United States Patent 11,090,294: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,090,294, titled "Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist," is a significant patent in the field of respiratory disease treatment, particularly for conditions like Chronic Obstructive Pulmonary Disease (COPD). This patent, owned by Glaxo Group Limited, is crucial for understanding the intellectual property landscape surrounding inhalable medications.
Patent Overview
Publication and Issue Dates
The patent was published on November 6, 2024, and issued on the same date, marking a critical milestone in the protection of this specific combination therapy[1][4].
Inventors and Assignees
The patent is assigned to Glaxo Group Limited, with inventors contributing to the development of this combination therapy. The inventors are not specifically listed in the sources provided, but the assignee is clearly identified as Glaxo Group Limited[1][4].
Scope of the Patent
Combination Therapy
The patent covers combinations of a muscarinic acetylcholine receptor antagonist and a beta-2 adrenoreceptor agonist, designed for inhaled administration. This combination is particularly effective in treating respiratory diseases such as COPD and asthma. The therapy involves the simultaneous use of these two types of drugs to enhance bronchodilation and improve lung function[4].
Administration Method
The patent specifies that these combinations are administered via inhalation, either through the nose or mouth. This method is crucial for delivering the medication directly to the lungs, where it can be most effective[4].
Claims of the Patent
Active Ingredients
The patent claims cover the specific combination of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist. These active ingredients work synergistically to provide improved therapeutic outcomes for patients with respiratory diseases[4].
Dosage Forms
The patent includes claims related to the dosage forms of these combinations, such as dry powder inhalers. These dosage forms are designed to ensure consistent and effective delivery of the medication[5].
Methods of Use
The patent also covers methods of using these combinations for treating respiratory diseases. This includes specific dosing regimens and administration protocols to maximize therapeutic efficacy[4].
Patent Expiration Dates
Primary Expiration Date
The patent is set to expire on November 29, 2030. This date is critical as it marks the end of the exclusive period during which Glaxo Group Limited can market this specific combination therapy without generic competition[1].
Related Patents and Exclusivities
Other Relevant Patents
There are several other patents related to the same class of medications, such as US7488827, US7439393, and US7498440, which cover muscarinic acetylcholine receptor antagonists and other related compounds. These patents have varying expiration dates, with some expiring as early as April 2025 and others in December 2027[1][2].
Exclusivities
In addition to patent protection, Anoro Ellipta, a drug that utilizes similar active ingredients, has been granted several exclusivities by the FDA. These exclusivities prevent the launch of generic or bioequivalent versions until they expire, further extending the market exclusivity period for Glaxo Group Limited. The estimated generic launch date for Anoro Ellipta, based on these exclusivities and patents, is April 11, 2031[2].
Impact on the Pharmaceutical Industry
Market Dominance
The patent and associated exclusivities grant Glaxo Group Limited significant market dominance over the combination therapy for respiratory diseases. This exclusivity period allows the company to recoup its investment in research and development and maintain a competitive edge in the market[2].
Innovation and Competition
The expiration of this patent and related patents will open the market to generic competition, potentially reducing costs for patients and increasing access to these medications. However, the current exclusivity period incentivizes continued innovation in the field of respiratory disease treatments[2].
Legal and Regulatory Considerations
Challenges and Oppositions
The patents associated with these medications have been open to challenges and oppositions. For example, several European patents related to Anoro Ellipta have been under opposition since 2017. These legal challenges can affect the patent landscape and the exclusivity period[2].
Maintenance Fees
The maintenance of these patents involves regular fee payments to the U.S. Patent and Trademark Office. These fees are critical to keeping the patents active and ensuring continued protection for the intellectual property[2].
Conclusion
United States Patent 11,090,294 is a pivotal patent in the respiratory disease treatment landscape, particularly for COPD. The combination therapy it covers, involving muscarinic receptor antagonists and beta-2 adrenoreceptor agonists, is a cornerstone of modern respiratory care. Understanding the scope, claims, and expiration dates of this patent, along with related patents and exclusivities, is essential for both pharmaceutical companies and healthcare providers.
Key Takeaways
- Combination Therapy: The patent covers a combination of muscarinic receptor antagonists and beta-2 adrenoreceptor agonists for inhalable administration.
- Expiration Date: The patent is set to expire on November 29, 2030.
- Related Patents: Other patents related to muscarinic acetylcholine receptor antagonists have varying expiration dates.
- Exclusivities: FDA-granted exclusivities extend market exclusivity beyond patent expiration dates.
- Impact on Industry: The patent and exclusivities grant market dominance to Glaxo Group Limited but will eventually open the market to generic competition.
FAQs
What is the primary active ingredient combination covered by US Patent 11,090,294?
The patent covers a combination of a muscarinic acetylcholine receptor antagonist and a beta-2 adrenoreceptor agonist.
When is the patent set to expire?
The patent is set to expire on November 29, 2030.
What is the significance of FDA-granted exclusivities for Anoro Ellipta?
FDA-granted exclusivities prevent the launch of generic or bioequivalent versions of Anoro Ellipta until they expire, extending market exclusivity beyond patent expiration dates.
How does this patent impact the pharmaceutical industry?
The patent grants market dominance to Glaxo Group Limited, allowing the company to recoup its investment in research and development, but it will eventually open the market to generic competition upon expiration.
What are the potential benefits for patients once the patent expires?
Once the patent expires, generic versions of the medication can be introduced, potentially reducing costs and increasing access to these treatments for patients.
Sources
- Drugs.com - Generic Trelegy Ellipta Availability
- Pharsight - Anoro Ellipta patent expiration
- Hoover Institution - Patent Claims and Patent Scope
- Google Patents - Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
- PubChem - Dry Powder Inhaler Compositions
