Details for Patent: 11,426,407

Which drugs does patent 11,426,407 protect, and when does it expire?

Patent 11,426,407 protects TRIKAFTA (COPACKAGED) and is included in two NDAs.

This patent has forty-nine patent family members in thirty countries.

Summary for Patent: 11,426,407

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:	16/836,155
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Understanding the Scope and Claims of United States Patent 11,426,407: A Detailed Analysis

Introduction

United States Patent 11,426,407, assigned to Vertex Pharmaceuticals Inc., is a critical patent protecting the drug Trikafta (copackaged), a groundbreaking treatment for cystic fibrosis. This analysis delves into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

Assignment and Ownership

The patent is owned by Vertex Pharmaceuticals Inc., a leading biotechnology company specializing in the development of treatments for serious diseases, including cystic fibrosis[4].

Priority Date and Filing

The priority date for this patent is October 6, 2014, indicating the initial filing date of the patent application. This date is crucial as it sets the baseline for determining the patent's term and any potential prior art considerations[5].

Scope of the Patent

Patented Use

The patent covers the use of a combination of modulators for the cystic fibrosis transmembrane conductance regulator (CFTR), specifically elexacaftor, tezacaftor, and ivacaftor. These modulators are designed to treat cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene or other mutations responsive based on in vitro data[1][4].

Pharmaceutical Compositions and Methods of Treatment

The patent encompasses pharmaceutical compositions, methods of treatment, and processes for making the modulators. This includes solid forms of the active ingredients and specific formulations that enhance the efficacy and stability of the drug[1][4].

Claims of the Patent

Independent and Dependent Claims

The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific limitations. For example, claims might cover the specific chemical structures of the modulators, the methods of administering the drug, and the pharmaceutical compositions containing these modulators[3].

Claim Language and Scope

The claim language is critical in defining the patent's 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 fewer and more specific assertions tend to have a higher probability of grant and a shorter examination process[3].

Patent Landscape

Global Patent Coverage

Trikafta (copackaged) is protected by patents in 43 countries, with the US patents contributing to about 23.5% of the total global patent coverage. This extensive global protection ensures that Vertex Pharmaceuticals maintains exclusivity over the drug across various markets[4].

US Patent Count

There are 32 US drug patents associated with Trikafta (copackaged), all of which are currently active and none of which have expired yet. These patents cover various aspects of the drug, including the active ingredients, pharmaceutical compositions, and methods of treatment[4].

Patent Expiration and Generic Entry

The earliest date for generic entry is estimated to be December 8, 2037, based on the current patent expirations. However, this date can change due to patent challenges, generic licensing, or other legal activities affecting the patent term[1][4].

Legal Activities and Challenges

Patent Litigation and PTAB Cases

There have been several legal activities and challenges related to the patents protecting Trikafta (copackaged). For instance, patent litigation cases and PTAB (Patent Trial and Appeal Board) cases indicate strong interest in generic launch. Recent data suggest that a significant percentage of patent challenges are decided in favor of the generic patent challenger, which could impact the patent landscape[1][4].

Recent Legal Activities

Recent activities include payments of maintenance fees, electronic reviews, and post-issue communications. These activities are crucial for tracking the latest developments in the patent process and understanding any potential changes to the patent term or scope[4].

Impact on Innovation and Competition

Patent Quality and Scope

The debate over patent quality and scope is relevant here. Broader patents with less clarity can lead to increased licensing and litigation costs, potentially diminishing innovation incentives. However, the narrowing of claims during the examination process, as seen in this patent, can mitigate these issues[3].

Generic Competition

The eventual generic entry, expected around December 8, 2037, will significantly impact the market. Generic competition can reduce drug prices and increase accessibility, but it also challenges the innovator company's market share and revenue streams[1][4].

Conclusion

United States Patent 11,426,407 is a pivotal patent in the treatment of cystic fibrosis, protecting the innovative combination of elexacaftor, tezacaftor, and ivacaftor. The patent's scope, claims, and the broader patent landscape highlight the complex interplay between innovation, legal protection, and market competition.

Key Takeaways

• Patent Ownership: Owned by Vertex Pharmaceuticals Inc.
• Priority Date: October 6, 2014.
• Patented Use: Treatment of cystic fibrosis in patients with specific CFTR gene mutations.
• Global Protection: Patents in 43 countries, with 32 US patents.
• Patent Expiration: Estimated generic entry date is December 8, 2037.
• Legal Activities: Ongoing patent challenges and litigation.
• Impact on Innovation: Balanced between protecting innovation and facilitating generic competition.

FAQs

Q: What is the primary use of the drug protected by United States Patent 11,426,407?

A: The primary use is the treatment of cystic fibrosis in patients aged 12 years and older with at least one F508del mutation in the CFTR gene or other responsive mutations.

Q: Who owns the patent for Trikafta (copackaged)?

A: The patent is owned by Vertex Pharmaceuticals Inc.

Q: When is the earliest estimated date for generic entry of Trikafta (copackaged)?

A: The earliest estimated date for generic entry is December 8, 2037.

Q: How many US patents protect Trikafta (copackaged)?

A: There are 32 US drug patents protecting Trikafta (copackaged).

Q: What are the potential impacts of patent challenges on the generic launch date?

A: Patent challenges can change the patent term, potentially allowing for earlier generic entry if the challenges are successful.

Sources

1. Drug Patent Watch: TRIKAFTA (COPACKAGED) - Summary.
2. Drug Patent Watch: Patent 11,426,407 - Claims, international patent, expiration and generic entry.
3. SSRN: Patent Claims and Patent Scope.
4. Pharsight - GreyB: Trikafta (copackaged) patent expiration.
5. Unified Patents Portal: US-20190269683-A1 - Modulators of Cystic Fibrosis Transmembrane Conductance Regulator.

Drugs Protected by US Patent 11,426,407

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	11,426,407		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	11,426,407		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	11,426,407		Y	Y		TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes	11,426,407		Y	Y		TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407

International Family Members for US Patent 11,426,407

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	102180
Australia	2015328174
Australia	2020220185
Australia	2023201404
Brazil	112017007167
Canada	2963792