United States Patent 9,527,845: A Comprehensive Analysis of Claims and Patent Landscape
Introduction
United States Patent 9,527,845, assigned to Novira Therapeutics, Inc., addresses a significant global health issue: the treatment of chronic hepatitis B virus (HBV) infection. This patent is part of a broader series of applications and continuations, making it crucial to understand its claims, the patent landscape, and its implications.
Background of HBV Infection
Chronic HBV infection affects over 5% of the world population, with more than 350 million people worldwide and 1.25 million individuals in the U.S. afflicted. Despite the availability of a prophylactic HBV vaccine, effective treatments for chronic infection remain a critical need[1].
Patent Overview
The patent, titled "Derivatives and methods of treating hepatitis B infections," was granted on December 30, 2015. It is a continuation of several earlier applications, including provisional applications filed in 2014 and 2015. The patent claims priority to these earlier applications, which is a common strategy in patent filing to secure earlier filing dates[1].
Claims and Inventions
The patent describes compounds and methods for treating HBV infections. The claims include:
- Compound Formulas: The patent details specific chemical compounds, such as those of Formula I and Formula II, designed to inhibit HBV replication.
- Pharmaceutical Compositions: These include formulations of the claimed compounds, either alone or in combination with other therapeutic agents.
- Methods of Treatment: The patent outlines methods for using these compounds to inhibit, suppress, or prevent HBV infection in subjects[1].
Patent Filing Process
The patent application process for this invention followed a typical path:
- Priority Applications: The initial applications were filed in the U.S., starting a 12-month clock for filing international and other national/regional applications.
- International PCT Application: An international Patent Cooperation Treaty (PCT) application was likely filed to extend the period for national/regional filings and to gain an opinion on patentability from the International Searching Authority (ISA)[3].
Patent Landscape
Global Filings
The patent is part of a broader global filing strategy. Similar applications have been filed in multiple jurisdictions, leveraging the PCT system to secure protection in over 150 countries. This approach allows the applicant to delay national/regional filings until after receiving an opinion on patentability from the ISA[3].
Pending and Granted Patents
The patent landscape includes pending applications in various countries and regional patent offices. For example, related applications have been filed in 34 countries and two regional patent offices, with additional filings planned via the PCT system[3].
Challenges and Amendments
Even if a patent is granted, it can be challenged, leading to amendments, revocation, or no change to its scope. The granted patent provides negative rights, allowing the owner to restrict others from making, using, or selling the invention, but it does not automatically grant the right to make, use, or sell if other patent rights are in place[3].
Assessment of Patentability
The ISA has assessed the patentability of similar claims in related applications. While some claims were deemed too broad for an inventive step, more narrowly defined claims were found to be inventive. This assessment is not binding but provides valuable insights for both the applicant and third parties[3].
Strategic Filing and Prosecution
To achieve speedy grants, applicants often limit claims to the scope deemed inventive by the ISA. For example, Pfizer has pre-emptively limited claims in associated European patent applications to align with positive ISA opinions. This strategy may also be applied here to secure broader protection through divisional applications[3].
Technological and Therapeutic Impact
The patented compounds and methods represent a significant advancement in the treatment of HBV infections. Engineered nucleases, such as those described in related patents, recognize and cleave specific sequences within the HBV genome, offering a targeted therapeutic approach[4].
Market and Regulatory Considerations
The patent's impact extends beyond the scientific community to regulatory and market realms. The ability to secure broad international protection can influence market strategies, licensing agreements, and the overall commercial viability of the treatment.
Conclusion and Future Directions
United States Patent 9,527,845 is a critical component in the fight against HBV infections, offering new therapeutic options. Understanding the claims, the patent landscape, and the strategic filings is essential for both the applicant and competitors in the pharmaceutical industry.
Key Takeaways
- Global Health Impact: The patent addresses a significant global health issue affecting millions.
- Complex Filing Strategy: The patent is part of a complex global filing strategy using PCT and national/regional applications.
- Inventive Claims: Narrowly defined claims have been deemed inventive by the ISA.
- Strategic Prosecution: Limiting claims to align with ISA opinions can facilitate speedy grants.
- Market and Regulatory Implications: Broad international protection can influence market strategies and licensing agreements.
Frequently Asked Questions (FAQs)
What is the main focus of United States Patent 9,527,845?
The main focus is on derivatives and methods for treating hepatitis B infections.
How does the patent filing process typically start?
The process typically starts with filing a priority application in the applicant’s home country, which begins a 12-month clock for filing international and other national/regional applications.
What is the role of the International Searching Authority (ISA) in patent applications?
The ISA assesses the patentability of the claimed invention, providing an opinion that is useful for both the applicant and third parties, although it is not binding on contracting states.
Why are narrowly defined claims often preferred in patent applications?
Narrowly defined claims are often preferred because they are more likely to be deemed inventive and thus granted, as opposed to broader claims that may be rejected for lack of an inventive step.
How does the patent landscape influence market strategies for pharmaceutical companies?
The patent landscape can significantly influence market strategies by determining the scope of protection, licensing agreements, and the overall commercial viability of a treatment, allowing companies to plan their market entry and competition strategies accordingly.
