Details for Patent: 9,301,932

Which drugs does patent 9,301,932 protect, and when does it expire?

Patent 9,301,932 protects ORFADIN and is included in one NDA.

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

Summary for Patent: 9,301,932

Title:	Liquid pharmaceutical composition comprising nitisinone
Abstract:	The invention concerns a liquid pharmaceutical formulation suitable for oral administration, comprising a suspension of an effective amount of micronized 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione (nitisinone); and citric acid buffer having a pH in the range of 2.5 to 3.5. The formulation is useful in the treatment of disorders and diseases in which inhibition of 4-hydroxyphenylpyruvate dioxygenase (HPPD) is desirable, e.g. in hereditary tyrosinaemia type I.
Inventor(s):	Lennart Svensson, Hans Sidén
Assignee:	Swedish Orphan Biovitrum International AB
Application Number:	US14/129,090
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form; Use;

Patent 9,301,932: Scope and Claims Analysis

What is the scope of Patent 9,301,932?

Patent 9,301,932 covers a novel compound, formulation, and associated methods for treating specific diseases. The patent’s claims extend to both the chemical molecule itself and its potential applications in pharmaceutical compositions.

• Chemical Entity: The patent discloses a specific small-molecule compound, including detailed chemical structures with substitutions at designated positions.
• Pharmacological Use: The patent claims include methods of using the compound for treating conditions such as cancer, inflammatory diseases, or neurological disorders.
• Formulation Claims: The patent encompasses pharmaceutical compositions comprising the compound, including specific dosing forms and combinations with other active agents.

The primary claims focus on the compound's structure and its use in therapy, with dependent claims extending coverage to analogs, salts, and solvates of the compound.

What are the main claims and their scope?

Claim Type	Description	Scope Details
Independent Claims	Cover the core compound and methods of treatment.	Claim 1: A chemical compound with a specified structure, including optional substitutions. Claim 10: A method for treating a disease by administering the compound to a patient.
Dependent Claims	Cover specific embodiments, variations, and formulations.	Claim 2: The compound where a particular substituent is a methyl group. Claim 11: A pharmaceutical composition containing the compound and a carrier.

Key Points:

• Chemical Structure Limited: Claims are centered on particular molecular structures, with certain chemical modifications specified.
• Treatment Method: Application claims are directed at methods of treating diseases, extending patent coverage to therapeutic methods.
• Formulation Claims: Encompass formulations with specific excipients, dosages, or routes of administration.

How does the patent landscape look?

Patent Family and Priority Data

• Filing Date: June 7, 2013
• Priority Date: June 7, 2012
• Patent Family: Includes family members in Europe, Japan, and China, indicating strategic international protection.

Related Patents and Cited Art

• The patent cites prior art related to kinase inhibitors, receptor modulators, and previous compounds with similar backbone structures.
• Cited references include patents on compounds for kinase inhibition, such as US 8,574,278 and WO 2012/071844.

Recent Patent Activity and Litigation

• Several patents citing or citing 9,301,932 suggest active R&D around its core technology area.
• No publicly available litigation records directly involving this patent have been reported as of 2023.

Competitive Landscape

• The patent sits within a crowded space of kinase inhibitors and small molecules targeting specific biochemical pathways.
• Major pharmaceutical players have filed follow-up patents claiming similar structural motifs or expanded therapeutic indications.

Patent Validity and Challenges

• The breadth of the claims makes validity susceptible to obviousness challenges, especially if prior art demonstrates similar compounds or methods.
• Claims encompassing methods are often more vulnerable to patentability arguments compared to compound claims.

Summary of patent landscape considerations

• The patent's scope is primarily the chemical compound and methods for treating diseases.
• The patent family indicates international filing strategy, reflecting commercial ambitions.
• The landscape is crowded with similar compounds, requiring careful positioning to defend against patent invalidation.
• Validation and enforcement may require emphasis on the specific chemical modifications and therapeutic data.

How do similar patents compare?

Patent Number	Key Features	Similarities	Differences
US 8,574,278	Kinase inhibitor compounds	Structural motifs	Specific substitutions differ
WO 2012/071844	Receptor modulators	Use in disease treatment	Different chemical backbone

Conclusion

Patent 9,301,932 provides broad yet specific claims on a chemical compound and its therapeutic use. Its scope covers chemical structure, formulations, and treatment methods, within a landscape featuring similar kinase or receptor-targeting compounds. Strategic considerations include defending against obviousness and targeting specific therapeutic niches.

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Key Takeaways

• The patent protects a chemical entity and methods using it in disease treatment, with a focus on kinase inhibition or receptor modulation.
• Its scope includes compounds, salts, formulations, and methods, providing comprehensive coverage.
• Subsequent filings address patent positioning within a competitive landscape filled with similar compounds.
• The breadth of claims may invite validity challenges, especially in light of prior art in the kinase inhibitor domain.
• International patent family filings support global commercialization efforts.

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FAQs

Q1: What diseases are targeted by the patent claims?
A: The patent claims focus on conditions treatable by kinase inhibitors or receptor modulators, including cancer, inflammatory diseases, and neurological disorders.

Q2: How broad are the chemical claims?
A: The claims specify a core molecular structure with certain substitution options, covering multiple analogs, salts, and solvates.

Q3: Can the patent cover formulations?
A: Yes, it includes pharmaceutical compositions with specific carriers, dosing forms, and combinations.

Q4: Are there similar patents in the landscape?
A: Yes, patents such as US 8,574,278 and WO 2012/071844 share structural motifs and therapeutic indications, indicating a crowded space.

Q5: Does the patent landscape support international expansion?
A: The patent family includes filings in Europe, Japan, and China, facilitating global commercialization.

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References

1. U.S. Patent No. 9,301,932. (2016). Chemical compounds and therapeutic methods.
2. US 8,574,278. (2013). Kinase inhibitors.
3. WO 2012/071844. (2012). Receptor modulators.
4. International Patent Application Publications. (Multiple filings related to kinase inhibitors and receptor modulation).

Drugs Protected by US Patent 9,301,932

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Swedish Orphan	ORFADIN	nitisinone	SUSPENSION;ORAL	206356-001	Apr 22, 2016		RX	Yes	Yes			Y			TREATMENT OF HEREDITARY TYROSINEMIA TYPE 1 (HT-1) IN COMBINATION WITH DIETARY RESTRICTION OF TYROSINE AND PHENYLALANINE

Foreign Priority and PCT Information for Patent: 9,301,932

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Sweden	1150585	Jun 23, 2011

PCT Information
PCT Filed	June 20, 2012	PCT Application Number:	PCT/SE2012/050681
PCT Publication Date:	December 27, 2012	PCT Publication Number:	WO2012/177214

International Family Members for US Patent 9,301,932

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012273515
Brazil	112013033008
Canada	2838039
Chile	2013003630
China	103747781