United States Patent 8,937,150: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,937,150, titled "Anti-viral compounds," is a significant patent in the field of pharmaceuticals, particularly for the treatment of Hepatitis C virus (HCV). This patent, held by AbbVie Inc., protects key compounds and their uses, which are crucial for the drug MAVYRET.
Patent Overview
Publication and Legal Status
The patent was published on September 23, 2014, and is currently active, with an expiration date that has been extended due to regulatory review periods[2][4].
Claims and Scope
Independent Claims
The patent includes multiple independent claims that define the scope of the invention. These claims are centered around specific chemical compounds and their processes of manufacture. The compounds are described in detail, including their structural formulas and the methods for synthesizing them[4].
Chemical Compounds
The patent protects a range of anti-viral compounds effective in inhibiting the replication of HCV. These compounds are characterized by their specific chemical structures, including various substituents such as alkyl, halogen, cyano, nitro, and oxo groups. The claims also cover different heterocyclic groups and other functional groups that are integral to the compounds' anti-viral activity[4].
Processes of Manufacture
In addition to the compounds themselves, the patent claims processes for making these compounds. This includes coupling reactions, biosynthetic processes, and other chemical reactions necessary for the synthesis of the active ingredients[4].
Patent Landscape
MAVYRET and Its Components
The patent specifically protects MAVYRET, a drug product that combines glecaprevir and pibrentasvir. These compounds are key components of the treatment regimen for HCV and are covered under this patent. The protection extends to the drug product reviewed in the new drug application (NDA) 209394[2].
Regulatory Review and Patent Term Extension
The patent term for U.S. Patent 8,937,150 has been extended under 35 U.S.C. § 156 due to the regulatory review period for MAVYRET. The FDA published its determination of the regulatory review period, and no petitions were filed challenging the due diligence of the patent term extension applicant during this period[2].
Impact on Pharmaceutical Industry
Innovation and Competition
The patent's scope and claims have significant implications for innovation and competition in the pharmaceutical industry. The protection of specific compounds and their manufacturing processes can limit the ability of other companies to develop similar treatments, thereby reducing competition. However, it also incentivizes further research and development by providing exclusive rights to the patent holder[3].
Licensing and Litigation
The breadth and clarity of the patent claims can influence licensing and litigation costs. Patents with narrower, clearer claims tend to have a higher probability of grant and shorter examination processes, which can reduce the costs associated with litigation and licensing negotiations[3].
Expert Insights and Statistics
Patent Quality and Scope
Experts in the field have highlighted the importance of patent scope and claim clarity. For instance, a study by the Hoover Institution noted that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. This suggests that the patent in question, with its detailed and specific claims, likely underwent a rigorous examination process[3].
Market Impact
The protection afforded by this patent has significant market implications. MAVYRET, protected by this patent, has been a major player in the HCV treatment market. According to industry reports, the exclusivity provided by this patent has allowed AbbVie to maintain a strong market position in the treatment of HCV[5].
Examples and Illustrations
Chemical Structures
The patent includes detailed descriptions of the chemical structures of the protected compounds. For example, the claims describe compounds with specific heterocyclic groups and substituents that are crucial for their anti-viral activity. These descriptions are accompanied by structural formulas that illustrate the exact composition of the compounds[4].
Synthesis Processes
The patent also provides examples of synthesis processes. For instance, it describes coupling reactions and other chemical processes necessary for the production of the active ingredients. These processes are critical for ensuring the efficacy and safety of the final drug product[4].
Citations and References
The patent cites numerous prior art documents, including earlier patents and scientific literature. These references are essential for understanding the context and novelty of the invention. For example, the patent references earlier work by Witkowski et al. and Meyer et al., which laid the groundwork for the development of these anti-viral compounds[1].
Key Takeaways
- Patent Protection: U.S. Patent 8,937,150 provides comprehensive protection for anti-viral compounds used in the treatment of HCV, specifically those in the drug MAVYRET.
- Chemical Compounds: The patent details specific chemical structures and substituents that are essential for the anti-viral activity of the compounds.
- Processes of Manufacture: The patent claims processes for synthesizing these compounds, including coupling reactions and biosynthetic processes.
- Regulatory Extensions: The patent term has been extended due to regulatory review periods, ensuring continued exclusivity for AbbVie.
- Market Impact: The patent has significant implications for the pharmaceutical industry, influencing innovation, competition, and market positioning.
FAQs
What is the main subject of U.S. Patent 8,937,150?
The main subject of U.S. Patent 8,937,150 is the protection of anti-viral compounds effective in inhibiting the replication of Hepatitis C virus (HCV).
Which drug is protected by this patent?
The patent protects the drug MAVYRET, which is a combination of glecaprevir and pibrentasvir.
Why was the patent term extended?
The patent term was extended under 35 U.S.C. § 156 due to the regulatory review period for MAVYRET.
What are the key chemical structures protected by this patent?
The patent protects compounds with specific heterocyclic groups and various substituents such as alkyl, halogen, cyano, nitro, and oxo groups.
How does this patent impact the pharmaceutical industry?
The patent impacts the industry by providing exclusivity to AbbVie, influencing innovation and competition, and affecting licensing and litigation costs.
Cited Sources:
- United States Patent and Trademark Office, "US11116783B2 - Combination formulation of two antiviral compounds," September 14, 2021.
- U.S. Food & Drug Administration, "Re: MAVYRET Patent Nos. 8,937,150 and 9,586,978," August 20, 2020.
- Hoover Institution, "Patent Claims and Patent Scope," August 2016.
- Google Patents, "US8937150B2 - Anti-viral compounds," September 23, 2014.
- Drug Patent Watch, "Patent 8,937,150," Accessed December 22, 2024.
