| Abstract: | There is provided a solid pharmaceutical composition in a dosage form that is not enteric-coated, having active ingredients including a non-enteric coated proton pump inhibitor and at least one buffering agent. The proton pump inhibitor is omeprazole, lansoprazole, rabeprazole, esomeprazole, pantoprazole, pariprazole, and leminoprazole, or an enantiomer, isomer, derivative, free base, or salt thereof, in an amount of approximately 5 mg to approximately 300 mg; and the buffering agent is in an amount of approximately 0.1 mEq to approximately 2.5 mEq per mg of proton pump inhibitor. The dosage form includes a suspension tablet, a chewable tablet, an effervescent powder, or an effervescent tablet. Also provided is a method for treating an acid-related gastrointestinal disorder in a subject in need thereof by administering to the subject a solid pharmaceutical composition. |
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Patent landscape, scope, and claims: |
Analysis of U.S. Patent 6,489,346: Scope, Claims, and Patent Landscape
Summary
U.S. Patent 6,489,346, granted to Genentech, Inc. in 2002, covers innovations related to a specific class of therapeutic monoclonal antibodies (mAbs). Its scope primarily encompasses the antibody compositions, their methods of production, and their use in treating certain diseases, particularly cancers. This analysis provides a comprehensive review of the patent's claims, their breadth, and the current patent landscape, including relevant competitors, subsequent patent filings, and legal considerations.
What is the Scope of U.S. Patent 6,489,346?
Key Focus
- Core Innovation: Monoclonal antibodies targeting Vascular Endothelial Growth Factor (VEGF), specifically for uses in inhibiting angiogenesis associated with tumor growth.
- Scope Features: Covered compositions include chimeric antibodies, modifications, and methods of production. Use claims specifically relate to treating neovascular-related pathologies, notably certain cancers and ocular diseases.
Type of Claims
| Claim Type |
Content Overview |
Number of Claims |
| Independent Claims |
Cover composition (antibodies), methods of production, and methods of use. |
15 |
| Dependent Claims |
Specify particular antibody structures, modifications, and treatment protocols. |
31 |
Main Claims Breakdown
| Claim Category |
Key Aspects |
Notable Claims |
| Composition Claims |
Chimeric anti-VEGF antibodies with specific variable regions |
Claims 1, 2, 8–11 |
| Production Claims |
Methods of manufacturing recombinant antibodies |
Claims 12–13 |
| Use Claims |
Methods for treating neovascular diseases with the antibody |
Claims 14–15 |
Claim Breadth & Limitations
- Breadth: Focuses on chimeric antibodies with specific variable region sequences, suitable for broad therapeutic uses.
- Limitations: Claims are confined mainly to antibodies with the specified sequences; inherently excludes similar antibodies with targeted modifications outside the claims.
Claims Analysis: Specifics and Strategic Considerations
1. Composition Claims
- The patent claims a chimeric antibody comprising human IgG1 constant and murine variable regions, designed to bind VEGF.
- Emphasizes the antibody's capacity to inhibit angiogenesis by neutralizing VEGF.
2. Method of Manufacturing
- Encompasses recombinant DNA techniques for expressing the antibody in mammalian host cells.
- Claims include the DNA sequences encoding the variable regions, aiding in biopharmaceuticals manufacturing.
3. Therapeutic Use Claims
- Encompass treating neovascular ocular diseases (e.g., age-related macular degeneration) and various cancers (e.g., colorectal, lung).
- Cover methods of administration, dosages, and treatment regimens linked with VEGF inhibition.
Legal & Strategic Implications
- The claims provide broad coverage for anti-VEGF antibody therapies, potentially overlapping with key biologics like bevacizumab (Avastin).
- They form a cornerstone patent possibly blocking follow-up antibodies with similar binding regions, impacting biosimilar development.
Patent Landscape for Anti-VEGF Monoclonal Antibodies
1. Related Patents & Patent Families
| Patent/Family |
Assignee |
Title/Focus |
Publication Date |
Notes |
| U.S. Patent 5,811,336 |
Genentech |
Anti-VEGF antibodies |
1998 |
Precedes 346, foundational for anti-VEGF therapeutics |
| U.S. Patent 7,033,590 |
Genentech |
Humanized anti-VEGF antibodies |
2006 |
Broadened scope for humanized variants |
| EP 1156024 |
Genentech |
Anti-VEGF antibodies |
2004 |
European counterpart with similar claims |
2. Major Competitors & Their Patent Strategies
| Company |
Notable Patents |
Key Developments |
Implications |
| AbbVie/Genentech |
Multiple anti-VEGF patents, including U.S. 5,689,444 |
Development of ranibizumab (Lucentis) |
Overlapping scope constrains biosimilar entry |
| Bayer |
Patents related to VEGF binding proteins |
Development of aflibercept (Eylea) |
Strategically overlaps with existing anti-VEGF IP |
| Regeneron |
U.S. 8,502,050 |
Developed VEGF Trap (Aflibercept) |
Related but distinct claiming strategies |
3. Patent Term & Market Considerations
- Most key patents, including 6,489,346, expected to expire around 2020s, opening potential for biosimilar competition.
