Details for Patent: 10,206,877

Which drugs does patent 10,206,877 protect, and when does it expire?

Patent 10,206,877 protects ALYFTREK and SYMDEKO (COPACKAGED) and is included in two NDAs.

This patent has sixty-four patent family members in twenty-nine countries.

Summary for Patent: 10,206,877

Title:	Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Abstract:	The present invention features compositions comprising a plurality of therapeutic agents wherein the presence of one therapeutic agent enhances the properties of at least one other therapeutic agent. In one embodiment, the therapeutic agents are cystic fibrosis transmembrane conductance regulators (CFTR) such as a CFTR corrector or CFTR potentiator for the treatment of CFTR mediated diseases such as cystic fibrosis. Methods and kits thereof are also disclosed.
Inventor(s):	Phenix; Brian Dean (Acton, MA), Bagnol; Laurent Jean-Claude (Burlington, MA), Brodeur; Geoffrey Glen (Somerville, MA), Chandran; Sachin (Somerville, MA), Dokou; Eleni (Cambridge, MA), Ferris; Lori Ann (Medford, MA), Knezic; Dragutin (Watertown, MA), McCarty; Katie Lynn (Watertown, MA), Medek; Ales (Winchester, MA), Waggener; Sara A. (N. Billerica, MA)
Assignee:	Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:	14/686,117
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

United States Patent 10,206,877: A Detailed Analysis of Scope and Claims

Introduction

United States Patent 10,206,877, hereafter referred to as the '877 patent, is a significant intellectual property asset in the pharmaceutical sector. This patent protects specific compositions and methods related to therapeutic agents, particularly those used in the treatment of cystic fibrosis.

Patent Overview

The '877 patent is associated with SYMDEKO (COPACKAGED), a medication used for the treatment of cystic fibrosis. This patent is part of a larger family of patents, with sixty-four patent family members spread across twenty-nine countries[1].

Claims and Scope

The '877 patent claims compositions comprising multiple therapeutic agents, where the presence of one therapeutic agent enhances the properties of another. Here are some key aspects of the claims:

Therapeutic Agents

The patent covers combinations of therapeutic agents that work synergistically. For example, it includes claims for compositions that combine a CFTR modulator with other therapeutic agents to enhance the efficacy of the treatment[1].

Enhanced Properties

The claims specify that the presence of one therapeutic agent must enhance the properties of another. This could include improved stability, bioavailability, or therapeutic efficacy[1].

Specific Compositions

The patent details specific compositions that are protected, including the exact formulations and ratios of the therapeutic agents involved. These compositions are designed to optimize the treatment outcomes for patients with cystic fibrosis[1].

Patent Landscape

The '877 patent operates within a complex patent landscape, particularly in the field of cystic fibrosis treatments.

Global Protection

With sixty-four patent family members in twenty-nine countries, this patent provides extensive global protection for the covered compositions and methods. This widespread protection is crucial for maintaining market exclusivity and preventing generic or biosimilar competition[1].

Related Patents

The '877 patent is part of a broader portfolio of patents related to cystic fibrosis treatments. Other patents, such as those held by Vertex Pharmaceuticals (e.g., US 10,987,348 B2), also cover modulators of ATP-binding cassette transporters, including the CFTR protein[4].

Regulatory and Legal Context

Understanding the regulatory and legal context is essential for navigating the patent landscape.

FDA Approval

The '877 patent is included in one New Drug Application (NDA) with the FDA, indicating that the compositions and methods covered by this patent have undergone rigorous regulatory scrutiny and approval[1].

Patent Litigation

While the '877 patent itself may not be involved in current litigation, the broader context of patent disputes in the pharmaceutical sector highlights the importance of robust patent protection. For instance, other patents in the tech and pharmaceutical sectors often face challenges under 35 U.S.C. § 101 regarding the validity of claims related to abstract ideas or natural phenomena[2].

Economic and Market Impact

The economic and market impact of the '877 patent is significant.

Market Exclusivity

By protecting specific compositions and methods, the '877 patent ensures market exclusivity for the patented products. This exclusivity allows the patent holder to recoup investment in research and development and maintain a competitive edge in the market[1].

Innovation Incentives

The patent system, including the '877 patent, provides incentives for innovation by offering protection for novel and non-obvious inventions. This encourages further research and development in the field of cystic fibrosis treatments[3].

Technical Details and Innovations

The technical details of the '877 patent highlight the innovative aspects of the compositions and methods covered.

CFTR Modulators

The patent includes claims for compositions that modulate the CFTR protein, which is crucial for treating cystic fibrosis. These modulators can improve the function of the CFTR protein, leading to better treatment outcomes[1].

Synergistic Effects

The synergistic effects between different therapeutic agents are a key innovation. By combining these agents, the patent holders have developed compositions that offer enhanced therapeutic benefits compared to single-agent treatments[1].

Future Implications

The '877 patent has several future implications for the pharmaceutical industry and patients.

Continued Innovation

The protection offered by the '877 patent will likely drive continued innovation in cystic fibrosis treatments. Researchers and pharmaceutical companies will be incentivized to develop new and improved therapies within the scope of this patent[3].

Patient Access

The exclusivity provided by the patent ensures that patients have access to high-quality, FDA-approved treatments. However, it also means that generic or biosimilar alternatives may not be available until the patent expires, potentially affecting affordability and accessibility[1].

Key Takeaways

• Global Protection: The '877 patent has extensive global protection with sixty-four patent family members in twenty-nine countries.
• Therapeutic Agents: The patent covers compositions of multiple therapeutic agents that work synergistically.
• Regulatory Approval: The patent is included in one FDA-approved NDA.
• Market Exclusivity: The patent ensures market exclusivity, allowing the patent holder to recoup R&D investments.
• Innovation Incentives: The patent system incentivizes further innovation in cystic fibrosis treatments.

FAQs

1. What is the main subject matter of United States Patent 10,206,877?

   • The main subject matter is compositions comprising multiple therapeutic agents for the treatment of cystic fibrosis.

2. How many patent family members does the '877 patent have globally?

   • The '877 patent has sixty-four patent family members in twenty-nine countries.

3. What is the significance of the '877 patent in the pharmaceutical sector?

   • It provides market exclusivity and protects specific compositions and methods for treating cystic fibrosis, ensuring high-quality treatments and incentivizing further innovation.

4. Is the '877 patent involved in any current litigation?

   • There is no indication that the '877 patent itself is currently involved in litigation, but it operates within a sector where patent disputes are common.

5. How does the '877 patent impact patient access to treatments?

   • The patent ensures access to high-quality, FDA-approved treatments but may delay the availability of generic or biosimilar alternatives until the patent expires.

Cited Sources

1. Drug Patent Watch, "Patent 10,206,877".
2. CAFC, "MOBILE ACUITY LTD. v. BLIPPAR LTD."
3. USPTO, "Patent Claims Research Dataset".
4. United States Patent, "US 10,987,348 B2".

Drugs Protected by US Patent 10,206,877

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	218730-002	Dec 20, 2024		RX	Yes	Yes	10,206,877		Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VNZ AND A COMPOSITION ACCORDING TO CLAIM 1 OF US10206877
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	10,206,877		Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	10,206,877		Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	10,206,877		Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877

International Family Members for US Patent 10,206,877

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015247850
Australia	2019250116
Brazil	112016023422
Canada	2944140