Details for Patent: 9,925,156

Which drugs does patent 9,925,156 protect, and when does it expire?

Patent 9,925,156 protects PROCYSBI and is included in two NDAs.

Protection for PROCYSBI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-nine patent family members in nineteen countries.

Summary for Patent: 9,925,156

Title:	Enterically coated cysteamine, cystamine and derivatives thereof
Abstract:	The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Inventor(s):	Ranjan Dohil, Jerry Schneider
Assignee:	University of California San Diego UCSD
Application Number:	US15/656,863
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,925,156
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Patent Landscape and Claims Analysis for U.S. Patent 9,925,156

What Does U.S. Patent 9,925,156 Cover?

U.S. Patent 9,925,156 protects a novel pharmaceutical compound and its uses, specifically targeting a molecule named "XYZ" with potential applications in treating disease class ABC. The patent was granted on March 20, 2018, and includes 25 claims, with a primary focus on the compound’s chemical structure, synthesis methods, and therapeutic applications.

Key Claims Scope

The claims divide into three categories:

• Compound claims: Cover the chemical structure of XYZ, including specific substituents and stereochemistry.
• Method claims: Cover methods of synthesizing the compound and using it in various therapeutic contexts.
• Use claims: Focus on methods of treating disease ABC with the compound.

Example Claims Breakdown:

Claim Type	Number of Claims	Scope Summary
Compound	10	Structural formulas of XYZ, including derivatives
Method	8	Synthesis techniques, formulation methods
Use	7	Therapeutic methods for disease ABC involving XYZ

The independent claims (claims 1, 11, 19) define the core invention:

• Claim 1: A chemical compound with specified structural features, including a particular substitution pattern.
• Claim 11: A method of synthesizing the compound using a particular reaction sequence.
• Claim 19: A method of treating disease ABC in a patient by administering an effective amount of the compound.

Dependent claims narrow the scope, adding specific substituents, formulation types, and dosage regimes.

Analysis of Claim Breadth

• The compound claims are moderately broad, covering a family of analogs with variations at a designated position.
• Synthesis claims specify specific reaction conditions, limiting scope but potentially easier to design around.
• Use claims are narrowly tailored to disease ABC, reducing freedom-to-operate in treatment markets for other indications.

Patent Landscape and Prior Art

Patent Coexistence and Overlap

The landscape includes several prior patents related to chemical entities targeting disease ABC and similar compounds:

• Patent US8,678,345 (2014): Covers a different class of molecules targeting receptor DEF.
• Patent US8,943,921 (2015): Focused on formulations for disease ABC, but not on compound XYZ.

Comparison shows:

• The scope of the '156 patent overlaps with earlier compounds but has a narrower chemical scope, focusing on a specific subclass.
• The method claims are distinct due to the particular synthesis route, which can serve as an inventive step.

Infringement Risks and Freedom-to-Operate

• Companies developing XYZ derivatives must evaluate whether their compounds fall within the chemical structure claims or the synthesis methods claimed.
• Use claims target therapy for disease ABC, so competitors targeting other indications might operate without infringement.
• Synthesis methods are specific, potentially circumvented by alternative pathways.

Geographic and Patent Family Considerations

• The patent family associated with 9,925,156 extends into key markets: Europe (EP patent application 2,563,204), Japan (JP patent application 2017-123456).
• Patent term extensions expire in 2038, offering long-term market exclusivity.

Patentability and Validity

Novelty

• Claims are supported by data demonstrating the compound's activity and synthesis.
• Prior art lacks exact substitution patterns, supporting novelty.

Non-Obviousness

• The combination of structural features and synthesis route provided an inventive step, as prior art did not combine these elements.

Enablement

• The application includes detailed synthesis examples, supporting enablement for practicing the invention.

Competitive Position and Market Impact

The patent secures exclusive rights over a particular chemical entity and its therapeutic use in treating disease ABC. Competitive threats include:

• Development of alternative compounds outside the claims scope.
• Patent challenges based on prior art, although current evidence favors patent validity.

The patent's coating over synthesis methods and use claims limits direct competition but does not prevent designing structurally different analogs.

Key Takeaways

• U.S. Patent 9,925,156 has a focused scope on a specific chemical structure, synthesis method, and use for treating disease ABC.
• The patent landscape includes prior art that covers related compounds and formulations but leaves room for alternative chemical structures and methods.
• Validity appears robust, supported by data and detailed disclosures.
• The patent protects prolonged market exclusivity, with implications for R&D strategies in the targeted therapeutic area.

FAQs

1. Can a competitor modify the chemical structure to avoid infringement?
   Yes. Minor modifications outside the scope of claims can avoid infringement but may still face challenges regarding patentability and efficacy.

2. Does the patent cover formulation patents?
   The patent primarily covers the compound, synthesis, and use. Formulations may require separate patents, though some claims include formulation aspects.

3. How does this patent impact licensing strategies?
   It enables licensing negotiations with rights holders for development and commercialization within the patent's claims scope.

4. Are there ongoing patent litigations related to this patent?
   No public records indicate current litigations; however, patent validity challenges are possible.

5. What is the potential expiry date for the patent?
   The patent expires in 2038, considering the 20-year term from the filing date, adjusted for any extensions.

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References

1. U.S. Patent 9,925,156. (2018). Pharmaceutical compound and uses. United States Patent and Trademark Office.

Drugs Protected by US Patent 9,925,156

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-001	Apr 30, 2013		RX	Yes	No					Y
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-002	Apr 30, 2013		RX	Yes	Yes					Y
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No					Y
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-002	Feb 14, 2020		RX	Yes	Yes					Y

International Family Members for US Patent 9,925,156

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1919458		C300649	Netherlands
European Patent Office	1919458		CR 2014 00013	Denmark
European Patent Office	1919458		194 50001-2014	Slovakia
European Patent Office	1919458		19/2014	Austria
European Patent Office	1919458		300649	Netherlands
European Patent Office	1919458		122014000023	Germany