Details for Patent: 9,925,265

Which drugs does patent 9,925,265 protect, and when does it expire?

Patent 9,925,265 protects KENGREAL and is included in one NDA.

This patent has fifty-seven patent family members in seventeen countries.

Summary for Patent: 9,925,265

Title:	Methods of treating or preventing stent thrombosis
Abstract:	The present invention is directed to the following: methods of treating or preventing stent thrombosis using pharmaceutical compositions comprising cangrelor and optionally bivalirudin; methods of reducing mortality in a subject undergoing stent implantation using pharmaceutical compositions comprising cangrelor and optionally bivalirudin; medicaments comprising cangrelor and optionally bivalirudin useful for treating or preventing stent thrombosis, or useful for reducing mortality in a subject undergoing stent implantation; pharmaceutical compositions comprising cangrelor and bivalirudin; and methods of preparing a medicament comprising cangrelor and optionally bivalirudin useful for treating or preventing stent thrombosis, or useful for reducing mortality in a subject undergoing stent implantation.
Inventor(s):	Clive Arthur ARCULUS-MEANWELL, Simona Skerjanec
Assignee:	Chiesi Farmaceutici SpA
Application Number:	US12/943,717
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,925,265
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

Scope and claims for US Patent 9,925,265 (cangrelor ± bivalirudin for stent thrombosis/MI, IV bolus + infusion)

US 9,925,265 is a US method-of-treatment patent centered on intravenous cangrelor at a specific bolus-and-continuous-infusion regimen (bolus about 30 µg/kg, then continuous infusion) for stent thrombosis and related endpoints (including mortality reduction over ~1 year when combined with bivalirudin). Dependent claim scope expands by (i) adding bivalirudin, (ii) defining timing around stent implantation/PCI, (iii) specifying stent types (bare metal and drug-eluting), (iv) capturing multiple stent-thrombosis time windows (intra-, acute, sub-acute, late, very late), and (v) locking in concentration ranges and infusion parameters.

The claims are strong in two respects for freedom-to-operate (FTO) and litigation: (1) they pin a dosing program (bolus dose and infusion rate), and (2) they capture clinical use scenarios tied to stent implantation and mortality reduction with combination therapy. They are narrower than a broad “cangrelor use for PCI thrombosis” asset because they do not read on other dose levels, other routes, oral regimens, or other anticoagulation agents unless they fall within the claim language.

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What does US 9,925,265 claim cover for stent thrombosis treatment?

Independent claim 1 claims a method of treating stent thrombosis by administering a pharmaceutical composition comprising cangrelor with the following required elements:

1. Indication: treating stent thrombosis in a subject in need thereof.
2. Administration route: intravenous.
3. Dosing regimen (locked):
   • Bolus: about 30 µg/kg cangrelor
   • then continuous intravenous infusion
4. Procedural trigger: stent thrombosis is induced by implantation of:
   • a bare metal stent or
   • a drug-eluting stent.

Claim 26 is effectively a prevention mirror with similar regimen requirements and a prevention timing concept (periprocedural / during PCI or other vascular stent implantation).

Claim 1 scope boundaries

• Must be IV bolus + continuous infusion, not bolus only.
• Bolus must be about 30 µg/kg (the “about” term adds flexibility but still constrains the numeric anchor).
• Stent thrombosis must be linked to bare metal or drug-eluting stent implantation. The claim does not expressly cover non-stent thrombosis phenotypes or non-coronary vascular devices unless they are covered by “other vascular stent implantation” only in claim 26.
• Does not require additional antithrombotics in claim 1 (those are optional via dependent claims).

Dependent claim 7: time-window capture

Claim 7 expands claim 1 by defining the thrombosis timing categories as inclusive:

• intraprocedural, acute, sub-acute, late, or very late stent thrombosis.

This matters for design-around: any clinical framing that treats only very early/no stent thrombosis window might still fall inside claim 7 once the treated condition is categorized within those terms.

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How does US 9,925,265 define the cangrelor dosing regimen (bolus 30 µg/kg + infusion)?

Independent claim 1 sets the regimen anchor, and the dependent claims further define the infusion rate and formulation strength.

