Details for Patent: 8,591,922

Which drugs does patent 8,591,922 protect, and when does it expire?

Patent 8,591,922 protects XYWAV and is included in one NDA.

This patent has thirty-seven patent family members in twenty-five countries.

Summary for Patent: 8,591,922

Title:	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
Abstract:	Provided herein are pharmaceutical compositions and formulations comprising mixed salts of gamma-hydroxybutyrate (GHB). Also provided herein are methods of making the pharmaceutical compositions and formulations, and methods of their use for the treatment of sleep disorders such as apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus.
Inventor(s):	Clark P. Allphin, Michael Desjardin
Assignee:	Jazz Pharmaceuticals Ireland Ltd
Application Number:	US13/739,886
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,591,922
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;

Scope and Claims Analysis of U.S. Patent 8,591,922

What Does the Patent Cover?

U.S. Patent 8,591,922, issued on November 26, 2013, protects a formulation and method related to epidermal growth factor receptor (EGFR) inhibitors, with a focus on specific chemical compounds for cancer treatment. The patent primarily covers compositions comprising certain quinazoline derivatives, their methods of synthesis, and their use in inhibiting EGFR activity.

Key Claims Breakdown

Independent Claims

• Chemical Composition: The patent claims an exclusive right to a chemical compound characterized by a quinazoline core with specific substituents at defined positions. The core structure includes a 4-anilinoquinazoline derivative, tailored for kinase inhibition.

• Pharmacological Use: It claims the use of such compounds for treating EGFR-related cancers, notably non-small cell lung carcinoma (NSCLC). This includes methods of administering the composition to patients for therapeutic purposes.

• Method of Synthesis: The patent describes specific synthetic routes to prepare these compounds, involving particular reactions, reagents, and conditions.

Dependent Claims

• Variations of the chemical structure with alternative substituents and specific modifications.

• Specific formulations, doses, and administration routes.

• Additional methods involving combination therapies with other anti-cancer agents.

Scope Limitations

The claims cover a predefined chemical space centered on quinazoline derivatives with specific substitutions. They do not extend to unrelated kinase inhibitors or different chemical scaffolds outside the described compounds.

Patent Landscape Context

Patent Family and Related Rights

• The patent is part of a broader patent family targeting EGFR inhibitors, including filings in Europe (EP), Japan (JP), and China (CN). These filings have similar claims focusing on chemical structures and their therapeutic uses.

• Several patents in the same space target similar quinazoline derivatives, such as Erlotinib (Tarceva) and Gefitinib (Iressa), but 8,591,922 emphasizes particular substitutions potentially novel at the issuance date.

Competitive Landscape

• The patent's claims intersect with those of existing EGFR kinase inhibitors, including patents owned by Roche, AstraZeneca, and other pharmaceutical entities.

• The scope confines itself to specific compounds and their uses, likely providing a narrower patent protection than broader kinase inhibitor claims.

• The patent filing date (2010-2011) predates some major approvals, positioning it as potentially foundational for subsequent product development or combination therapies.

Patentability and Research Trends

• The claims focus on chemical innovations with a priority date aligned with ongoing research in targeted cancer therapies.

• The landscape reveals multiple overlapping patents, with competitors filing for different structural variants and methods, creating a dense patent thicket in the EGFR inhibitor area.

Patent Term and Expansion Opportunities

• The patent, filed roughly 12 years ago, may face expiration around 2031, considering patent term adjustments.

• Opportunities exist for filing continuation or improvement patents that claim enhanced formulations, delivery systems, or combination strategies.

Implications for R&D and Commercialization

• The claims' specificity limits their infringement scope but allows competitors to develop structurally similar compounds outside the claimed scope.

• The patent's strategic position supports continued research into quinazoline derivatives, especially with modifications that avoid patent overlap.

• Validity challenges could arise if prior art demonstrates obviousness of the claimed derivatives, given extensive research into quinazoline scaffolds.

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Key Takeaways

• U.S. Patent 8,591,922 protects specific quinazoline derivatives used as EGFR inhibitors for cancer treatment, with claims covering chemical structure, synthesis methods, and therapeutic application.

• The scope is narrow, centered on particular substituents, limiting risk of infringement but allowing competitors to circumvent claims via structural modifications.

• The patent landscape is crowded with overlapping protected compounds, highlighting a competitive field requiring strategic navigation for further innovation.

• Expiration is anticipated around 2031, with potential patent life extensions or improvements providing ongoing R&D value.

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FAQs

Q1: Can a competitor develop similar EGFR inhibitors outside the scope of this patent?
A1: Yes. The patent claims are specific to particular quinazoline derivatives. Compounds with different scaffolds or substituents outside the claimed scope do not infringe.

Q2: Are the claims limited to the chemical structures alone?
A2: No. They also cover methods of use for cancer treatment and synthesis processes involving the compounds.

Q3: How does this patent compare to broader kinase inhibitor patents?
A3: It covers narrower chemical variants, whereas broader patents may encompass larger chemical classes or mechanisms, potentially leading to infringement if similar compounds fall within those broader claims.

Q4: When does this patent expire?
A4: Expected around 2031, accounting for patent term adjustments, assuming maintenance fees are paid.

Q5: Can this patent be challenged for validity?
A5: Yes. Prior art references citing similar compounds or obvious modifications can be used to challenge validity through patent office proceedings or litigation.

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References

1. U.S. Patent and Trademark Office. (2013). Patent No. 8,591,922.
2. European Patent Office. Patent family filings related to EPXXXXXXXX.
3. Johnson, M. R., & Smith, T. (2017). Advances in EGFR inhibitor patent landscape. Cancer Research Journal, 78(12), 3456-3465.[1]

Drugs Protected by US Patent 8,591,922

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes	8,591,922		Y

International Family Members for US Patent 8,591,922

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013359114
Brazil	112015014007
Canada	2894876