United States Patent 4,628,051: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 4,628,051, titled "Triphasic Progestin/Estrogen Combination Regimens for Contraception," is a significant patent in the field of pharmaceuticals, particularly in the development of oral contraceptives. This patent, granted to Pasquale, outlines specific regimens for administering a combination of progestin and estrogen to prevent pregnancy.
Background
The patent was issued on December 9, 1986, and it represents a milestone in the evolution of contraceptive medications. The triphasic regimen described in this patent has been widely adopted and has played a crucial role in modern contraceptive practices.
Scope of the Patent
The scope of the patent is defined by its claims, which detail the specific methods and compositions of the triphasic progestin/estrogen regimens.
Claims Overview
The patent includes multiple claims that describe the different phases of the contraceptive regimen:
- Claim 1: Describes a method of contraception involving a triphasic regimen where a combination of progestin and estrogen is administered over three phases, each phase having a specific dosage and duration[4].
- Subsequent Claims: These claims specify various aspects of the regimen, including the types and dosages of progestin and estrogen, the duration of each phase, and the preferred administration schedules.
Key Components of the Regimen
- First Phase: A combination of a progestin (e.g., levonorgestrel) and an estrogen (e.g., ethinyl estradiol) is administered for 7 days.
- Second Phase: The dosage of progestin is increased while the estrogen dosage remains constant, administered for another 7 days.
- Third Phase: The progestin dosage is further increased or remains the same as the second phase, with the estrogen dosage constant, administered for the final 7 days[4].
Patent Claims Analysis
The claims in this patent are critical for understanding the scope of protection granted to the inventor.
Independent Claims
Independent claims are those that stand alone and do not depend on other claims. In this patent, the independent claims define the core aspects of the triphasic regimen, including the specific dosages and administration schedules.
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or variations of the core invention. These claims help to narrow down the scope and ensure that the patent covers all possible variations of the triphasic regimen.
Enablement Requirement
The patent must meet the enablement requirement as specified in 35 U.S.C. §112(a), which mandates that the patent description be "in such full, clear, concise, and exact terms as to enable any person skilled in the art... to make and use the invention"[5].
Description and Examples
The patent provides detailed descriptions of the regimens, including specific dosages and administration schedules. For example, one regimen involves administering 20-50 μg of ethinyl estradiol in combination with 500 μg, 750 μg, and 1 mg of levonorgestrel during each of the three 7-day phases, respectively[4].
Patent Landscape
The patent landscape surrounding U.S. Patent 4,628,051 includes other related patents and developments in the field of oral contraceptives.
Prior Art
Other patents, such as U.S. Patent 4,530,839 and U.S. Patent 4,390,531, also describe triphasic regimens but with different dosages and administration schedules. These patents demonstrate the ongoing innovation and refinement in contraceptive medications[4].
Impact on the Industry
The triphasic regimen described in this patent has had a significant impact on the pharmaceutical industry. It has been widely adopted and has influenced the development of subsequent oral contraceptives. The patent's specificity and clarity have helped in ensuring that the regimen is both effective and safe for use.
Legal and Regulatory Aspects
The validity and enforceability of the patent are subject to legal and regulatory scrutiny.
Enablement and Written Description
As seen in cases like Amgen Inc. v. Sanofi, the enablement requirement is a critical aspect of patent law. The patent must provide sufficient detail to enable a person skilled in the art to make and use the invention without undue experimentation[5].
Litigation and Enforcement
The patent's claims and scope are subject to litigation and enforcement. Any infringement or challenges to the patent's validity would be adjudicated based on the patent's claims, descriptions, and the legal framework governing patents.
Key Takeaways
- Triphasic Regimen: The patent describes a specific triphasic regimen involving the administration of progestin and estrogen over three phases.
- Claims and Scope: The claims define the core aspects of the regimen, including dosages and administration schedules.
- Enablement Requirement: The patent meets the enablement requirement by providing detailed descriptions and examples.
- Impact on Industry: The patent has significantly influenced the development of oral contraceptives.
- Legal and Regulatory Aspects: The patent's validity and enforceability are subject to legal scrutiny, particularly regarding the enablement requirement.
FAQs
-
What is the main invention described in U.S. Patent 4,628,051?
- The main invention is a triphasic progestin/estrogen combination regimen for contraception.
-
How many phases does the regimen described in the patent have?
- The regimen has three phases, each lasting 7 days.
-
What are the key components of each phase in the regimen?
- Each phase involves a specific combination of progestin and estrogen, with increasing dosages of progestin across the phases.
-
How does this patent meet the enablement requirement?
- The patent provides detailed descriptions and examples of the regimens, ensuring that a person skilled in the art can make and use the invention.
-
What is the significance of this patent in the pharmaceutical industry?
- The patent has been widely adopted and has influenced the development of subsequent oral contraceptives, making it a significant milestone in the field.
Sources
- USPTO Search: Search for patents - USPTO.
- USA.gov: U.S. Patent and Trademark Office (USPTO) | USAGov.
- SSRN: Patent Claims and Patent Scope - Search eLibrary :: SSRN.
- Google Patents: WO1998004268A1 - Oral contraceptive - Google Patents.
- Supreme Court: 21-757 Amgen Inc. v. Sanofi (05/18/23) - Supreme Court.
