Details for Patent: 8,598,181

Which drugs does patent 8,598,181 protect, and when does it expire?

Patent 8,598,181 protects TRIKAFTA (COPACKAGED) and SYMDEKO (COPACKAGED) and is included in three NDAs.

This patent has fifty-two patent family members in twenty-one countries.

Summary for Patent: 8,598,181

Title:	Modulators of ATP-binding cassette transporters
Abstract:	Compounds of the present invention and pharmaceutically acceptable compositions thereof, are useful as modulators of ATP-Binding Cassette ("ABC") transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator ("CFTR"). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Inventor(s):	Hadida Ruah; Sara S. (La Jolla, CA), Grootenhuis; Peter D. J. (San Diego, CA), Van Goor; Fredrick (San Diego, CA), Zhou; Jinglan (San Diego, CA), Bear; Brian (Oceanside, CA), Miller; Mark T. (San Diego, CA), McCartney; Jason (Cardiff by the Sea, CA), Numa; Mehdi Michel Jamel (San Diego, CA), Yang; Xiaoqing (San Diego, CA)
Assignee:	Vertex Pharmaceuticals Incorporated (Cambridge, MA)
Application Number:	12/829,879
Patent Claim Types: see list of patent claims	Use;

Understanding the Scope and Claims of United States Patent 8,598,181

Introduction

United States Patent 8,598,181, titled "Modulators of ATP-binding cassette transporters," is a significant patent in the field of pharmaceuticals and biotechnology. This patent, assigned to Vertex Pharmaceuticals Incorporated, covers compounds and compositions that modulate ATP-binding cassette (ABC) transporters, which are crucial in various biological processes and disease treatments.

Background

ABC transporters are a family of proteins that play a vital role in the transport of molecules across cell membranes. These transporters are involved in numerous physiological and pathological processes, including the transport of drugs, lipids, and other substrates. The patent in question focuses on modulators of these transporters, which can be used to treat a variety of diseases.

Patent Claims

The patent includes several claims that define the scope of the invention. Here are some key aspects of these claims:

Independent Claims

The independent claims are the broadest claims in the patent and define the core of the invention. For US Patent 8,598,181, these claims typically involve the structure and composition of the modulators, such as specific chemical groups and their arrangements.

• Claim 1: This claim often sets the foundation by describing the general structure of the modulators, including the presence of specific functional groups and their attachments to the core molecule[4].

Dependent Claims

Dependent claims narrow down the scope of the independent claims by adding additional features or limitations. These claims help to specify particular embodiments of the invention.

• Dependent Claims: These claims may include specifications such as the type of substituents on the core molecule, the presence of specific heteroaryl or aryl groups, and other detailed structural features that further define the modulators[4].

Scope of the Patent

The scope of the patent is determined by the language of the claims and the descriptions provided in the specification.

Chemical Compounds

The patent covers a wide range of chemical compounds that act as modulators of ABC transporters. These compounds are described in detail, including their chemical structures, substituents, and functional groups.

• Chemical Groups: The patent specifies various chemical groups such as carbonyl, aliphatic, heteroaryl, and aryl groups, along with their possible substitutions and arrangements[4].

Pharmaceutical Applications

The modulators covered by this patent are intended for use in treating various diseases, including cystic fibrosis, emphysema, chronic obstructive pulmonary disease (COPD), and dry eye syndromes.

• Disease Treatments: The patent highlights the therapeutic potential of these modulators in managing and treating diseases associated with ABC transporter dysfunction[4].

Practical Applications

The practical applications of the claimed modulators are a crucial aspect of the patent.

Real-World Use

The modulators are designed to improve the function of ABC transporters, which can lead to tangible benefits such as enhanced drug efficacy, reduced side effects, and improved patient outcomes.

• Example: In the context of cystic fibrosis, modulating ABC transporters can help in correcting the defective protein function, thereby improving respiratory health[4].

Patent Landscape

The patent landscape surrounding US Patent 8,598,181 involves several key factors:

Prior Art

The patent must differentiate itself from prior art, which includes existing knowledge and previous patents in the field. The unique structural features and specific applications of the modulators distinguish this patent from earlier works.

• Novelty: The patent's claims must be novel and non-obvious over the prior art to be granted. The detailed structural descriptions and specific therapeutic applications ensure that the patent meets these criteria[4].

Patent Scope Metrics

Research on patent scope metrics, such as independent claim length and independent claim count, can provide insights into the breadth and clarity of the patent claims. Narrower claims with clear and specific language are generally associated with higher patent quality and a shorter examination process[3].

Subject Matter Eligibility

In the context of recent updates on patent eligibility, particularly those related to AI and software patents, it is important to note that the eligibility of US Patent 8,598,181 is based on its practical applications and tangible benefits.

• Practical Applications: The patent's focus on specific, practical applications of the modulators in treating diseases ensures that it meets the criteria for patent eligibility, as it integrates abstract ideas into concrete technological improvements[1].

Key Takeaways

• Structural Specificity: The patent claims are highly specific regarding the chemical structure and composition of the modulators.
• Therapeutic Applications: The modulators are designed to treat a range of diseases associated with ABC transporter dysfunction.
• Patent Scope: The patent's scope is defined by its claims, which are narrowed down by dependent claims to specify particular embodiments.
• Practical Applications: The patent's focus on real-world applications ensures its eligibility and relevance.
• Patent Landscape: The patent differentiates itself from prior art through its unique structural features and specific therapeutic applications.

FAQs

1. What is the main subject of US Patent 8,598,181?

   • The main subject is modulators of ATP-binding cassette (ABC) transporters.

2. What diseases are targeted by the modulators in this patent?

   • The modulators are intended to treat diseases such as cystic fibrosis, emphysema, COPD, and dry eye syndromes.

3. How do the claims in this patent ensure patent eligibility?

   • The claims ensure patent eligibility by specifying practical applications and tangible benefits, integrating abstract ideas into concrete technological improvements.

4. What metrics can be used to measure the scope of patent claims?

   • Metrics such as independent claim length and independent claim count can be used to measure the scope and clarity of patent claims.

5. Why is the structural specificity of the modulators important in this patent?

   • The structural specificity is crucial because it defines the unique features of the modulators and differentiates them from prior art, ensuring novelty and non-obviousness.

Sources

1. Mintz, "Understanding the 2024 USPTO Guidance Update on AI Patent Eligibility"
2. FDA, "Patent Extension Application for SYMDEKO Patent No. 8598181"
3. SSRN, "Patent Claims and Patent Scope"
4. Google Patents, "US8598181B2 - Modulators of ATP-binding cassette transporters"
5. PubChem, "Generation of modulators of transporters having an ATP binding cassette"

Drugs Protected by US Patent 8,598,181

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	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No						TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes						TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No						TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes						TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No						TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes						TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

International Family Members for US Patent 8,598,181

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007235260
Brazil	PI0710965
Canada	2648719
Canada	2869945
China	101460489
China	103254177