United States Patent 5,210,079: A Detailed Analysis
Overview of the Patent
United States Patent 5,210,079, titled "Treatment of Chronic Renal Failure with Imidazole Angiotensin-II Receptor Antagonists," was granted on May 11, 1993, to E.I. Du Pont de Nemours and Company. This patent is significant in the field of pharmaceuticals, particularly for the treatment of hypertension and chronic renal failure.
Inventors and Assignee
The inventors listed on the patent are David J. Carini, John V. Duncia, and Pancras C. Wong, all affiliated with E.I. Du Pont de Nemours and Company in Wilmington, Delaware[4].
Field of the Invention
This patent pertains to a method of treating chronic renal failure using imidazole angiotensin-II (AII) receptor antagonists. The invention specifically involves the use of these antagonists to counteract the effects of angiotensin II, which is implicated in the progression of chronic renal failure[4].
Claims
The patent includes several claims that define the scope of the invention:
Independent Claims
- The patent has multiple independent claims that protect the method of treating chronic renal failure using imidazole angiotensin-II receptor antagonists. These claims are broad and cover various aspects of the treatment method, including the specific compounds used and their administration[4].
Dependent Claims
- Dependent claims further specify the independent claims by detailing particular aspects such as the dosage, administration route, and specific compounds within the class of imidazole angiotensin-II receptor antagonists[4].
Claim Structure and Value
The structure and number of claims in a patent can significantly impact its value. For U.S. Patent 5,210,079:
- Number of Claims: The patent has a substantial number of claims, which can indicate a higher inventive contribution and greater investment by the applicant. This is often associated with higher patent value[3].
- Type of Claims: The patent includes both product and method claims. Product claims, which protect new products or substances, generally offer wider legal protection and are often more valuable than method claims[3].
Patent Landscape
Related Patents and Applications
- This patent is part of a series of continuations and continuations-in-part, indicating a complex and evolving patent strategy. It is a continuation of U.S. Ser. No. 542,351, filed June 22, 1990, which itself is a continuation-in-part of earlier applications[4].
Expiration and Exclusivity
- The patent was scheduled to expire on November 11, 2010, with an additional period of pediatric exclusivity. This expiration date marked the end of the exclusive rights granted to the patent holder for this specific method of treatment[1].
Generic Approvals
- Following the expiration of the patent, generic versions of the drug, such as Losartan Potassium Tablets, were approved by the FDA. These generic approvals were based on Abbreviated New Drug Applications (ANDAs) that did not infringe on the method-of-use claims of the original patent[1].
Legal and Regulatory Aspects
Paragraph IV Certification
- Generic drug manufacturers seeking approval for their versions of the drug had to file a Paragraph IV certification, stating that the patent was invalid, unenforceable, or would not be infringed by their manufacture, use, or sale of the drug. This certification is a critical step in the process of challenging the exclusivity of the original patent[1].
Risk Evaluation and Mitigation Strategy (REMS)
- The FDA may require a REMS for the listed drug, which would also apply to any generic versions approved under an ANDA. This ensures that the safety and efficacy of the drug are closely monitored post-marketing[1].
Impact on Pharmaceutical Industry
Innovation and Competition
- The expiration of U.S. Patent 5,210,079 and the subsequent approval of generic versions have increased competition in the market for angiotensin-II receptor antagonists. This competition can drive innovation as companies seek to develop new and improved treatments[1].
Cost and Accessibility
- Generic versions of the drug are generally more affordable than the brand-name version, making the treatment more accessible to a wider population. This can have significant public health implications by increasing the availability of effective treatments for chronic renal failure and hypertension[1].
Key Takeaways
- Patent Scope: U.S. Patent 5,210,079 covers a method of treating chronic renal failure using imidazole angiotensin-II receptor antagonists.
- Claims Structure: The patent includes multiple independent and dependent claims that protect the method and specific compounds.
- Patent Landscape: The patent is part of a complex series of continuations and has significant implications for generic drug approvals.
- Legal and Regulatory: The patent's expiration and subsequent generic approvals are governed by Paragraph IV certifications and REMS requirements.
- Industry Impact: The patent's expiration has increased competition and accessibility of the treatment.
Frequently Asked Questions
Q: What is the main subject of U.S. Patent 5,210,079?
A: The main subject is a method of treating chronic renal failure using imidazole angiotensin-II receptor antagonists.
Q: Who are the inventors of this patent?
A: The inventors are David J. Carini, John V. Duncia, and Pancras C. Wong.
Q: What is the significance of the patent's expiration date?
A: The expiration date marked the end of the exclusive rights granted to the patent holder, allowing for generic versions of the drug to be approved.
Q: How do generic drug manufacturers challenge the exclusivity of this patent?
A: They file a Paragraph IV certification stating that the patent is invalid, unenforceable, or will not be infringed by their manufacture, use, or sale of the drug.
Q: What is the impact of this patent on the pharmaceutical industry?
A: The patent's expiration has increased competition and made the treatment more accessible by allowing generic versions to enter the market.
Cited Sources
- FDA Document: Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg[1].
- U.S. Patent Document: ION BINDING POLYMERS AND USES[2].
- Research Paper: Examining the relation between patent value and patent claims[3].
- U.S. Patent Document: Treatment of Chronic Renal Failure with Imidazole Angiotensin-II Receptor Antagonists[4].
