Details for Patent: 10,022,352

Which drugs does patent 10,022,352 protect, and when does it expire?

Patent 10,022,352 protects TRIKAFTA (COPACKAGED), ALYFTREK, and SYMDEKO (COPACKAGED), and is included in four NDAs.

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

Summary for Patent: 10,022,352

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 Sabina (La Jolla, CA), Grootenhuis; Peter Diederik Jan (San Diego, CA), Van Goor; Fredrick F. (San Diego, CA), Zhou; Jinglan (San Diego, CA), Bear; Brian Richard (Carlsbad, CA), Miller; Mark Thomas (San Diego, CA), McCartney; Jason (Cardiff by the Sea, CA), Numa; Mehdi Michel Djamel (San Diego, CA)
Assignee:	Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:	15/078,800
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Understanding the Scope and Claims of United States Patent 10,022,352

Introduction

United States Patent 10,022,352, assigned to Vertex Pharmaceuticals Incorporated, is a significant patent in the pharmaceutical industry, particularly in the treatment of cystic fibrosis. This patent protects key drugs such as TRIKAFTA and SYMDEKO, which are copackaged formulations. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.

Patent Overview

Title: Modulators of ATP-binding cassette transporters Abstract: The patent covers compounds and pharmaceutical compositions that act as modulators of ATP-binding cassette (ABC) transporters, including the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR). These compounds are useful in treating diseases mediated by ABC transporters[1].

Inventors and Assignee

The patent was invented by a team of researchers including Hadida Ruah, Sara Sabina, Grootenhuis Peter Diederik Jan, Van Goor Fredrick F., Zhou Jinglan, Bear Brian Richard, Miller Mark Thomas, McCartney Jason, and Numa Mehdi Michel Djamel. It is assigned to Vertex Pharmaceuticals Incorporated, a leading biotechnology company based in Boston, MA[1].

Patent Claims

The patent includes various claim types such as use, composition, and dosage form claims. Here are some key aspects of the claims:

• Use Claims: These claims specify the therapeutic uses of the compounds, particularly in treating cystic fibrosis and other ABC transporter-mediated diseases.
• Composition Claims: These claims describe the chemical structures and formulations of the compounds.
• Dosage Form Claims: These claims outline the specific dosage forms in which the compounds are administered, including copackaged formulations like TRIKAFTA and SYMDEKO[1].

International Patent Protection

The patent has a significant international footprint with fifty-two patent family members in twenty-one countries. This extensive global protection ensures that the intellectual property rights of Vertex Pharmaceuticals are safeguarded across multiple jurisdictions[1].

Patent Expiration and Generic Entry

Understanding the patent expiration dates is crucial for predicting when generic versions of the drugs might enter the market. The patent's expiration dates vary by country, and supplementary protection certificates (SPCs) may extend the patent life in some jurisdictions. For instance, in Australia, the estimated expiration date is subject to subscription for detailed information[1].

Therapeutic Applications

The compounds covered by this patent are specifically designed to modulate CFTR, a protein defective in patients with cystic fibrosis. By correcting the function of CFTR, these drugs improve the respiratory and digestive health of patients with this debilitating genetic disorder.

Market Impact

TRIKAFTA and SYMDEKO, protected by this patent, have revolutionized the treatment of cystic fibrosis. These drugs have shown significant efficacy in clinical trials and have been approved by regulatory bodies such as the FDA. The market dominance of these drugs is a direct result of the innovative research and development efforts of Vertex Pharmaceuticals, which are safeguarded by this patent[1].

Patent Scope Metrics

The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. This patent, with its well-defined claims, likely underwent a rigorous examination process to ensure its validity and scope[3].

Claim Construction and Validity

Claim construction is a critical aspect of patent law, and it is reviewed de novo on appeal. The validity of patent claims, including those in Patent 10,022,352, is presumed under U.S. law. However, challenges to validity can arise through inter partes review (IPR) or other legal proceedings. The claims must be clear and definite to avoid issues of indefiniteness, which can lead to invalidation[2].

Global Patent System Integration

The global patent landscape is increasingly integrated, with tools like the Global Dossier and Common Citation Document (CCD) facilitating the search and analysis of patent applications across different jurisdictions. These tools help in understanding the patent family and related applications, which is crucial for managing intellectual property rights globally[4].

Public Access to Patent Information

The U.S. Patent and Trademark Office (USPTO) provides various resources for public access to patent information, including the Public Search Facility and Patent and Trademark Resource Centers (PTRCs). These resources enable researchers, inventors, and businesses to search and analyze patents, including those like Patent 10,022,352, to understand their scope and claims[4].

Conclusion and Key Takeaways

• Patent Scope and Claims: The patent covers specific compounds and formulations useful in treating cystic fibrosis and other ABC transporter-mediated diseases.
• International Protection: Extensive global protection with patent family members in multiple countries.
• Therapeutic Impact: Significant improvement in the treatment of cystic fibrosis through drugs like TRIKAFTA and SYMDEKO.
• Market Dominance: Protected by this patent, these drugs have a strong market presence due to their efficacy and regulatory approvals.
• Patent Validity: Presumed valid under U.S. law, but subject to challenges through IPR or other legal proceedings.
• Global Integration: Part of an integrated global patent system, with tools facilitating cross-jurisdictional analysis.

FAQs

Q: What is the primary therapeutic application of the compounds covered by Patent 10,022,352? A: The primary therapeutic application is the treatment of cystic fibrosis by modulating the CFTR protein.

Q: Which drugs are protected by this patent? A: The drugs protected by this patent include TRIKAFTA and SYMDEKO, both copackaged formulations.

Q: How does the global patent protection for this patent work? A: The patent has fifty-two patent family members in twenty-one countries, ensuring global protection of Vertex Pharmaceuticals' intellectual property.

Q: What metrics can be used to measure the scope of a patent like 10,022,352? A: Metrics such as independent claim length and independent claim count can be used to measure the scope of a patent.

Q: Where can one find detailed information about the patent's expiration dates and supplementary protection certificates? A: Detailed information about the patent's expiration dates and supplementary protection certificates can be found through subscription services or by contacting the relevant patent offices.

Sources

1. DrugPatentWatch - Patent 10,022,352
2. CAFC - VASCULAR SOLUTIONS LLC v. MEDTRONIC, INC.
3. SSRN - Patent Claims and Patent Scope
4. USPTO - Search for patents

Drugs Protected by US Patent 10,022,352

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	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-001	Dec 20, 2024		RX	Yes	No			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No			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			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

International Family Members for US Patent 10,022,352

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007235260
Brazil	PI0710965
Canada	2648719
Canada	2869945
China	101460489
China	103254177
Cyprus	1116979