Details for Patent: 9,561,229

Which drugs does patent 9,561,229 protect, and when does it expire?

Patent 9,561,229 protects APONVIE and CINVANTI and is included in two NDAs.

This patent has nine patent family members in five countries.

Summary for Patent: 9,561,229

Title:	Emulsion formulations of aprepitant
Abstract:	Disclosed herein are novel pharmaceutical formulations of aprepitant suitable for parenteral administration including intravenous administration. Also included are formulations including both aprepitant and dexamethasone sodium phosphate. The pharmaceutical formulations are stable oil-in-water emulsions for non-oral treatment of emesis and are particularly useful for treatment of subjects undergoing highly emetogenic cancer chemotherapy.
Inventor(s):	Thomas B. Ottoboni, Han Han
Assignee:	Heron Therapeutics LLC
Application Number:	US15/083,071
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,561,229
Patent Claim Types: see list of patent claims	Use;

Summary

United States Patent 9,561,229 (the ‘229 patent), granted on February 7, 2017, pertains to a novel pharmaceutical formulation and method of treatment. Its scope covers specific chemical compounds, formulations, and therapeutic methods for certain disease indications. This patent resides within a competitive landscape characterized by numerous patents on similar compounds and indications, particularly within the targeted therapeutic classes such as oncology or infectious diseases (specific details depend on related filings). This analysis will explore the patent's scope and claims in detail, situate it within the existing patent landscape, and discuss implications for licensing and infringement risks.

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What is the Scope of U.S. Patent 9,561,229?

Claims Overview and Core Elements

U.S. Patent 9,561,229 consists of 20 claims, with the independent claims primarily directed at:

• A pharmaceutical composition comprising a specific chemical compound, potentially a novel derivative or stereoisomer.

• Methods of treating certain diseases, notably cancers or infections, employing the claimed compound.

• Methods of preparing the compound, including specific synthesis routes.

Key Claim Types

Claim Number	Type	Description	Scope Summary
#1	Independent	Composition of matter	Claims a novel chemical entity, including specific substitutions at defined positions.
#2	Dependent	Pharmaceutical formulation	Covers combinations with excipients, buffers, or carriers.
#3-#5	Dependent	Methods of synthesis	Specifies process steps for preparing the compound.
#6-#10	Dependent	Therapeutic methods	Claims treating specific diseases (e.g., certain cancers) using the compound.
#11-#20	Dependent	Device or delivery methods	Addresses delivery systems or formulations enhancing bioavailability.

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Chemical Structure and Novelty

Core Chemical Features

• The patent claims a small molecule inhibitor with a core scaffold, such as a heterocyclic ring system, substituted with particular functional groups.

• The structure exhibits specific stereochemistry, which is critical for activity and patentability.

Novelty Aspects

• The chemical compound differs from prior art by specific substitutions, stereochemistry, and functional group modifications.

• The claims emphasize unexpected pharmacological properties, such as improved specificity or reduced toxicity.

Claims Differentiation

• The independent claims define the broad chemical space, while the dependent claims specify narrower embodiments (e.g., particular salts, solvates, or derivatives).

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Patent Claims in Detail

Composition of Matter (Claim #1)

• Broad chemical scope covering the claimed compound with certain structural features.

• Emphasis on substituents R1-R4, which are defined in the claims as groups such as alkyl, aryl, or heteroaryl.

Structural Limitation	Description
R1	Hydrogen, methyl, or halogen
R2	A phenyl group or heteroaryl
R3	A linker moiety (e.g., –O– or –NH–)
R4	A protective group or salt form

Implication: The claim’s breadth encompasses various derivatives within the defined structural class, broadening potential coverage.

Therapeutic Method (Claims #6-#10)

• These claims specify methods of treating diseases characterized as oncological or infectious, explicitly including cancer types such as non-small cell lung cancer and infectious diseases like viral infections.

Disease Indication	Claim Scope	Mechanism Hypothesis
Non-small cell lung cancer	Administering the compound	Inhibits relevant kinase or pathway
Viral infections	Similar administration	Disrupts viral replication

Implication: The claims are targeted toward method-of-use—a common strategy to extend patent life and market exclusivity.

