targeted queries.

The Google Patents text didn't load a "References Cited" list. Let me try USPTO/Justia/PatentGuru and the parent patent for the cited references.

Prior Art for US 9,415,016 — Search Results and §102 Analysis

Search limitation — read this first

I attempted to retrieve the verbatim front‑page "References Cited" list for US 9,415,016 from the USPTO/Google Patents/Espacenet records. That list did not load in any source I reached. The Google Patents text for the patent reproduces the abstract, description, claims‑linked chemical data, and "Similar Documents," but not the examiner‑cited "U.S. Patent Documents" / "Foreign Patent Documents" boxes. I could not reach USPTO PatentCenter directly within this session.

Consequently:

• I cannot give you a certified, complete list of the examiner‑cited references on the '016 face.
• What I can give you, authoritatively, is the set of patent and literature references expressly cited inside the '016 specification itself (the full text you supplied is the authoritative source), plus a set of family/similar‑document listings I found — the latter flagged as not confirmed to be front‑page citations.
• Consistent with the prior generated section, I still do not have the verbatim granted claims, so the §102 mapping below is against the inferred independent claim (composition comprising linagliptin + metformin HCl + L‑arginine + excipients) rather than verified claim language. I flag that as provisional.

Contradiction flag: Your previously generated summary states the priority date as 2008‑04‑03 (EP 08154039). A Unified Patents mirror page surfaced in this session lists 2008‑04‑02 for the same family member. The Google Patents record and Espacenet both say 2008‑04‑03; I treat 2008‑04‑03 as controlling and the 04‑02 entry as a mirror‑side discrepancy, but I am flagging it rather than silently harmonizing it.

Part 1 — References expressly cited in the '016 specification

A. Linagliptin / BI‑1356 compound and structure art (the DPP‑4 inhibitor)

These are the references the patent uses to support the compound itself and the genus of formula (I)/(II)/(III).

B. Formulation / polymorph art for the DPP‑4 inhibitor

C. Third‑party DPP‑4 inhibitor patent art (sitagliptin, vildagliptin, saxagliptin, denagliptin, alogliptin, others)

D. Partner‑drug art

Part 2 — Family / "similar document" listings (NOT confirmed front‑page citations)

Unified Patents and the Justia "front‑page" table for the sibling patent US 10,022,379 (same title/specification family) surfaced the following BI and third‑party documents. I am listing them as leads only, because I could not confirm they appear on the '016 face:

• US 7,569,574 B2 — Purine derivatives (BI), 2002‑08‑21 priority.
• US 7,495,003 B2 — 8‑(3‑amino‑piperidin‑1‑yl)‑7‑(but‑2‑ynyl)‑xanthines (BI), linagliptin‑class compound.
• US 7,501,426 B2 — BI xanthine derivatives.
• US 7,470,716 B2 — Imidazoles and triazoles (BI).
• US 7,432,262 B2 — Imidazopyridazinediones (BI).
• US 8,034,941 B2 — Imidazopyridazinone/pyridone derivatives (BI).
• US 8,119,648 B2 — BI xanthine derivatives.
• US 8,637,530 B2 — 8‑(3‑amino‑piperidin‑1‑yl)‑xanthines (BI).
• US 9,155,705 B2 — the direct parent of '016 (Friedl et al.), US 12/935,634.
• US 10,022,379 B2 / US 10,973,827 B2 — later continuations in the same family.
• Cited by the family: US 5,223,499 A; US 5,444,068 A; US 6,037,349 A; US 5,686,611 A; CZ 301487 B6; EA 007485 B1; WO 2010/086411 A1 — these are association‑list items, likely citing rather than cited documents, and I flag them as unverified.

Important: the parent US 9,155,705 and the other BI family members are the same inventive entity / same benefit chain as '016 and therefore are not §102 prior art against '016. Neither is the US 2015/0366812 A1 pre‑grant publication of the '016 application itself, nor the grandparent EP 08154039 / PCT/EP2009/053978.

Part 3 — Bottom line on anticipation

Testing the drafted/apparent independent claim (a pharmaceutical composition/tablet comprising a DPP‑4 inhibitor + metformin hydrochloride + L‑arginine + one or more pharmaceutically acceptable excipients) against every reference above:

1. No reference cited in the specification discloses all claimed elements. Every listed document discloses at most one of the three required actives (linagliptin or metformin or another DPP‑4 inhibitor). None discloses the combination, and none discloses L‑arginine as a stabilizer in a DPP‑4‑inhibitor/metformin FDC tablet. Accordingly, none anticipates under §102 as to the FDC claims.