Key dosing features

• Bolus: about 30 µg/kg cangrelor (required in claim 1 and replicated in claim 26).
• Continuous infusion: required by claim 1 and claim 26, with rate specified in claim 20.

Claim 20: infusion rate lock

• continuous intravenous infusion at about 4 µg/kg/min cangrelor.

This numeric constraint is one of the most operationally important claim features. If an administered regimen uses a different infusion rate, it is less likely to satisfy claim 20, but claim 1 itself still requires “continuous infusion” without the 4 µg/kg/min limitation. In practice, claim construction will turn on whether the 4 µg/kg/min limitation is required to practice claim 1 or only applies to a narrower dependent claim.

Concentration range limitations (claims 14–15)

• claim 14: about 1 mg/mL cangrelor
• claim 15: about 5 mg/mL cangrelor

These appear in dependent claims attached to claim 1, 3, or 5. That means the base claim 1 does not require these concentrations, but it can become relevant if an asserted method is mapped to a specific reconstituted product concentration used in studies or commercial supply.

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What does US 9,925,265 cover for myocardial infarction prevention or treatment?

Independent claim 5 claims:

• Method of treating or preventing myocardial infarction in a subject in need thereof,
• via a pharmaceutical composition comprising cangrelor,
• administered IV as bolus about 30 µg/kg then continuous infusion.

Dependent claim 6

• adds optional bivalirudin to the pharmaceutical composition.

Dependent claim 7 relevance

Claim 7 is dependent on claim 1 in the text provided, but it is the same thrombosis-time-window cluster. For MI methods (claim 5), the presence/absence of claim 7’s timing language is critical. The MI claim set does not, on its face, repeat stent thrombosis timing categories unless the patent ties them through a dependency chain not included in the excerpt.

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What does US 9,925,265 claim for mortality reduction in stent implantation?

Independent claim 3 claims a combination method aimed at reducing mortality in a subject undergoing stent implantation:

• administer to the subject:
  • an effective amount of cangrelor composition, and
  • an effective amount of bivalirudin composition,
• with the cangrelor regimen required:
  • IV bolus about 30 µg/kg, then continuous infusion
• the method reduces a “likelihood of mortality” compared to not receiving that cangrelor regimen.

Dependent claim 13

• mortality reduced over a period of about one year after stent implantation.

This is an endpoint/timing limitation that can be used to argue noninfringement if the demonstrated effect is measured differently or if the clinical strategy does not claim/seek mortality reduction for that time horizon.

Dependent claims 4 and 16–19: formulation-level combination specificity

• claim 4: cangrelor and bivalirudin are in the same pharmaceutical composition (single composition).
• claims 16–19: specify both drugs’ concentrations (mg/mL) combinations, including:
  • 1 mg/mL cangrelor + 1 mg/mL bivalirudin
  • 1 mg/mL cangrelor + 5 mg/mL bivalirudin
  • 5 mg/mL cangrelor + 1 mg/mL bivalirudin
  • 5 mg/mL cangrelor + 5 mg/mL bivalirudin

These dependent claims are potentially useful in litigation mapping if the accused regimen used a particular concentration in prepared syringes/infusate.

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How does the combination with bivalirudin expand infringement risk (claims 3, 4, 21–23, 24)?

Is bivalirudin required to be concurrent or can it be separate?

• claim 24: cangrelor and bivalirudin administered concurrently.
• claim 3 (independent) does not itself demand concurrency, but it requires administering effective amounts of each composition.
• claim 21: defines bivalirudin administration modes as:
  • bolus,
  • infusion,
  • or bolus followed by infusion prior to stent implantation continued during the period of stent implantation.

Bivalirudin dosing constraints

• claim 22: IV bolus about 0.75 mg/kg
• claim 23: continuous IV infusion about 1.75 mg/kg/h

These numeric constraints, like claim 20 for cangrelor, create a dosing design-around lever. If an accused protocol uses different bivalirudin dosing, it may avoid the narrower dependent claim structures, while still potentially intersecting claim 3 depending on whether the asserted theory relies on the dependent limitations.

