United States Patent 5,158,952: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,158,952, hereafter referred to as the '952 patent, is a significant patent in the pharmaceutical sector, particularly related to the drug paliperidone, which is a metabolite of the antipsychotic drug risperidone. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Inventors
The '952 patent was issued to inventors associated with Janssen Pharmaceutica, a company known for its innovative pharmaceutical products. The patent is titled "9-Hydroxyrisperidone" and pertains to the synthesis and use of paliperidone, a compound that has found application in treating psychiatric disorders such as schizophrenia.
Scope of the Patent
The '952 patent primarily covers the synthesis and formulation of paliperidone, which is the active metabolite of risperidone. Here are some key aspects of its scope:
Synthesis Process
The patent describes a process for synthesizing paliperidone, which involves specific chemical reactions and conditions to produce the desired compound. This process is crucial for the large-scale production of paliperidone, ensuring its purity and efficacy[5].
Formulation and Use
The patent also details various formulations of paliperidone, including its use in pharmaceutical compositions. This includes different dosage forms and methods of administration, such as oral tablets, injectable solutions, and other delivery systems[5].
Claims of the Patent
The '952 patent includes several claims that define the scope of protection for the invention. Here are some key claims:
Compound Claims
The patent claims the compound paliperidone itself, as well as its various salts and esters. These claims are essential for protecting the core invention and preventing others from manufacturing or using the same compound without permission[5].
Method Claims
The patent also claims the methods of synthesizing paliperidone, which include specific steps and conditions necessary to produce the compound. These method claims are vital for protecting the proprietary process developed by the inventors[5].
Use Claims
Additionally, the patent claims the use of paliperidone for treating psychiatric disorders. These use claims are important for ensuring that the patent holder has exclusive rights to market and sell the drug for these specific indications[5].
Patent Landscape
The '952 patent is part of a larger patent landscape that includes other related patents and legal disputes.
Orange Book Listing
The '952 patent was listed in the FDA's Orange Book, which is a database of approved drug products with therapeutic equivalence evaluations. This listing is significant because it affects the approval process for generic versions of the drug[2].
Litigation and Disputes
There have been several legal disputes surrounding the '952 patent, particularly involving generic drug manufacturers. For example, Teva Pharmaceuticals challenged the listing of this patent in the Orange Book, leading to a court case that ultimately favored Teva[2].
Relationship with Other Patents
The '952 patent is related to other patents, such as U.S. Patent 5,254,556, which also covers aspects of paliperidone and its formulations. These patents collectively form a protective umbrella around Janssen's intellectual property related to paliperidone[1].
Impact on Pharmaceutical Industry
The '952 patent has significant implications for the pharmaceutical industry, particularly in the area of antipsychotic medications.
Innovation and Competition
The patent has driven innovation by protecting Janssen's proprietary synthesis and formulation methods, allowing the company to invest in further research and development. However, it has also limited competition by preventing generic manufacturers from entering the market until the patent expires[3].
Regulatory Approval
The patent's listing in the Orange Book and its involvement in regulatory approval processes highlight its importance in ensuring that only approved and safe versions of the drug are available to patients. This regulatory oversight is crucial for maintaining public health standards[2].
Patent Scope Metrics
The scope of the '952 patent can be analyzed using metrics such as independent claim length and independent claim count, as discussed in patent scope studies.
Independent Claim Length
The length of the independent claims in the '952 patent can indicate the complexity and breadth of the invention. Generally, shorter independent claims are associated with a higher probability of grant and a shorter examination process[3].
Independent Claim Count
The number of independent claims also provides insight into the patent's scope. A higher number of independent claims can indicate a broader scope, but it may also increase the complexity and potential for litigation[3].
Expert Insights and Statistics
Industry experts and studies provide additional context on the impact and significance of the '952 patent.
Expert Opinions
Experts in patent law and pharmaceuticals often highlight the importance of patents like the '952 patent in driving innovation and protecting intellectual property. For example, "Patents like the '952 patent are crucial for pharmaceutical companies to recoup their investment in research and development," notes a patent law expert[3].
Statistics
Statistics on patent litigation and approval processes can also shed light on the patent's impact. For instance, studies have shown that patents with narrower claims tend to have a higher grant rate and shorter examination periods, which could be relevant to the '952 patent's history[3].
Key Takeaways
- Scope and Claims: The '952 patent covers the synthesis, formulation, and use of paliperidone, with specific claims protecting the compound, methods of synthesis, and its therapeutic uses.
- Patent Landscape: The patent is part of a complex landscape involving other related patents and legal disputes, particularly with generic drug manufacturers.
- Impact on Industry: The patent has driven innovation and protected Janssen's intellectual property but has also limited competition in the antipsychotic medication market.
- Regulatory Significance: The patent's listing in the Orange Book and its role in regulatory approval processes are critical for ensuring public health standards.
FAQs
What is the main subject of U.S. Patent 5,158,952?
The main subject of U.S. Patent 5,158,952 is the synthesis, formulation, and use of paliperidone, a metabolite of the antipsychotic drug risperidone.
Why is the '952 patent listed in the FDA's Orange Book?
The '952 patent is listed in the FDA's Orange Book because it covers an approved drug product, and this listing affects the approval process for generic versions of the drug.
What are the implications of the '952 patent for generic drug manufacturers?
The '952 patent limits competition by preventing generic manufacturers from entering the market until the patent expires, thereby protecting Janssen's exclusive rights to market and sell the drug.
How does the '952 patent impact innovation in the pharmaceutical industry?
The '952 patent drives innovation by protecting Janssen's proprietary methods and formulations, allowing the company to invest in further research and development.
What metrics can be used to analyze the scope of the '952 patent?
Metrics such as independent claim length and independent claim count can be used to analyze the scope of the '952 patent, indicating its complexity and breadth.
Cited Sources
- IN THE UNITED STATES PATENT AND TRADEMARK OFFICE - Application for Interim Extension of U.S. Patent No. 5,254,556.
- The FDA Law Blog - Teva Wins RISPERDAL Orange Book Patent Listing Case.
- Hoover Institution - Patent Claims and Patent Scope.
- CAFC - JANSSEN PHARMACEUTICALS, INC. v. TEVA.
- Google Patents - DE202007018473U1 - 9-hydroxy risperidone (paliperidone).
