Details for Patent: 9,931,334

Which drugs does patent 9,931,334 protect, and when does it expire?

Patent 9,931,334 protects ORKAMBI, TRIKAFTA (COPACKAGED), and SYMDEKO (COPACKAGED), and is included in five NDAs.

This patent has thirty-four patent family members in nineteen countries.

Summary for Patent: 9,931,334

Title:	Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
Abstract:	The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
Inventor(s):	Hurter; Patricia (Harvard, MA), Rowe; William (Medford, MA), Young; Christopher R. (Waltham, MA), Costache; Adriana (Cambridge, MA), Connelly; Patrick R. (Harvard, MA), Krawiec; Mariusz (Marlborough, MA), Gong; Yuchuan (Waukegan, IL), Feng; Yushi (Zionsville, IN), Trudeau; Martin (Shannon, CA)
Assignee:	Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:	15/584,324
Patent Claim Types: see list of patent claims	Use; Composition;

Understanding the Scope and Claims of United States Patent 9,931,334

Introduction

United States Patent 9,931,334, titled "Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide," is a patent that delves into the solid state forms of a specific chemical compound. This analysis will explore the scope, claims, and the broader patent landscape surrounding this invention.

The Invention: Compound 1

The patent focuses on solid state forms of the compound N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, hereafter referred to as Compound 1. This compound is described in detail, including its chemical structure and various solid state forms such as polymorphs, solvates, and amorphous forms[1].

Scope of the Patent

The scope of the patent is defined by the claims, which must be clear, concise, and fully supported by the description of the invention. Here, the claims cover various aspects of Compound 1, including its preparation, physical properties, and potential uses.

Claims

The claims in this patent are structured to define the matter for which protection is sought. They include:

• Independent Claims: These define the broadest scope of the invention, such as the solid state forms of Compound 1.
• Dependent Claims: These narrow down the scope by specifying particular characteristics or methods related to the independent claims, such as specific polymorphs or solvates of Compound 1[2].

Description and Support

The description section of the patent provides detailed information about the invention, including how to make and use the solid state forms of Compound 1. This section must be enabling, meaning it must teach a person with ordinary skill in the art how to make and use the invention[4].

Patent Landscape

The patent landscape for Compound 1 involves understanding the broader context of similar inventions and the technological area it belongs to.

Technological Area

Compound 1 falls within the realm of pharmaceutical or chemical compounds, specifically those related to quinoline derivatives. This area is highly competitive, with numerous patents covering various aspects of quinoline compounds and their applications.

Prior Art

The patent must be novel, useful, and nonobvious over the prior art. The description and claims must distinguish the invention from existing knowledge in the field. This involves a thorough search of prior art to ensure that the solid state forms of Compound 1 are not already disclosed or obvious from what is known[5].

Commercial and Practical Implications

The solid state forms of Compound 1 could have significant commercial implications, particularly in the pharmaceutical industry. Different solid state forms can affect the solubility, stability, and bioavailability of a drug, making this patent potentially valuable for drug development.

Cost and Time Considerations

The process of obtaining and maintaining a patent can be costly and time-consuming. For a patent like US 9,931,334, the costs could range from $8,000 to $20,000 for a U.S. non-provisional patent application, with additional costs incurred during patent prosecution and maintenance[5].

Expedited Examination

Given the competitive nature of the pharmaceutical industry, expedited examination programs such as Accelerated Examination or Track One Prioritized Examination might be considered to reduce the examination time from several years to about 12 months. This can be crucial for bringing a new drug to market quickly[4].

International Protection

For global market protection, international patent applications would be necessary. This involves additional costs and complexities, including navigating different patent laws and regulations in various countries[5].

Key Takeaways

• Clear and Concise Claims: The patent claims must clearly define the solid state forms of Compound 1 and be fully supported by the description.
• Novelty and Nonobviousness: The invention must be novel, useful, and nonobvious over prior art.
• Commercial Value: The solid state forms of Compound 1 have potential commercial value, especially in drug development.
• Cost and Time: The patent process is costly and time-consuming, with options for expedited examination.
• International Protection: Global protection requires additional steps and costs.

FAQs

Q: What is the main subject of United States Patent 9,931,334? A: The main subject is the solid state forms of the compound N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide.

Q: Why are solid state forms important in pharmaceuticals? A: Solid state forms can affect the solubility, stability, and bioavailability of a drug, making them crucial for drug development.

Q: How long does the patent examination process typically take? A: The process can take two to five years, but expedited examination programs can reduce this time to about 12 months.

Q: What are the key requirements for patent claims? A: Claims must be clear, concise, and fully supported by the description of the invention.

Q: How much does it typically cost to obtain and maintain a U.S. patent? A: The cost can range from $8,000 to $20,000 for a non-provisional patent application, with additional costs for prosecution and maintenance.

Sources

1. US9931334B2 - Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide.
2. 1824-The Claims - USPTO.
3. Inventing AI - USPTO.
4. TIMELINE AND COSTS FOR PATENT FILINGS - SBIR.
5. Intellectual Property Protection - KU Office of Research.

Drugs Protected by US Patent 9,931,334

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-003	Sep 2, 2022		RX	Yes	No	9,931,334		Y			TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-001	Aug 7, 2018		RX	Yes	No	9,931,334		Y			TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-002	Aug 7, 2018		RX	Yes	Yes	9,931,334		Y			TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No	9,931,334		Y			TREATMENT OF CF IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes	9,931,334		Y			TREATMENT OF CF IN PATIENTS AGED 2 TO
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-002	Sep 28, 2016		RX	Yes	No	9,931,334		Y			METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT AGE 6 OR OLDER HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-001	Jul 2, 2015		RX	Yes	Yes	9,931,334		Y			METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT AGE 6 OR OLDER HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR

International Family Members for US Patent 9,931,334

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006332726
Brazil	PI0620960
Canada	2635581
China	101384172
Cyprus	1118980
Cyprus	1122861
Denmark	1993360