United States Patent 4,772,475: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,772,475, titled "Controlled-release multiple units pharmaceutical formulation," is a significant patent in the pharmaceutical industry, particularly in the realm of drug delivery systems. This patent, granted to Boehringer Ingelheim Pharmaceuticals, Inc., covers a novel formulation that enhances the safety and efficacy of drug delivery.
Background
The patent was filed on October 22, 1986, and granted on September 27, 1988. It is part of a series of patents related to the drug tamsulosin hydrochloride, used primarily for the treatment of benign prostatic hyperplasia (BPH)[1].
Patent Scope
Claims
The patent claims cover a specific type of pharmaceutical formulation known as a controlled-release multiple units formulation. This formulation is designed to release the active substance in a controlled manner, ensuring a steady and consistent therapeutic effect over a prolonged period. The claims include:
- The pharmaceutical formulation itself.
- The method of preparing the formulation.
- The use of specific controlling agents to regulate the release of the active substance[4].
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length and count to measure the breadth and clarity of patent claims. For Patent 4,772,475, the independent claims are detailed and specific, indicating a narrower scope that is more focused on the unique aspects of the controlled-release formulation. This narrow scope can be associated with a higher probability of grant and a shorter examination process[3].
Patent Claims and Clarity
Claim Clarity and Validity
The clarity and validity of patent claims are crucial for maintaining patent quality. Patent 4,772,475 avoids the pitfalls of overly broad or unclear claims, which can lead to increased litigation and licensing costs. The claims are well-defined, ensuring that the patent does not diminish incentives for innovation[3].
Examination Process
The examination process for this patent likely involved a thorough review to ensure that the claims were narrow and specific. This process tends to narrow the scope of patent claims, making them more precise and less prone to disputes[3].
Patent Landscape
Related Patents
The patent landscape surrounding 4,772,475 includes several related patents that cover different aspects of the drug and its formulation. These include:
- Patents covering the drug per se (e.g., 4,731,478 and 4,703,063).
- Patents covering the pharmaceutical formulation (e.g., 4,772,475).
- Patents covering the use or indication of the drug (e.g., 4,868,216)[1].
Exclusivity and Generic Entry
The approval of the original new drug application (NDA) for tamsulosin hydrochloride granted Boehringer Ingelheim Pharmaceuticals, Inc. a period of exclusivity. This exclusivity period, typically five years from the approval date, prevents the submission of an Abbreviated New Drug Application (ANDA) for the same indication. However, ANDAs can be submitted after four years if they include a certification that the patent is invalid or will not be infringed[2].
Patent Expiration and Generic Entry
Patent Expiration Date
The patent 4,772,475 expired on February 27, 2006. The expiration of this patent, along with other related patents, opened the door for generic versions of the drug to enter the market[1][5].
Impact on Generic Entry
The expiration of the patent allowed other pharmaceutical companies to develop and market generic versions of tamsulosin hydrochloride. This increased competition can lead to lower prices and greater accessibility of the drug for patients[2].
Regulatory Considerations
FDA Regulations
The FDA plays a critical role in managing patent information and ensuring compliance with regulatory requirements. The FDA's "Orange Book" is the reference of record for patent expiry dates, although discrepancies can sometimes occur due to data integrity issues[2].
GATT and U.S. Patent Regulations
Changes in GATT and U.S. patent regulations have affected the patent landscape. The Uruguay Round Agreements Act (URAA) extended the term of patents issued on or after June 8, 1995, from 17 years from the date of issue to 20 years from the date of filing. This harmonization has impacted the expiration dates of many U.S. drug patents[2].
Industry Impact
Innovation and Competition
The controlled-release formulation covered by Patent 4,772,475 has contributed significantly to the treatment of BPH. The expiration of this patent has fostered competition, encouraging innovation in drug delivery systems and potentially leading to new formulations and treatments.
Cost and Accessibility
The entry of generic versions of tamsulosin hydrochloride has made the drug more affordable and accessible to patients. This shift can have a positive impact on public health by increasing the availability of effective treatments.
Key Takeaways
- Patent Scope: The patent covers a controlled-release multiple units pharmaceutical formulation with specific claims related to the formulation and its preparation.
- Claim Clarity: The claims are well-defined and narrow, ensuring clarity and validity.
- Patent Landscape: The patent is part of a broader landscape that includes related patents covering the drug, formulation, and use.
- Exclusivity and Generic Entry: The patent's expiration allowed for generic entry, increasing competition and accessibility.
- Regulatory Considerations: The FDA's regulations and GATT harmonization have impacted the patent's expiration date.
Frequently Asked Questions
What is the main subject of United States Patent 4,772,475?
The main subject of this patent is a controlled-release multiple units pharmaceutical formulation, particularly for the drug tamsulosin hydrochloride used in treating BPH.
When did the patent expire?
The patent 4,772,475 expired on February 27, 2006.
What impact did the patent's expiration have on the pharmaceutical market?
The expiration of the patent allowed for the entry of generic versions of tamsulosin hydrochloride, increasing competition and making the drug more affordable and accessible.
How does the FDA manage patent information for drug products?
The FDA manages patent information through the "Orange Book," which is the reference of record for patent expiry dates. However, discrepancies can occur due to data integrity issues.
What are the implications of GATT and U.S. patent regulations on drug patents?
The harmonization of GATT and U.S. patent regulations extended the term of patents issued on or after June 8, 1995, from 17 years to 20 years from the date of filing, affecting the expiration dates of many U.S. drug patents.
Cited Sources:
- CENTER FOR DRUG EVALUATION AND RESEARCH, "New Drug Application for Tamsulosin Hydrochloride," April 15, 1997.
- FOI Services, "Patent Drugs Under Patent," June 13, 2006.
- Hoover Institution, "Patent Claims and Patent Scope," August 18, 2024.
- Google Patents, "Controlled-release multiple units pharmaceutical formulation," US4772475A.
- Drug Patent Watch, "Patent 4772475," Detailed Information.
