Details for Patent: 10,758,534

Which drugs does patent 10,758,534 protect, and when does it expire?

Patent 10,758,534 protects TRIKAFTA (COPACKAGED) and is included in two NDAs.

This patent has fifty-one patent family members in thirty-one countries.

Summary for Patent: 10,758,534

Title:	Modulators of cystic fibrosis transmembrane conductance regulator
Abstract:	The present invention features a compound of formula I: ##STR00001## or a pharmaceutically acceptable salt thereof, where R.sub.1, R.sub.2, R.sub.3, W, X, Y, Z, n, o, p, and q are defined herein, for the treatment of CFTR mediated diseases, such as cystic fibrosis. The present invention also features pharmaceutical compositions, method of treating, and kits thereof.
Inventor(s):	Miller; Mark Thomas (San Diego, CA), Anderson; Corey (San Diego, CA), Arumugam; Vijayalaksmi (San Marcos, CA), Bear; Brian Richard (Carlsbad, CA), Binch; Hayley Marie (Encinitas, CA), Clemens; Jeremy J. (San Diego, CA), Cleveland; Thomas (San Diego, CA), Conroy; Erica (Columbus, OH), Coon; Timothy Richard (Carlsbad, CA), Frieman; Bryan A. (La Jolla, CA), Grootenhuis; Peter Diederik Jan (San Diego, CA), Gross; Raymond Stanley (Poway, CA), Hadida-Ruah; Sara Sabina (La Jolla, CA), Khatuya; Haripada (San Diego, CA), Joshi; Pramod Virupax (San Diego, CA), Krenitsky; Paul John (San Diego, CA), Lin; Chun-Chieh (San Diego, CA), Marelius; Gulin Erdogan (San Diego, CA), Melillo; Vito (Escondido, CA), McCartney; Jason (Cardiff by the Sea, CA), Nicholls; Georgia McGaughey (Winchester, MA), Pierre; Fabrice Jean Denis (La Jolla, CA), Silina; Alina (San Diego, CA), Termin; Andreas P. (Encinitas, CA), Uy; Johnny (San Diego, CA), Zhou; Jinglan (San Diego, CA)
Assignee:	Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:	16/258,024
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Understanding the Scope and Claims of United States Patent 10,758,534

Introduction

United States Patent 10,758,534, assigned to Vertex Pharmaceuticals Incorporated, is a significant patent in the field of pharmaceuticals, particularly for the treatment of cystic fibrosis. This patent protects a class of compounds and their use in treating cystic fibrosis transmembrane conductance regulator (CFTR) mediated diseases.

Patent Overview

The patent, titled "Modulators of cystic fibrosis transmembrane conductance regulator," was granted on September 15, 2020. It is part of a broader portfolio of patents related to CFTR modulators developed by Vertex Pharmaceuticals[4].

Claims and Scope

Independent Claims

The patent includes multiple independent claims that define the scope of the invention. These claims are crucial as they delineate what is protected under the patent. Here are some key aspects:

• Compound Claims: The patent claims specific chemical compounds of formula I, which are modulators of the CFTR protein. These compounds are designed to correct the defective CFTR protein function associated with cystic fibrosis[4].
• Pharmaceutical Compositions: The patent also claims pharmaceutical compositions containing these compounds, which are formulated for administration to patients[4].
• Methods of Treatment: The claims extend to methods of treating CFTR-mediated diseases using these compounds. This includes specific dosages and administration routes[4].

Dependent Claims

Dependent claims further narrow down the scope of the independent claims by adding additional limitations. These claims often specify particular aspects of the compounds, compositions, or treatment methods, providing a more detailed description of the protected subject matter.

Patent Expiry and Maintenance

Patent Expiry

The patent is set to expire in October 2035, approximately 10 years from the current date. This expiry date is critical for understanding the timeline during which the patent holder has exclusive rights to the invention[1].

Maintenance Fees

To keep the patent in force, the patent holder must pay maintenance fees at specified intervals. For example, the fourth-year maintenance fee for this patent was paid in March 2024[1].

Global Patent Coverage

While the patent in question is a U.S. patent, it is part of a global patent strategy. Trikafta, a related product, has patent protection in 43 countries, with the U.S. patents contributing to about 23.5% of the total global patent coverage[1].

Legal and Regulatory Aspects

Claim Construction

The interpretation of patent claims is a critical legal aspect. Claim construction is a question of law that is reviewed de novo on appeal. This means that the court's interpretation of what the claims cover is subject to a fresh review without deference to the lower court's decision[2].

Patent Validity

U.S. patents are accompanied by a presumption of validity. However, this does not preclude challenges to the patent's validity through inter partes review (IPR) or other legal proceedings. The validity of the claims can be contested based on grounds such as anticipation, obviousness, or lack of written description[2].

Metrics for Measuring Patent Scope

Independent Claim Length and Count

Research suggests that the scope of a patent can be measured using metrics such as the length and count of independent claims. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].

Impact on Innovation and Litigation

Patent Quality and Innovation

The breadth and clarity of patent claims can significantly impact innovation. Overly broad or unclear claims can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation. The claims in this patent are carefully crafted to ensure clarity and specificity, which is crucial for maintaining a healthy innovation ecosystem[3].

Litigation and Enforcement

The patent landscape around CFTR modulators is complex and has seen various legal challenges. For instance, the enforcement of these patents involves navigating through potential infringement claims and defending against validity challenges. The clear and specific claims in this patent help in mitigating some of these risks[2].

Examples and Statistics

Clinical Impact

The compounds protected under this patent have shown significant clinical benefits in treating cystic fibrosis. For example, Trikafta, a product related to these compounds, has been shown to improve lung function and reduce hospitalizations in patients with cystic fibrosis.

Economic Impact

The economic impact of these patents is substantial. The development and commercialization of CFTR modulators have generated billions of dollars in revenue for Vertex Pharmaceuticals. This revenue is crucial for funding further research and development in the field.

Key Takeaways

• Specific Claims: The patent includes specific claims for compounds, pharmaceutical compositions, and methods of treatment for CFTR-mediated diseases.
• Global Coverage: The patent is part of a broader global patent strategy with protection in 43 countries.
• Legal Aspects: Claim construction and patent validity are critical legal considerations that can impact the enforcement and defense of the patent.
• Innovation Impact: The clarity and specificity of the claims are important for maintaining innovation incentives and reducing litigation costs.
• Clinical and Economic Impact: The compounds protected under this patent have significant clinical and economic benefits.

FAQs

Q: What is the primary subject matter of United States Patent 10,758,534? A: The primary subject matter is modulators of the cystic fibrosis transmembrane conductance regulator (CFTR) and their use in treating CFTR-mediated diseases.

Q: When is the patent set to expire? A: The patent is set to expire in October 2035.

Q: How is the scope of a patent measured? A: The scope of a patent can be measured using metrics such as the length and count of independent claims.

Q: What is the significance of claim construction in patent law? A: Claim construction is a question of law that determines the meaning and scope of patent claims, and it is reviewed de novo on appeal.

Q: How do overly broad or unclear patent claims impact innovation? A: Overly broad or unclear patent claims can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation.

Drugs Protected by US Patent 10,758,534

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			Y	Y		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			Y	Y		TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No			Y	Y		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	212273-002	Jun 8, 2021		RX	Yes	No			Y	Y		TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR 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			Y	Y		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

International Family Members for US Patent 10,758,534

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	102180
Australia	2015328174
Australia	2020220185
Australia	2023201404
Brazil	112017007167