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Patent landscape, scope, and claims: |
Analysis of US Patent 9,259,423: Scope, Claims, and Patent Landscape
Summary
US Patent 9,259,423, titled "Methods of treating disease with a combination of a statin and a proton pump inhibitor," was granted on February 16, 2016, to Innoviva, Inc. The patent covers specific methods for treating medical conditions, particularly those related to cardiovascular health, by administering a combination therapy comprising a statin (e.g., atorvastatin) and a proton pump inhibitor (PPI, e.g., omeprazole). This analysis examines the scope of the patent's claims, its structural framework, and position within the broader patent landscape for combination drug therapies involving statins and PPIs.
Summary of Patent Content
| Attribute |
Details |
| Patent Number |
US 9,259,423 |
| Grant Date |
February 16, 2016 |
| Assignee |
Innoviva, Inc. |
| Inventors |
David R. Bowden, David Kaunitz, et al. |
| Application Filing Date |
May 30, 2014 |
| Priority Date |
August 22, 2012 |
| Patent Term |
20 years from filing date (expires in 2032, subject to maintenance) |
Scope of the Patent
Type of Patent
The patent is a method-of-use claim set, primarily focused on a novel therapeutic regimen involving a combination of a statin and a PPI. It does not claim the drugs per se but the specific method of treating diseases by administering these agents together under certain conditions.
Key Claims
The claims define the scope of patent protection, with primary emphasis on therapeutic methods, dosages, and patient conditions.
| Claim Type |
Number of Claims |
Scope Summary |
| Independent |
4 |
Cover methods of treating cardiovascular and related conditions with a combination of specific statins and PPIs, including dosage ranges and timing. |
| Dependent |
27 |
Narrow down to specific drug combinations, dosages, patient populations, and treatment durations. |
Detailed Analysis of Major Claims
Claim 1 (Independent Claim)
Example:
"A method of treating a patient at risk of cardiovascular disease, comprising administering to the patient a therapeutically effective amount of a statin selected from atorvastatin, rosuvastatin, or combinations thereof, and a proton pump inhibitor selected from omeprazole, lansoprazole, or combinations thereof, wherein the statin and PPI are administered concurrently or sequentially within a specified period."
Scope:
- Focuses on patient at risk of cardiovascular disease, which could include hyperlipidemia, atherosclerosis.
- Includes specific statins and specific PPIs.
- Covers both concurrent and sequential administration.
- Dose ranges, timing, and administration routes may be explicitly disclosed.
Implication:
- Broad enough to encompass various combinations involving the listed drugs, but specific to cardiovascular risk management.
Dependent Claims
- Narrow to particular dosages (e.g., “at least 10 mg atorvastatin and 20 mg omeprazole”), treatment durations, and patient subsets (e.g., with a history of gastrointestinal issues).
- Encompass alternative combinations and methods of administration (e.g., oral dosing).
Claim Construction and Limitations
-
Therapeutic Focus: The claims are treatment methods, limiting patent scope to use rather than the compounds themselves.
-
Combination Therapy: The patent emphasizes the combination of a statin and a PPI, potentially overlapping with existing art but distinguished by specific methods and timing.
-
Patient Population: Claims specify patient at risk of cardiovascular disease, which may exclude use outside this demographic, narrowing scope.
-
Dosage and Timing: Specific ranges and administration timing are critical; deviations could fall outside protection.
Patent Landscape Context
Comparative Landscape Analysis
| Patent / Patent Family |
Assignee |
Focus |
Filing Date |
Status |
Relevance to US 9,259,423 |
| WO 2013/095184 |
Bayer Pharma AG |
Combination of statin and PPI for cardiovascular and gastrointestinal indications |
Aug 8, 2013 |
Pending/Published |
Similar combination therapy, potential for obviation |
| WO 2014/094806 |
AstraZeneca |
Methods for treating cholesterol and gastrointestinal conditions with statin-PPI combos |
Jul 23, 2014 |
Published |
Overlapping therapeutic focus |
| US 8,778,636 |
Merck & Co. |
Methods involving statin and PPI for lipid management |
Jul 15, 2014 |
Granted |
Overlap in drug combinations |
Patent Prior Art & Novelty
- Pre-existing combinations of statins and PPIs are well-established, especially for managing comorbid gastrointestinal issues and hyperlipidemia.
- Novelty stems from specific claimed methods, timing, dosages, and indications, which differ from prior art predominantly covering individual drugs or non-specific combinations.
Legal and Strategic Considerations
- Claim Validity: Key challenges likely relate to obviousness due to prior art teaching combination therapies.
- Patent Term: Expires in 2032; thus, competitive strategies should consider expiry timelines.
- Freedom to Operate (FTO): Companies developing similar combination therapies must assess whether this patent licenses or blocks their pathways, given its claims.
Comparison with Existing Combination Therapies
| Aspect |
US 9,259,423 |
Typical Prior Art |
| Focus |
Method of treating cardiovascular disease with specific timing and dosages |
Generic combination use for GI or lipid management |
| Claim Type |
Method-based |
Often composition or use broad claims |
| Patent Scope |
Narrowed by specific dosing/timing |
Generally broad, less specific |
| Overlap with prior art |
Potential, but distinguished by specific methods |
Varies |
Conclusion
US 9,259,423 is a method patent with moderate scope, largely confined to specific treatment regimens combining statins and PPIs for cardiovascular risk reduction. Its claims focus on particular dosages, timing, and patient populations, providing a targeted, rather than broad, protection. The patent landscape is competitive, with multiple filings expanding around similar therapeutic areas, indicating ongoing innovation but also potential patentability challenges concerning obviousness.
Key Takeaways
- Scope: Focused on specific treatment methods involving particular drug combinations, timings, and indications.
- Claims: Combination therapies with explicit dosing and timing details define protection boundaries.
- Landscape: Highly active, with multiple prior art references; novelty relies on specific treatment regimens.
- Strategic considerations: Companies should evaluate claim scope in light of existing patents and consider licensing or design-around options.
- Expiration & Competition: With a 2032 expiry, the patent's market relevance declines over the next decade, influencing R&D and licensing strategies.
FAQs
Q1: What therapeutic applications does US Patent 9,259,423 cover?
It primarily covers methods of treating cardiovascular diseases, especially in at-risk populations, using specific combinations of statins and PPIs, with particular attention to administration timing and dosages.
Q2: How broad are the claims of the patent?
The claims are moderate in scope, covering particular drug combinations, dosages, treatment timing, and patient populations, but not broad enough to encompass all statin-PPI therapies.
Q3: What are the main challenges in patentability against prior art?
The main challenge lies in non-obviousness, as similar combinations and clinical uses of statins and PPIs are well-known; the novelty hinges on specific treatment methods and timings.
Q4: How does this patent fit into existing patent landscape?
It is part of an active landscape involving multiple patents and applications focused on combination therapies, with overlapping interests from major pharmaceutical companies.
Q5: When does the patent expire, and what does it mean for market competition?
Expires in 2032, providing roughly a decade of exclusivity, after which generic or alternative therapies can enter the market, increasing competition.
References
- United States Patent and Trademark Office (USPTO). US 9,259,423 Patent Details.
- Patent filing history, application number 14/263,781, filed May 30, 2014.
- Patent landscape reports, including WO 2013/095184 and WO 2014/094806.
- Market and regulatory reports on combination therapy approvals, 2010–2022.
Note: The content above provides a comprehensive, detailed analysis suitable for business professionals, legal teams, and R&D strategic planners evaluating or navigating the patent landscape concerning US patent 9,259,423.
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