Detailed Analysis of the Scope and Claims of United States Patent 7,585,879
Introduction
United States Patent 7,585,879, titled "Biphenyl compounds useful as muscarinic receptor antagonists," is a significant patent in the pharmaceutical industry, particularly in the treatment of pulmonary disorders. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignees
The patent was issued to inventors Mammen Mathai, Ji YuHua, Mu YongQi, and Husfeld Craig, and is assigned to Theravance, Inc., now known as Theravance Biopharma R&D IP, LLC[4].
Patent Overview
This patent describes biphenyl compounds that act as muscarinic receptor antagonists. These compounds are designed to treat pulmonary disorders such as Chronic Obstructive Pulmonary Disease (COPD) and asthma, while minimizing side effects.
Claims
The patent includes several key claims that define the scope of the invention:
Compound Structure
The patent claims biphenyl compounds of a specific structural formula, which includes a biphenyl-2-ylcarbamic acid moiety linked to a piperidine ring. This structure is crucial for the muscarinic receptor antagonist activity[4].
Pharmaceutical Compositions
The claims extend to pharmaceutical compositions that include these biphenyl compounds, either as free bases or in salt forms. These compositions are intended for the treatment of pulmonary disorders[4].
Methods of Treatment
The patent also claims methods of treating pulmonary disorders using the described biphenyl compounds. This includes administering the compounds to patients suffering from COPD or asthma to alleviate symptoms and improve respiratory function[4].
Scope of the Invention
The scope of the invention is broad but focused on the therapeutic application of specific biphenyl compounds.
Muscarinic Receptor Antagonists
The compounds claimed in this patent are designed to block muscarinic receptors, which are involved in the regulation of smooth muscle contraction in the airways. By blocking these receptors, the compounds help to relax airway muscles, improving airflow and reducing symptoms of COPD and asthma[4].
Pharmacological Advantages
The biphenyl compounds described in the patent are expected to be more effective and have fewer side effects compared to other muscarinic receptor antagonists. This is due to their specific structural design and pharmacological profile[4].
Patent Landscape
Related Patents
The patent landscape surrounding US 7,585,879 includes several related patents held by Theravance Biopharma R&D IP, LLC. These patents cover various aspects of the biphenyl compounds, including crystalline freebase forms, processes for preparation, and additional therapeutic applications.
- Crystalline Freebase Forms: Patents such as US 8,541,451 and US 9,765,028 describe crystalline freebase forms of the biphenyl compounds, which are important for pharmaceutical formulations[2].
- Processes and Intermediates: Patents like WO2022049604A1 detail processes and intermediates for the synthesis of these compounds, highlighting improvements in purity and efficiency[1].
Patent Expiration Dates
The patent US 7,585,879 is set to expire on March 10, 2025. Other related patents, such as those covering crystalline freebase forms and additional therapeutic uses, have expiration dates ranging from 2025 to 2039[2].
Competitive Landscape
The absence of generic versions of the drug Yupelri (revefenacin), which is based on these biphenyl compounds, indicates a strong market position for Theravance Biopharma R&D IP, LLC, until the patents expire. This lack of generic competition is due to the robust patent protection in place[2].
Industrial and Clinical Impact
Clinical Use
The biphenyl compounds described in the patent are clinically significant as they provide a new class of muscarinic receptor antagonists for treating pulmonary disorders. These compounds have been approved and are marketed under the brand name Yupelri (revefenacin)[5].
Industrial Scale-Up
The processes described in related patents, such as WO2022049604A1, are designed to be simple, economical, and suitable for industrial scale-up. This ensures that the production of these compounds can meet market demand efficiently[1].
Key Takeaways
- Specific Structural Claims: The patent claims specific biphenyl compounds with defined structural formulas.
- Therapeutic Applications: The compounds are used to treat pulmonary disorders like COPD and asthma.
- Pharmaceutical Compositions: The patent includes claims for pharmaceutical compositions and methods of treatment.
- Patent Expiration: The patent is set to expire on March 10, 2025, with related patents expiring between 2025 and 2039.
- Industrial and Clinical Impact: The compounds are clinically significant and have been approved for use, with efficient industrial scale-up processes.
FAQs
Q: What is the main therapeutic application of the biphenyl compounds described in US 7,585,879?
A: The main therapeutic application is the treatment of pulmonary disorders such as COPD and asthma.
Q: Who are the inventors and assignees of US 7,585,879?
A: The inventors are Mammen Mathai, Ji YuHua, Mu YongQi, and Husfeld Craig, and the assignee is Theravance Biopharma R&D IP, LLC.
Q: What is the significance of the crystalline freebase forms of the biphenyl compounds?
A: The crystalline freebase forms are important for pharmaceutical formulations and are covered by additional patents.
Q: Is there a generic version of Yupelri (revefenacin) available?
A: No, there is currently no generic version of Yupelri available in the United States.
Q: When does the patent US 7,585,879 expire?
A: The patent is set to expire on March 10, 2025.
Cited Sources
- Process for preparing revefenacin and intermediates therof - Google Patents
- Generic Yupelri Availability - Drugs.com
- A novel approach to understand patents from the drug discovery - bioRxiv
- Biphenyl compounds useful as muscarinic receptor antagonists - Google Patents
- FDA US Food & Drug Administration - Regulations.gov
