Details for Patent: 9,012,496

Which drugs does patent 9,012,496 protect, and when does it expire?

Patent 9,012,496 protects SYMDEKO (COPACKAGED) and TRIKAFTA (COPACKAGED) and is included in two NDAs.

This patent has eight patent family members in seven countries.

Summary for Patent: 9,012,496

Title:	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)cyclopropanecarbox- amide and administration thereof
Abstract:	A pharmaceutical composition comprising Compound 1, (R)-1-(2,2-difluorobenzo[d][1,3]dioxo-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide, 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:	13/942,617
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Understanding the Scope and Claims of United States Patent 9,012,496

To delve into the specifics of the United States Patent 9,012,496, it is crucial to analyze several key aspects, including the patent's scope, claims, and the broader patent landscape.

Patent Overview

United States Patent 9,012,496, though not directly provided in the sources, can be analyzed using general principles of patent law and analysis.

Patent Scope

The scope of a patent is defined by its claims, which are the legal boundaries of what the patent protects. Here are some key points to consider:

Claim Language

The language used in the claims is critical. Claims must be clear and distinct, particularly pointing out and distinctly claiming the subject matter of the invention. If the claims are too broad or indefinite, they can be invalidated[5].

Independent and Dependent Claims

Patents typically include both independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims build upon the independent claims and provide additional details or limitations[3].

Claim Length and Count

Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims tend to have a higher probability of grant and a shorter examination process[3].

Claims Analysis

To understand the specific claims of Patent 9,012,496, one would need to review the patent document itself.

Claim Structure

• Independent Claims: These define the core of the invention and are typically broader.
• Dependent Claims: These add specific details or limitations to the independent claims.

Claim Interpretation

Claims must be interpreted in light of the specification, the prosecution history, and the knowledge of those skilled in the art. If claims fail to inform with reasonable certainty about the scope of the invention, they can be deemed indefinite[5].

Patent Landscape

The patent landscape includes the broader context of related patents, patent families, and the technological field.

Global Dossier

Tools like the Global Dossier provided by the USPTO allow users to see the patent family for a specific application, including related applications filed at participating IP Offices. This can help in understanding the global reach and relatedness of the patent[4].

Forward and Backward Citations

Forward citations indicate the influence of the patent on subsequent inventions, while backward citations show the prior art that the patent builds upon. These citations can provide insights into the patent's significance and scope[3].

Inventorship and Ownership

Correct inventorship is crucial for the validity of a patent. Errors in inventorship, especially those made with deceptive intent, can render the patent unenforceable[2].

Patent Assignment

Changes in ownership can be tracked through the Patent Assignment Search website. This is important for understanding the current and past owners of the patent[4].

Enforceability and Litigation

The enforceability of a patent is tied to its validity and the clarity of its claims. Patents with indefinite or overly broad claims are more likely to face challenges in litigation[5].

Case Law Precedents

Court decisions, such as those from the Court of Appeals for the Federal Circuit, provide precedents that can affect the interpretation and enforceability of patent claims. For example, cases like Nautilus, Inc. v. Biosig Instruments, Inc. emphasize the importance of clear and distinct claims[5].

Public Search and Access

The USPTO Public Search Facility and online resources like the Publication Site for Issued and Published Sequences (PSIPS) provide public access to patent information, facilitating research and analysis[4].

Key Takeaways

• Clear Claims: The clarity and distinctness of patent claims are critical for the patent's validity and enforceability.
• Patent Scope Metrics: Metrics such as independent claim length and count can help in assessing the breadth and clarity of patent claims.
• Global Context: Understanding the global patent family and related applications is essential for a comprehensive analysis.
• Inventorship: Correct and honest inventorship is vital to ensure the patent's enforceability.
• Litigation Risks: Patents with indefinite or overly broad claims are at higher risk of being challenged in litigation.

Frequently Asked Questions (FAQs)

1. What is the importance of clear and distinct claims in a patent?

Clear and distinct claims are essential because they define the legal boundaries of the invention. If claims are indefinite or too broad, they can be invalidated, rendering the patent unenforceable[5].

2. How can the scope of a patent be measured?

The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics have been shown to have explanatory power for several correlates of patent scope[3].

3. Why is correct inventorship crucial for a patent?

Correct inventorship is crucial because errors, especially those made with deceptive intent, can render the patent unenforceable. Ensuring the true and only inventors are listed is essential for the patent's validity[2].

4. What tools are available for searching and analyzing patents?

Tools such as the Global Dossier, the USPTO Public Search Facility, and the Publication Site for Issued and Published Sequences (PSIPS) are available for searching and analyzing patents[4].

5. How do forward and backward citations impact the analysis of a patent?

Forward citations indicate the influence of the patent on subsequent inventions, while backward citations show the prior art that the patent builds upon. These citations provide insights into the patent's significance and scope within the technological field[3].

Sources Cited:

1. United States Patent and Trademark Office. US 10,987,348 B2.
2. Oregon State University. Determining Inventorship for US Patent Applications.
3. SSRN. Patent Claims and Patent Scope.
4. United States Patent and Trademark Office. Search for patents.
5. Court of Appeals for the Federal Circuit. MAXELL, LTD. v. AMPEREX TECHNOLOGY LIMITED.

Drugs Protected by US Patent 9,012,496

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	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	9,012,496					TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR THE F508DEL MUTATION AND A SECOND MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	9,012,496					TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR THE F508DEL MUTATION AND A SECOND MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No	9,012,496					TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes	9,012,496					TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes	9,012,496					TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR

International Family Members for US Patent 9,012,496

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