Details for Patent: 8,481,573

Which drugs does patent 8,481,573 protect, and when does it expire?

Patent 8,481,573 protects ZEPOSIA and is included in one NDA.

This patent has forty-eight patent family members in twenty-six countries.

Summary for Patent: 8,481,573

Title:	Modulators of sphingosine phosphate receptors
Abstract:	Compounds of the following generic structure are provided: Such compounds activate a sphingosine-I-phosphate receptor of the subtype 1 (S1P1), and have utility in the treatment of malconditions mediated by S1P1 activation. More specifically, such compounds are beneficial in the treatment of, for example, multiple sclerosis, transplant rejection and/or adult respiratory syndrome.
Inventor(s):	Edward Roberts, Hugh Rosen, Steven Brown, Miguel A. Guerrero, Xuemei Peng, Ramulu Poddutoori
Assignee:	Scripps Research Institute
Application Number:	US13/605,561
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,481,573
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Patent 8,481,573: Scope, Claims, and Landscape Analysis

What Is the Scope of Patent 8,481,573?

United States Patent 8,481,573 covers a novel pharmaceutical composition designed to treat a specific disease indication using a defined chemical compound. The patent claims extend to the compound itself, methods of synthesizing it, and its application in medicinal formulations.

The patent's claims encompass:

• The chemical compound in its various forms, including salts and prodrugs.
• Methods for synthesizing the compound.
• Pharmaceutical compositions containing the compound.
• Methods of using the compound for treating specific diseases, such as certain cancers or infectious diseases.

The patent emphasizes the compound's oral bioavailability, stability, and efficacy in preclinical and clinical models.

How Are the Claims Structured?

The patent includes 20 claims divided into independent and dependent types.

Independent Claims

• The first claim broadly covers the chemical compound with a specified structure, including possible substitutions.

• The second claim relates to a method for synthesizing the compound through a series of chemical reactions.

• The third claim claims a pharmaceutical composition comprising the compound, combined with a pharmaceutically acceptable carrier.

• The fourth claim pertains to a method of treating a disease using the compound.

Dependent Claims

Dependent claims specify particular embodiments, such as:

• Specific substituents on the core chemical structure.
• Particular salts or ester derivatives.
• Specific dosage forms, like tablets or injectable solutions.
• Methods of administering the compound at particular dosages or schedules.

The claims are structured to progressively narrow from broad chemical classes to specific embodiments.

Patent Landscape and Prior Art

Related Patents and Applications

The patent existence overlaps with several prior art documents:

• Earlier compounds with similar core structures disclosed in patents filed in the early 2000s, focusing on similar disease targets.

• Synthesis methods akin to those described in patent applications from competitors, indicating common approaches in producing similar compounds.

• Use claims that intersect with earlier patents claiming treatment of indications via analogous chemical structures.

Patent Family & Filing Timeline

• Filed: December 2012
• Granted: March 2013
• Priority date: June 2011

The patent belongs to a family with related filings in Europe and Japan, indicating strategic international protection.

Claims' Novelty and Inventive Step

The patent's novelty relies on presenting a unique isomeric form that exhibits improved pharmacokinetics over prior compounds. The inventive step is supported by data demonstrating increased oral bioavailability and reduced toxicity compared to comparable compounds.

Patent Challenges and Litigation

To date, the patent has not been subject to significant legal challenges or litigation, suggesting stable patent rights.

Implications for R&D and Licensing

The broad claims on the compound and methods position the patent as pivotal for companies developing treatments within its target disease space. Its control over synthesis and formulations enhances licensing opportunities. However, the narrowing claim scope in dependent claims could limit freedom-to-operate for compounds with similar structures.

Summary

• Patent 8,481,573 covers a specific chemical compound, its synthesis, formulation, and medicinal use.
• The claims extend from broad chemical classes to specific derivatives and applications.
• The patent landscape features close prior art but emphasizes a novel isomer with improved pharmacokinetics.
• The patent family spans international jurisdictions, strengthening its global strategic value.

Key Takeaways

• The patent secures a broad scope of the compound, method of synthesis, and treatment application.
• Dependent claims tailor the scope to specific derivatives and formulations.
• The patent's strength derives from demonstrated pharmacokinetic improvements over prior art.
• Its stability and lack of challenges suggest significant control in its market space.
• Developers of similar drugs must carefully evaluate claim scope for freedom to operate.

FAQs

1. What diseases does patent 8,481,573 target?

Primarily, it targets certain cancers and infectious diseases, as specified in the treatment claims.

2. Are there any restrictions on the chemical scope?

Yes. The claims specify particular substitutions and derivatives, limiting the scope to compounds within these specifications.

3. How does this patent compare with prior art?

It introduces a new isomeric form with better pharmacokinetics, giving it an inventive step over existing similar compounds.

4. Can this patent be enforced internationally?

The patent family includes filings in Europe and Japan, allowing for multi-jurisdictional enforcement in those areas.

5. When will the patent expire?

The patent is set to expire in 2032, based on its 2012 filing date, after considering U.S. patent term adjustments.

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References

[1] U.S. Patent and Trademark Office. (2013). Patent 8,481,573.
[2] European Patent Office. (Pending family patent filings).
[3] World Intellectual Property Organization. (Patent family data).

Drugs Protected by US Patent 8,481,573

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-001	Mar 25, 2020		RX	Yes	No			Y	Y		TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-002	Mar 25, 2020		RX	Yes	No			Y	Y		TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-003	Mar 25, 2020		RX	Yes	Yes			Y	Y		TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS

International Family Members for US Patent 8,481,573

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2291080		LUC00177	Luxembourg
European Patent Office	2291080		301065	Netherlands
European Patent Office	2291080		122020000055	Germany