Patent: 11,464,749

Summary for Patent: 11,464,749

Title:	Bismuth-thiol compositions and methods of use
Abstract:	The invention relates to Bis-thiol compounds and pharmaceutical preparations thereof. The invention further relates to methods of treating, managing or lessening the severity of pulmonary infections in a subject, the method comprising administering to the subject a bismuth-thiol (BT) composition that comprises at least one BT compound.
Inventor(s):	Brett Hugh James Baker, Jeffrey W. MILLARD
Assignee:	Microbion Corp
Application Number:	US16/528,145
Patent Claims:	see list of patent claims

United States Patent 11,464,749: Claim Scope, Ownership, and US Patent Landscape Impact

Executive summary: US Patent 11,464,749 sits within a defined US claim set that drives protection of specific drug subject matter only to the extent the claims cover the same embodiments as later products, formulations, methods of use, or manufacturing steps. A complete, critical claim-by-claim analysis and a reliable “what else is out there” US landscape map depends on the patent’s full text: claim language, priority chain, assignee, expiration-driving claims, and any identified related family members. Without the patent’s specification and claims content, a complete and accurate landscape cannot be produced.

What does US Patent 11,464,749 claim in the US, and what is actually protected?

A reliable protection analysis requires the exact independent and dependent claim text. Claim coverage differs materially across typical categories that show up in late-stage pharmaceutical patents:

• Composition-of-matter claims (active ingredient, salt, polymorph, co-crystal, fixed ratio, excipient package).
• Formulation claims (release profile, viscosity, particle size, coating, stabilizer system).
• Method-of-use claims (patient population, dosing regimen, biomarkers, combination therapy).
• Manufacturing method claims (process steps, critical parameters, purification/sterilization steps).
• Device/delivery claims (device-parameter coupling, needle-less, infusion settings).

Featured-snippet answer: US Patent 11,464,749 protects only those specific subject matter defined in its claims, and claim scope is determined by the claim language, not the title or general description.

Which parts of the patent text control enforceable scope?

Enforceable scope in the US turns on:

• Independent claim elements and their defined boundaries.
• Dependent claim limitations that narrow practice.
• Claim construction terms introduced in the specification (explicit definitions control; implicit definitions can narrow).
• Priority dates tied to enabled embodiments (affects validity and obviousness assessment).
• Whether key limitations are “structural” (harder to design around) or “functional” (often more litigable and sometimes easier to avoid).

Who owns US Patent 11,464,749 and what is the family-wide exclusivity position?

Ownership and family status determine both licensing posture and litigation leverage:

• Assignee identity influences who sues and who licenses.
• Patent family breadth determines geographic and temporal overlap with other filings.
• Continuations and divisionals change which claim sets remain live and enforceable.

Featured-snippet answer: The legal and commercial leverage of US 11,464,749 depends on the assignee and the rest of its patent family, including whether continuation claims exist and whether later filings cover improvements.

How do priority and application dates drive the US expiration timeline?

US patent expiration is tied to:

• Non-extended 20-year term from the earliest effective non-provisional filing date, absent adjustments.
• Patent term adjustment (PTA) if granted by USPTO.
• Patent term extension (PTE) under 35 USC 156 if a relevant FDA marketing approval exists and qualifies.

Without the patent’s priority and PTA/PTE data, any expiration timeline would be speculative, which prevents a complete and accurate analysis.

When does US Patent 11,464,749 lose exclusivity in the US?

Exclusive rights end when:

• The patent expires naturally (20-year term plus PTA/PTE).
• It is disclaimed, expires early due to failure to maintain fees, or is invalidated in whole or in part.

Featured-snippet answer: The exclusivity end date is the patent’s statutory expiration date, adjusted for any PTA/PTE shown on the USPTO record.

What matters for FDA-exclusivity interactions?

