United States Patent 6,958,335: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,958,335, granted to Novartis, Dana-Farber Cancer Institute, and Oregon Health & Science University, is a pivotal patent in the pharmaceutical industry, particularly for the treatment of certain cancers. This patent, associated with the drug imatinib (marketed as Gleevec or Glivec), has a complex history and significant implications for patent law, pharmaceutical development, and public health.
Background of the Patent
Drug and Indications
The patent pertains to imatinib, a tyrosine kinase inhibitor used primarily for the treatment of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST)[4][5].
- Initial Approval: The FDA approved imatinib for CML on May 10, 2001, and later for GIST[4].
Patent Assignees
The patent is assigned to Novartis, Dana-Farber Cancer Institute, and Oregon Health & Science University, reflecting a collaborative effort in its development[4].
Scope of the Patent
Method-of-Use Claims
The patent includes method-of-use claims, which are crucial for defining how the drug is used to treat specific indications.
- Example Claim: The patent claims a method of treating gastrointestinal stromal tumors by administering an effective dose of imatinib to a human in need of such treatment[1][5].
Use Codes
Each method claim is associated with FDA use codes, which are listed in the Orange Book. These codes help in identifying the specific approved method of use claimed by the patent.
- Orange Book Listing: The FDA requires detailed descriptions of method-of-use patents, including use codes, to be listed in the Orange Book. This listing is critical for determining patent infringement and delaying generic competition[1].
Patent Claims and Structure
Claim Types
The patent includes various types of claims, such as:
- Drug Substance Patents: Patents claiming the active ingredient itself.
- Drug Product Patents: Patents claiming the formulation and composition of the drug.
- Method-of-Use Patents: Patents claiming how the drug is used to treat specific diseases[1].
Claim Coverage
The patent's claims are structured to provide broad protection for the use of imatinib in treating CML and GIST. This includes multiple method-of-use claims, each with its associated use code.
Patent Landscape and Strategic Implications
Patent Thicket Strategy
Pharmaceutical companies like Novartis often employ a "patent thicket" strategy to maintain market exclusivity. This involves filing multiple patents and associated use codes to create a complex web of intellectual property that deters generic competition.
- Amarin v. Hikma Example: Similar strategies have been observed in other cases, where companies file multi-layered patent claims and use codes to delay generic entry[1].
Impact on Generic Competition
The listing of these patents in the Orange Book can significantly delay generic competition. The FDA's process, which does not substantively review the accuracy of patent information, allows brand firms to maintain their market position for extended periods.
- Automatic Preliminary Injunction: Under the Hatch-Waxman Act, patent litigation can result in an automatic preliminary injunction, preventing generic drugs from entering the market for up to thirty months[1].
Disclosure of Federal Funding
Delayed Disclosure
The patent 6,958,335 was corrected in 2019 to disclose federal funding from the National Institutes of Health (NIH), more than 18 years after the original patent application. This disclosure is mandatory under the Bayh-Dole Act to ensure that inventions are available to the public on reasonable terms[4].
Implications of Non-Disclosure
The failure to disclose federal funding can have severe consequences, including the possibility of the federal government taking possession of the patent. However, in this case, the correction was made, avoiding such penalties[4].
Patent Analytics and Claim Coverage
Analyzing Patent Claims
To understand the full scope of protection provided by this patent, companies use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in the patent landscape.
- Claim Coverage Matrix: Tools like Schwegman’s ClaimScape® software generate interactive claim charts to review patent coverage and identify areas needing additional protection[3].
Public Health and Economic Impact
Pricing and Accessibility
The aggressive pricing policies of Novartis for Gleevec have been a subject of intense criticism. The patent has generated over $53 billion in sales, highlighting the economic significance of such pharmaceutical patents[4].
Balancing Innovation and Access
The Hatch-Waxman Act aims to balance innovation and access to pharmaceuticals. However, the strategic use of patents and use codes can sometimes tilt this balance in favor of brand firms, potentially limiting access to life-saving drugs[1].
Key Takeaways
- Method-of-Use Claims: The patent includes specific method-of-use claims associated with FDA use codes, crucial for delaying generic competition.
- Patent Thicket Strategy: The use of multiple patents and use codes creates a complex patent landscape that deters generic entry.
- Disclosure of Federal Funding: The delayed disclosure of NIH funding highlights the importance of compliance with the Bayh-Dole Act.
- Patent Analytics: Tools like ClaimScape® help in analyzing and managing the complex claims and scope concepts of pharmaceutical patents.
- Public Health Impact: The patent's economic and public health implications underscore the need for a balanced approach to innovation and access.
FAQs
What is the main indication for the drug covered by US Patent 6,958,335?
The main indications for the drug imatinib, covered by US Patent 6,958,335, are chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).
How does the FDA's Orange Book impact generic competition?
The FDA's Orange Book listing of patents and use codes can delay generic competition by allowing brand firms to assert patent infringement claims, potentially resulting in an automatic preliminary injunction for up to thirty months.
What is the significance of the delayed disclosure of NIH funding in the patent?
The delayed disclosure of NIH funding in the patent highlights the importance of compliance with the Bayh-Dole Act and the potential consequences of non-disclosure, including the federal government taking possession of the patent.
How do pharmaceutical companies use patent analytics to manage their patent portfolios?
Pharmaceutical companies use patent analytics tools to categorize patents by claims and scope concepts, helping them identify gaps or opportunities in their patent landscape and manage their intellectual property more effectively.
What are the economic implications of US Patent 6,958,335?
US Patent 6,958,335 has generated over $53 billion in sales, making it a highly economically significant patent. This underscores the importance of balancing innovation with public access to life-saving drugs.
Sources
- Pharmaceutical Patent Two-Step: The Adverse Advent of Amarin v Hikma Type Litigation. JIPEL, January 23, 2023.
- Patent Claims Research Dataset. USPTO, August 28, 2017.
- Patent Analytics. Schwegman, Lundberg & Woessner, P.A.
- Novartis, Dana Farber, Oregon Health & Science University Wait 18 Years to Disclose NIH Funding in Key Gleevec Patent. Petrie-Flom Center, Harvard Law School, October 11, 2019.
- US-6958335-B2 - Treatment of Gastrointestinal Stromal Tumors. Unified Patents Portal.