Same composition vs separate compositions

• claim 4 requires “same pharmaceutical composition.” If the accused protocol uses separate infusion lines or distinct formulations, claim 4 may be harder to fit, but independent claim 3 may remain possible if it does not explicitly require “same pharmaceutical composition.” The excerpt does not show the exact composition-structure requirement for claim 3 beyond “an effective amount of a pharmaceutical composition comprising cangrelor” and “an effective amount of a pharmaceutical composition comprising bivalirudin.”

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What does US 9,925,265 require about timing relative to stent implantation and PCI?

Timing is heavily structured in claims 9–12 and 25.

Stent implantation setting

• claim 8: implantation of bare-metal or drug-eluting stent.
• claim 9: stent implantation during percutaneous coronary intervention (PCI).

Pre-, during, or post-implantation

• claim 10: cangrelor administered before, during, or combination thereof (with respect to stent implantation).
• claim 12: cangrelor administered prior to stent implantation and continued during stent implantation.
• claim 27: cangrelor administered after stent implantation.

The combined claim set means the patent is not limited to strict pre-procedure dosing. A protocol that begins during PCI or continues through implantation has multiple claim hooks; a protocol starting after implantation is still targeted via claim 27.

Bivalirudin timing

• claim 11: bivalirudin administered before, during, or combination.
• claim 21: bivalirudin administered prior to stent implantation with continued administration during the stent implantation period (or bolus only / infusion only variants).

Periprocedural PCI anchor for bivalirudin

• claim 25: bivalirudin administered periprocedurally to PCI.

This increases the likelihood that a PCI protocol with periprocedural anticoagulation steps will map to the combination claim.

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What formulations and route constraints are built into US 9,925,265?

This is a method-of-use patent, but it contains surrogate product features.

Required administration route

• cangrelor: intravenously (bolus + infusion).
• bivalirudin: parenterally in claim 3, and IV modes in dependent claim 21–23.

Concentration-dependent dependent claims

• cangrelor: about 1 mg/mL (claim 14) or about 5 mg/mL (claim 15).
• bivalirudin: combined concentration pairings (claims 16–19).

If an accused protocol uses a different concentration in reconstituted dosing, it may avoid the dependent concentration claims, though it may still practice the broader method elements unless the concentration is required by the asserted claim.

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How strong is the patent estate for US 9,925,265 relative to cangrelor + stent thrombosis practice?

Based solely on the excerpted claims, the enforceability posture is structurally favorable for infringement theories because the patent pins down:

• a specific platelet P2Y12 inhibitor regimen (cangrelor IV bolus ~30 µg/kg + infusion),
• a procedural context (PCI with bare metal or drug-eluting stent),
• multiple thrombosis timing categories (claim 7),
• combination therapy with an anticoagulant (bivalirudin) including dosing anchors (0.75 mg/kg bolus; 1.75 mg/kg/h infusion),
• and an endpoint window for mortality reduction (~1 year).

The primary vulnerability for challengers is not the therapeutic concept, but rather whether an accused clinical protocol matches the numeric regimen and endpoint characterization embedded in the claim dependencies. A common litigation posture is to argue noninfringement on dosing or timing elements, not on broad concept coverage.

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Which companies are likely exposed to US 9,925,265 method-claim infringement?

Exposure typically tracks two vectors:

1. Any protocol using IV cangrelor with a bolus near 30 µg/kg followed by continuous infusion during PCI/stent implantation, including MI/stent thrombosis indications.
2. Any protocol pairing cangrelor with bivalirudin where dosing aligns to the dependent claims and where the clinical objective includes mortality reduction over ~one year.

Because the excerpt does not include assignee, prosecution history, or the patent’s priority date, it is not possible to map definitively to named companies or to identify whether this is directed at an investigational protocol versus an approved regimen. The claim text alone is insufficient to establish a company-specific infringement probability list.

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What generic or biosimilar entry risks exist if US 9,925,265 is asserted?

This patent is a method-of-treatment claim tied to small-molecule regimens. “Generic risk” analysis is therefore about whether generic cangrelor (if available) could be used in the claimed manner and still avoid direct infringement.

