Detailed Analysis of the Scope and Claims of United States Patent 7,488,827
Introduction
United States Patent 7,488,827, granted to Glaxo Group Limited, is a significant patent in the pharmaceutical industry, particularly in the realm of respiratory diseases. This patent is associated with the drug product ANORO™ ELLIPTA™, which contains the active ingredients umeclidinium bromide and vilanterol.
Patent Overview
Patent Details
- Patent Number: 7,488,827
- Issue Date: February 10, 2009
- Inventors: Dramane I. Laine, Michael R. Palovich, Brent W. McCleland, Christopher E. Neipp, and Sonia N. Thomas
- Assignee: Glaxo Group Limited[1][4].
Scope of the Patent
The patent primarily covers muscarinic acetylcholine receptor antagonists, specifically umeclidinium bromide, which is one of the active ingredients in ANORO™ ELLIPTA™. This medication is used for the treatment of chronic obstructive pulmonary disease (COPD) and other respiratory conditions.
Active Ingredients
- Umeclidinium Bromide: A muscarinic acetylcholine receptor antagonist that helps relax the airway muscles, making it easier to breathe.
- Vilanterol: A beta 2 agonist that also helps to relax the airway muscles and improve breathing[1][4].
Claims of the Patent
The patent includes several claims that define the scope of protection for the invention.
Key Claims
- Claims 1-5, 7-9, 11-18: These claims specifically cover the approved active ingredient umeclidinium bromide as part of the drug product ANORO™ ELLIPTA™. Claim 1 is particularly noteworthy as it outlines the composition and use of umeclidinium bromide in the context of the medication[1].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 7,488,827 includes several related patents held by Glaxo Group Limited.
Medicament Dispenser Patents
- Patents such as 8,511,304 and 8,534,281 cover the medicament dispenser used with ANORO™ ELLIPTA™. These patents describe the mechanism for dispensing distinct medicament dose portions and are crucial for the delivery system of the drug[2].
Combination Therapy Patents
- Patent 9,750,726 covers combinations of a muscarinic acetylcholine receptor antagonist and a beta 2 agonist, which is relevant to the dual-action mechanism of ANORO™ ELLIPTA™[2].
Patent Expiration Dates
- U.S. Patent 7,488,827: The patent term is set to expire on April 27, 2025, but an extension has been sought to extend the term up to December 18, 2027[1].
- Related Patents: Other related patents have expiration dates ranging from June 14, 2027, to November 29, 2030[2].
Regulatory and Legal Aspects
Patent Term Extension
The applicant has sought an extension of the patent term under 35 U.S.C. § 156, citing the regulatory review period for the drug product. The extension calculation includes the time from the IND submission date to the NDA approval date, which totals 966 days[1].
Maintenance Fees
The first maintenance fee for U.S. Patent 7,488,827 was paid on July 25, 2012, ensuring the patent remains active[1].
Patent Analytics and Claim Coverage
To fully understand the protection and gaps in the patent landscape, patent analytics tools can be employed.
Claim Coverage Matrix
A Claim Coverage Matrix helps in categorizing patents by claims and scope concepts, making it easier to identify which patents and claims are actively protecting the intellectual property. This tool is particularly useful for large portfolios, as it helps in filtering, searching, and analyzing large numbers of patent claims concurrently[3].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® software can be reviewed by technical experts to determine whether a particular scope concept is applicable to a target product or method. This approach helps in identifying gaps in current coverage and highlighting future design opportunities[3].
Impact on the Pharmaceutical Industry
The protection provided by U.S. Patent 7,488,827 and related patents is crucial for Glaxo Group Limited's market position with ANORO™ ELLIPTA™. The expiration dates and any extensions will significantly impact the availability of generic versions of the drug.
"Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims."[2]
Key Takeaways
- U.S. Patent 7,488,827 covers the active ingredient umeclidinium bromide in ANORO™ ELLIPTA™.
- Related Patents: Include those covering the medicament dispenser and combination therapy.
- Patent Expiration: The patent term is set to expire on April 27, 2025, with a sought extension to December 18, 2027.
- Regulatory Aspects: The patent term extension is based on the regulatory review period.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for understanding the patent landscape.
FAQs
What is the primary active ingredient covered by U.S. Patent 7,488,827?
The primary active ingredient covered is umeclidinium bromide, a muscarinic acetylcholine receptor antagonist.
What is the drug product associated with this patent?
The drug product is ANORO™ ELLIPTA™, used for treating COPD and other respiratory conditions.
When is the patent set to expire?
The patent is set to expire on April 27, 2025, but an extension has been sought to extend the term up to December 18, 2027.
What other patents are related to U.S. Patent 7,488,827?
Related patents include those covering the medicament dispenser and combination therapy of muscarinic acetylcholine receptor antagonists and beta 2 agonists.
How does patent analytics help in understanding the patent landscape?
Patent analytics tools like Claim Coverage Matrix and Claim Charts help in categorizing patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities.
Sources
- Regulations.gov: FEB 0 6 2014 - Regulations.gov
- Drugs.com: Generic Anoro Ellipta Availability - Drugs.com
- SLWIP: Patent Analytics | Intellectual Property Law
- Google Patents: US7488827B2 - Muscarinic acetylcholine receptor antagonists
- Regulations.gov: !.;,. _tif' - Regulations.gov
