United States Patent 4,258,062: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,258,062, titled "Phenoxy-amino-propanols," is a significant patent in the field of pharmaceuticals, particularly focusing on new compounds and their physiologically acceptable salts. This patent, granted to Merck, has implications for the development and use of certain pharmaceutical agents.
Background of the Patent
The patent was filed on June 25, 1979, and granted on March 24, 1981. It relates to the synthesis and use of phenoxy-amino-propanols, which are compounds with specific pharmacological properties[1].
Scope of the Patent
Chemical Compounds
The patent describes a series of phenoxy-amino-propanol compounds, which are characterized by their chemical structure. These compounds are synthesized through specific chemical reactions and have been found to possess various physiological activities. The scope includes the compounds themselves, their salts, and methods for their preparation[1].
Pharmacological Use
The phenoxy-amino-propanols covered by this patent are highly β-adrenoreceptor selective, making them useful in the treatment of cardiovascular diseases. For example, bisoprolol, a compound related to this patent, is used as a beta-blocker and was first introduced into the German market in 1986[5].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically describe the chemical structure of the compounds, their synthesis methods, and their pharmacological uses. For instance, Claim 1 might describe a specific phenoxy-amino-propanol compound, while subsequent claims might cover its salts, methods of preparation, and therapeutic applications[1].
Dependent Claims
Dependent claims further narrow down the scope by specifying particular aspects of the compounds, such as specific substituents, dosage forms, or methods of administration. These claims build upon the independent claims to provide a detailed description of the invention's scope[1].
Patent Landscape
Related Patents
The patent landscape surrounding US 4,258,062 includes other patents related to the synthesis, use, and formulation of similar compounds. For example, patents like US 6733789B1 describe multiparticulate formulations of bisoprolol, which is a compound covered under the broader scope of US 4,258,062[5].
Base Patents and Collateral Patents
In the context of pharmaceutical patents, the concept of "base patents" and "collateral patents" is crucial. Base patents typically claim the active pharmaceutical ingredient or method of use, while collateral patents cover other aspects such as dosage forms, methods of manufacture, or specific uses. US 4,258,062 can be considered a base patent for phenoxy-amino-propanols, with other patents extending its scope to various formulations and applications[4].
Patent Term and Extensions
Original Term
The original term of a patent in the United States is typically 17 years from the grant date. However, changes in patent law, such as those introduced by the Uruguay Round Agreements Act (URAA), have extended the term to 20 years from the filing date for patents filed after June 8, 1995[2].
Extensions Under 35 U.S.C. 156
For patents that undergo regulatory reviews by the FDA or Department of Agriculture, the term can be extended up to five years under 35 U.S.C. 156. This provision is relevant for pharmaceutical patents, as it compensates for the time spent in regulatory approval processes. However, US 4,258,062, being granted before these changes, would not be subject to these extensions[2].
Metrics for Measuring Patent Scope
Independent Claim Length and Count
Research has shown that metrics such as independent claim length and count can be used to measure patent scope. Narrower claims, as seen in patents like US 4,258,062, are often associated with a higher probability of grant and a shorter examination process. These metrics help in assessing the breadth and clarity of patent claims[3].
Impact on Innovation and Licensing
Patent Quality and Innovation
The scope and claims of patents like US 4,258,062 can significantly impact innovation and licensing. Broader patents can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation. However, well-defined and narrower claims, as in this patent, can facilitate clearer boundaries and reduce legal disputes[3].
Industry Expert Insights
Industry experts emphasize the importance of clear and specific patent claims. For example, "Patents with narrower claims at publication are associated with a higher probability of grant and a shorter examination process," notes a study on patent scope metrics[3].
Illustrative Statistics
- Patent Term Extensions: Patents extended under 35 U.S.C. 156 can see their term extended by up to five years, with some extensions recalculated to ensure they do not exceed the maximum allowed period[2].
- Claim Metrics: Patents with an average of 2-3 independent claims tend to have a higher grant rate compared to those with broader or more numerous claims[3].
Key Takeaways
- Specific Claims: US 4,258,062 includes specific claims that define the chemical structure and pharmacological use of phenoxy-amino-propanols.
- Patent Landscape: The patent is part of a broader landscape that includes related patents on formulations and applications of similar compounds.
- Regulatory Extensions: While this patent is not subject to term extensions under 35 U.S.C. 156, such provisions are crucial for other pharmaceutical patents.
- Innovation Impact: Clear and specific claims can facilitate innovation by reducing legal ambiguities and costs.
FAQs
What are phenoxy-amino-propanols used for?
Phenoxy-amino-propanols, as described in US 4,258,062, are used primarily as beta-blockers in the treatment of cardiovascular diseases.
How do patent term extensions work under 35 U.S.C. 156?
Patent term extensions under 35 U.S.C. 156 can extend the patent term by up to five years for products subject to regulatory reviews by the FDA or Department of Agriculture.
What metrics are used to measure patent scope?
Metrics such as independent claim length and count are used to measure patent scope, with narrower claims often associated with a higher probability of grant and shorter examination process.
Why are clear patent claims important?
Clear and specific patent claims are important because they reduce legal ambiguities and costs, facilitating innovation and licensing.
How does the patent landscape affect the scope of US 4,258,062?
The patent landscape includes related patents on formulations and applications of similar compounds, which can extend the scope and use of the phenoxy-amino-propanols covered by US 4,258,062.
Sources
- US4258062A - Phenoxy-amino-propanols - Google Patents
- Extension Under 35 U.S.C. 156(e)(1) - United States Patent and Trademark Office
- Patent Claims and Patent Scope - SSRN
- The Franklin Pierce Center for Intellectual Property at the University of New Hampshire - IP Mall
- US6733789B1 - Multiparticulate bisoprolol formulation - Google Patents
