Detailed Analysis of the Scope and Claims of United States Patent 4,464,394
Introduction
United States Patent 4,464,394, titled "Improved pharmaceutical composition containing 13-CIS vitamin A acid," is a significant patent in the field of pharmaceuticals, particularly concerning the use of isotretinoin, a derivative of vitamin A. This patent, granted in 1984, has had a lasting impact on the treatment of various skin conditions, including acne.
Background and Inventors
The patent was granted to Werner Bollag, a Swiss chemist, who worked extensively on the therapeutic applications of vitamin A derivatives. Bollag's work led to the development of isotretinoin, which has become a cornerstone in the treatment of severe acne and other dermatological conditions[2].
Scope of the Patent
Therapeutic Use of Isotretinoin
The patent primarily focuses on the therapeutic use of 13-CIS vitamin A acid, also known as isotretinoin. It describes the composition and methods for using this compound in treating various skin conditions, particularly severe acne. The scope includes the formulation of isotretinoin into pharmaceutical compositions suitable for oral administration[2].
Pharmaceutical Compositions
The patent details various pharmaceutical compositions containing isotretinoin. These compositions include different excipients and formulations designed to enhance the stability, bioavailability, and efficacy of the drug. The patent also discusses the importance of the hydrophilic and lipophilic properties of the excipients in these formulations[2].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- The pharmaceutical composition containing 13-CIS vitamin A acid (isotretinoin) and specific excipients.
- Methods for preparing these compositions.
- The therapeutic use of these compositions for treating skin conditions such as acne[2].
Dependent Claims
Dependent claims further specify the details of the independent claims, including:
- Specific ratios of isotretinoin to excipients.
- Particular methods of preparation.
- Dosage forms such as capsules or tablets[2].
Patent Landscape
Related Patents and Continuations
The patent 4,464,394 is part of a broader patent landscape related to isotretinoin. Later patents, such as U.S. Patent No. 7,435,427 and U.S. Patent No. 8,367,102, build upon the initial work described in this patent. These subsequent patents cover additional formulations, methods of use, and specific dosages of isotretinoin[4].
Litigation and Enforcement
The importance of this patent is also evident in litigation related to generic versions of isotretinoin. For example, the case involving Ranbaxy and Actavis (now part of Teva Pharmaceuticals) highlights the efforts to protect the intellectual property surrounding isotretinoin formulations. The defendants' submission of an Abbreviated New Drug Application (ANDA) for a generic version of Absorica® (isotretinoin) led to patent infringement claims based on the '427 and '102 patents, which are continuations and related to the original '394 patent[1].
Impact on Pharmaceutical Industry
Innovation and Competition
The patent has driven innovation in the pharmaceutical industry by encouraging the development of new formulations and delivery systems for isotretinoin. However, it has also led to significant litigation costs and licensing complexities, which can impact the incentives for further innovation[3].
Market Dominance
The patent and its continuations have allowed the original patent holders and their successors to maintain a significant market presence in the treatment of severe acne. This dominance is reflected in the ongoing legal battles to protect the patent rights against generic competitors[1].
Metrics for Measuring Patent Scope
Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and independent claim count can be useful in assessing the breadth and clarity of patents. Narrower claims, as seen in some of the continuations of this patent, are often associated with a higher probability of grant and shorter examination processes[3].
Conclusion
United States Patent 4,464,394 is a pivotal patent in the pharmaceutical industry, particularly in the treatment of severe acne with isotretinoin. Its scope and claims have set the foundation for subsequent patents and formulations, influencing both innovation and competition in the market.
Key Takeaways
- Therapeutic Use: The patent focuses on the therapeutic use of isotretinoin for treating skin conditions.
- Pharmaceutical Compositions: It details various compositions and formulations of isotretinoin.
- Patent Landscape: The patent is part of a broader landscape including later patents and continuations.
- Litigation: It has been involved in significant litigation related to generic versions of isotretinoin.
- Impact: The patent has driven innovation but also increased litigation and licensing costs.
FAQs
What is the main subject of United States Patent 4,464,394?
The main subject is the therapeutic use of 13-CIS vitamin A acid, also known as isotretinoin, in treating skin conditions like severe acne.
Who is the inventor of this patent?
The inventor is Werner Bollag, a Swiss chemist.
What are the key claims of this patent?
The key claims include the pharmaceutical composition containing isotretinoin, methods for preparing these compositions, and the therapeutic use of these compositions.
How has this patent impacted the pharmaceutical industry?
It has driven innovation in isotretinoin formulations but also led to significant litigation and licensing complexities.
What metrics can be used to measure the scope of this patent?
Metrics such as independent claim length and independent claim count can be used to assess the breadth and clarity of the patent.
Are there any notable legal cases related to this patent?
Yes, there have been notable cases, such as the one involving Ranbaxy and Actavis, related to patent infringement claims for generic versions of isotretinoin.
Sources
- Case 1:14-cv-03653-JEI-AMD Document 1 Filed 06/06/14
- Improved pharmaceutical composition containing 13-CIS vitamin A acid
- Patent Claims and Patent Scope
- PHARMACEUTICAL SEMI-SOLID COMPOSITION OF SOTRETINOIN
