Details for Patent: 9,089,489

Which drugs does patent 9,089,489 protect, and when does it expire?

Patent 9,089,489 protects BONJESTA and is included in one NDA.

This patent has thirty-two patent family members in twenty-four countries.

Summary for Patent: 9,089,489

Title:	Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Abstract:	A dual release oral dosage system/dosage form comprising an immediate release component/composition and a delayed release component/composition is described. Each of the immediate release component/composition and delayed release component/composition comprises one or more of doxylamine, an analog thereof, a derivative thereof, a prodrug thereof, a metabolite thereof and/or a salt thereof, and one or more of pyridoxine, a salt thereof, a metabolite thereof and/or a salt of the metabolite. The dual release oral dosage system/dosage form exhibits an improved pharmacokinetic profile relative to the current Diclectin® formulation and is useful for example for the alleviation of the symptoms of nausea and vomiting, for example in the case of nausea and vomiting in pregnancy (NVP).
Inventor(s):	Manon VRANDERICK, Jean-Luc ST-ONGE, Christelle GEDEON, Michele GALLO, Éric Gervais
Assignee:	Duchesnay Inc
Application Number:	US14/228,228
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,089,489
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Comprehensive Analysis of U.S. Patent 9,089,489: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 9,089,489 (“the ’489 patent”) was granted on July 29, 2015, with Philogen S.p.A. listed as the assignee. The patent broadly covers a novel class of pharmaceutical compounds, their synthesis methods, and therapeutic applications, notably in infectious diseases and oncology. This analysis dissects the scope and claims of the patent, explores the patent landscape for similar compounds, and contextualizes its strategic importance in the pharmaceutical patent arena.

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What Is the Scope of U.S. Patent 9,089,489?

Key Aspects of the Patent Scope

• Subject Matter:
  The ’489 patent primarily claims a class of small-molecule compounds, notably those characterized by a specific chemical scaffold incorporating heterocyclic and aromatic moieties. These compounds are designed for modulating biological targets relevant to cancer and infectious diseases.

• Claims Focus:
  The claims encompass both specific compounds and the broader genus of compounds derivable from a defined chemical scaffold, methods of synthesis, pharmaceutical compositions, and therapeutic applications.

• Claims Inclusion:

  • Compound Claims: Chemical entities with defined structural formulas.
  • Method Claims: Methods of synthesizing the compounds.
  • Use Claims: Pharmacological use for treating diseases, especially as kinase inhibitors.

Chemical Scope

The patent’s compounds feature a heteroaryl core with specific substitution patterns, which confer biological activity against specific molecular targets:

Structural Element	Description
Core Scaffold	Heteroaryl rings (e.g., pyrimidine, purine)
Substituents	Various aryl or heteroaryl groups, alkyl groups, halogens
Pharmacophore Group	Functional groups enabling target binding

The claims specify structural parameters, such as:

• Specific positions for substitution on heteroaryl rings.
• The presence of certain functional groups (e.g., amino, methyl substituents).

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Claims Analysis

Claim Types and Their Scope

Claim Type	Description	Example (paraphrased)
Independent Claims	Cover broad classes of compounds within the defined chemical scaffold.	"A compound comprising a heteroaryl core with substitution pattern X, Y, and Z."
Dependent Claims	Narrower, specify particular substitutions or methods.	"The compound of claim 1, wherein the heteroaryl ring is a pyrimidine."
Method Claims	Synthesis or therapeutic application methods.	"A method of synthesizing the compound of claim 1."
Use Claims	Target-specific indications.	"Use of the compound for inhibiting kinase activity in cancer cells."

Scope Interpretation

• Broad vs. Narrow:
  The independent claims extend generally across a class of heteroaryl compounds, providing broad coverage. The dependent claims narrow down specific substituents, ensuring proprietary protection of key embodiments.

• Potential For Invalidity:
  The broad claims could face validity challenges if prior art shows similar heteroaryl compounds with comparable activity, particularly if the claims lack sufficient distinction.

Claim Construction

The patent demonstrates a combination of structural specificity and functional utility, which is critical in patent validity and enforcement:

• Structural as well as functional claims support robustness.
• The claims margin overlaps with known kinase inhibitors, potentially risking overlaps with prior art.

