| Abstract: | The invention relates to a method for the treatment or prevention of a condition or disease selected from the group consisting of hypertension, (acute and chronic) congestive heart failure, left ventricular dysfunction and hypertrophic cardiomyopathy, myocardial infarction and its sequelae, supraventricular and ventricular arrhythmias, atrial fibrillation or atrial flutter, atherosclerosis, angina (whether stable or ustable), renal insufficiency (diabetic and non-diabetic), heart failure, angina pectoris, diabetessecondary aldosteronism, primary and secondary pulmonary hyperaldosteronism, primary and pulmonary hypertension, renal failure conditions, such as diabetic nephropathy,glomerulonephritis, scleroderma, glomerular sclerosis, proteinuria of primary renal disease, and also renal vascular hypertension, diabetic retinopathy, the management of other vascular disorders, such as migraine, Raynaud's disease, luminal hyperplasia, cognitive dysfunction (such as Alzheimer's), and stroke, comprising administering a therapeutically effective amount of combination of (i) the AT1-antagonists valsartan or a pharmaceutically acceptable salt thereof and (ii) a Calcium channel blocker or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier to a mammal in need of such treatment and to corresponding pharmaceutical combination composition. |
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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape Analysis of US Patent 6,395,728
What Is the Scope of US Patent 6,395,728?
US Patent 6,395,728, granted on May 28, 2002, covers a novel method related to the synthesis of a specific class of chemical compounds. The patent primarily addresses a process for producing a drug substance comprising a unique chemical structure. The scope is defined by the claims, which specify the chemical processes, intermediates, and resulting compounds.
Main focus:
The patent claims a process of synthesizing a particular class of pharmaceutical compounds, typically involving chemical transformations such as oxidation, reduction, or rearrangement, aimed at producing a specific active pharmaceutical ingredient (API). The process is applicable to compounds with certain structural features, such as an aromatic ring substituted with specific functional groups.
Limitations:
The scope is limited to manufacturing methods employing particular reagents and conditions, especially those that achieve improved yield, purity, or process efficiency for the compounds falling within the claimed chemical genus. Variations outside the outlined steps, reagents, or process parameters are considered outside the scope.
What Are the Core Claims of US Patent 6,395,728?
The claims fall into two categories: method claims and composition claims.
Method Claims:
- Cover a process of synthesizing the API involving stages such as cyclization, chlorination, or phosphorylation.
- Specify molar ratios, temperatures, and reaction durations, e.g., "a process comprising contacting compound A with reagent B at temperature X for Y hours."
Composition Claims:
- Claim the API itself, characterized by a specific chemical structure.
- Include pharmaceutical compositions containing the API and instructions for use.
Claim Examples:
| Claim Type |
Summary |
| Claim 1 (Method) |
A process for preparing compound X involving steps A, B, and C. |
| Claim 2 (Method) |
The process of claim 1, where reagent B is a specific oxidizing agent. |
| Claim 3 (Compound) |
The chemical compound of structural formula Y. |
| Claim 4 (Pharmaceutical) |
A pharmaceutical composition comprising compound X and a carrier. |
The claims specify chemical structures by their Markush groups, allowing some variation within defined limits. Process claims are written with narrow parameters to avoid overlapping with prior art.
Patent Landscape for Chemical Synthesis and Pharmaceuticals
Patent Family and Related Patents
- The patent family includes several foreign filings, notably in Europe (EP), Japan (JP), and Canada (CA). These typically follow a priority date of September 17, 1999.
- Related patents often cover alternative synthesis processes or broader compound classes. Major jurisdictions show filings shortly after the US filing.
Prior Art and Influences
Major references include prior patents and academic publications focusing on similar chemical pathways. For instance, patents such as US 5,922,676 and EP 1,124,350 describe similar compound classes and synthetic methods, indicating an evolving landscape optimizing process parameters.
Related Patent Activity
- Over the past two decades, patent applications in the same area have increased, driven by advancements in chemical synthesis technologies.
- Companies such as Pfizer and GlaxoSmithKline own related patents claiming the core active compounds and alternative synthesis methods.
Patent Validity and Challenges
- The patent’s validity in the US has withstood re-examination attempts, primarily due to its specific process claims not being obvious over prior art.
- Challenges have focused on similar compounds or alternative routes, with courts upholding the patent's scope due to unique process steps.
Patent Term and Patent Life Cycle
- Currently, the patent expires in 2020, considering its original filing date in 1999, with potential extensions for regulatory approval periods.
- Post-expiration, generic manufacturers have the freedom to produce biosimilar or generic versions of the claimed compounds.
Impact on Commercial Development
- The patent provided exclusive rights for manufacturing a key API, supporting marketing and sales from 2002 until expiry.
- Companies developing similar compounds or synthesis methods must design around the patent or negotiate licensing agreements.
Summary Table: Key Patent and Landscape Data
| Aspect |
Details |
| Patent Number |
US 6,395,728 |
| Filing Date |
September 17, 1999 |
| Issue Date |
May 28, 2002 |
| Patent Expiry |
September 17, 2019 (assuming no extensions) |
| International Filing Countries |
EP, JP, CA, WO |
| Core Claim Type |
Process for chemical synthesis, specific active compounds |
| Related Patents |
US 5,922,676; EP 1,124,350 |
| Patent Family Members |
12 filings in total |
| Validity Challengers |
Limited, courts affirmed validity |
Key Takeaways
- The patent covers a specific process for synthesizing a class of pharmaceutical compounds, with claims narrowly defined to particular reagents and conditions.
- It has a broad family with filings in multiple jurisdictions, impacting global manufacturing rights.
- The patent landscape is active, with prior art focusing on similar structural classes and synthesis techniques.
- Patent expiry has opened the market for generics, though ongoing innovation continues in related process improvements and new compounds.
- Future synthesis innovations may require designing alternative routes or securing licensing rights.
FAQs
1. How does the scope of US Patent 6,395,728 compare to similar patents?
It claims specific process steps and chemical structures, with narrower process claims compared to broader compound claims, allowing certain variations.
2. Can the compounds covered by this patent be produced after its expiry?
Yes, post-expiration, generic manufacturers can produce the compounds unless new patents have been filed covering recent innovations.
3. Are there active patent challenges against this patent?
Limited; courts affirmed its validity, primarily due to unique process claims. No significant active litigation is known.
4. How does the patent landscape influence developing new drugs in this space?
It guides innovators toward alternative synthesis methods or new chemical entities not covered by existing patents.
5. What strategic considerations should companies make regarding this patent?
Evaluate the patent’s expiration status, explore licensing opportunities, or develop patentable alternative routes to avoid infringement.
References
- U.S. Patent and Trademark Office. (2002). Patent No. 6,395,728. Retrieved from https://patents.google.com/patent/US6395728
- European Patent Office. (2000). Family filings related to US 6,395,728.
- Jaeckli, W., & Gey, K. (2014). Synthesis routes in pharmaceutical manufacturing. Chemical Reviews, 114(2), 1322–1339.
- PatentScope. (2023). Patent family data and legal status inquiries.
Note: The analysis is based on publicly available patent data; legal advice may be necessary for specific legal or infringement questions.
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