Details for Patent: 8,415,387

Which drugs does patent 8,415,387 protect, and when does it expire?

Patent 8,415,387 protects TRIKAFTA (COPACKAGED) and SYMDEKO (COPACKAGED) and is included in three NDAs.

This patent has fifty-two patent family members in twenty-one countries.

Summary for Patent: 8,415,387

Title:	Modulators of ATP-binding cassette transporters
Abstract:	Compounds of the present invention and pharmaceutically acceptable compositions thereof, are useful as modulators of ATP-Binding Cassette ("ABC") transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator ("CFTR"). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Inventor(s):	Ruah; Sara S. Hadida (La Jolla, CA), Grootenhuis; Peter D. J. (San Diego, CA), Miller; Mark T (San Diego, CA), McCartney; Jason (Cardiff By The Sea, CA), van Goor; Fredrick (San Diego, CA), Numa; Mehdi Michel Djamel (San Diego, CA), Zhou; Jinglan (San Diego, CA), Bear; Brian (Oceanside, CA)
Assignee:	Vertex Pharmaceuticals Incorporated (Cambridge, MA)
Application Number:	12/619,412
Patent Claim Types: see list of patent claims	Use;

Analyzing the Scope and Claims of United States Patent 8,415,387

Introduction

United States Patent 8,415,387, associated with the drug SYMDEKO, is a significant patent in the pharmaceutical industry. This patent, along with others related to SYMDEKO, has undergone regulatory review and is subject to patent term extension applications. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background of SYMDEKO and Patent 8,415,387

SYMDEKO is a human drug product approved by the FDA on February 12, 2018. The patent in question, U.S. Patent No. 8,415,387, is one of several patents related to this drug that have been subject to regulatory review and subsequent patent term extension applications[1].

Regulatory Review and Patent Term Extension

The FDA's determination of the regulatory review period for SYMDEKO is crucial for the patent term extension. Under the Drug Price Competition and Patent Term Restoration Act of 1984, patents can be extended for up to 5 years if the product was subject to FDA regulatory review before its first commercial marketing. The FDA advised the USPTO that SYMDEKO underwent such a review, paving the way for potential patent term extensions[1].

Claims of Patent 8,415,387

The claims of a patent are its most critical components, as they define the scope of the invention. For U.S. Patent No. 8,415,387, the claims would typically include specific formulations, methods of use, or other aspects related to SYMDEKO. These claims are essential for understanding what is protected under the patent and what would constitute infringement.

Patent Term Extension Applications

The patent holder has submitted applications for various lengths of patent term extension, ranging from 616 days to 1,532 days. These applications are based on the regulatory review period determined by the FDA and are subject to USPTO calculations and statutory limitations[1].

Petitions and Redetermination

Any interested party can petition the FDA to determine whether the applicant for the patent term extension acted with due diligence during the regulatory review period. Such petitions must comply with specific requirements, including timeliness and the provision of sufficient facts to merit an FDA investigation[1].

Patent Landscape Analysis

To understand the broader patent landscape, it is essential to analyze the claims and scope of U.S. Patent No. 8,415,387 in conjunction with other related patents. This involves:

Claim Coverage Matrix

Using tools like a Claim Coverage Matrix, one can categorize patents by claims and scope concepts. This helps in identifying which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[3].

Claim Charts

Interactive claim charts generated by software like ClaimScape® can be used to review patent coverage with technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, highlighting areas where claim coverage may be lacking[3].

Impact of Recent USPTO Guidance

The USPTO's 2024 guidance update on AI and software-related emerging technologies, while not directly applicable to pharmaceutical patents like U.S. Patent No. 8,415,387, provides insights into the evolving landscape of patent eligibility. This guidance emphasizes the integration of judicial exceptions into practical applications and the role of human contribution in AI-assisted inventions, which could have broader implications for future pharmaceutical and biotechnological patents[4].

Strategic Considerations

For companies holding patents like U.S. Patent No. 8,415,387, it is crucial to:

Track Patents by Claims and Scope Concepts

Regularly categorize and analyze patents to ensure comprehensive coverage and identify potential gaps or opportunities[3].

Monitor Regulatory Changes

Stay updated with regulatory changes and guidance updates from the USPTO and FDA to ensure compliance and maximize the protection of intellectual property[4].

Engage in Continuous Innovation

Use patent analytics tools to explore new design options and future directions, ensuring that the company remains competitive in the market[3].

Conclusion

Understanding the scope and claims of U.S. Patent No. 8,415,387 is vital for navigating the complex landscape of pharmaceutical patents. By leveraging tools like claim coverage matrices and interactive claim charts, companies can ensure robust protection of their intellectual property. Staying informed about regulatory changes and engaging in continuous innovation are key strategies for maintaining market dominance.

Key Takeaways

• Regulatory Review: The FDA's determination of the regulatory review period is crucial for patent term extensions.
• Claims Analysis: The claims of a patent define its scope and are essential for understanding what is protected.
• Patent Term Extensions: Applications for patent term extensions are subject to USPTO calculations and statutory limitations.
• Petitions and Redetermination: Interested parties can petition the FDA to review the applicant's due diligence during the regulatory review period.
• Patent Landscape Analysis: Tools like claim coverage matrices and interactive claim charts are essential for analyzing the patent landscape.
• Strategic Considerations: Companies must track patents by claims, monitor regulatory changes, and engage in continuous innovation.

FAQs

1. What is the significance of the FDA's regulatory review period for patent term extensions? The FDA's determination of the regulatory review period is essential for calculating the potential length of a patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984.

2. How can companies analyze the patent landscape for patents like U.S. Patent No. 8,415,387? Companies can use tools like claim coverage matrices and interactive claim charts to categorize patents by claims and scope concepts, helping to identify gaps or opportunities in their intellectual property protection.

3. What are the implications of the USPTO's 2024 guidance update on AI and software-related emerging technologies for pharmaceutical patents? While the guidance is not directly applicable, it emphasizes the importance of integrating judicial exceptions into practical applications and the role of human contribution in AI-assisted inventions, which could have broader implications for future pharmaceutical and biotechnological patents.

4. How can interested parties challenge the patent term extension applications for U.S. Patent No. 8,415,387? Interested parties can petition the FDA to determine whether the applicant acted with due diligence during the regulatory review period, provided the petition complies with all the necessary requirements.

5. What is the importance of continuous innovation in maintaining patent protection? Continuous innovation helps companies to stay competitive by exploring new design options and future directions, ensuring that their intellectual property remains valuable and protected.

Sources

1. Federal Register, Volume 89 Issue 184 - "Determination of Regulatory Review Period for Purposes of Patent Extension; SYMDEKO"
2. Regulations.gov - "Patent Extension Application for SYMDEKO Patent No. 8,415,387"
3. SLWIP - "Patent Analytics | Intellectual Property Law"
4. Mintz - "Understanding the 2024 USPTO Guidance Update on AI Patent"

Drugs Protected by US Patent 8,415,387

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	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 CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes						TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes						TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

International Family Members for US Patent 8,415,387

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007235260
Brazil	PI0710965
Canada	2648719
Canada	2869945
China	101460489
China	103254177
Cyprus	1116979