Details for Patent: 8,883,206

Which drugs does patent 8,883,206 protect, and when does it expire?

Patent 8,883,206 protects KALYDECO and TRIKAFTA (COPACKAGED) and is included in two NDAs.

This patent has twenty-one patent family members in thirteen countries.

Summary for Patent: 8,883,206

Title:	Pharmaceutical composition and administrations thereof
Abstract:	The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.
Inventor(s):	Dokou; Eleni (Cambridge, MA), Jamzad; Shahla (Belmont, MA), Caesar, Jr.; John P. (Lancaster, MA), Fawaz; Majed (Foxboro, MA), Das; Laura (Charlestown, MA), Gu; Chong-Hui (Weban, MA), Hurter; Patricia Nell (Harvard, MA), Israni; Meghna Jai (Boston, MA), Johnston; Meghan M. (Wakefield, MA), Knezic; Dragutin (Watertown, MA), Kuzmission; Andrew G. (Shrewsburg, MA), Wang; HongRen (Lexington, MA)
Assignee:	Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:	14/286,856
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,883,206
Patent Claim Types: see list of patent claims	Composition; Compound; Formulation; Dosage form;

United States Patent 8,883,206: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 8,883,206, titled "Pharmaceutical composition and administrations thereof," is a significant patent in the pharmaceutical industry, particularly in the context of drug formulations and their administration. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background

The patent, assigned to Vertex Pharmaceuticals, pertains to pharmaceutical compositions containing a solid dispersion of a specific compound, N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline 3-carboxamide. This compound is often used in treatments for cystic fibrosis and other diseases[4].

Scope of the Patent

The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are the key elements:

Pharmaceutical Compositions

The patent covers pharmaceutical compositions that include a solid dispersion of the specified compound. This solid dispersion is crucial for improving the bioavailability and stability of the drug[4].

Administration Methods

The patent also includes methods of administering these pharmaceutical compositions. This encompasses various forms such as oral granules, tablets, and other formulations designed to enhance patient compliance and efficacy[4].

Claims Analysis

The claims of the patent are the legal boundaries that define what is protected. Here is a breakdown of the types of claims:

Independent Claims

Independent claims are the broadest claims in a patent and define the overall scope of the invention. For US8883206B2, these claims focus on the pharmaceutical composition itself and the method of its administration[4].

Dependent Claims

Dependent claims are narrower and build upon the independent claims. They often specify particular aspects or variations of the invention, such as specific dosages, formulations, or administration routes[4].

Claim Construction

Claim construction is a critical process in patent law that determines the meaning and scope of the claims. This is often a point of contention in patent litigation. The courts use an objective test to determine what one of ordinary skill in the art at the time of the invention would have understood the terms to mean[5].

Patent Landscape

The patent landscape surrounding US8883206B2 involves several key aspects:

Related Patents

Vertex Pharmaceuticals holds a portfolio of patents related to cystic fibrosis treatments, including other patents like US10,646,481B2, which also deal with similar compounds and formulations[1][2].

Litigation

The patent has been involved in litigation, as seen in the case against Lupin Limited and Lupin Pharmaceuticals, Inc., where Vertex alleged infringement of several patents, including US8883206B2. This highlights the importance of these patents in protecting Vertex's intellectual property[2].

Industry Impact

The patent's impact extends beyond legal battles; it influences the development and marketing of cystic fibrosis treatments. Companies must navigate these patents to develop generic or alternative treatments, ensuring they do not infringe on existing claims[2].

Patent Scope Metrics

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

Innovation and Patent Quality

The debate over patent quality and scope is ongoing. Patents with overly broad or unclear claims can impede innovation by increasing licensing and litigation costs. The USPTO's examination process tends to narrow the scope of patent claims, ensuring that only valid and clear claims are granted[3].

Expert Insights

Industry experts emphasize the importance of clear and well-defined patent claims. For example, a Federal Trade Commission (FTC) report noted that unclear or overly broad claims, particularly in software and internet patents, can hinder innovation[3].

Statistics and Examples

• Patent Maintenance Payments: Patents with narrower claims tend to have lower maintenance payments, indicating a more focused and valid scope[3].
• Forward Citations: Patents with clearer claims receive more forward citations, suggesting their importance and impact on subsequent innovations[3].

Conclusion

The United States Patent 8,883,206 is a critical component in the pharmaceutical landscape, particularly for treatments of cystic fibrosis. Understanding its scope, claims, and the broader patent landscape is essential for both legal and business strategies.

Key Takeaways

• The patent protects specific pharmaceutical compositions and their administration methods.
• Claim construction is crucial in determining the scope of protection.
• The patent is part of a larger portfolio of related patents held by Vertex Pharmaceuticals.
• Litigation and industry impact highlight the patent's significance.
• Metrics such as claim length and count can measure patent scope.
• Clear and well-defined claims are essential for promoting innovation.

FAQs

What is the main subject of the United States Patent 8,883,206?

The main subject is pharmaceutical compositions containing a solid dispersion of a specific compound used in treatments for cystic fibrosis.

Who is the assignee of this patent?

The assignee is Vertex Pharmaceuticals.

What are the key claims of this patent?

The key claims include the pharmaceutical composition itself and the methods of its administration.

How does claim construction impact this patent?

Claim construction determines the meaning and scope of the claims, which is crucial in patent litigation and ensuring the patent's validity.

What is the broader impact of this patent on the pharmaceutical industry?

The patent influences the development and marketing of cystic fibrosis treatments, requiring companies to navigate these patents to avoid infringement.

Cited Sources

1. United States Patent and Trademark Office, "US10646481.pdf"
2. Insight.rpxcorp.com, "Case 1:23-cv-00583-UNA Document 1 Filed 05/26/23"
3. Hoover Institution, "Patent Claims and Patent Scope"
4. Google Patents, "US8883206B2 - Pharmaceutical composition and administrations thereof"
5. GovInfo, "Case 3:15-cv-06075-PGS-DEA Document 164 Filed 06/27"

Drugs Protected by US Patent 8,883,206

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	KALYDECO	ivacaftor	GRANULE;ORAL	207925-004	May 3, 2023		RX	Yes	No			Y
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-005	May 3, 2023		RX	Yes	No			Y
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-003	Apr 29, 2019		RX	Yes	No			Y
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-001	Mar 17, 2015		RX	Yes	No			Y
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-002	Mar 17, 2015		RX	Yes	Yes			Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No			Y

International Family Members for US Patent 8,883,206

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013226076
Brazil	112014021090
Canada	2865519
China	104470518
China	109966264
European Patent Office	2819670