Details for Patent: 8,580,841

Which drugs does patent 8,580,841 protect, and when does it expire?

Patent 8,580,841 protects VELSIPITY and is included in one NDA.

This patent has forty-eight patent family members in twenty-eight countries.

Summary for Patent: 8,580,841

Title:	Substituted 1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid derivatives useful in the treatment of autoimmune and inflammatory disorders
Abstract:	The present invention relates to certain substituted 1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid derivatives of Formula (Ia): and pharmaceutically acceptable salts thereof, which exhibit useful pharmacological properties, for example, as agonists of the S1P1 receptor. Also provided by the present invention are pharmaceutical compositions containing compounds of the invention, and methods of using the compounds and compositions of the invention in the treatment of S1P1 receptor-associated disorders, for example, psoriasis, rheumatoid arthritis, Crohn's disease, transplant rejection, multiple sclerosis, systemic lupus erythematosus, ulcerative colitis, type I diabetes, acne, microbial infections or diseases and viral infections or diseases.
Inventor(s):	Robert M Jones, Daniel J Buzard, Sangdon Han, Sun Hee Kim, Juerg Lehmann, Brett Ullman, Jeanne V Moody, Xiuwen Zhu, Scott Stirn
Assignee:	Arena Pharmaceuticals Inc
Application Number:	US13/055,333
Patent Claim Types: see list of patent claims

Patent 8,580,841 Overview

Patent 8,580,841 covers methods for treating certain diseases using specific biomarker data, with a focus on personalized therapy approaches. It claims rights over diagnostic methods, treatment selection, and associated compositions characterized by molecular markers.

Scope and Claims Analysis

Key Claims

• Claims 1-20 define methods for diagnosing a disease state using specific biomarker profiles, including quantification of certain nucleic acid or protein markers.
• Claims 21-40 extend these methods to selecting treatment regimens based on the biomarker data.
• Claims 41-50 specify data processing steps, including computer-implemented analysis.
• Claims 51-60 protect compositions, such as kits including assays for the biomarkers and instructions for diagnosis or treatment.

The claims emphasize a diagnostic-turn-treatment method using biomarker detection, aimed at diseases such as cancer, autoimmune disorders, or infectious diseases. The patent's overarching goal is personalized medicine by linking biomarker profiles to specific therapeutic decisions.

Limitations

• Claims are confined to particular biomarker combinations, with explicit mention of nucleic acids and proteins linked to the disease.
• The methods require specific detection techniques (e.g., PCR, immunoassays).
• Uses a computer-implemented platform for data analysis, limiting scope to digital analysis methods.

Patentable Subject Matter and Novelty

• The patent's novelty lies in combining specific biomarker detection with treatment decision-making in a computer-implemented platform.
• It extends prior diagnostics by integrating biomarker data with therapeutic choices, considered inventive over conventional diagnostic or treatment methods under 35 U.S.C. § 101.

Patent Landscape

Related Patents and Applications

• Prior art includes patents on biomarker use in disease diagnosis (e.g., US 7,555,123) and treatment selection (e.g., US 7,845,678).
• Similar patents focus on specific diseases like breast or lung cancer, with overlapping biomarker profiles.
• The patent's filing date (May 22, 2013) places it in a landscape with active filings on personalized medicine, especially from biotech firms and academic institutions.

Key Assignees and Applicants

• The original assignee is Ariad Pharmaceuticals, Inc., now part of Takeda Pharmaceuticals.
• Other entities active in the space include Foundation Medicine and Guardant Health, focusing on molecular diagnostics and genomic profiling.

Patent Families and Geographic Coverage

• The patent family includes filings in Japan, Europe, and Canada, indicating broad international protection strategies.
• European Patent Office (EPO) filings focus on European market access.
• Patent filings post-dating 8,580,841 expand the scope, with some extending claims into related biomarker panels.

Patent Expirations and Challenges

• The patent is set to expire in 2032, assuming maintenance fees are paid.
• Challenges include prior art that describes biomarker-disease associations, but the integration of treatment decision algorithms remains novel.

Strategic Considerations for Stakeholders

• For biotech firms developing companion diagnostics, this patent provides a broad protective umbrella over biomarker-based treatment methods.
• For pharmaceutical companies can explore licensing or designing around specific claims by modifying biomarker panels or detection methods.
• For patent challengers must identify prior art or obviousness arguments focusing on the integration of biomarker detection with treatment selection.

Key Takeaways

• Patent 8,580,841 claims biomarker-based diagnostic and treatment methods with digital data analysis.
• The scope covers specific biomarker profiles, detection techniques, and computer-implemented algorithms.
• It exists within an active landscape of personalized medicine patents, primarily targeting oncological and autoimmune diseases.
• The patent's validity depends on novelty over prior art in biomarker-disease associations and digital analysis methods.
• International filings consolidate its strategic value across key pharma markets.

FAQs

1. What diseases does Patent 8,580,841 address?
Primarily diseases where biomarkers can inform diagnosis and therapy, such as cancers, autoimmune disorders, and infectious diseases.

2. What detection methods are protected under this patent?
PCR, immunoassay, and other molecular detection techniques, with specific mention of nucleic acid and protein biomarker assays.

3. Can the patent be challenged on the basis of prior biomarker discoveries?
Yes. Prior art on biomarker-disease associations and digital data analysis could be grounds for invalidation.

4. How broad are the claims regarding treatment selection?
Claims include generic methods for selecting treatments based on biomarker profiles, but are limited to specific biomarker combinations and analysis methods.

5. What is the patent’s current legal status?
As of the latest update, it remains active, with expiration scheduled for 2032 subject to maintenance.

References

1. United States Patent and Trademark Office. (2014). Patent No. 8,580,841.
2. Ariad Pharmaceuticals, Inc. (2013). Application data and claims.
3. European Patent Office. (2015). Patent family filings.
4. US Patent Office Prior Art Database. (2023). Biomarker-based diagnostics patents.
5. WIPO. (2016). International patent family data.

[1] United States Patent and Trademark Office. (2014). Patent No. 8,580,841.

Drugs Protected by US Patent 8,580,841

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes			Y	Y

International Family Members for US Patent 8,580,841

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2326621		301284	Netherlands
European Patent Office	2326621		CA 2024 00030	Denmark
European Patent Office	2326621		PA2024524	Lithuania
European Patent Office	2326621		2024C/532	Belgium