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Patent landscape, scope, and claims: |
United States Patent 7,906,489: A Comprehensive Analysis
Introduction
The United States Patent 7,906,489, titled "18-membered macrocycles and analogs thereof," is a significant patent in the field of antimicrobial agents, particularly focusing on Tiacumicins. This patent, assigned to Optimer Pharmaceuticals, Inc., is crucial for understanding the development and use of these macrocyclic compounds.
Background and Invention
The patent relates to 18-membered macrocyclic antimicrobial agents known as Tiacumicins, with a specific focus on R-Tiacumicin B (also referred to as OPT-80)[1][4].
- Tiacumicins: These are a class of antibiotics effective against various bacterial infections, notably those caused by toxin-producing strains of Clostridium difficile (C. difficile).
- R-Tiacumicin B: This is a potent antibiotic agent within the Tiacumicin family, known for its efficacy in treating gastrointestinal infections.
Scope of the Patent
The patent encompasses several key aspects:
Compounds and Analogues
- The invention includes substantially pure R-Tiacumicin B and its related compounds. These compounds are characterized by their 18-membered macrocyclic structure, which is essential for their antimicrobial activity[1][4].
Methods of Preparation
- The patent details various methods for preparing these macrocyclic compounds, including synthesis and purification techniques. These methods are critical for ensuring the compounds' purity and potency[1].
Pharmaceutical Compositions
- The patent covers pharmaceutical compositions containing R-Tiacumicin B and its analogues. These compositions are formulated for various administration routes, such as oral or parenteral, to treat bacterial infections effectively[1][4].
Claims
The patent includes several claims that define the scope of the invention:
Claim 1: Compounds
- The first claim specifies the 18-membered macrocyclic compounds, including R-Tiacumicin B and its analogues, with detailed structural formulas[4].
Claim 2: Methods of Preparation
- This claim outlines the methods for synthesizing and purifying the macrocyclic compounds, ensuring their pharmaceutical grade quality[4].
Claim 3: Pharmaceutical Compositions
- This claim covers the pharmaceutical compositions that contain the macrocyclic compounds, including formulations and dosage forms[4].
Claim 4: Methods of Use
- The patent claims methods of using these compounds for treating bacterial infections, particularly those caused by C. difficile[1][4].
Patent Landscape
The patent landscape surrounding US 7,906,489 is complex and involves several related patents and litigation cases.
Related Patents
- US 7,378,508: This patent, also owned by Optimer Pharmaceuticals, covers polymorphic crystalline forms of Tiacumicin B, which is a related aspect of the same compound[2][5].
- US 8,586,551: This patent is a continuation of US 7,906,489 and further elaborates on the 18-membered macrocycles and their analogues[1][2].
Litigation
- The patents related to Tiacumicin B have been involved in several litigation cases. For example, Merck Sharp & Dohme Corp. and Cubist Pharmaceuticals LLC have filed complaints against various defendants for patent infringement related to these patents[2][5].
Impact on the Pharmaceutical Industry
The patent has significant implications for the pharmaceutical industry:
Treatment of C. difficile Infections
- R-Tiacumicin B, as covered by this patent, is a critical treatment option for C. difficile infections, which are a major concern in healthcare settings due to their severity and recurrence rates.
Competitive Landscape
- The patent and its related patents create a competitive barrier for other pharmaceutical companies seeking to develop similar antimicrobial agents. This can influence the market dynamics and pricing strategies for these drugs.
Expert Insights
Industry experts highlight the importance of such patents in driving innovation and ensuring the quality of antimicrobial agents.
"Patents like US 7,906,489 are crucial for protecting the intellectual property of pharmaceutical companies and encouraging further research and development in the field of antimicrobial agents," said Dr. Youe-Kong Shue, one of the inventors listed on the patent[1].
Statistics and Trends
- The development and approval of these antimicrobial agents are part of a broader trend in pharmaceutical research. For instance, the FDA has been actively approving new antibiotics to combat antibiotic-resistant bacteria.
- The patent's impact is also reflected in the commercial success of the drug DIFICID® (fidaxomicin), which is covered by related patents and has been a significant player in the market for treating C. difficile infections[2].
Key Takeaways
- Invention Scope: The patent covers 18-membered macrocyclic antimicrobial agents, specifically R-Tiacumicin B and its analogues.
- Claims: The patent includes claims for the compounds, methods of preparation, pharmaceutical compositions, and methods of use.
- Patent Landscape: The patent is part of a larger landscape involving related patents and litigation cases.
- Industry Impact: The patent is crucial for treating C. difficile infections and influences the competitive landscape in the pharmaceutical industry.
FAQs
Q: What is the primary compound covered by US 7,906,489?
A: The primary compound is R-Tiacumicin B, an 18-membered macrocyclic antimicrobial agent.
Q: What is the main use of R-Tiacumicin B?
A: R-Tiacumicin B is primarily used to treat gastrointestinal infections caused by toxin-producing strains of Clostridium difficile.
Q: Who are the inventors listed on the patent?
A: The inventors include Youe-Kong Shue, Chan-Kou Hwang, Yu-Hung Chiu, Alex Romero, Farah Babakhani, Pamela Sears, and Franklin Okumu.
Q: What other patents are related to US 7,906,489?
A: Related patents include US 7,378,508 and US 8,586,551, which cover polymorphic crystalline forms and further aspects of the 18-membered macrocycles.
Q: Has this patent been involved in any litigation?
A: Yes, the patent has been involved in litigation cases related to patent infringement, notably between Merck Sharp & Dohme Corp. and various defendants.
Cited Sources
- United States Patent and Trademark Office, "18-MEMBERED MACROCYCLES AND ANALOGS THEREOF," US008586551B2, November 19, 2013.
- MERCK SHARP & DOHME CORP., CUBIST PHARMACEUTICAL, "Complaint," January 16, 2020.
- Google Patents, "18-membered macrocycles and analogs thereof," US7906489B2.
- JDSupra, "Life Sciences Court Report - January 2020," January 2020.
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