2. The only references with any §102 exposure would be if a claim read on:

   • the linagliptin compound per se → WO 2004/018468 (ex. 2(142)) and/or US 7,495,003 would anticipate; or
   • metformin alone → US 3,174,901.

   Neither claim type appears in the '016 claim set as inferred.

3. Practical relevance is therefore §103, not §102. The genuine novelty/obviousness battleground is the L‑arginine stabilizing element (and the specific dosage‑form architecture — monolayer, bilayer, press‑coated/tablet‑in‑tablet/"bull's eye," and drug‑layered film‑coated tablets). The closest single‑active art — WO 2007/128721 (linagliptin polymorphs) and WO 2007/128724 (linagliptin formulations) — would be the most useful starting points for an obviousness attack, but they disclose neither metformin HCl nor L‑arginine.

What you should retrieve to complete this properly

To move from "provisional" to "authoritative," pull these three primary records:

1. USPTO PatentCenter for application 14/836,996 → the "References Cited" / PTO‑892 and the verbatim claims. This is the only way to get the true examiner‑cited list (https://patentcenter.uspto.gov).
2. The printed PDF of US 9,415,016 (front page, "References Cited" columns) at patentimages.storage.googleapis.com (linked from https://patents.google.com/patent/US9415016/en).
3. The file wrapper / IDS for the parent US 9,155,705 (12/935,634), since the continuation's cited art generally mirrors the parent's.

Until (1)–(3) are in hand, I will not represent the reference list above as the complete examiner‑cited set, and I note again that publication dates for the WO documents are approximations from the WO number series, not individually verified in this session.

I'll first try to retrieve the actual "Prior Art" section (cited references) for this patent, plus verify claim scope, since the excerpt provided to me contains the prior-art keywords but not the cited-reference list.

I now have the verbatim claim 1 and key prior-art leads. Let me pull the full claim set and identify the cited prior-art references.

Prior-art source note (important)

Before analyzing, one procedural caveat: the material provided to me contains the Google Patents "Prior art keywords" field — but those keywords (methyl; pharmaceutical composition; tablet; composition according; amino) are algorithmically extracted from the patent's own claim/description text, not prior-art references. The actual "Prior Art" section of the page (the cited patent/non-patent reference list) did not load in the supplied text, and my search attempts to retrieve that specific list were cut short by the tool limit. I therefore build this §103 analysis on (a) the references cited inside the specification text that was provided, and (b) references surfaced by search that I can attribute to a URL. Anything I could not verify is flagged explicitly. I did not auto-correct any patent or case number.

Obviousness Analysis of US 9,415,016 B2 under 35 U.S.C. § 103

1. Correction to an earlier section (cross-reference)

The previously generated Patent Summary described the independent claim as a composition comprising "a DPP-4 inhibitor (linagliptin/BI 1356), metformin hydrochloride, L-arginine, and one or more pharmaceutically acceptable excipients," and called L-arginine "the distinguishing stabilizing feature." I have now retrieved verbatim claim 1, and the earlier inference was over-specified:

Claim 1 (verbatim): "A pharmaceutical composition comprising or made from: (a) 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine in a dosage of 2.5 mg or 5 mg, (b) metformin hydrochloride, (c) one or more pharmaceutical excipients, and (d) a basic amino acid having an intramolecular amino group and alkaline characteristics, which basic amino acid is present in an amount sufficient to suppress degradation of said [linagliptin], wherein the pharmaceutical composition is a tablet comprising a film-coat; and wherein the pharmaceutical composition comprises the following amounts (% by weight of total coated tablet mass): 0.1–0.5% of [linagliptin], and 47–85% of metformin hydrochloride."
— Source: https://www.drugpatentwatch.com/p/patent-claims/[9415016](/patent/9415016)

L-arginine is not recited in claim 1 — it first appears in claim 9. Claim 3 recites "L-arginine, L-lysine and L-histidine." This matters for the obviousness analysis: the independent claim is broader than the earlier summary assumed, which widens the prior-art attack surface (the basic-amino-acid genus is easier to reach than L-arginine specifically).

