Details for Patent: 10,058,546

Which drugs does patent 10,058,546 protect, and when does it expire?

Patent 10,058,546 protects ALYFTREK and SYMDEKO (COPACKAGED) and is included in two NDAs.

This patent has eight patent family members in seven countries.

Summary for Patent: 10,058,546

Title:	Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxo1-5-y1)-N-(1-(2,3-dihydroxypropy1)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-y1)-1H-indol-5-y1) cyclopropanecarbox-amide and administration thereof
Abstract:	A pharmaceutical composition comprising Compound 1, (R)-1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarbox- amide, and at least one excipient selected from: a filler, a disintegrant, a surfactant, a glidant and a lubricant, the composition being suitable for oral administration to a patient in need thereof to treat a CFTR mediated disease such as Cystic Fibrosis. Methods for treating a patient in need thereof include administering the pharmaceutical composition of Compound 1 are also disclosed.
Inventor(s):	Alargova; Rossitza Gueorguieva (Brighton, MA), Dunbar; Craig Antony (Needham, MA), Kadiyala; Irina Nikolaevna (Newton, MA)
Assignee:	Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:	15/342,999
Patent Claim Types: see list of patent claims	Use; Composition;

Analyzing the Scope and Claims of United States Patent 10,058,546

Introduction

United States Patent 10,058,546, titled "Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl) cyclopropanecarboxamide and administration thereof," is a patent that covers specific pharmaceutical compositions and their administration. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

The patent, assigned the number US10058546B2, pertains to pharmaceutical compositions involving a specific cyclopropanecarboxamide compound. This compound is designed for various therapeutic applications, particularly in the treatment of diseases where such compounds can be effective.

Scope of the Patent

The scope of a patent is defined by its claims, which outline the boundaries of what is protected by the patent. Here are some key aspects of the scope:

Claim Structure

The patent includes multiple claims, each defining a different aspect of the invention. These claims can be categorized into independent and dependent claims. Independent claims stand alone and define the invention broadly, while dependent claims build upon the independent claims and provide more specific details[3].

Independent Claims

Independent claims in this patent typically describe the pharmaceutical composition itself, including the specific chemical structure of the cyclopropanecarboxamide compound, its formulation, and the methods of its administration. For example, Claim 1 might describe the compound's chemical structure and its pharmaceutical formulation.

Dependent Claims

Dependent claims further specify the invention by detailing particular embodiments, such as specific dosages, administration routes, or additional components in the pharmaceutical composition. These claims narrow down the scope to cover specific variations of the invention.

Claim Analysis

To understand the patent's scope, it is crucial to analyze the claims in detail.

Claim Length and Count

Research suggests that the length and count of independent claims can be indicative of the patent's scope. Narrower claims, both in terms of length and count, are often associated with a higher probability of grant and a shorter examination process[3].

Claim Language

The language used in the claims is critical. It must be clear and specific to avoid ambiguity and ensure that the scope of the patent is well-defined. In the case of US10058546B2, the claims meticulously describe the chemical structure and the pharmaceutical formulations, ensuring clarity and specificity.

Patent Landscape

Understanding the broader patent landscape is essential for assessing the significance and potential impact of this patent.

Prior Art

The patent landscape includes prior art, which are existing patents and publications that relate to the same or similar inventions. The Common Citation Document (CCD) application, for instance, consolidates prior art cited by multiple patent offices, helping to visualize the prior art landscape for a specific invention[1].

International Patent Offices

The invention may also be patented or pending in other countries. Searching international patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), can reveal the global reach of this patent[1].

Competing Patents

Identifying competing patents in the same field can provide insights into the competitive landscape. This involves searching patent databases using relevant keywords and classifications to find similar inventions.

Search Tools and Resources

Several tools and resources are available to help in the analysis of this patent and its landscape:

Patent Public Search

The USPTO's Patent Public Search tool is a powerful resource for searching prior art and understanding the patent landscape. It provides enhanced access to prior art and allows for more flexible and powerful searches[1].

Global Dossier

The Global Dossier service allows users to access the file histories of related applications from participating IP Offices, providing a comprehensive view of the patent family and related applications[1].

Patent and Trademark Resource Centers (PTRCs)

Local PTRCs offer training in patent search techniques and maintain local search resources, which can be invaluable for a detailed analysis of the patent landscape[1].

Practical Implications

Understanding the scope and claims of US10058546B2 has practical implications for several stakeholders:

Inventors and Researchers

For inventors and researchers, knowing the exact scope of the patent helps in avoiding infringement and in identifying areas for further innovation.

Industry and Manufacturers

Companies involved in pharmaceutical manufacturing need to understand the patent's scope to ensure they do not infringe on existing patents and to identify potential licensing opportunities.

Regulatory Bodies

Regulatory bodies, such as the FDA, need to be aware of the patent landscape to ensure that approved pharmaceuticals do not infringe on existing patents.

Key Takeaways

• Clear Claims: The patent's claims are clear and specific, defining the chemical structure and pharmaceutical formulations.
• Narrow Scope: The use of narrower claims can indicate a higher probability of grant and a shorter examination process.
• Global Reach: The invention may be patented or pending in other countries, necessitating a global search.
• Competitive Landscape: Identifying competing patents is crucial for understanding the market and potential licensing opportunities.
• Resources: Utilizing tools like Patent Public Search, Global Dossier, and PTRCs can facilitate a comprehensive analysis.

FAQs

1. What is the main subject of United States Patent 10,058,546?

   • The main subject is pharmaceutical compositions involving a specific cyclopropanecarboxamide compound and its administration.

2. How do independent and dependent claims differ in a patent?

   • Independent claims define the invention broadly, while dependent claims provide more specific details and build upon the independent claims.

3. What tools can be used to search for prior art related to this patent?

   • Tools such as the USPTO's Patent Public Search, Global Dossier, and international patent databases like those from the EPO and WIPO can be used.

4. Why is it important to analyze the scope of a patent?

   • Analyzing the scope helps in avoiding infringement, identifying areas for further innovation, and understanding licensing opportunities.

5. How can the scope of a patent affect its examination process?

   • Narrower claims are often associated with a higher probability of grant and a shorter examination process, as they are clearer and more specific[3].

Drugs Protected by US Patent 10,058,546

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	10,058,546					TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WITH AT LEAST ONE F508DEL OR G551D AND AN A455E, 2789+5G->A, OR 3849+10KBC->T CFTR MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546 FURTHER COMPRISING VNZ
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	10,058,546					TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	10,058,546					TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	10,058,546					TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	10,058,546					TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546

International Family Members for US Patent 10,058,546

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	092857
Australia	2013290444
Australia	2018208694
Canada	2878057
European Patent Office	2872122
Hong Kong	1209318
Taiwan	201408295