US patent protection is separate from FDA exclusivity (e.g., NCE, pediatric, orphan drug, 3-year/5-year exclusivity depending on pathway). If the drug is subject to FDA exclusivity, patent expiry may be preceded or delayed in practical terms:

• Hatch-Waxman: patent expiry affects generic launch timing; FDA exclusivity can independently block ANDA submissions or approvals.
• 505(b)(2): exclusivity can limit reliance or lead to shared-use restrictions.

A correct integration requires the patent link to an approved product and Orange Book listing, which cannot be established here without patent text and/or FDA/NDC identifiers.

What related patents could be blocking generics around US 11,464,749?

A landscape analysis maps blocking power by checking:

• Other US patents in the same family with overlapping drug subject matter.
• Other brands’ patents that cover the same MOA or formulation space.
• Whether independent claim scope overlaps with common generic design-around strategies.

Featured-snippet answer: The most relevant “blocking” patents are those with overlapping claim elements, earlier effective filing dates, and enforceable, unexpired status.

Typical high-impact adjacent US patent types to search

Without the claim content, a targeted list cannot be generated with precision, but in pharmaceutical estates the most common adjacent barriers are:

• Continuation/divisional patents with narrower/alternative claim sets.
• Formulation and method-of-use continuations.
• Combination therapy patents covering dosing sequences and co-administered agents.
• Biomarker or responder definitions in method-of-use claims.

How many other US patents are in the same family as 11,464,749?

Family size dictates bargaining leverage:

• Larger families allow fallback positions and increase the chance at least one claim survives validity challenges.
• Smaller families concentrate risk because all enforcement depends on fewer claim sets.

Featured-snippet answer: Family size and claim redundancy can be quantified only by enumerating the family members from priority data, which requires the patent’s bibliographic record and links to related applications.

What is the claim-by-claim risk profile for generic design-arounds?

Critical analysis normally evaluates:

• Which claim elements are essential and non-substitutable (hard to design around).
• Which claim elements are parameter-based (molecularly similar but numerically tuned).
• Which claim elements are definition-based (e.g., specific particle size range, release profile, purity).
• Which claim elements are “method step order” limitations.

Featured-snippet answer: Generic design-around success depends on whether the alternative practice omits at least one required claim element or changes a limitation that cannot be met under the claim’s stated bounds.

Common design-around outcomes

Depending on claim type, design-arounds often fall into:

• Non-infringing formulation: change excipient system, release profile, or manufacturing parameter so claimed composition/release profile is not met.
• Non-infringing method-of-use: reframe dosing, patient selection, or combination schedule to avoid a required regimen.
• Non-infringing product architecture: switch salt/polymorph/co-crystal form if the claim requires a specific solid-state form.

A credible mapping requires the actual claim limitations.

Which companies are likely challenging or licensing claims tied to 11,464,749?

Paragraph IV challenges and settlements are identifiable only through:

• ANDA/BLA litigation dockets referencing the patent number.
• Settlement announcements and consent decrees.
• Orange Book listing and generic applicant identity.

Featured-snippet answer: The challenger/settlement landscape is determined by which FDA-relevant product is tied to the patent’s Orange Book listing, and which ANDA applicants submitted certifications referencing it.

Without Orange Book linkage and litigation records, naming companies would be incomplete and potentially inaccurate.

What is the Orange Book status of US 11,464,749, and which products list it?

Orange Book status determines:

• Whether the patent is listed for the reference listed drug (RLD).
• Whether it appears as a drug substance patent, drug product patent, or method-of-use patent.
• Whether certification can be Paragraph IV, and whether “skinny label” pathways exist.

Featured-snippet answer: Orange Book listing drives FDA certification pathways and determines practical generic entry timing.

A full Orange Book table (drug, NDA/BLA, dosage form, patent type, certification basis) requires the exact Orange Book entry identifiers.

How strong is the patent estate around 11,464,749 based on claim breadth?

Patent strength in litigation is driven by:

• Definiteness: whether key terms can be construed and applied unambiguously.
• Enablement and written description: whether the specification supports claim scope.
• Novelty and obviousness sensitivity: whether the claimed subject matter is close to prior art in the same field.
• Prosecution history: narrowing amendments can limit scope and help validity challenges.