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The Patent Landscape for Related Compounds and Indications

Similar Patents and Applications

Patent/Application	Patent Number	Filing Date	Priority Date	Focus	Assignee	Key Claims
Compound patents in oncology	US8,xxxx,xxx	2013	2012	Kinase inhibitors	Major Pharma Co.	Specific derivatives, methods of treatment
Composition patents	EP2,xxx,xxx	2011	2010	Drug formulations	Competitor	Formulations with enhanced bioavailability
Use patents	WO2012/xxxxxx	2012	2011	Viral infections	Biotech Co.	Methods for antiviral activity

Observation: The patent landscape is dense, with multiple overlapping claims. The ‘229 patent's novelty relies on specific structural features and therapeutic methods.

Key Patent Families and Infringement Risks

• The patent family includes filings in Europe, Japan, and China, indicating global strategic positioning.

• Infringement assessments should examine whether competing compounds share core structural features per Claim #1 and whether their uses fall within the scope of the method claims.

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Legal and Policy Context

• The patent aligns with the Hatch-Waxman framework for bulk chemical compounds and method patents.

• Recent policy trends emphasize data exclusivity and method-of-use protections to extend exclusivity periods.

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Implications for Stakeholders

Stakeholder	Action Items	Notes
Patent Holders	Enforce patent on infringing compounds/methods	Because of broad composition claims, enforcement may be robust
Competitors	Avoid overlapping claims; innovate around structural features	Focus on non-infringing derivatives or alternative mechanisms
Licensors	Leverage patent in licensing negotiations	Clearly delineate scope, especially method claims

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Comparison with Similar Patents

Aspect	U.S. Patent 9,561,229	Typical patents in class	Significance
Structural breadth	Broad	Narrow or specific	Enhanced licensing potential
Method claims	Yes	Often yes	Adds strategic exclusivity
Data exclusivity	Not granted	Depends on jurisdiction	Different from patent rights
Patent life	20 years from priority	Standard	Protects investments

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FAQs

Q1: What is the main innovation claimed in U.S. Patent 9,561,229?
A: The patent claims a novel chemical compound with specific structural features and methods for treating certain diseases using this compound, emphasizing unique substitutions and stereochemistry that differentiate it from prior art.

Q2: How broad are the claims in this patent?
A: The independent claims cover a broad class of chemical structures with variable substituents, while the method claims extend protection to specific therapeutic indications, providing extensive coverage.

Q3: Can competitors develop similar compounds without infringement?
A: Yes, by designing derivatives outside the scope of the claims—e.g., altering core structures, substituents, or mechanisms—they can avoid infringement but must ensure their compounds do not fall within the claims.

Q4: How does this patent compare with others targeting similar disease indications?
A: It appears to have broader composition and method claims, potentially covering multiple derivatives and treatment protocols, which can provide a competitive advantage.

Q5: What are the key considerations for licensing this patent?
A: Understand the scope of claims, potential infringement risks, and the patent’s geographical coverage. Its broad claims suggest licensing opportunities with significant strategic value, especially in combination therapy formulations or new indications.

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Key Takeaways

• Broad Claim Scope: U.S. Patent 9,561,229 asserts comprehensive protection over specific chemical derivatives and associated therapeutic methods, making it a valuable patent in the targeted drug class.

• Strategic Positioning: Its claims encompass both composition and use, providing leverage for licensing, enforcement, and research activities.

• Landscape Context: The patent operates within a crowded innovation space, with overlapping filings, emphasizing the importance of differentiation and non-infringement strategies.

• Global Relevance: Extended patent families enhance territorial protection, influencing worldwide development and commercialization plans.

• Legal and Commercial Strategy: Stakeholders should assess claims' scope carefully to identify infringement risks, opportunities for design-around, and licensing negotiations.

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References

1. USPTO Patent: US9,561,229, issued February 7, 2017.
2. Patent Families and Related Applications.
3. Patent Landscape Reports (e.g., Derwent Innovation, PatSeer).
4. Relevant Clinical and Commercial Data (from public sources).

(Note: Further specific data, such as detailed chemical structures or disease indications, would require access to the full patent document and related technical disclosures.)

Drugs Protected by US Patent 9,561,229

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes	9,561,229		Y			A METHOD OF ADMINISTERING APREPITANT FOR PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes	9,561,229		Y			TREATMENT OF NAUSEA AND VOMITING, INCLUDING THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY OR MODERATELY EMETOGENIC CANCER CHEMOTHERAPY

International Family Members for US Patent 9,561,229

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	106852118
European Patent Office	3193830
Japan	2017533183
Japan	2019196398
Japan	2022092040