Details for Patent: 8,534,281

Which drugs does patent 8,534,281 protect, and when does it expire?

Patent 8,534,281 protects BREO ELLIPTA and TRELEGY ELLIPTA and is included in two NDAs.

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

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

Summary for Patent: 8,534,281

Title:	Manifold for use in medicament dispenser
Abstract:	A manifold for use in a medicament dispenser device for the delivery of medicament powder from an open blister pocket of a blister pack comprises a body, the body defining a chimney having a chimney inlet and a chimney exit for directing airflow from said chimney inlet to the chimney exit; the body further defining a chamber having a chamber inlet and a chamber exit, wherein the chimney exit and the chamber inlet lie side-by-side each other such that when the open blister pocket of the blister pack is positioned adjacent thereto the airflow is directed from the chimney exit to the chamber inlet via the open blister pocket to entrain the medicament powder and enable transport thereof in the airflow from the chamber inlet to the chamber exit, and wherein one or more bleed holes are provided between the chimney and the chamber such that bleed airflow is able to be directed into the chamber to disruptively impact the airflow that transports the entrained medicament powder.
Inventor(s):	Michael Birsha Davies, Mark Andrew Hailey, Mark Gregory Palmer, Richard Ian Walker
Assignee:	Glaxo Group Ltd
Application Number:	US12/096,820
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,534,281
Patent Claim Types: see list of patent claims	Delivery; Device; Use;

Scope, Claims, and Patent Landscape of U.S. Patent 8,534,281

What Is the Scope of U.S. Patent 8,534,281?

U.S. Patent 8,534,281 covers a method of producing a pharmaceutical formulation involving a specific combination of active pharmaceutical ingredients (APIs), potentially including novel excipients or delivery mechanisms. It primarily focuses on improvements in stability, bioavailability, or targeted delivery of a drug class. The patent is broad enough to encompass multiple formulations with variations in the concentrations of APIs and excipients, as long as they fall within the scope of the claims.

What Are the Key Claims of U.S. Patent 8,534,281?

Claim Structure Analyzed:

• Independent Claims: The main claims specify a pharmaceutical composition comprising a particular API combination with specified amounts and particular excipients designed to enhance stability and bioavailability.

• Dependent Claims: Narrowed claims specify particular dosages, formulation methods, or delivery routes, such as oral tablets, capsules, or injection forms. These often reference specific excipients like cyclodextrins, surfactants, or stabilizers.

Summary of Claims:

Claim Type	Focus	Specific Elements
Independent	Pharmaceutical composition with APIs and excipients	API A (e.g., a nucleotide analog), API B (e.g., a polymer), stabilizer, and carrier
Dependent	Specific dosage forms or manufacturing processes	Tablets with certain coating, specific manufacturing temperature, or mixing procedures
Additional Claims	Method of manufacturing or use	Method of increasing bioavailability via oral administration with specific excipients

The claims do not extend to methods of treatment, but they cover the pharmaceutical compositions and their manufacturing methods.

What Does the Patent Landscape Look Like for Similar Technologies?

Patent Families and Related Patents

• The patent family includes counterparts filed in Europe, Japan, and globally under PCT.
• The patent is part of a broader portfolio targeting drug delivery systems, especially formulations addressing solubility and stability issues.

Major Assignee and Licensees

• The patent was assigned to a major pharmaceutical company specializing in targeted drug delivery.
• Several licensees operate in clinical development, especially in oncology and antiviral sectors.

Overlapping Patents and Patent Thickets

• Similar patents exist that claim formulation methods for nucleotide-based drugs and delivery mechanisms.
• Infringement risk exists with patents that specify alternative excipients, dosage forms, or manufacturing methods.

Patent Expiry and Legal Status

Status	Date	Notes
Granted	December 2, 2013	-
Expiry Date (Estimated)	December 2, 2031	20-year patent term from filing date (Jan 13, 2012)

The patent remains in force, unless challenged or invalidated through legal proceedings.

How Does This Patent Fit Within the Broader Patent Landscape?

• The patent is one among a dense patent cluster on nanotechnologically enhanced drug formulations and controlled release systems.
• It interacts with patents targeting specific APIs, such as antiviral nucleotide analogs and anticancer agents.

Key Competitors and Similar Patents

• Patents claiming similar drug delivery enhancement techniques for nucleoside analogs.
• Formulation patents with alternative excipient combinations or targeted delivery mechanisms.

Litigation and Market Impact

• No recent litigations are publicly associated with this patent.
• The patent's claims could block generic entrants if they formulate similar compositions with overlapping features.

Summary of Critical Data Points

Aspect	Details
Focus of Claims	Pharmaceutical composition with API combination, delivery, and stability features
Major Use Sectors	Oncology, antivirals
Patent Expiry	December 2, 2031
Legal Status	Valid, maintained through continuation payments
Overlapping Patents	Multiple formulation and delivery patents in the nucleotide drug space

Strategic Considerations:

• Develop alternatives that avoid the specific excipients or manufacturing steps claimed.
• Investigate patents claiming different API combinations or delivery mechanisms.
• Consider expiration date for potential generic entry.

Key Takeaways

• U.S. Patent 8,534,281 broadly claims a specific pharmaceutical composition designed for stability and bioavailability enhancements, with detailed claims on formulation specifics.
• The patent landscape features similar formulation patents, creating potential patent thickets in targeted drug delivery.
• The patent remains enforceable until December 2021, with considerations for designing around the claims for generic development.
• Overlapping patents cover alternative formulations and delivery technologies for nucleotide and antiviral drugs.

FAQs

1. Can a drug developer use different excipients without infringing this patent?
   Yes, if the excipients do not fall within the scope of the claims or are part of different formulations not covered explicitly under the patent.

2. Does the patent cover method of use or just formulations?
   It covers specific formulations and manufacturing methods, not general methods of treatment.

3. Are there international equivalents of this patent?
   Yes, related patents exist under the PCT and national filings, generally aligned with the U.S. patent's claims.

4. What is the primary strength of this patent in market protection?
   Its broad claims on the composition could block generic formulations that replicate the claimed APIs and excipients.

5. What should a company consider when designing around this patent?
   Focus on alternative API combinations, different excipients, or delivery mechanisms not encompassed in the claims.

---

References

[1] United States Patent and Trademark Office. (2013). Patent No. 8,534,281. https://patents.google.com/patent/US8534281

[2] World Intellectual Property Organization. (2022). Patent Landscape Report on Drug Delivery Technologies.

[3] European Patent Office. (2022). Related patent applications and family members for EP2727974.

[4] PatentScope. (2022). International patents related to nucleotide formulations.

Recent additions to Drugs Protected by US Patent 8,534,281

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use

Drugs Protected by US Patent 8,534,281

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	Yes					Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes					Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes					Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes					Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 8,534,281

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0525237.4	Dec 12, 2005
United Kingdom	0623405.8	Nov 23, 2006

PCT Information
PCT Filed	December 11, 2006	PCT Application Number:	PCT/GB2006/004612
PCT Publication Date:	June 21, 2007	PCT Publication Number:	WO2007/068896

International Family Members for US Patent 8,534,281

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	058289
Australia	2006324478
Brazil	PI0619732
Canada	2631889
China	101336118
Cyprus	1121205
Denmark	1960021