Also flagging a contradiction between the two prior sections: the Patent Summary says the '016 patent is Orange-Book-listed for Trijardy XR (empagliflozin/linagliptin/metformin), whereas the Litigation Summary says JENTADUETO XR (NDA 208026). These are different products/NDAs; the patent may be listed against more than one, but the discrepancy should be reconciled against the FDA Orange Book directly.

2. Effective filing date and which §102/§103 regime applies

• Earliest priority: 2008-04-03 (EP 08154039); a US provisional 61/087,343 of 2008-08-08; PCT/EP2009/053978 filed 2009-04-02 (published as WO 2009/121945); the instant application US 14/836,996 filed 2015-08-27.
• Because the earliest priority predates 2013-03-16, the pre-AIA §102/§103 framework governs the priority-supported subject matter. This has a practical consequence: BI's own earlier published applications remain available as §102(b)/§102(a) "printed publication" art (pre-AIA §103(c) disqualifies only art that is prior art solely under §102(f)/(g)). So BI's own WO publications cited in the specification are usable against these claims.

3. PHOSITA

A person of ordinary skill in the art as of April 2008: a pharmaceutical formulation scientist (or team) with an advanced degree in pharmaceutics/medicinal chemistry and 2–5 years' experience developing oral solid dosage forms, familiar with (i) DPP-4 inhibitor chemistry, (ii) the physicochemical incompatibility of amine-containing drugs (Maillard/carbonyl-amine chemistry), and (iii) conventional excipient/buffer selection.

4. Claim 1 deconstructed into elements

5. The prior-art landscape (as documented)

Reference set A — the compound and its combination (all BI, all published before the priority date):

• WO 2004/018468 (published 2004) — cited in the specification as disclosing linagliptin (i.e., the compound) at example 2 (142). The specification states: "purine derivatives of formula (I) can be obtained as described in WO 2002/068420, WO 2004/018468, WO 2005/085246, WO 2006/029769 or WO 2006/048427." Supplied patent text, Description.
• US 8,106,060 (8-(3-amino-piperidin-1-yl)-xanthines) — same genus; expressly states the compounds "may also be used in conjunction with other active substances. Suitable therapeutic agents for such combinations include for example antidiabetic agents such as metformin…" (https://www.sumobrain.com/patents/us/8-3-amino-piperidin-1/[8106060](/patent/8106060).html).
• WO 2007/128721 (crystalline forms of BI 1356) and WO 2007/128724 (formulations of BI 1356) — both cited in the specification's Description ("Polymorphous crystal modifications and formulations of particular DPP-4 inhibitors are disclosed in WO 2007/128721 and WO 2007/128724"). Both published before the April 2008 priority.
• Metformin: US 3,174,901, cited in the specification.
• US 2004/018468 / US 8,106,060 / WO 2007/128724 also disclose tablet and film-coated tablet dosage forms.

Reference set B — the DPP-4-inhibitor + metformin fixed-dose combination was already public before 2008-04-03:

• EUCREAS "Scientific Discussion" (EMEA), October 2007 — the European approval/public-assessment report for the vildagliptin + metformin fixed-dose combination tablet. This reference appears in the search report of the family's Eurasian counterpart EA 029395 (corresponding to WO 2009/121945): "(56) ANONYMOUS 'Eucreas. Scientific discussion' [Online] October 2007 … URL:http://www.emea.europa.eu/humandocs/PDFs/EPAR/eucreas/H-807-en6.pdf." This establishes that an FDC tablet of a DPP-4 inhibitor with metformin was a known, approved, commercially available dosage form.
• Janumet (sitagliptin + metformin FDC tablet, US) was approved 2007 — the general concept of a DPP-4i/metformin FDC tablet was firmly in the art in the US market.
• BI's own clinical-trial registrations, publicly indexed before the priority date: NCT00601250 (registered 2008-01-25), NCT00622284 — "Efficacy and safety of BI 1356 in combination with metformin in patients with type 2 diabetes," dated 13 February 2008 — and NCT00602472. These are cited as category-A references in the EA 029395 search report. They publicly disclose the BI 1356 + metformin combination per se before April 2008.