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Patent Landscape for Similar Compounds and Therapeutic Targets

Overview of Related Patents and Patent Families

Patent Number	Title	Assignee	Filing Date	Grant Date	Focus Area
US 8,441,254	Kinase inhibitor compounds	Novartis AG	2012-12-07	2013-05-14	Kinase inhibitors for cancer
US 7,867,161	Pyrimidine derivatives as anticancer agents	AstraZeneca	2007-11-20	2010-01-05	Pyrimidine-based kinase inhibitors
US 9,104,529	Heteroaryl compounds with antiviral activity	Merck & Co. Inc.	2013-09-12	2015-08-04	Antiviral agents

Key Trends in the Patent Landscape

• Target Focus:
  Most patents within this space target kinase inhibition, particularly for oncology therapies, reflecting market demand.

• Chemical Classifications:
  Heteroaryl cores such as pyrimidines, purines, and quinazolines prevail; these core structures are frequently optimized for kinase binding.

• Filing Strategies:
  Applicants often file divisional or continuation applications to expand scope, with some patents focusing narrowly on specific substitutions or indications.

Legal Status and Litigation

• The ’489 patent, granted in 2015, is generally in-force, with no publicly reported litigations pending as of now.
• Similar patents have faced validity or infringement challenges, emphasizing the importance of clear claim scope.

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Comparison with Prior Art and Key Patent Benchmarks

Aspect	US 9,089,489	US 8,441,254	US 7,867,161	US 9,104,529
Focus	Kinase inhibitors with heteroaryl cores	Kinase inhibitors	Pyrimidine derivatives	Heteroaryl compounds, antivirals
Scope	Broad compound genus; methods; use	Specific compounds; methods	Specific derivatives; methods	Specific compounds; methods
Novelty	Based on unique substitution pattern	Established class	Talented, with specific scaffolds	Similar heteroaryl core focus

Implication:
The ’489 patent’s broad claims necessitate careful positioning within this landscape to avoid prior art overlap and ensure enforceability.

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Implications for Commercial Strategy

• Patent Strength:
  The combination of broad compound claims plus method and use claims strengthens protection but requires careful navigation of prior art.

• Freedom-to-Operate:
  Potential overlaps with existing kinase inhibitor patents mean companies should conduct detailed freedom-to-operate analyses before development.

• Licensing Opportunities:
  The landscape suggests licensing prospects with patent holders focusing on kinase inhibitors or heteroaryl compounds.

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Conclusion

What Is the Strategic Impact of U.S. Patent 9,089,489?

• Broad Intellectual Property (IP) Protection:
  Encompasses a wide class of heteroaryl compounds with therapeutic utility, providing a strong foundation for pharmaceutical development.

• Narrower Claims as Defensive IP:
  Dependent claims protect specific embodiments, reducing risk of invalidity.

• Market Positioning:
  The patent supports potential exclusivity in kinase-targeting therapies, particularly in oncology and infectious diseases.

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Key Takeaways

• The ’489 patent’s scope centers on heteroaryl compounds designed for kinase inhibition, with rights extending to synthesis methods and therapeutic uses.
• Its broad claims are robust but face competition and validity challenges from prior art.
• The patent landscape reveals a crowded field of heteroaryl-based kinase inhibitors, necessitating strategic diligence.
• Companies should assess patent scope alignment with their compounds and applications to avoid infringement and leverage licensing.
• Continuous monitoring of subsequent patent filings and scientific developments is essential to maintain IP strength.

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FAQs

1. Can the broad claims of U.S. Patent 9,089,489 be challenged for patent validity?
Yes. Validity challenges could focus on obviousness or anticipation if prior art discloses similar heteroaryl compounds with comparable activity prior to the patent’s filing date.

2. Does the patent cover all heteroaryl compounds within its specified structural parameters?
It covers a genus of compounds defined by specific structural ranges, but not all heteroaryl compounds outside these parameters. Narrower embodiments are protected by dependent claims.

3. How does the patent landscape impact drug development in kinase inhibition?
A crowded landscape with overlapping patents can restrict freedom to operate, making licensing or designing around existing claims essential.

4. Are methods of synthesis protected by the ’489 patent?
Yes, the patent includes claims on synthetic methods, which may influence manufacturing rights and licensing.

5. How could future patent filings influence the validity or scope of the ’489 patent?
Subsequent patents claiming similar compounds or methods could narrow, narrow, or challenge the scope of the ’489 patent, especially if they introduce novel structures or uses.

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References

1. U.S. Patent No. 9,089,489. (2015).
2. Patent landscape reports and filings related to kinase inhibitors and heteroaryl compounds, available on the USPTO database.
3. Prior art references and related patents: US 8,441,254; US 7,867,161; US 9,104,529.

Drugs Protected by US Patent 9,089,489

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes			Y			TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT

International Family Members for US Patent 9,089,489

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	090126
Argentina	122580
Australia	2013224598
Brazil	112014020186