United States Patent 8,829,186: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 8,829,186, titled "Method for Preparation of Pitavastatin and Pharmaceutical Acceptable Salts Thereof," was granted to Cadila Healthcare Limited on September 9, 2014. This patent is significant in the pharmaceutical industry, particularly in the context of statin drugs used to lower cholesterol levels. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignee
The patent was invented by Shriprakash Dhar Dwivedi, Dhimant Jasubhai Patel, Alpesh Pravinchandra Shah, and Brij Khera, with Cadila Healthcare Limited as the assignee[1].
Background of Pitavastatin
Pitavastatin is a statin drug used to treat high cholesterol and reduce the risk of cardiovascular disease. It works by inhibiting the enzyme HMG-CoA reductase, which is crucial in the biosynthesis of cholesterol.
Scope of the Patent
The patent covers a method for preparing pitavastatin and its pharmaceutical acceptable salts. Here are the key aspects of the scope:
Chemical Synthesis
The patent describes a detailed process for synthesizing pitavastatin, including the preparation of intermediates and the final compound. This involves a series of chemical reactions and purification steps to ensure the high purity of the final product[1].
Pharmaceutical Acceptable Salts
The invention also includes the preparation of pharmaceutical acceptable salts of pitavastatin, which are essential for enhancing the drug's stability, solubility, and bioavailability. These salts can be formed with various alkali or alkaline earth metals[1].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention:
Independent Claims
The independent claims outline the core method of preparing pitavastatin and its salts. These claims are critical as they define the novel and non-obvious aspects of the invention that distinguish it from prior art[1].
Dependent Claims
Dependent claims further specify the method by detailing specific steps, conditions, and reagents used in the synthesis. These claims provide additional protection by covering various embodiments of the invention[1].
Patent Claims Analysis
The analysis of patent claims is crucial for understanding the patent's scope and potential impact.
Claim Length and Count
Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process[3].
Clarity and Specificity
The clarity and specificity of patent claims are essential for ensuring that the patent meets statutory requirements. The USPTO has emphasized the importance of clear and concise language in patent applications to avoid issues during examination and potential litigation[4].
Patent Landscape
The patent landscape surrounding US 8,829,186 involves several key aspects:
Competitors and Prior Art
The pharmaceutical industry is highly competitive, with multiple companies developing and manufacturing statin drugs. The patent's validity depends on its ability to distinguish itself from prior art, including other methods of synthesizing pitavastatin and its salts[1].
Litigation and Challenges
Patents in the pharmaceutical sector are often subject to litigation and challenges, such as inter partes reviews (IPRs). The validity of claims can be challenged based on prior art, written description requirements, and other statutory criteria[5].
Regulatory and Examination Process
The USPTO plays a critical role in the examination and granting of patents.
Enhanced Patent Quality Initiative
The USPTO has implemented various initiatives to improve patent quality, including the Enhanced Patent Quality Initiative. This initiative focuses on ensuring that patents meet statutory requirements for novelty, clarity, and non-obviousness[4].
Examination Time and Tools
The examination process involves assessing the clarity and scope of patent claims. The USPTO has analyzed the time needed for thorough examinations and has identified areas where additional time is warranted. Tools such as glossaries of key terms and claim charts have been considered to enhance clarity, although their implementation is subject to stakeholder feedback[4].
Industry Impact
The patent's impact on the industry is multifaceted:
Market Competition
By securing a patent for a specific method of synthesizing pitavastatin, Cadila Healthcare Limited gains a competitive advantage in the market. This can influence pricing, market share, and the overall availability of the drug[1].
Innovation and R&D
The patent encourages innovation by providing a protected method that can be improved upon or used as a basis for further research and development in the field of statin drugs.
Key Takeaways
- Method of Synthesis: The patent covers a detailed method for preparing pitavastatin and its pharmaceutical acceptable salts.
- Scope and Claims: The patent includes independent and dependent claims that define the novel and non-obvious aspects of the invention.
- Patent Landscape: The patent operates within a competitive pharmaceutical landscape, subject to challenges and litigation.
- Regulatory Compliance: The patent must meet statutory requirements for clarity, novelty, and non-obviousness, aligning with USPTO initiatives.
- Industry Impact: The patent affects market competition and encourages further innovation in statin drug research.
FAQs
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What is the main subject of United States Patent 8,829,186?
- The main subject is a method for preparing pitavastatin and its pharmaceutical acceptable salts.
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Who are the inventors of this patent?
- The inventors are Shriprakash Dhar Dwivedi, Dhimant Jasubhai Patel, Alpesh Pravinchandra Shah, and Brij Khera.
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What is the significance of pharmaceutical acceptable salts in this patent?
- These salts enhance the stability, solubility, and bioavailability of pitavastatin.
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How does the USPTO ensure patent quality?
- The USPTO implements initiatives like the Enhanced Patent Quality Initiative and uses metrics such as claim length and count to ensure clarity and specificity.
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What are the potential challenges to the validity of this patent?
- Challenges can include inter partes reviews based on prior art, written description requirements, and other statutory criteria.
Sources
- United States Patent and Trademark Office. Method for Preparation of Pitavastatin and Pharmaceutical Acceptable Salts Thereof, US 8,829,186 B2, September 9, 2014.
- USA.gov. U.S. Patent and Trademark Office (USPTO).
- Hoover Institution. Patent Claims and Patent Scope, August 18, 2016.
- Government Accountability Office. Intellectual Property: Patent Office Should Define Quality, Reassess, June 30, 2016.
- United States Court of Appeals for the Federal Circuit. Regents of the University of Minnesota v. Gilead Sciences, Inc., March 6, 2023.