Reference set C — the stability/stabilizer element:

• The specification itself concedes the general knowledge base: amine drugs "react with reducing sugars and with other reactive carbonyl groups and with carboxylic acid functional groups formed for example at the surface of microcrystalline cellulose by oxidation," forming N-acetyl and N-carbamoyl derivatives, and that a "nucleophilic and/or basic agent (e.g. a buffering and/or pH modifying agent)" can protect against this. It names L-arginine, L-lysine, L-histidine as suitable basic amino acids and states they have "an intramolecular amino group and alkaline characteristics (isoelectric point, pI: 7.59–10.76)."
• ⚠️ I could not, within this session, verify a single pre-April-2008 reference that specifically teaches a basic amino acid (arginine/lysine/histidine) to stabilize a free-base DPP-4 inhibitor in an FDC with metformin HCl. I therefore treat Element D as the contested element and present the strongest argument I can ground, flagging where a specific reference would be needed. The candidate references surfaced in the family's own search report — WO 2008/113000, WO 2006/135693, WO 2007/078726, WO 2007/041053 (cited in EA 029395), plus Thomas Leo et al., J. Pharmacol. Exp. Ther. April 2008, vol. 325(1) — could not be verified as to content here, and I do not attribute specific teachings to them.

6. The obviousness combinations

Combination 1 (primary): WO 2004/018468 + metformin art + Eucreas/clinical-trial disclosures + conventional stabilizer knowledge

Why each element is met:

• A: WO 2004/018468 (example 2(142)) discloses linagliptin. The 2.5 mg and 5 mg doses are routine dose-selection from the compound's disclosed unit-dose range ("0.5 mg, 1 mg, 2.5 mg, 5 mg and 10 mg," per the instant specification) — a result-effective variable arrived at by routine optimization. The specification itself recites these as the particular strengths, confirming they are conventional selections.
• B: Metformin and its hydrochloride are old (US 3,174,901).
• C/E: Excipients and film-coated tablets are conventional; the specification uses only conventional materials (D-mannitol, corn starch, pregelatinized starch, copovidone, magnesium stearate, colloidal anhydrous silica, hypromellose, propylene glycol, TiO₂, iron oxides, talc).
• F: The % ranges follow arithmetically from the claimed doses and tablet mass. Linagliptin 2.5 mg or 5 mg in a ~600–1,200 mg combined tablet ≈ 0.2–0.8% (the claimed 0.1–0.5% bracket); metformin HCl 500–1,000 mg ≈ 47–85%. That is numerical-range obviousness (In re Peterson, 315 F.2d 817 (CCPA 1963); In re Geisler, 116 F.3d 1465 (Fed. Cir. 1997)).

Motivation to combine A + B: The specification's own "Partner drugs to be combined with the DPP-4 inhibitors … are biguanides (e.g. metformin…)"; US 8,106,060 expressly names metformin as a combination partner; and DPP-4 inhibition (GLP-1 preservation) and metformin (hepatic glucose suppression) act by complementary, non-overlapping mechanisms in the same disease (type 2 diabetes), giving a predictable additive benefit — the classic "combination of known elements with predictable results" (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007)). Eucreas (Oct 2007) and the BI 1356+metformin trial registrations (Jan–Feb 2008) supply both the motivation and the reasonable expectation of success that such an FDC tablet would work.

Combination 2 (stabilizer-focused): General formulation knowledge + the acknowledged incompatibility problem

If Element D is the only point of novelty, the §103 case turns on whether adding a basic amino acid / buffering agent to a free-base amine DPP-4 inhibitor FDC was obvious. Arguments:

1. Known chemistry, known fix. The incompatibility between primary/secondary amines and reactive carbonyls (reducing sugars, oxidized cellulose) is textbook Maillard/carbonyl-amine chemistry, and the well-known remedy is to control the micro-environment (pH/moisture) with a basic excipient or buffer. The specification itself frames the solution as the use of "a suitable nucleophilic and/or basic agent (e.g. a buffering and/or pH modifying agent)" — language that reads as conventional formulation technique rather than a discovery.
2. The recited stabilizers are a closed class of the obvious choices. Arginine, lysine, and histidine are the three canonical basic amino acids (pI 7.59–10.76) — as the patent itself recites. Selecting one of three known pharmaceutically acceptable basic amino acids is the paradigm of "obvious to try."
3. Predictable mechanism, no unexpected result. The specification states the effect "seems to be concentration dependent" and that "L-arginine may act as stabilizing and buffering agent." A result that follows directly from a known mechanism (buffering) is a predictable result and cuts against non-obviousness.
4. The functional limitation ("amount sufficient to suppress degradation") is satisfied by routine, finite experimentation — the recognized number of candidate basic amino acids and the narrow dose range make this a bounded optimization.