Method-claim risk is high if generic cangrelor is permitted

If a generic cangrelor is marketed, its label may or may not include the claimed dosing regimen. Even with a narrower label, enforcement under method claims often hinges on actual clinical practice, not only label wording, depending on jurisdictional standards.

Bivalirudin combination does not lower risk

Bivalirudin is an anticoagulant that can be used with multiple antiplatelet agents. The combination regimen is a key infringement hook. A generic strategy changing bivalirudin dose or route could be a design-around if it avoids dependent numeric limitations.

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What patent litigation issues would be central for US 9,925,265?

Even without knowing the litigation docket history, the excerpted claim structure points to the litigation issues that matter in claim-construction and infringement:

1. Dose matching: “about 30 µg/kg” and infusion rate “about 4 µg/kg/min.”
2. Definition of stent thrombosis categories: intraprocedural/acute/sub-acute/late/very late.
3. Link to stent type: bare metal vs drug-eluting.
4. Timing: pre/during/post stent implantation and PCI.
5. Mortality endpoint framing: “over a period of about one year after stent implantation.”
6. Concurrency and composition structure: whether cangrelor and bivalirudin are in the “same pharmaceutical composition” (claim 4) and whether they are administered concurrently (claim 24).

In a typical dispute, these become construction and proof issues for experts: protocol charts, pharmacy admixture records, infusion pumps, and clinical trial definitions.

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How does US 9,925,265 compare with typical cangrelor patent scopes (concept vs regimen locks)?

Compared with patents that claim broad use of cangrelor for PCI or ACS, US 9,925,265 is regimen-specific because it incorporates:

• IV route,
• bolus dose anchor (~30 µg/kg),
• infusion requirement and rate (dependent),
• stent implantation as the procedural context,
• and combination therapy with bivalirudin including dosing and concentrations (dependent).

That makes it narrower than “cangrelor for preventing thrombosis in PCI,” but it is more enforceable against a narrow set of protocols that reproduce the claimed regimen.

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Key claim matrix for US 9,925,265 (elements that drive infringement)

Claim	Core method	Required drug(s)	Required route	Dosing anchor(s)	Procedural/condition limits	Other limits
1	Treat stent thrombosis	Cangrelor	IV bolus + continuous infusion	Bolus ~30 µg/kg; infusion (rate not required in claim 1)	Stent thrombosis induced by bare metal or drug-eluting stent implantation	Stent type tied to induced thrombosis
2	Claim 1 + bivalirudin	Cangrelor + bivalirudin	(via composition)	(no bivalirudin dose specified in claim 2)	Same as claim 1	Adds bivalirudin presence
3	Reduce mortality during stent implantation	Cangrelor + bivalirudin	IV for cangrelor; parenteral for bivalirudin	Cangrelor bolus ~30 µg/kg; infusion	Stent implantation	Mortality reduced vs not receiving cangrelor regimen
4	Claim 3 + same composition	Cangrelor + bivalirudin	IV	Same as claim 3	Same as claim 3	Cangrelor and bivalirudin in same pharmaceutical composition
5	Treat/prevent MI	Cangrelor	IV bolus + continuous infusion	Bolus ~30 µg/kg	MI	No stent-type limitation stated in claim 5 excerpt
6	Claim 5 + bivalirudin	Cangrelor + bivalirudin	(via composition)	Same cangrelor regimen	MI	Adds bivalirudin presence
7	Claim 1 + timing window	Cangrelor	IV	Same as claim 1	Stent thrombosis time categories	Covers intra, acute, sub-acute, late, very late
9	Claim 3 + PCI setting	Cangrelor + bivalirudin	Parenteral/IV	Same as claim 3 excerpt	PCI	Locks procedural context to PCI
10–12	Claim 3 timing variants	Cangrelor + bivalirudin	IV	Same as cangrelor regimen	Before/during/combination; specifically continued from prior to during for claim 12	Timing relative to implantation
13	Claim 3 + mortality window	Cangrelor + bivalirudin	IV/parenteral	Same as claim 3	Stent implantation	Mortality reduced over ~1 year
14–15	Concentration dependent	Cangrelor	IV	Same bolus regimen	Depends on attached claim set	1 mg/mL or 5 mg/mL cangrelor
16–19	Concentration pairings	Cangrelor + bivalirudin	IV	Same regimen	Depends on attached claim	cangrelor and bivalirudin concentration combinations
20	Infusion rate lock	Cangrelor	IV infusion	infusion ~4 µg/kg/min	Depends	Narrows infusion regimen
21–23	Bivalirudin admin modes and dosing	Cangrelor + bivalirudin	IV	bivalirudin bolus ~0.75 mg/kg; infusion ~1.75 mg/kg/h (dependent)	Before/during stent implantation period	Locks administration pattern
24	Concurrency	Cangrelor + bivalirudin	IV/parenteral	Same regimen	Stent implantation	Administered concurrently
25	Periprocedural bivalirudin for PCI	Cangrelor + bivalirudin	Parenteral/IV	Same regimen	PCI	“Periprocedurally to PCI”
26	Prevent stent thrombosis	Cangrelor	IV bolus + continuous infusion	Bolus ~30 µg/kg then infusion	Prevention during PCI or other vascular stent implantation	Prevention framing
27	After stent implantation dosing	Cangrelor (+ context of claim 3)	IV	Same regimen	After stent implantation	Post-implantation administration

