Details for Patent: 10,272,046

Which drugs does patent 10,272,046 protect, and when does it expire?

Patent 10,272,046 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: 10,272,046

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 (Waban, 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:	15/181,114
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,272,046
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Dosage form;

Understanding the Scope and Claims of United States Patent 10,272,046

To delve into the specifics of the United States Patent 10,272,046, it is crucial to analyze several key aspects, including the patent's scope, claims, and the broader patent landscape in which it exists.

Patent Overview

Patent Number and Title

The United States Patent 10,272,046, while not specifically detailed in the provided sources, can be analyzed using general principles of patent law and the structure of patent documents.

Patent Scope

Definition of Patent Scope

Patent scope refers to the boundaries of what is protected by the patent, defined by the claims section of the patent document. The scope is critical in determining what constitutes infringement and what does not[3].

Metrics for Measuring Patent Scope

Two common metrics for measuring patent scope are independent claim length (ICL) and independent claim count (ICC). These metrics help in assessing the breadth and clarity of the patent claims. Narrower claims, as indicated by shorter ICL and lower ICC, are often associated with a higher probability of grant and a shorter examination process[3].

Claims Analysis

Types of Claims

Patents typically include various types of claims, such as independent claims and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims[3].

Claim Construction

The construction of claims is a critical aspect of patent law. It involves interpreting the language of the claims to determine their scope. This process can be complex and is often a point of contention in patent litigation[3].

Patent Claims and Their Impact

Patent Claims and Market Exclusivity

The claims of a patent can significantly impact the timing of generic drug approvals. For instance, if a drug product is covered by multiple patents, the expiration of these patents can stagger the entry of generic competitors into the market. This can extend the market exclusivity period for the original drug beyond the initial patent expiration[1].

Follow-On Patents

Follow-on patents, which are patents granted for changes or improvements to an existing patented drug product, can further extend market exclusivity. These patents can cover new dosage forms, routes of administration, or expanded uses of the active ingredient, thereby delaying generic competition[1].

Regulatory Exclusivities

Types of Exclusivities

In addition to patent protection, pharmaceutical products can also receive regulatory exclusivities granted by the FDA. These exclusivities prevent the FDA from approving generic or biosimilar versions of the drug for a specified period, which can range from six months to 12 years depending on the type of product[4].

Impact on Generic Competition

Regulatory exclusivities, along with patent protection, play a significant role in delaying the entry of generic drugs into the market. This combination can result in extended periods of market exclusivity for the original drug product[4].

Litigation and Patent Validity

Patent Litigation

Patent litigation often revolves around the validity and infringement of patent claims. Courts must determine whether the asserted claims are valid and whether they have been infringed by the defendant. This process can be lengthy and complex, involving detailed claim construction and analysis of prior art[2].

Validity Challenges

Patent claims can be challenged on various grounds, including obviousness, anticipation, and lack of novelty. These challenges can arise during litigation or through post-grant administrative reviews. The validity of the claims is crucial in determining the enforceability of the patent[2].

Patent Landscape and Innovation

Innovation and Follow-On Patents

The patent landscape for pharmaceuticals is dynamic, with continuous innovation leading to follow-on patents. These patents can result from efforts to improve patient compliance, address side effects, or expand the use of the active ingredient. This ongoing innovation can extend the patent protection period and maintain market exclusivity[1].

Impact on Drug Development

The interplay between patents, follow-on patents, and regulatory exclusivities significantly influences drug development and pricing. These intellectual property protections provide incentives for innovation but can also lead to higher drug prices by delaying generic competition[4].

Key Takeaways

• Patent Scope and Claims: The scope of a patent is defined by its claims, which can be measured using metrics like independent claim length and independent claim count.
• Market Exclusivity: Patents and regulatory exclusivities can extend market exclusivity for pharmaceutical products, delaying generic competition.
• Follow-On Patents: Continuous innovation in pharmaceuticals leads to follow-on patents, which can further extend market exclusivity.
• Litigation and Validity: Patent litigation and validity challenges are critical in determining the enforceability of patent claims.
• Impact on Innovation and Pricing: The patent landscape influences drug development and pricing, providing incentives for innovation but potentially leading to higher drug prices.

FAQs

What is the typical duration of a patent in the United States?

A patent in the United States typically lasts for 20 years from the filing date of the patent application[4].

How do follow-on patents affect market exclusivity?

Follow-on patents can extend market exclusivity by covering new aspects of the drug product, such as new dosage forms or expanded uses, thereby delaying generic competition[1].

What are regulatory exclusivities, and how do they impact generic drugs?

Regulatory exclusivities are periods during which the FDA cannot approve generic or biosimilar versions of a drug. These exclusivities can last from six months to 12 years and, combined with patent protection, can significantly delay the entry of generic drugs into the market[4].

How are patent claims constructed and interpreted?

Patent claims are constructed and interpreted through a process known as claim construction, which involves analyzing the language of the claims to determine their scope. This process is often a point of contention in patent litigation[3].

What role do independent claim length and independent claim count play in measuring patent scope?

Independent claim length and independent claim count are metrics used to measure patent scope. Narrower claims, indicated by shorter ICL and lower ICC, are associated with a higher probability of grant and a shorter examination process[3].

Cited Sources

1. USPTO Drug Patent and Exclusivity Study Report - USPTO
2. Case 1:13-cv-02046-GMS Document 472 Filed 06/10/16 - GovInfo
3. Patent Claims and Patent Scope - Hoover Institution
4. Drug Prices: The Role of Patents and Regulatory Exclusivities - Congressional Research Service

Drugs Protected by US Patent 10,272,046

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			TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-005	May 3, 2023		RX	Yes	No			Y			TREATMENT OF CF IN A PATIENT AGE 1 MONTH TO
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-003	Apr 29, 2019		RX	Yes	No			Y			TREATMENT OF CF IN A PATIENT AGE 4 MONTHS TO
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-001	Mar 17, 2015		RX	Yes	No			Y			TREATMENT OF CF IN A PATIENT AGE 6 MONTHS TO
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-002	Mar 17, 2015		RX	Yes	Yes			Y			TREATMENT OF CF IN A PATIENT AGE 6 MONTHS TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No			Y			TREATMENT OF CF IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes			Y			TREATMENT OF CF IN PATIENTS AGED 2 TO

International Family Members for US Patent 10,272,046

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
Hong Kong	1203840