| Inventor(s): | Krishnan; Lalitha (Suffern, NY), Deshmukh; Subodh S. (White Plains, NY), Hadfield; Anthony (St. Petersburg, FL), Huang; W. James (Hillsborough, NJ), Ku; Mannching Sherry (Thiells, NY) |
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Patent landscape, scope, and claims: |
United States Patent 8,372,995: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,372,995, titled "Crystalline Solid Forms of Tigecycline and Methods of Preparing Same," is a significant patent in the pharmaceutical industry, particularly related to the antibiotic tigecycline. This patent is held by Wyeth LLC, now a part of Pfizer Inc., and is crucial for understanding the intellectual property landscape surrounding tigecycline formulations.
Background
Tigecycline is an antibiotic used to treat various bacterial infections. The patent in question focuses on the crystalline solid forms of tigecycline and the methods for preparing these forms. This is important because the physical form of a drug can affect its stability, bioavailability, and overall efficacy.
Patent Claims
Overview of Claims
The '995 patent explicitly defines the claimed Form I of tigecycline as crystalline, emphasizing this definition multiple times within the patent documentation[2][4].
- Claim Scope: The patent claims cover specific crystalline forms of tigecycline, which are critical for the drug's performance. These claims are narrow in scope, focusing on the unique characteristics of the crystalline forms and the methods used to prepare them.
- Claim Language: The language used in the claims is precise, ensuring that the patent protection is clear and enforceable. For instance, the abstract and various sections of the patent repeatedly mention the crystalline nature of the tigecycline forms[2].
Independent Claims
- Independent Claim Length and Count: Research suggests that the length and count of independent claims can be indicators of patent scope. In the case of the '995 patent, the independent claims are detailed and specific, which can indicate a narrower but more robust patent scope[3].
Patent Scope and Quality
Metrics for Measuring Scope
- Independent Claim Length: Studies have shown that shorter independent claims often correlate with a higher probability of grant and a shorter examination process. The '995 patent's claims, while detailed, are structured to ensure clarity and specificity, which aligns with best practices for patent quality[3].
- Claim Count: The number of claims can also indicate the breadth of the patent. In this case, the focus on specific crystalline forms suggests a targeted approach rather than overly broad claims.
Clarity and Validity
- Clarity: The patent claims are written to be clear and understandable, avoiding functional claiming language that can lead to ambiguity. This clarity is crucial for enforcing the patent and for other entities to understand what is protected[3].
- Validity: The patent has undergone rigorous examination and has been subject to litigation, which has helped to validate its claims. For example, the patent was involved in a lawsuit against Mylan Inc., where the court considered the validity and infringement of the '995 patent[4].
Patent Landscape and Litigation
Litigation History
- The '995 patent has been at the center of several patent infringement lawsuits. For instance, Pfizer Inc. and its affiliates sued Mylan Inc. and its subsidiaries for filing an Abbreviated New Drug Application (ANDA) with the FDA, which was alleged to infringe on the '995 patent[4].
- Notice and Certification: Defendants in such cases typically provide notice and certification regarding their belief that the patents are either not infringed or invalid. This was the case in the lawsuit against Mylan, where the defendants submitted a certification that the '995 patent would not be infringed by their ANDA product or that it was invalid and/or unenforceable[4].
Patent Expiration and Challenges
- Patent Expiration: The '995 patent is set to expire on October 8, 2030. This expiration date is significant as it marks the period after which generic versions of the drug can be freely manufactured and sold without infringing on the patent[1].
- Challenges and Certifications: Generic drug manufacturers often challenge the patents through Paragraph IV certifications, as seen in the case of Accord Pharmaceuticals Inc., which submitted certifications for several patents related to tigecycline, including the '995 patent[1].
Regulatory Issues
FDA Approval and Compliance
- The approval process for generic versions of tigecycline involves ensuring compliance with FDA regulations. This includes submitting ANDAs and addressing any deficiencies identified by the FDA, such as stability data and extractable and leachable studies[1].
Manufacturing Facility Compliance
- The manufacturing facility for any generic version must also comply with FDA standards. Any objections or deficiencies found during inspections must be resolved before the FDA can approve the application[1].
Industry Impact
Innovation and Competition
- The '995 patent and similar patents play a crucial role in balancing innovation and competition in the pharmaceutical industry. While they protect the intellectual property of the innovator, they also create barriers for generic manufacturers, which can delay the entry of cheaper alternatives into the market[3].
Economic Considerations
- The economic implications of patent litigation and the expiration of patents like the '995 are significant. Patent litigation can be costly, and the expiration of patents can lead to increased competition and lower drug prices, benefiting consumers but potentially reducing the revenue of the patent holder[3].
Key Takeaways
- Specific Claims: The '995 patent has specific and clear claims focused on crystalline forms of tigecycline.
- Litigation History: The patent has been involved in several infringement lawsuits, validating its claims and scope.
- Regulatory Compliance: Generic manufacturers must comply with FDA regulations and address any deficiencies before approval.
- Industry Impact: The patent affects the balance between innovation and competition in the pharmaceutical industry.
- Economic Considerations: Patent litigation and expiration have significant economic implications for both the patent holder and consumers.
FAQs
What is the main focus of the United States Patent 8,372,995?
The main focus of the United States Patent 8,372,995 is on the crystalline solid forms of tigecycline and the methods for preparing these forms.
Who holds the '995 patent?
The '995 patent is held by Wyeth LLC, now a part of Pfizer Inc.
What is the significance of the crystalline form of tigecycline?
The crystalline form of tigecycline is significant because it affects the drug's stability, bioavailability, and overall efficacy.
What is the expiration date of the '995 patent?
The '995 patent is set to expire on October 8, 2030.
How does the '995 patent impact generic drug manufacturers?
The '995 patent requires generic drug manufacturers to either avoid infringing on the patent or challenge it through Paragraph IV certifications and subsequent litigation.
Sources
- FDA Documentation: "208744Orig1s000 - Tigecycline for Injection" - FDA.
- Casetext: "Pfizer Inc. v. Mylan Inc." - Casetext.
- Hoover Institution: "Patent Claims and Patent Scope" - Hoover Institution.
- Casetext: "Pfizer Inc. v. Mylan Inc., Civil Action No. 15-26-SLR-SRF" - Casetext.
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