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When does US 9,925,265 lose exclusivity (expiration and regulatory exclusivity)?

No expiration timeline can be computed from the excerpt alone because exclusivity and patent term depend on the patent’s filing date, priority date, PTA/PTAB events, and maintenance status, and regulatory exclusivity depends on FDA approval date and exclusivity grants for the specific cangrelor product and indication. The claim text does not contain those required data.

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Key Takeaways

• US 9,925,265 is regimen-anchored: it requires IV cangrelor bolus about 30 µg/kg followed by continuous infusion in the claimed stent thrombosis/MI contexts.
• Stent context is explicit in the core stent thrombosis claims: bare metal or drug-eluting stents during PCI.
• Combination therapy is the expansion lever: adding bivalirudin enables a mortality reduction method (dependent on ~one-year window) and adds dosing/admin mode constraints (0.75 mg/kg bolus; 1.75 mg/kg/h infusion) in dependent claims.
• Numerical and timing dependencies create design-around pathways focused on infusion rate, bolus/dose targets, and procedural timing, as well as composition/concurrency structure.
• Enforcement is likely to focus on protocol proof: infusion pump rates, admixture concentrations, and clinical endpoint definitions.

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FAQs

1) Does US 9,925,265 require the use of bare metal or drug-eluting stents in all claims?
Only the stent thrombosis core (claim 1/related) expressly ties the thrombosis to bare metal or drug-eluting stents in the excerpt; the MI claim (claim 5) is not presented with the same stent-type linkage.

2) Can a protocol that gives cangrelor by bolus only avoid US 9,925,265?
The excerpted claims require continuous infusion after the bolus in both treatment and prevention independent claims.

3) Is “about 30 µg/kg” a hard limit?
It is a numeric anchor with “about,” but the claims still require the bolus to be administered in that approximate range, and dependent claims also operationalize infusion rate.

4) What role does the “about one year” mortality endpoint play?
It is a dependent limitation in claim 13 attached to the mortality-reduction method, supporting narrower infringement theories tied to that timeframe.

5) Does administering cangrelor after stent implantation fall within the claims?
The excerpt includes a dependent claim (claim 27) that covers cangrelor administered after stent implantation.

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References

1. US Patent 9,925,265 (claims excerpt provided).

Drugs Protected by US Patent 9,925,265

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes						METHOD OF REDUCING THE RISK OF PERIPROCEDURAL MYOCARDIAL INFARCTION, AND STENT THROMBOSIS IN A PATIENT UNDERGOING PCI BY ADMINISTERING INTRAVENOUSLY 30 UG/KG BOLUS BEFORE PCI AND THEN A CONTINUOUS INFUSION

International Family Members for US Patent 9,925,265

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009246396
Australia	2010319612
Australia	2012295343
Australia	2013381855