United States Patent 4,870,105: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,870,105, assigned to Braintree Laboratories, Inc., is a significant patent that has had a notable impact in the field of medical research and treatments. This patent, which will be the focus of our analysis, involves a method of using calcium acetate for treating hyperphosphatemia, a condition often associated with kidney disease.
Background
The patent was granted on October 26, 1989, and it has been a subject of litigation and scrutiny, particularly in the case of Braintree Laboratories, Inc. v. Nephro-Tech, Inc.[2].
Claims and Scope
Primary Claims
The patent primarily covers a method for treating hyperphosphatemia using calcium acetate. The claims are specific to the use of calcium acetate as a phosphate binder, which helps in reducing phosphate levels in the blood. Here is a summary of the key claims:
- Method of Treatment: The patent describes a method of treating hyperphosphatemia by administering calcium acetate to patients, particularly those with renal insufficiency.
- Dosage and Administration: The claims specify the dosage and administration protocols for calcium acetate, ensuring its efficacy and safety in clinical use.
Dependent Claims
The dependent claims further elaborate on the method, including specific dosages, administration routes, and patient populations. These claims help in narrowing down the scope and ensuring that the patent covers a specific and novel application of calcium acetate.
Patent Landscape
Technological Field
The patent falls under the "Drugs and Medical Instruments" field, one of the six broad technology fields categorized by the USPTO[1]. This field is highly competitive and subject to stringent examination processes due to the critical nature of medical treatments.
Allowance Rates
Historically, the allowance rates for patents in the "Drugs and Medical Instruments" field have been lower compared to other fields. According to a study by Carley, Hegde, and Marco, the allowance rate for this field has decreased substantially over time, reflecting the increasing scrutiny and complexity in medical patent applications[1].
Litigation and Enforcement
Braintree Laboratories, Inc. v. Nephro-Tech, Inc.
The patent was at the center of a patent infringement lawsuit where Braintree Laboratories, Inc. alleged that Nephro-Tech, Inc.'s calcium acetate product infringed on their patent. The court ultimately found in favor of Braintree Laboratories, Inc., ruling that the patent was valid and infringed upon by the defendants[2].
Validity and Infringement
The litigation highlighted several key issues:
- Validity: The defendants challenged the patent's validity on grounds of obviousness and anticipation. However, the court upheld the patent's validity after considering the evidence and expert testimony.
- Infringement: The court found that Nephro-Tech, Inc.'s product did indeed infringe on the method-of-use patent held by Braintree Laboratories, Inc.
Impact on the Medical Field
Advancements in Hyperphosphatemia Treatment
The patent marked a significant advancement in the treatment of hyperphosphatemia, particularly for patients with renal insufficiency. Calcium acetate, as a phosphate binder, has become a standard treatment option in managing this condition.
Market Significance
The patent's significance extends beyond its technical contributions. It has influenced the market by setting a standard for phosphate binders and shaping the competitive landscape in the medical industry. Companies developing similar treatments must navigate around this patent or seek licensing agreements to avoid infringement[5].
Search and Examination Process
USPTO Resources
For patents like 4,870,105, the USPTO provides several resources for searching and examining prior art. Tools such as the Patent Public Search, Global Dossier, and Common Citation Document (CCD) are crucial in ensuring that patents are novel and non-obvious[4].
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset can be used to analyze the scope and claims of patents like 4,870,105. This dataset provides detailed information on claims from US patents and applications, helping in understanding the patent's position within the broader patent landscape[3].
Conclusion
United States Patent 4,870,105 is a pivotal patent in the medical field, particularly in the treatment of hyperphosphatemia. Its scope and claims are specific and well-defined, and it has withstood legal challenges to its validity and infringement. The patent's impact on the medical field is significant, and it continues to influence the development of treatments for kidney disease.
Key Takeaways
- Specific Method of Treatment: The patent covers a specific method of using calcium acetate to treat hyperphosphatemia.
- Litigation and Validity: The patent was upheld in court against challenges of obviousness and anticipation.
- Market Impact: It has set a standard for phosphate binders and influenced the competitive landscape in the medical industry.
- USPTO Resources: Tools like Patent Public Search and Global Dossier are essential for examining prior art and ensuring patent novelty.
FAQs
1. What is the primary claim of United States Patent 4,870,105?
The primary claim of the patent is a method for treating hyperphosphatemia using calcium acetate.
2. In what field does this patent fall under according to the USPTO classification?
The patent falls under the "Drugs and Medical Instruments" field.
3. What was the outcome of the litigation involving this patent?
The court found in favor of Braintree Laboratories, Inc., ruling that the patent was valid and infringed upon by the defendants.
4. How has this patent impacted the treatment of hyperphosphatemia?
The patent has marked a significant advancement in the treatment of hyperphosphatemia, making calcium acetate a standard treatment option for patients with renal insufficiency.
5. What resources can be used to analyze the scope and claims of this patent?
Resources such as the USPTO's Patent Public Search, Global Dossier, and the Patent Claims Research Dataset can be used to analyze the scope and claims of this patent.
Cited Sources
- Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203.
- Braintree Laboratories, Inc. v. Nephro-Tech, Inc., 81 F. Supp. 2d 1122 (1999).
- USPTO. (2017). Patent Claims Research Dataset.
- USPTO. (2018). Search for patents.
- DrugPatentWatch. Patent 4,870,105.
