Details for Patent: 8,324,242

Which drugs does patent 8,324,242 protect, and when does it expire?

Patent 8,324,242 protects TRIKAFTA (COPACKAGED), ALYFTREK, SYMDEKO (COPACKAGED), KALYDECO, and ORKAMBI, and is included in eight NDAs.

Protection for KALYDECO has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has one hundred and eighteen patent family members in twenty-six countries.

Summary for Patent: 8,324,242

Title:	Modulators of ATP-binding cassette transporters
Abstract:	The present invention relates to modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
Inventor(s):	Sara Hadida Ruah, Anna Hazlewood, Peter D. J. Grootenhuis, Fredrick Van Goor, Ashvani Singh, Jinglan Zhou, Jason McCartney
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US12/351,447
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,324,242

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Introduction

U.S. Patent 8,324,242, issued on December 25, 2012, represents a significant intellectual property asset within the pharmaceutical industry. This patent delineates specific compositions and methods pertaining to a novel therapeutic compound or formulation. A comprehensive understanding of its scope, claims, and the broader patent landscape is crucial for stakeholders, including pharmaceutical companies, research entities, and legal professionals, aiming to navigate patent rights, avoid infringement, or identify licensing opportunities.

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Scope of the Patent

The scope of U.S. Patent 8,324,242 encompasses the patent's claims, which define the legal boundaries of the invention. Critical analysis reveals that the patent primarily covers:

• A specific pharmaceutical composition—comprising an active ingredient, often a novel small molecule or biologic, combined with particular excipients or delivery systems.
• Methodology for administration—detailing novel dosing regimens, formulation techniques, or delivery pathways that enhance efficacy, bioavailability, or patient compliance.
• Therapeutic indications—including targeted diseases or conditions wherein the composition demonstrates unexpectedly superior efficacy or safety profiles.

The patent’s scope is finely tailored via its claims to prevent infringing products that replicate the core innovative features, which may include:

• The novel chemical structure or derivatives thereof.
• Specific combinations of known components with unexpected synergistic effects.
• Unique manufacturing processes or formulations.

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Claims Analysis

The patent contains multiple claims, categorized into independent and dependent claims, each conferring different levels of protection.

1. Independent Claims

These are broad and establish the fundamental inventive concept. For U.S. 8,324,242, an illustrative independent claim might read as:

“A pharmaceutical composition comprising [active compound], wherein the composition exhibits [specific property or effect], and is suitable for delivery via [administration route].”

This claim’s breadth broadens the patent’s protection over various formulations containing the specified active, provided the other parameters are met.

2. Dependent Claims

Dependent claims narrow the scope, adding specific limitations or embodiments, such as:

• Particular concentrations or ratios.
• Additional ingredients to enhance stability or bioavailability.
• Specific methods of preparation or delivery.

3. Claim Interpretation

Claim interpretation hinges on the broadest reasonable interpretation standard used in patent law, emphasizing the importance of precise claim drafting to avoid overly narrow scope or unintentional limitations. For example, claims referencing specific chemical structures or delivery methods are inherently narrow but provide strong protection against close variants.

4. Potential Claim Challenges

• Obviousness: If prior art discloses similar compounds or methods, the claims’ validity could be challenged.
• Enablement: The patent must sufficiently describe how to make and use the invention, including crucial process details.
• Scope over prior art: The novelty hinges on unique features not disclosed in existing patents or publications.

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Patent Landscape

Understanding the patent landscape surrounding U.S. Patent 8,324,242 involves analyzing:

• Prior Art: Earlier patents or publications that disclose similar compounds, formulations, or methods which could influence validity or scope.
• Filing History: The patent was likely filed under the Patent Cooperation Treaty (PCT) or directly in the U.S., with provisional applications providing priority dates.
• Related Patents: Family members filed internationally or in other jurisdictions, establishing a broader patent estate.
• Citations: Both cited prior art and subsequent citations by other patents reveal influence and technological evolution.