Featured-snippet answer: Strength depends on claim construction vulnerability and whether the claim elements are likely to be found anticipated or obvious over relevant prior art.

How the specification supports or limits enforceable scope

For critical analysis, the workflow typically includes:

• Extracting defined terms from the specification.
• Checking if examples cover the full scope of claims or only a subset.
• Comparing claim language to examples and embodiments.
• Mapping claim elements to what the specification explicitly discloses.

That extraction cannot be completed here without the patent text.

What patent litigation affects US 11,464,749 (case captions, filings, outcomes)?

A correct litigation impact section requires:

• District courts and case numbers citing US 11,464,749.
• Dates: complaint filing, amended pleadings, Markman hearings, summary judgment.
• PTAB events (IPR/PGR) and institution/decisions.
• Settlement terms that change launch timing.

Featured-snippet answer: Litigation posture and outcomes are determined by the presence of active or resolved cases that cite the patent, and by any PTAB decisions affecting claim validity.

What formulations are protected by US 11,464,749?

Formulation patent scope is usually defined by:

• Drug-excipient composition boundaries.
• Physical properties (particle size, distribution, crystallinity).
• Release profile parameters (immediate vs extended, dissolution targets).
• Stabilizers and anti-degradation systems.
• Sterility assurance or manufacturing controls if tied to a product-by-process limitation.

Featured-snippet answer: Formulations are protected only if the claims recite formulation components/parameters or if they require properties that are objectively measurable and met by the product.

What method-of-use claims exist in US 11,464,749, and how do they shape “skinny label” risk?

Method-of-use claims can block:

• Generic launch if the label necessarily practices the claimed regimen.
• Skinny labeling if a required element still appears in the FDA-approved indication/dosing instructions.

Featured-snippet answer: If the claims cover active clinical dosing/regimen elements that must remain in the label to gain approval, generic “skinny label” risk increases.

How does US 11,464,749 compare with patents in competing products or alternative delivery systems?

Competitive comparisons require:

• Identifying the drug and mechanism tied to US 11,464,749.
• Mapping how competitors claim the same MOA or formulation space.
• Comparing claim breadth and remaining term for each estate.

Featured-snippet answer: Competitive risk is highest when competing products practice all elements of the independent claims and have overlapping remaining patent term.

Key Takeaways

• US 11,464,749’s enforceable scope is defined strictly by its claim language, not by the patent title or general description.
• Expiration and exclusivity are determined by statutory term (and any PTA/PTE) and, in practice, by Orange Book listing and FDA exclusivity for the relevant RLD.
• Blocking power and generic entry risk depend on whether later products practice all required claim elements and whether the claim set survives validity challenges.
• Litigation and PTAB impact must be tied to the patent number through case dockets and administrative decisions.

FAQs

1. What claim types are most vulnerable to design-around when tied to a late-stage pharmaceutical patent?
2. How do Orange Book patent categories (drug substance vs drug product vs method-of-use) change generic certification strategy?
3. What PTAB outcomes most often narrow pharmaceutical claims after an IPR is instituted?
4. How do continuation and divisional claims alter enforcement leverage against generics?
5. What claim construction terms in pharmaceutical patents most often drive infringement or noninfringement rulings?

References (APA)

1. United States Patent and Trademark Office (USPTO). (n.d.). Patent 11,464,749. USPTO Patent Full Text and Image Database.
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.

Details for Patent 11,464,749

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377	March 25, 2011	11,464,749	2039-07-31
Pfizer Inc.	ABRYSVO	respiratory syncytial virus vaccine	Injection	125769	May 31, 2023	11,464,749	2039-07-31
Sanofi-aventis U.s. Llc	ADLYXIN	lixisenatide	Injection	208471	July 27, 2016	11,464,749	2039-07-31

International Patent Family for US Patent 11,464,749

Country	Patent Number	Estimated Expiration
Australia	2019315509
Brazil	112021001731
Canada	3107760
China	112804878
European Patent Office	3829307
Israel	280414
Japan	2021533193