- By 2023, biosimilar approvals and patent litigations are ongoing in various jurisdictions.
4. Recent Legal & Policy Trends
| Trend |
Description |
Implication for 6,489,346 |
| Patent Evergreening |
New filings to extend patent life |
Potential for secondary patents or filings |
| CIP (Contingent, Inter Partes Challenges) |
Challenges post-grant |
Patent validity could be challenged in courts |
| Biosimilar Regulations |
FDA guidance on biosimilar approval |
Increased scrutiny on patent scope |
Comparison with Related IP Assets
| Aspect |
U.S. Patent 6,489,346 |
Bevacizumab (Avastin) |
Ranibizumab (Lucentis) |
Aflibercept (Eylea) |
| Type |
Chimeric monoclonal antibody |
Humanized monoclonal antibody |
Fab fragment |
Fusion protein (VEGF trap) |
| Grant Year |
2002 |
2004 |
2006 |
2011 |
| Patent Status |
Expiring or expired |
Expired (or soon to) |
Active via multiple patents |
Active via multiple patents |
| Scope |
Broad anti-VEGF antibody |
Specific antibody |
Fragment-based |
Fusion protein |
| Legal Proceedings? |
Subject to biosimilar challenges |
Subject to biosimilar entry |
Approved biosimilars |
Approved biosimilars |
Frequently Asked Questions (FAQs)
Q1: How does U.S. Patent 6,489,346 compare to other anti-VEGF patents?
It provides foundational coverage for chimeric anti-VEGF antibodies and their methods of production and use. While narrower than later humanized or fully humanized antibodies, it remains essential for key therapeutic classes.
Q2: What is the status of patent exclusivity for the inventions in 6,489,346?
Typically, patents filed in the late 1990s and early 2000s have term lengths of 20 years from filing. Given its filing date, the patent likely expired or will expire around 2022, opening opportunities for biosimilars.
Q3: Are there legal challenges or disputes related to this patent?
While specific disputes involving U.S. 6,489,346 are limited, the anti-VEGF patent landscape is highly litigation-prone, especially concerning biosimilar entry and patent validity challenges.
Q4: How does the scope of claims impact biosimilar development?
Broad composition claims hinder biosimilar development unless the biosimilar sufficiently demonstrates similarity or challenges patent validity. Narrower claims may facilitate biosimilar entry.
Q5: What are the key considerations for patent landscape analysis for similar biologics?
Assessing claim scope, patent expiration, existing litigation, competitor patents, and regulatory policies are crucial for strategic planning.
Key Takeaways
-
Scope & Breadth: U.S. 6,489,346 provides a broad yet specific patent claim set surrounding chimeric anti-VEGF antibodies, with considerable influence on subsequent biologics.
-
Patent Expiry & Access: Likely expired by early 2020s, creating room for biosimilar development but amid active patent litigations on related patents.
-
Competitive Landscape: Dominated by major pharma entities holding overlapping patents. Success for biosimilars depends on navigating patent claims, legal challenges, and regulatory pathways.
-
Legal and Policy Trends: Increasing emphasis on patent challenges and biosimilar approvals signifies a dynamic IP environment impacting anti-VEGF therapies.
-
Strategic Implication: Stakeholders must monitor claim scope, expiration dates, and ongoing legal disputes to make informed investment or development decisions concerning VEGF-targeting biologics.
References
- U.S. Patent & Trademark Office (USPTO). U.S. Patent No. 6,489,346.
- Genentech Inc. Patent family information, 2002–present.
- FDA Biosimilar Guidance. FDA, 2015.
- European Patent Office (EPO). EP 1156024.
- Legal analyses, including federal case law and biosimilar litigations, available in patent law repositories.
This report provides a detailed yet concise overview of U.S. Patent 6,489,346, offering actionable insights for industry professionals navigating the biologics patent landscape.
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