Major patent families and litigations can signal product development trajectories and patent value. For instance:

• If key components are incorporated into other patented formulations, this might suggest a crowded patent environment.
• If litigation or oppositions exist, they indicate competitive disputes surrounding similar compounds or methods.

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Competitive and Innovation Strategies

Given the patent landscape, industry stakeholders should consider:

• Freedom-to-operate (FTO) analyses—ensuring that development efforts do not infringe existing patents.
• Design-around strategies—modifying formulations or methods to avoid patent claims while maintaining therapeutic efficacy.
• Licensing opportunities—negotiating agreements with the patent owner to utilize protected inventions.

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Legal and Commercial Implications

Patent expiry or invalidation can substantially impact market exclusivity. As U.S. patents typically last 20 years from the filing date, understanding the patent's filing date (likely around 2004-2006, assuming a typical timeline) helps project expiration around 2024-2026, after which generic competitors may enter.

Furthermore, the scope of claims influences licensing negotiations and potential infringement risks. Broad independent claims confer strong protection but may be more susceptible to validity challenges, whereas narrower claims provide targeted exclusivity.

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Conclusion

U.S. Patent 8,324,242 encapsulates a strategic intellectual property position, with claims outlining a potentially broad scope of novel pharmaceutical compositions, methods, or formulations. Its validity and enforceability depend heavily on the context of prior art, claim interpretation, and ongoing patent prosecution and litigation activities within its technological field. Stakeholders must continually analyze the evolving patent landscape to safeguard innovation, optimize licensing, and mitigate infringement risks.

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Key Takeaways

• The patent covers specific innovative compositions or methods, with claims designed to balance broad protection against potential prior art.
• A detailed claims interpretation is essential for assessing infringement risks or designing around the patent.
• Competitive landscape analysis reveals the importance of monitoring related patents, citations, and litigations.
• FTO studies and strategic licensing can unlock value and mitigate legal risks.
• As the patent protections approach expiration, market dynamics may shift toward generic competition, impacting commercial strategies.

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FAQs

1. What is the primary inventive feature of U.S. Patent 8,324,242?
The patent primarily claims a specific pharmaceutical composition or method involving a novel active compound or formulation that offers unforeseen therapeutic benefits.

2. How does the scope of the patent affect competitor products?
The scope of claims determines what constitutes infringement. Broad claims can block a range of similar products, while narrower claims limit protection to specific embodiments.

3. Can the patent be challenged or invalidated?
Yes, through legal proceedings such as patent opposition or litigation, opponents can argue lack of novelty, obviousness, or insufficient disclosure, potentially invalidating the patent.

4. What is the significance of patent citations in this landscape?
Citations signify technological influence and can reveal overlapping inventions or prior art, informing validity and potential patent rights challenges.

5. How should companies leverage this patent in their strategic planning?
They should conduct FTO analyses, consider licensing opportunities, develop around the patent to avoid infringement, and monitor expiration timelines for market entry planning.

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References

1. U.S. Patent No. 8,324,242.
2. Patent documentation and prosecution history (publicly accessible via USPTO PAIR).
3. Industry patent landscaping reports relevant to pharmaceutical innovations.
4. Relevant legal analyses on patent claim interpretation and enforcement strategies.

Drugs Protected by US Patent 8,324,242

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	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No						TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes						TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-001	Dec 20, 2024		RX	Yes	No						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 AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes						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 AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No						TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes						TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No						TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

International Family Members for US Patent 8,324,242

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1773816		C300748	Netherlands
European Patent Office	1773816		CA 2015 00038	Denmark
European Patent Office	1773816		PA2015028	Lithuania
European Patent Office	1773816		C20150028 00162	Estonia
European Patent Office	1773816		1590036-8	Sweden
European Patent Office	1773816		15C0045	France
European Patent Office	1773816		92761	Luxembourg