Understanding the Scope and Claims of United States Patent 9,604,948
Introduction
United States Patent 9,604,948, issued on March 28, 2017, is a significant patent in the pharmaceutical industry, particularly related to the drug vericiguat. This patent is crucial for understanding the complexities of patent claims, scope, and the broader patent landscape in the pharmaceutical sector.
Patent Overview
Inventors and Assignments
The patent was invented by Peter Fey, Alfons Grunenberg, and Donald Bierer, who were under a valid employment agreement with Bayer Pharma Aktiengesellschaft. The rights to the patent were assigned to Bayer Intellectual Property GmbH and later to Adverio Pharma GmbH, with these assignments recorded in the U.S. Patent and Trademark Office (USPTO)[1].
Claims of the Patent
Active Ingredient and Pharmaceutical Compositions
The patent claims vericiguat, the active ingredient of a human drug product, and pharmaceutical compositions containing this active ingredient. This includes claims to the active ingredient per se, as well as compositions or formulations that contain vericiguat and are approved for commercial marketing or use[1].
Manufacturing and Use Methods
In addition to claiming the active ingredient and its compositions, the patent also includes claims to methods for manufacturing vericiguat and methods of using vericiguat. These claims are essential for protecting the intellectual property related to both the production and application of the drug[1].
Patent Scope and Protection
Extension of Patent Term
The patent term for U.S. Patent 9,604,948 is set to expire on November 26, 2032, but the applicant has sought an extension under 35 U.S.C. §156. This extension, if granted, would extend the patent term by 784 days, resulting in a new expiry date of January 19, 2035[1].
Coverage Under FDA Approval
The patent satisfies the requirements for a term extension because it claims the approved product, VERQUVO®, and methods related to its use and manufacture. This ensures that the patent protection aligns with the FDA-approved product and its manufacturing processes[1].
Challenges in Patent Claims and Scope
Genus Claims and Enablement
In the pharmaceutical and biotechnology industries, genus claims are common but face significant challenges. The Federal Circuit's rigid application of Section 112(a) of the U.S. patent laws has made it difficult for innovators to claim the full scope of their inventions. Genus claims must include a written description that enables any person skilled in the art to make and use the invention, which can be a fact-intensive inquiry[3].
Balancing Broad and Narrow Claims
Patent claims must strike a balance between being broad enough to protect the invention and narrow enough to avoid invalidation. Broad claims that attempt to capture more than what is described in the patent application can be invalidated, while narrow claims can be easily designed around by competitors. This balance is critical in the pharmaceutical industry, where billions of dollars are invested in bringing new drugs to market[3].
Metrics for Measuring Patent Scope
Independent Claim Length and Count
Research has identified simple metrics to measure patent scope, such as independent claim length (ICL) and independent claim count (ICC). These metrics help in understanding the breadth and clarity of patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[5].
Impact on Pharmaceutical and Biotechnology Industries
Market and Innovation
The pharmaceutical and biotechnology industries are heavily reliant on robust and predictable patent protection to support their commercialization strategies. The market for these therapeutics is expanding, with biologics such as antibodies becoming a dominant class of new drugs. However, the current jurisprudence on patent disclosure laws is causing significant challenges, making it difficult for innovators to secure meaningful patent protection[3].
Economic Implications
The inability to secure broad yet valid patent claims can lead to increased licensing and litigation costs, which can diminish incentives for innovation. This is particularly problematic in industries where billions of dollars are invested in developing new drugs and bringing them to market[3].
Example: VERQUVO®
Practical Application
VERQUVO®, the drug product covered by U.S. Patent 9,604,948, is a practical example of how patent claims and scope play out in real-world applications. The patent's claims to vericiguat and its methods of manufacture and use ensure that the intellectual property related to this drug is protected, which is crucial for its commercial success[1].
Key Takeaways
- Patent Claims: U.S. Patent 9,604,948 claims vericiguat, its pharmaceutical compositions, and methods for its manufacture and use.
- Patent Scope: The patent's scope is critical for protecting the intellectual property related to VERQUVO®, and it satisfies the requirements for a term extension under 35 U.S.C. §156.
- Challenges: The patent faces challenges related to genus claims and the need to balance broad and narrow claims to ensure validity and enforceability.
- Metrics: Metrics such as independent claim length and count are used to measure patent scope and help in understanding the breadth and clarity of claims.
- Industry Impact: The patent landscape significantly affects the pharmaceutical and biotechnology industries, influencing innovation and commercialization strategies.
FAQs
What is the main subject of U.S. Patent 9,604,948?
U.S. Patent 9,604,948 primarily covers vericiguat, the active ingredient of the human drug product VERQUVO®, along with its pharmaceutical compositions and methods for its manufacture and use.
Who are the inventors of U.S. Patent 9,604,948?
The inventors of U.S. Patent 9,604,948 are Peter Fey, Alfons Grunenberg, and Donald Bierer.
What is the current status of the patent term for U.S. Patent 9,604,948?
The patent term for U.S. Patent 9,604,948 is set to expire on November 26, 2032, but an extension has been sought to extend the term by 784 days, resulting in a new expiry date of January 19, 2035.
What challenges do genus claims face in the pharmaceutical industry?
Genus claims in the pharmaceutical industry face challenges due to the Federal Circuit's rigid application of Section 112(a), requiring a detailed written description that enables any person skilled in the art to make and use the invention.
How are patent scope and claim clarity measured?
Patent scope and claim clarity can be measured using metrics such as independent claim length (ICL) and independent claim count (ICC), which help in understanding the breadth and clarity of patent claims.
Sources
- Regulations.gov: Patent Number - Regulations.gov
- PubChem: Substituted 5-fluoro-1H-pyrazolopyridines and their use - PubChem
- DigitalCommons@NYLS: Eviscerating Patent Scope - DigitalCommons@NYLS
- Google Patents: US9604948B2 - Process for preparing substituted 5-fluoro-1H-pyrazolopyridines - Google Patents
- Hoover Institution: Patent Claims and Patent Scope - Hoover Institution
