Detailed Analysis of the Scope and Claims of United States Patent 7,973,031
Introduction
United States Patent 7,973,031, granted on July 5, 2011, is a significant patent in the pharmaceutical sector, particularly for the treatment of certain cancers. This patent is owned by Novartis and covers methods and compositions related to the drug midostaurin.
Patent Overview
The patent claims a method of using midostaurin, the active ingredient of a human drug product, and methods of using pharmaceutical compositions containing midostaurin. This drug is marketed under the brand name RYDAPT® and is used for the treatment of acute myeloid leukemia (AML) and other conditions such as mastocytosis[1][4].
Claims and Scope
The patent claims are broad and encompass several key aspects:
- Active Ingredient: The patent claims midostaurin per se, as well as compositions or formulations that contain midostaurin[1].
- Methods of Use: It includes methods of using midostaurin and pharmaceutical compositions containing midostaurin for therapeutic purposes[1].
- Regulatory Approval: The patent is eligible for extension under 35 U.S.C. § 156 because it satisfies the requirements for such extension, including the first received permission for commercial marketing or use under Section 505 of the Federal Food, Drug, and Cosmetic Act[1].
Patent Term and Extensions
The patent term of U.S. Patent 7,973,031 has been subject to adjustments and potential extensions. Here are the key points:
- Original Term: The patent term was set to expire on October 17, 2024, including 719 days of patent term adjustment (PTA) under 35 U.S.C. § 154(b)[1].
- Potential Extension: The patent could be eligible for an additional extension due to regulatory review periods. The applicants have claimed an extension of up to 1183 days, which would extend the patent term until January 13, 2028[1].
- Legal Challenges: The patent term adjustment has been subject to legal challenges, notably in the case of Novartis AG v. Lee, where Novartis contested the PTO's determinations on patent term adjustments[2].
Regulatory Review and Approval
The patent has undergone significant regulatory review:
- IND and NDA: The testing phase included the effective date of the Investigational New Drug (IND) application and the New Drug Application (NDA) review period. Detailed chronologies of these activities are provided in the patent term extension application[1].
- First Permission for Commercial Marketing: The permission for the commercial marketing or use of RYDAPT® was the first received under Section 505, making it eligible for patent term extension[1].
Litigation and Generic Challenges
The patent has been involved in several legal disputes, particularly regarding generic versions of RYDAPT®:
- ANDA Filings: Generic manufacturers, such as Teva, have filed Abbreviated New Drug Applications (ANDAs) with the FDA, seeking approval to manufacture and market generic versions of RYDAPT® before the patent's expiration. These filings have led to litigation, with Novartis asserting infringement under 35 U.S.C. § 271(e)(2)(A)[5].
- Patent Validity Challenges: Defendants in these cases have challenged the validity of the patents, including U.S. Patent 7,973,031, asserting that they are invalid or not infringed by the generic products[5].
Patent Landscape Analysis
To understand the broader patent landscape, several tools and strategies are employed:
- Claim Coverage Matrix: This involves categorizing patents by claims and scope concepts to identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
- Claim Charts: Interactive claim charts generated by software like ClaimScape® help in reviewing patent coverage with technical experts, identifying gaps in current coverage, and highlighting future design opportunities[3].
Impact on Pharmaceutical Industry
The patent's scope and claims have significant implications for the pharmaceutical industry:
- Market Exclusivity: The patent extensions and regulatory approvals provide Novartis with market exclusivity for RYDAPT®, preventing generic competition and maintaining a competitive edge[1][5].
- Research and Development: The protection afforded by this patent encourages continued research and development in targeted therapies, particularly in the treatment of AML and mastocytosis[4].
Key Takeaways
- Broad Claims: U.S. Patent 7,973,031 has broad claims covering midostaurin and its pharmaceutical compositions.
- Regulatory Extensions: The patent is eligible for term extensions due to regulatory review periods.
- Litigation: The patent has been involved in significant litigation regarding generic challenges.
- Market Impact: The patent provides Novartis with market exclusivity, influencing the competitive landscape in targeted cancer therapies.
FAQs
Q: What is the primary drug covered by U.S. Patent 7,973,031?
A: The primary drug covered is midostaurin, marketed under the brand name RYDAPT®.
Q: Why is U.S. Patent 7,973,031 eligible for patent term extension?
A: It is eligible due to the regulatory review period under 35 U.S.C. § 156, specifically the first received permission for commercial marketing or use under Section 505.
Q: What is the current status of the patent term for U.S. Patent 7,973,031?
A: The original term was set to expire on October 17, 2024, but it may be extended up to January 13, 2028, pending further adjustments.
Q: How does the patent impact generic competition?
A: The patent and its extensions prevent generic manufacturers from entering the market until the patent expires, maintaining Novartis's market exclusivity.
Q: What tools are used to analyze the patent landscape for U.S. Patent 7,973,031?
A: Tools such as Claim Coverage Matrix and Claim Charts are used to analyze the patent landscape and identify gaps or opportunities in patent coverage.
Cited Sources:
- U.S. Patent and Trademark Office. PAT032212-US-PCT IN THE UNITED STATES PATENT AND TRADEMARK OFFICE.
- Casetext. Novartis AG v. Lee, 740 F.3d 593.
- Schwegman, Lundberg & Woessner, P.A. Patent Analytics.
- DrugPatentWatch. Drugs covered by patent 7,973,031.
- RPX Insight. In the United States District Court.
