United States Patent 6,717,015: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,717,015, titled "Venlafaxine besylate," is a significant patent in the pharmaceutical industry, particularly in the development and formulation of venlafaxine, an antidepressant medication. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of Venlafaxine
Venlafaxine is a serotonin-norepinephrine reuptake inhibitor (SNRI) used primarily to treat depression, anxiety disorders, and some sleep disorders. The patent in question focuses on the besylate salt form of venlafaxine, which is crucial for its formulation into various dosage forms.
Scope of the Patent
The patent US 6,717,015 is centered on the composition and formulation of venlafaxine besylate, particularly in the context of extended release formulations. Here are some key aspects of its scope:
Extended Release Formulations
The patent describes the development of once-daily, encapsulated extended release formulations of venlafaxine besylate. These formulations are designed to provide a flattened drug plasma profile, which helps in reducing side effects such as nausea and vomiting that are common with multiple daily dosing regimens[1].
Dosage Forms
The patent emphasizes the ease of formulating venlafaxine besylate into various dosage forms, including hydrogel extended release tablets. This versatility is crucial for patient compliance and therapeutic efficacy[1].
Enantiomers and Metabolites
The patent also touches on the use of individual enantiomers and metabolites of venlafaxine. It suggests that using one isomer substantially without the presence of the other can reduce certain side effects, although commercial venlafaxine hydrochloride is typically a racemate[1].
Claims of the Patent
The claims of US 6,717,015 are critical in defining the scope of the invention and what the patentee is entitled to exclude others from making, using, or selling.
Claim Construction
Claim construction is a legal process that determines the meaning of the claims in a patent. For US 6,717,015, the claims would be interpreted based on their ordinary and customary meaning to a person of ordinary skill in the art at the time of the invention. This includes considering the claims, the specification, and the prosecution history of the patent[2].
Key Claims
- Composition Claims: These claims cover the specific composition of venlafaxine besylate and its formulation into extended release dosage forms.
- Method Claims: These claims cover the methods of preparing and administering the extended release formulations.
- Use Claims: These claims cover the therapeutic uses of the extended release formulations of venlafaxine besylate.
Patent Landscape
The patent landscape surrounding US 6,717,015 includes several related patents and legal cases that provide context and insights into its significance and impact.
Related Patents
- U.S. Pat. No. 6,274,171 and EP 0 797 991A1: These patents also disclose encapsulated extended release formulations for venlafaxine hydrochloride, highlighting the evolution of venlafaxine formulations[1].
- WO 99/22724: This patent discloses encapsulated venlafaxine hydrochloride extended release dosage forms that differ from those in U.S. Pat. No. 6,274,171 and EP 0 797 991A1, particularly in the absence of HPMC (Hydroxypropyl Methylcellulose)[1].
Legal Cases
- Wyeth v. Mylan Pharmaceuticals, Inc.: This case involved a dispute over the validity and infringement of patents related to extended release formulations of venlafaxine hydrochloride. The case highlights the importance of claim construction and the scope of patent protection in the pharmaceutical industry[2].
Impact on the Pharmaceutical Industry
The patent US 6,717,015 has significant implications for the pharmaceutical industry, particularly in the areas of drug formulation and intellectual property.
Drug Formulation
The development of extended release formulations of venlafaxine besylate has improved patient compliance and reduced side effects, making the medication more effective and tolerable for patients.
Intellectual Property
The patent has been a subject of legal disputes, emphasizing the importance of robust patent protection in the pharmaceutical industry. It underscores the need for thorough patent analytics to understand which patents and claims are actively protecting intellectual property and where gaps or opportunities exist[3].
Key Takeaways
- Extended Release Formulations: The patent focuses on once-daily, encapsulated extended release formulations of venlafaxine besylate.
- Claim Construction: The meaning of claims is determined by their ordinary and customary meaning to a person of ordinary skill in the art.
- Related Patents: Other patents like U.S. Pat. No. 6,274,171 and WO 99/22724 are part of the broader patent landscape.
- Legal Implications: The patent has been involved in legal disputes, highlighting the importance of robust patent protection.
- Impact on Industry: The patent has improved drug formulation and patient compliance, and it emphasizes the need for thorough patent analytics.
FAQs
What is the primary focus of US Patent 6,717,015?
The primary focus of US Patent 6,717,015 is the composition and formulation of venlafaxine besylate, particularly in extended release dosage forms.
How does the patent improve venlafaxine formulations?
The patent describes once-daily, encapsulated extended release formulations that provide a flattened drug plasma profile, reducing side effects like nausea and vomiting.
What is the significance of claim construction in this patent?
Claim construction is crucial as it determines the scope of the invention and what the patentee is entitled to exclude others from making, using, or selling.
Are there related patents to US 6,717,015?
Yes, patents like U.S. Pat. No. 6,274,171 and WO 99/22724 are related and part of the broader patent landscape for venlafaxine formulations.
What is the impact of this patent on the pharmaceutical industry?
The patent has improved drug formulation, patient compliance, and highlighted the importance of robust patent protection and thorough patent analytics in the pharmaceutical industry.
Sources
- US6717015B2 - Venlafaxine besylate - Google Patents
- Wyeth v. Mylan Pharmaceuticals, Inc. - Casetext
- Patent Analytics - SLWIP.com
