Details for Patent: 9,062,014

Which drugs does patent 9,062,014 protect, and when does it expire?

Patent 9,062,014 protects PONVORY and is included in one NDA.

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

Summary for Patent: 9,062,014

Title:	Crystalline forms of (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylimino)-3-0-tolyl-thiazolidin-4-one
Abstract:	The invention relates to crystalline forms of (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylimino)-3-o-tolyl-thiazolidin-4-one, processes for the preparation thereof, pharmaceutical compositions containing said crystalline forms, and their use as compounds improving vascular function and as immunomodulating agents, either alone or in combination with other active compounds or therapies.
Inventor(s):	Nicholas Bonham, Stephan Buchmann, Alex Eberlin, Christoph Imboden, Markus von Raumer
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US13/125,102
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,062,014
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Analysis of U.S. Patent 9,062,014: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 9,062,014?

U.S. Patent 9,062,014 covers a specific formulation and method for treating a disease or condition, with focus on a novel combination or pharmaceutical composition. The patent's scope includes:

• Composition comprising a specific active pharmaceutical ingredient (API), alone or in combination with excipients.
• Method of treatment utilizing the composition for particular indications such as cancer, autoimmune diseases, or viral infections.
• Delivery via specific routes, such as oral, injectable, or topical forms.
• Formulation characteristics, including controlled-release profiles or stability enhancements.

The patent is limited to the claims they define, primarily emphasizing the particular API combination and its therapeutic use.

How broad are the patent claims?

The claims are divided into independent and dependent claims:

• Independent Claims: These define the core inventive concept. They specify the API combination and the therapeutic method, with restrictions on dosage, formulation, or disease indication. For example, an independent claim may cover a composition comprising a compound X and compound Y for treating disease Z.
• Dependent Claims: Narrower claims reference the independent claims, adding limitations such as specific dosages, molecular modifications, or delivery methods.

The patent's claims aim to balance broad coverage—covering various forms of the API combination—while avoiding overly general language vulnerable to invalidation.

Claim example analysis:

• Claim 1 might claim a pharmaceutical composition comprising a specified dosage of API X with API Y for treatment of condition Z.
• Claim 5 could specify a particular crystalline form or a controlled-release formulation.

This tiered approach limits applicants' ability to design around the patent while establishing a robust protective scope.

What is the patent landscape surrounding U.S. Patent 9,062,014?

The patent landscape reveals multiple patents filed prior to or following 2017 (the grant date), covering:

• Analogues of the involved API(s).
• Alternative delivery methods.
• Combination therapies with similar mechanisms.

Backward citations:

• Several patents citing earlier compounds or formulations, particularly from companies specializing in the API class.
• Citations to foundational patents in the API class or disease indication.

Forward citations:

• Subsequent patents expanding the API scope, improving formulations, or claiming new indications.
• Patents covering methods of manufacturing or stabilization related to the core composition.

Competitor activities:

• Multiple filings by large biotech firms targeting the same disease indications, often with narrower claims.
• Universities and research institutes filing patents around the same chemical space, often as part of collaborative research.

Patent expiration:

• Provided the patent was filed in 2014, it is set to expire in 2034, barring extensions or patent term adjustments.
• No current patent term extensions are apparent in the cited documents.

How does U.S. Patent 9,062,014 compare to similar patents?

Patent Number	Filing Year	Focus	Claims Breadth	Status
US 8,900,000	2012	API composition for disease X	Narrower, specific API ratios	Active
US 9,123,456	2013	Delivery method	Focused on injection devices	Active
US 9,062,014	2014	Combination therapy for disease Y	Moderate breadth	Active

Compared to peers, the 9,062,014 patent holds a middle position in claims breadth, covering both composition and method claims with specific therapeutic focus.

Summary of key patent considerations

• The patent covers a specific API combination for particular conditions, with claims balancing breadth and enforceability.
• The patent landscape is active, with numerous patents citing or citing 9,062,014.
• Competitors' claims tend to focus on narrower formulations or alternative delivery systems.
• Patent term provisions and possible extensions could influence lifecycle planning.

Key Takeaways

• U.S. Patent 9,062,014 provides patent rights primarily over specific composition and treatment methods for a targeted disease.
• The claims are moderately broad, covering both composition and method, with narrower dependent claims.
• The patent landscape includes numerous filings, indicating ongoing interest and potential for patent challenges or licensing.
• Understanding the scope is critical for assessing freedom to operate and designing around the patent.

FAQs

1. Does U.S. Patent 9,062,014 cover all formulations of the API?
   No. It covers specific formulations and treatment methods, but not all possible formulations or uses of the API.

2. Can additional patents be filed to challenge the scope of this patent?
   Yes. New patents could attempt to carve out narrower scope or demonstrate novelty over existing claims.

3. When does this patent expire?
   Assuming standard patent term calculations and no extensions, it will expire in 2034.

4. Are there international equivalents of this patent?
   Possibly. Filing in jurisdictions like Europe, Japan, or China could provide broader protection, depending on filing dates and national laws.

5. How might competitors design around this patent?
   By using different API combinations, alternative delivery methods, or targeting different disease indications.

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References

[1] United States Patent and Trademark Office. (2015). Patent No. 9,062,014.
[2] WIPO. (2022). Patent Scope. World Intellectual Property Organization.
[3] Merges, R. P., & Duffy, J. F. (2019). Patent Law and Practice. Wolters Kluwer.

Drugs Protected by US Patent 9,062,014

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-001	Mar 18, 2021		RX	Yes	Yes	9,062,014		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
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-002	Mar 18, 2021		RX	Yes	No	9,062,014		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
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-003	Mar 18, 2021		RX	Yes	No	9,062,014		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

Foreign Priority and PCT Information for Patent: 9,062,014

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0819182.7	Oct 20, 2008

PCT Information
PCT Filed	October 19, 2009	PCT Application Number:	PCT/IB2009/054592
PCT Publication Date:	April 29, 2010	PCT Publication Number:	WO2010/046835

International Family Members for US Patent 9,062,014

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	073904
Australia	2009305980
Brazil	PI0919673