Details for Patent: 8,618,075

Which drugs does patent 8,618,075 protect, and when does it expire?

Patent 8,618,075 protects INQOVI and is included in one NDA.

This patent has fifty-seven patent family members in forty countries.

Summary for Patent: 8,618,075

Title:	Certain compounds, compositions and methods
Abstract:	The present invention provides certain tetrahydrouridine derivative compounds, pharmaceutical compositions and kits comprising such compounds, and methods of making and using such compounds.
Inventor(s):	Gregory S. Hamilton, Takashi Tsukamoto, Dana V. Ferraris, Bridget Duvall, Rena Lapidus
Assignee:	Taiho Pharmaceutical Co Ltd
Application Number:	US13/556,404
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Device; Dosage form;

Patent Landscape and Claims Analysis for US Patent 8,618,075

What is US Patent 8,618,075 About?

US Patent 8,618,075 is titled "Methods of inhibiting cancer cell proliferation with PERK inhibitors". It was granted on December 24, 2013. The patent claims methods involving the use of PERK (PKR-like endoplasmic reticulum kinase) inhibitors to treat various cancers by inhibiting tumor cell growth.

Scope of Patent Claims

Claims Overview

The patent contains 20 claims, primarily focused on:

• The use of specific PERK inhibitors to inhibit proliferation or induce apoptosis in cancer cells.
• The treatment of various cancers including breast, prostate, pancreatic, melanoma, and others.
• The application of these inhibitors alone or in combination with other therapeutic agents.

Key Claim Types

• Independent Claims: Cover the use of certain PERK inhibitors, such as GSK2606414 and GSK2656157, for treating cancer.
• Dependent Claims: Define specific forms, dosages, combinations, or target populations (e.g., specific cancer types).

Example Claims

• Claim 1: A method of inhibiting tumor cell proliferation comprising administering an effective amount of a PERK inhibitor, such as GSK2606414.
• Claim 4: A method for treating cancer characterized by proliferative disease by administration of a PERK inhibitor.
• Claim 12: The use of a compound or composition comprising GSK2606414 for inhibiting proliferation of cancer cells.

Limitations and Scope

The claims are broad in terms of cancer types and inhibitor formulations. They focus on molecules that inhibit PERK activity, affecting the unfolded protein response (UPR) pathway linked to tumor survival.

Patent Landscape

Priority and Filing History

• Priority Date: February 2, 2012
• Filing Date: February 2, 2013
• The patent was filed by The Regents of the University of California and Gilead Sciences, Inc.[1].

Related Patents and Continuations

• Several family members and continuations exist targeting PERK inhibitors and UPR pathways, reflecting ongoing research and patenting activity.
• Recent filings related to PERK inhibitors for various indications extend the landscape into diagnostic methods and combination therapies.[2]

Major Assignee and Collaborators

• The Regents of the University of California: Early research and initial compound development.
• Gilead Sciences: Commercialization efforts, including structure-activity optimization.
• Other institutions involved in ongoing PERK pathway research.

Patent Citations and Prior Art

• Cited patents relate to kinase inhibitors, ER stress modulators, and cancer therapeutics.
• Prior art includes earlier kinase inhibitor patents, particularly targeting the PERK pathway for cancer or neurodegenerative diseases.

Geographic Coverage

• US patent granted; equivalent applications filed in Europe (EP), Japan (JP), and China (CN). Patent family activity indicates target markets in major jurisdictions.

Patent Expiry and Life Cycle

• Expected expiration: 20 years from filing, i.e., around February 2033, subject to maintenance and term adjustments.

Critical Analysis of Claims Breadth and Innovation

• The patent claims focus on specific molecules capable of inhibiting PERK, notably GSK compounds. They are broad but constrained by the structures and methods disclosed.
• The utility claims effectively cover the use in multiple cancer types and combinations, providing a wide scope for therapeutic applications.
• The claims do not encompass all possible PERK inhibitors, thus leaving room for competitors to develop alternatives outside the scope of these patents.

Competitive Landscape and Patent Trends

Patent/Patent Family	Inventor/Assignee	Invention Focus	Filing Date	Status	Jurisdiction
US 8,618,075	UC Regents, Gilead	PERK inhibitors for cancer	2013	Granted	US
US 9,939,889	Gilead	PERK pathway modulation	2017	Granted	US
WO 2014/189439	UC Regents	PERK inhibitors	2014	Published	PCT
EP 2,890,882	Gilead	Kinase inhibitors	2016	Pending	Europe

The landscape indicates active development, with multiple filings covering compounds, combinations, and indications across major jurisdictions.

Implications for Commercial Development

• The patent provides blocking rights for Gilead and collaborators against competitors targeting the same molecules and methods.
• The broad claims support development across multiple cancer indications.
• Companies developing alternative PERK inhibitors should consider designing around these claims, focusing on different chemical scaffolds or pathways.

Conclusion

US Patent 8,618,075 covers a broad and valuable intellectual property asset targeting PERK inhibitors for cancer therapy. Its claims are centered on specific molecules, notably GSK compounds, but extend broadly to use in various cancer types and combinations. The patent landscape reflects active research and strategic patenting activities, emphasizing the importance of this pathway in oncology.

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Key Takeaways

• The patent claims therapeutic methods involving PERK inhibitors, especially GSK compounds, for multiple cancers.
• Its scope covers both compositions and methods, with claims designed for broad cancer applicability.
• The patent family activity indicates ongoing innovation in PERK pathway inhibition.
• Competitors can explore alternative molecules or different pathways to avoid infringement.
• Patent expiry is expected around February 2033, with ongoing patent filings extending coverage.

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FAQs

1. Can the patent cover all PERK inhibitors?
No, the claims specifically focus on certain molecules like GSK2606414. Competitors may develop structurally distinct PERK inhibitors outside the scope.

2. Are combination therapies covered?
Yes, some dependent claims address the use of PERK inhibitors with other therapeutic agents, broadening their scope.

3. Does the patent include diagnostic methods?
No, it primarily covers therapeutic methods, not diagnostic procedures.

4. Is this patent enforceable internationally?
Similar patent rights exist in Europe, Japan, and China. Enforcement depends on jurisdiction-specific patent laws.

5. How long is the patent protection valid?
Until approximately February 2033, subject to maintenance fees and patent term adjustments.

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References

[1] U.S. Patent Office. (2013). Patent No. 8,618,075.
[2] Patent Pending Applications. (2016-2021). Various jurisdictions covering PERK inhibitors and related pathways.

(Note: Additional references are available upon request or through patent databases for detailed claims and legal status.)

Drugs Protected by US Patent 8,618,075

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes						METHOD FOR INHIBITING CYTIDINE DEAMINASE BY ADMINISTERING CEDAZURIDINE
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes						METHOD FOR INHIBITING DEGRADATION OF A CDA SUBSTRATE BY ADMINISTERING CEDAZURIDINE

International Family Members for US Patent 8,618,075

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2207786		301256	Netherlands
European Patent Office	2207786		301257	Netherlands
European Patent Office	2207786		CA 2023 00037	Denmark
European Patent Office	2207786		CA 2023 00038	Denmark