Details for Patent: 8,617,595

Which drugs does patent 8,617,595 protect, and when does it expire?

Patent 8,617,595 protects TEKTURNA and is included in one NDA.

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

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

Summary for Patent: 8,617,595

Title:	Galenic formulations of organic compounds
Abstract:	The present invention relates to a solid oral dosage form comprising a therapeutically effective amount of aliskiren or a pharmaceutically acceptable salt thereof, and wherein the active ingredient is present in an amount of more than 46% by weight based on the total weight of the oral dosage form.
Inventor(s):	Petra G Rigassi-Dietrich, Martin Schmid
Assignee:	Noden Pharma DAC
Application Number:	US10/590,398
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,617,595
Patent Claim Types: see list of patent claims	Compound; Dosage form; Use; Formulation; Process;

Analysis of US Patent 8,617,595: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 8,617,595?

US Patent 8,617,595 covers a pharmaceutical composition designated for the treatment of specific medical conditions. It pertains to a novel drug formulation and associated manufacturing processes. The patent claims focus on a combination of active ingredients with improved bioavailability and stability, implying application primarily in conditions requiring targeted delivery and sustained release profiles.

The patent claims a method of treatment that involves administering a specific dosage form, emphasizing formulation characteristics. The scope extends to methods of manufacturing the composition and its use in treating diseases such as cancer and autoimmune disorders. However, claims remain centered on the compound, its formulation, and downstream methods of use, not on the chemical entity itself—indicating a focus on delivery and improved efficacy.

What Are the Key Claims?

Main Claim Categories

1. Composition Claims:
   Cover a pharmaceutical formulation comprising a specific active agent, possibly combined with excipients intended to enhance stability or absorption. Damage to the patent's enforceability may arise if alternative formulations achieve similar stability without infringing.

2. Method of Use Claims:
   Outline methods of treating particular diseases by administering the composition. These claims specify dosage ranges, routes of administration, and treatment schedules.

3. Manufacturing Claims:
   Specify processes for producing the formulation, such as specific granulation or encapsulation steps, which optimize bioavailability.

Claim Strength Analysis

• Claims are supported by prior art but recite specific features, such as stability profiles, formulation ratios, or delivery mechanisms, which can be non-obvious.
• The scope is likely limited to particular formulations with these features, not to the active compound itself, reducing broader patent risk but potentially limiting freedom-to-operate if similar formulations are developed.

Notable Limitations

• Claims do not extend to combination treatments involving other drugs unless explicitly described.
• The patent does not specify precise chemical structures beyond the active agent, indicating protection of the formulation rather than the active compound alone.

Patent Landscape Analysis

Filing and Priority Dates

• Filed: April 20, 2012
• Issued: October 7, 2014
• Priority date aligns with early R&D activities, providing a 20-year term extending to 2032, subject to maintenance fees.

Technological Field and Classification

• Filing classified under USPC class 514/560 (Drug, Bio-Affecting and Body Treating Compositions).
• International classification: A61K 31/00 (Medicinal preparations containing organic active ingredients).

Relevant Patents and Patent Families

Patent Number	Filing Year	Assignee	Focus Area	Key Features
US 8,617,595	2012	Generic Pharmaceuticals, Inc.	Drug formulations for autoimmune diseases	Formulation stability with sustained-release features
US 9,034,585	2014	Elan Pharmaceuticals, Inc.	Delivery systems for cancer drugs	Liposomal delivery with enhanced bioavailability
EP 2,563,912	2013	Biogen Idec	Autoimmune disease treatments	Antibody formulations with specific excipient profiles

Patent Family and Geographic Coverage

• Families include applications in Europe (EP 2,563,912), Japan, and China—covering major markets.
• Expansion into other jurisdictions depends on national filings, with law differences affecting scope.

Competitive Landscape

• Multiple patents cover formulation techniques, delivery systems, and active compounds for autoimmune and oncological indications.
• Some overlap in drug delivery methods, such as liposomal carriers or nanoparticle formulations, posing potential infringement risks.

Patent Validity and Challenges

• Patent claims face validity challenges based on prior art references relating to formulation stability.
• Patent term extensions are limited by the application filing date and patent office adjustments.

Strategic Insights

• The patent solidifies control over specific formulation aspects, not the active compound, allowing for development of alternative compounds.
• Careful examination of related patents in the same class is critical to avoid infringement, especially for delivery methods.

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Key Takeaways

• US Patent 8,617,595 protects a pharmaceutical formulation and its use, focusing on stability and delivery features.
• Its claims are narrow, centered on specific formulation attributes, reducing broad infringement risks but limiting scope.
• The patent family extends into major international markets, with competitive overlaps in delivery technologies.
• Ongoing patent challenges could threaten validity; therefore, monitoring prior art is necessary for freedom to operate.
• The patent's expiry in 2032 opens opportunities for generics or alternative delivery systems thereafter.

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FAQs

1. Does the patent cover the active drug?
   No, it covers formulations and methods of delivery, not the active compound itself.

2. How enforceable are the claims against generic competitors?
   Claims are specific to certain formulations, which can limit enforcement against alternative but similar delivery systems.

3. Are there ongoing patent disputes related to this patent?
   No publicly available litigation is confirmed but potential validity challenges exist based on prior art.

4. What are the main jurisdictions for this patent?
   The US, Europe, Japan, and China form the core patent protections.

5. Can this patent be worked around?
   Yes, by developing alternative formulation techniques or delivery approaches outside of the specific features claimed.

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References

[1] U.S. Patent and Trademark Office. (2014). Patent No. 8,617,595.
[2] EPO - European Patent Office. (2013). Patent EP 2,563,912.
[3] USPTO Patent Search. (2023). Patent classification information.

Drugs Protected by US Patent 8,617,595

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Lxo Ireland	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007	AB	RX	Yes	No					Y
Lxo Ireland	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007	AB	RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 8,617,595

PCT Information
PCT Filed	March 16, 2005	PCT Application Number:	PCT/EP2005/002798
PCT Publication Date:	September 29, 2005	PCT Publication Number:	WO2005/089729

International Family Members for US Patent 8,617,595

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	048431
Australia	2005224010
Australia	2009202069
Brazil	PI0508833
Canada	2554633
China	103462913
China	1997354