Combination 3 (drop-in / KSR variant)

Take any pre-2008 DPP-4i + metformin FDC (Eucreas, or Janumet) and substitute a free-base amino-containing DPP-4 inhibitor (linagliptin from WO 2004/018468) for the prior DPP-4i. When the substitution is seen to create the known amine-instability problem, the PHOSITA would apply the standard buffer/stabilizer remedy (basic amino acid) — the "obvious to try" route with a reasonable expectation of success.

7. Dependent claims

The dependent claims (per https://www.drugpatentwatch.com/p/patent-claims/9415016) largely recite routine design choices: the specific stabilizer (L-arginine, claim 9); dose strengths 2.5/5 mg (claims 4–5); metformin HCl range 100–1,500 mg (claim 6); excipient identities; and weight ratios DPP-4i:L-arginine 1:20–10:1 (claim 12) and 1:15–10:1 (claim 13). Ratios that bracket a preferred working range and excipient/strength selections ordinarily do not confer patentability absent a demonstrated unexpected effect (In re Applied Materials, 692 F.2d 1289 (Fed. Cir. 1982) — result-effective variable). ⚠️ I could not retrieve the complete verbatim claim set (the listing is truncated at claim 14), so I cannot rule out a clause in a dependent claim that contains a narrowing limitation not obvious in view of the art.

8. Counter-considerations (what could defeat the §103 attack)

• No verified specific stabilizer reference. For Combination 1/2 to be airtight, the examiner/plaintiff needs a pre-April-2008 reference or documented general knowledge that a basic amino acid suppresses degradation of this class of DPP-4 inhibitor. If Element D cannot be met with a concrete reference, the patentee will argue that the problem itself (that linagliptin degrades specifically in an FDC with metformin HCl, forming N-acetyl/N-carbamoyl derivatives) was newly recognized, and that recognizing and solving it is non-obvious. That is the patentee's strongest position.
• Trade-off / reverse teaching. The specification argues that L-arginine's alkalinity "may affect the dissolution profiles," necessitating minimization — a possible "teaching away" argument, though it reads more as an optimization tradeoff than a teaching away.
• Objective indicia. Commercial success (Jentadueto/Trijardy), the layered continuation strategy (US 9,155,705; 10,022,379; 10,973,827; 11,911,388), and the ANDA litigation wave are all consistent with a valuable claim; the patentee would cite these as secondary considerations (though commercial success must be tied by nexus to the arginine element).
• Pre-AIA §103(c). Because much of the closest art is BI's own earlier work, the patentee may argue common-ownership disqualification — but as noted in §2, that disqualification reaches only §102(f)/(g) art, not published applications/patents that are §102(a)/(b) printed publications. This should be briefed carefully.

9. Bottom line

• Elements A, B, C, E, F were all squarely in the prior art (linagliptin in WO 2004/018468; metformin in US 3,174,901; DPP-4i/metformin FDC tablets via Eucreas (Oct 2007), Janumet, and BI's own NCT00601250 / NCT00622284 disclosures of BI 1356 + metformin in Jan–Feb 2008; film-coated tablet/excipients conventional). A strong prima facie §103 case exists against everything except Element D.
• Element D (basic amino acid in a degradation-suppressing amount) is the gating issue. On the record I could verify, the argument that D is obvious rests on (i) the patent's own characterization of the problem as known carbonyl-amine/Maillard chemistry, and (ii) the conventional use of basic amino acids/buffers in solid dosage forms. That is a defensible but not yet fully evidenced position; a specific pre-2008 reference teaching a basic amino acid to stabilize an amine DPP-4 inhibitor would make it compelling.
• The numerical ranges and % weights are, standing alone, obvious as result-effective variables.

Caveats: (1) The verbatim "Prior Art" citation list from the Google Patents page was not retrievable here — this analysis uses the references cited within the supplied specification and references confirmed by URL. (2) Claim 1 was confirmed verbatim; the full claim set was truncated at claim 14, so a narrowing dependent claim cannot be excluded. (3) Contents of WO 2008/113000, WO 2006/135693, WO 2007/078726, WO 2007/041053 and Thomas Leo et al. (JPET 2008) were not verified and are not relied upon for any specific teaching. (4) The Trijardy XR vs. JENTADUETO XR Orange-Book discrepancy should be reconciled against the FDA Orange Book.