United States Patent 8,617,597: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,617,597, titled "Pharmaceutical composition containing a tetrahydrofolic acid," is a significant patent in the pharmaceutical industry, particularly in the realm of oral contraceptives and hormone replacement therapy. This patent, owned by Bayer Healthcare Pharmaceuticals Inc., protects a specific formulation of a pharmaceutical composition.
Background
The patent was granted on December 31, 2013, and is set to expire on February 8, 2030[2][4].
Scope of the Patent
Pharmaceutical Composition
The patent describes a solid pharmaceutical composition that includes a progestogen, an estrogen, a tetrahydrofolic acid or a salt thereof, and at least one pharmaceutically acceptable excipient or carrier. This composition is particularly suited for use as an oral contraceptive or in hormone replacement therapy[1].
Active Ingredients
- Progestogen: The patent specifies the use of drospirenone as the progestogen component.
- Estrogen: The composition includes an estrogen component, which can be in the form of ethinyl estradiol.
- Tetrahydrofolic Acid: This is a key component, which is included to enhance the efficacy of the formulation, particularly in reducing homocysteine levels and supporting folate metabolism[1].
Claims of the Patent
The patent includes multiple claims that define the scope of protection:
Claim 1
The first claim describes the pharmaceutical composition comprising a progestogen, an estrogen, a tetrahydrofolic acid or a salt thereof, and at least one pharmaceutical acceptable excipient or carrier[1].
Subsequent Claims
Subsequent claims further specify the types and amounts of the active ingredients, the form of the composition (e.g., tablets), and the method of administration. These claims also cover various aspects of the formulation, including the use of cyclodextrin complexes and other excipients to enhance stability and bioavailability[1].
Patent Landscape
Related Patents
The patent is part of a broader family of patents related to pharmaceutical compositions containing tetrahydrofolates. Other patents in this family include U.S. Pat. No. 6,190,693, which relates to pharmaceutical compositions suitable for oral contraceptive or hormone replacement therapy containing folic acid, and U.S. Pat. No. 6,011,040, which focuses on the use of tetrahydrofolates for influencing homocysteine levels[1].
Expired Patents
Several related patents have expired, such as U.S. Pat. No. 6958326 and U.S. Pat. No. 7163931, which were related to cyclodextrin-drospirenone inclusion complexes and estrogen-cyclodextrin complexes, respectively[2].
Active Patents
In addition to U.S. Patent 8,617,597, another active patent is U.S. Patent 11,617,751, which also protects a pharmaceutical composition containing tetrahydrofolic acid and is set to expire on July 17, 2030[2].
Exclusivities and Generic Launch
Beyaz, the drug protected by this patent, held exclusivities that expired in 2013. However, the patent protection remains in place until 2030. Generic manufacturers can seek FDA approval before the patent expiration by filing a Paragraph IV certification, which challenges the validity or enforceability of the patent[2].
Patent Analytics and Claim Coverage
To fully understand the protection offered by this patent, patent analytics tools can be used. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and potential future design opportunities. Claim charts generated by such tools can be reviewed by technical experts to determine the applicability of the patent claims to specific products or methods[3].
Impact on Market and Generic Entry
The expiration of this patent in 2030 will open up the market for generic versions of Beyaz. Understanding the full scope of patent protection, including international patents, is crucial for strategizing market entry. Companies can identify markets with weaker patent protection as potential entry points for generic products[2].
Key Takeaways
- Pharmaceutical Composition: The patent protects a specific formulation of an oral contraceptive or hormone replacement therapy containing a progestogen, estrogen, and tetrahydrofolic acid.
- Claims: The patent includes multiple claims specifying the active ingredients, their amounts, and the form of the composition.
- Patent Landscape: The patent is part of a broader family of related patents, with some having expired and others still active.
- Exclusivities and Generic Launch: The exclusivities have expired, but the patent remains in force until 2030, with generic launch possible after challenging the patent through a Paragraph IV certification.
- Patent Analytics: Tools like claim charts and scope concepts help in understanding the patent coverage and identifying gaps.
FAQs
What is the main focus of United States Patent 8,617,597?
The main focus of this patent is a pharmaceutical composition containing a progestogen, an estrogen, and a tetrahydrofolic acid, particularly for use as an oral contraceptive or in hormone replacement therapy.
When is the patent set to expire?
The patent is set to expire on February 8, 2030.
What are the key active ingredients in the patented composition?
The key active ingredients are drospirenone (progestogen), ethinyl estradiol (estrogen), and tetrahydrofolic acid.
How can generic manufacturers launch a generic version before the patent expiration?
Generic manufacturers can launch a generic version before the patent expiration by filing a Paragraph IV certification with the FDA, challenging the validity or enforceability of the patent.
What tools can be used to analyze the patent coverage and identify gaps?
Patent analytics tools, such as claim charts and scope concepts, can be used to analyze the patent coverage and identify gaps in protection.
Cited Sources:
- US Patent 8,617,597 - Pharmaceutical composition containing a tetrahydrofolic acid[1].
- Pharsight - Beyaz patent expiration[2].
- Schwegman - Patent Analytics[3].
- DrugBank - Levomefolic acid: Uses, Interactions, Mechanism of Action[4].
