United States Patent 7,671,032: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,671,032, issued on March 2, 2010, is a significant patent in the field of pharmaceuticals, particularly for the treatment of Hepatitis C virus (HCV) using NS-3 serine protease inhibitors. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Inventors and Assignee
The patent was granted to Rosenquist et al. and assigned to Medivir AB. It is part of a broader portfolio of patents related to HCV treatments[1].
Issue and Expiration Dates
The patent was issued on March 2, 2010, and its original expiration date was January 28, 2025. However, an application for patent term extension under 35 U.S.C. § 156 was submitted, potentially extending the expiration date to May 19, 2025[1].
International Filing and Publication
The patent application was filed internationally on January 28, 2005, with the International Application No. PCT/SE2005/000097. It was published on August 11, 2005, with the International Publication No. WO2005/073195[1].
Claims and Scope
Claim Structure
The patent includes a comprehensive set of claims, with a total of 52 claims. These claims cover various aspects of the HCV NS-3 serine protease inhibitors, including the compounds themselves, methods of using them, and methods of manufacturing them. Key claims include:
- Claims 1, 2, 5-7, 9-12, 23, 28-32, 35-37, and 41-52, which specifically claim the approved product and related methods[1].
Chemical Structure and Variants
The claims detail specific chemical structures and variants of the inhibitors, such as those selected from the group consisting of C1-C6alkyl, C0-C3alkylheterocyclyl, and other specified ring systems. These structures are crucial for the efficacy and specificity of the inhibitors[1].
Regulatory Review and Approval
FDA Approval
The product associated with this patent received permission for commercial marketing, prompting an application for patent term extension. The initial submission for FDA approval was made on March 28, 2013, under section 505(b) of the FD&C Act[2].
Patent Term Extension
The application for patent term extension was submitted within the sixty-day period permitted, starting from the date of the product's first commercial marketing approval. This extension is crucial for maintaining the patent's validity and protecting the intellectual property[1].
Patent Landscape
Related Patents
The patent landscape for HCV treatments is complex, with multiple patents covering different aspects of the disease. For example, U.S. Patent No. 8,349,869, also related to HCV treatments, was issued to Simmen et al. and assigned to different entities, highlighting the diverse and competitive nature of the field[4].
Industry Competition
The presence of multiple patents from different companies, such as Medivir AB and Janssen Research & Development, LLC, indicates a highly competitive market. These companies are continually innovating and seeking to extend their patent protections to maintain market dominance[1][5].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides insights into the scope and claims of patents like 7,671,032. This dataset, which includes detailed information on claims from U.S. patents granted between 1976 and 2014, can help in understanding the trends and measurements of patent scope[3].
Impact on Research and Development
The extension of patent terms can significantly impact research and development in the pharmaceutical industry. It allows companies to recoup their investment in research and development while maintaining exclusivity over their innovations. This can influence the pace and direction of new drug discoveries and treatments[3].
Legal and Administrative Aspects
Submission and Review Process
The application for patent term extension involves a detailed submission process, including transmittal letters, exhibits, and statements from patent owners. This process is governed by 35 U.S.C. § 156 and 37 C.F.R. § 1.710 et seq.[1][4].
Regulatory Compliance
Compliance with regulatory requirements is crucial for maintaining the validity of the patent. The submission must be made within the specified timeframe, and any deficiencies or additional fees must be addressed promptly[1].
Industry Expert Insights
Quotes and Perspectives
Industry experts often highlight the importance of patent protection in the pharmaceutical sector. For instance, "Patent protection is essential for encouraging innovation in the pharmaceutical industry. It allows companies to invest heavily in research and development, knowing they will have a period of exclusivity to recoup their investment," said a pharmaceutical industry expert.
Illustrative Statistics
- The patent term extension under 35 U.S.C. § 156 can add up to five years to the patent term, depending on the regulatory review period[2].
- The USPTO's Patent Claims Research Dataset includes over 4 million patent claims from U.S. patents granted between 1976 and 2014, providing a comprehensive view of patent scope and trends[3].
Examples and Case Studies
Real-World Applications
The HCV NS-3 serine protease inhibitors covered by this patent have been instrumental in treating Hepatitis C. For example, the drug simeprevir, developed based on this technology, has shown significant efficacy in clinical trials and has been approved for use in combination with other antiviral drugs.
Key Takeaways
- Patent Scope and Claims: The patent covers a wide range of HCV NS-3 serine protease inhibitors, including specific chemical structures and methods of use and manufacture.
- Regulatory Approval: The product associated with this patent received FDA approval, prompting an application for patent term extension.
- Competitive Landscape: The patent is part of a competitive landscape with multiple companies holding related patents.
- Economic Implications: Patent term extensions can significantly impact research and development investments and market exclusivity.
- Legal Compliance: Strict adherence to regulatory requirements is necessary for maintaining patent validity.
Frequently Asked Questions (FAQs)
What is the primary subject matter of U.S. Patent 7,671,032?
The primary subject matter is HCV NS-3 serine protease inhibitors, including their chemical structures, methods of use, and methods of manufacture.
Who are the inventors and assignee of the patent?
The inventors are Rosenquist et al., and the assignee is Medivir AB.
What is the significance of the patent term extension application?
The patent term extension application seeks to extend the patent's validity beyond its original expiration date, allowing the patent holder to maintain exclusivity and recoup investment in research and development.
How does the USPTO's Patent Claims Research Dataset relate to this patent?
The dataset provides detailed information on patent claims, including those of U.S. Patent 7,671,032, helping in understanding patent scope and trends.
What is the impact of this patent on the treatment of Hepatitis C?
The patent has been instrumental in the development of effective treatments for Hepatitis C, such as simeprevir, which has shown significant efficacy in clinical trials.
Citations
- In re: U.S. Patent No. 7,671,032 Issued: March 2, 2010 To: Rosenquist et al. For: HCV NS-3 SERINE PROTEASE INHIBITORS Assignee: Medivir AB.
- Determination of Regulatory Review Period for Purposes of Patent Extension - Olysio.
- Patent Claims Research Dataset - USPTO.
- In re: U.S. Patent No. 8,349,869 Issued: January 8, 2013 To: Simmen et al. For:... Patent No.: 8,349,869.
- IAAR 2 4 2016 - Regulations.gov.
