United States Patent 11,433,056: A Detailed Analysis of Scope, Claims, and Patent Landscape
Overview of the Patent
United States Patent 11,433,056, titled "Methods of treating gastrointestinal stromal tumors," is a significant patent in the pharmaceutical sector, particularly in the treatment of gastrointestinal stromal tumors (GISTs). Here is a detailed analysis of its scope, claims, and the broader patent landscape.
Patent Assignee and Inventors
The patent is assigned to Deciphera Pharmaceuticals, LLC, with inventors Rodrigo Ruiz Soto, Oliver Rosen, and Jama Pitman, all affiliated with Deciphera Pharmaceuticals in Waltham, MA[1].
Patent Abstract and Summary
The patent abstract describes methods for treating gastrointestinal stromal tumors by administering a therapeutically effective amount of ripretinib or a pharmaceutically acceptable salt thereof to a subject in need. This treatment is specifically aimed at patients suffering from grade 2 or grade 3 myalgia while being administered ripretinib daily[1].
Claims
The patent includes multiple claims that define the scope of the invention. These claims are categorized into use claims, which specify the method of treatment using ripretinib. The claims are detailed and ensure that the patent covers the specific therapeutic application of ripretinib for GISTs, including the management of side effects such as myalgia[1].
Patent Family and International Protection
Patent 11,433,056 has a substantial international presence, with twenty-one patent family members in twelve countries. This extensive coverage ensures that Deciphera Pharmaceuticals has broad protection for their invention globally[1].
Product and Generic Name
The patented product is marketed under the tradename QINLOCK, with the generic name ripretinib. QINLOCK was approved by the FDA on May 15, 2020, for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib[1].
Dosage and Administration
The patent specifies the dosage form as an oral tablet, highlighting the convenience and efficacy of this treatment method. The administration protocol, including the management of side effects, is a critical aspect of the patent claims[1].
Patent Expiration and Supplementary Protection
While the exact expiration date of the patent is not publicly disclosed without subscription, it is part of a larger strategy to extend patent protection through supplementary protection certificates (SPCs) in various countries. SPCs can extend the patent term beyond the standard 20 years from the filing date, providing additional market exclusivity[1].
Market Impact and Clinical Significance
The approval and patent protection of QINLOCK signify a significant advancement in the treatment of GISTs. Ripretinib's efficacy in managing side effects and its targeted mechanism of action make it a valuable option for patients who have exhausted other treatment options. This patent ensures that Deciphera Pharmaceuticals maintains a competitive edge in the market for GIST treatments[1].
Legal and Regulatory Framework
The patent is subject to the legal and regulatory framework governed by the United States Patent and Trademark Office (USPTO). The presumption of validity under 35 USC 282 ensures that each claim of the patent is presumed valid unless proven otherwise by clear and convincing evidence[5].
Patent Scope Metrics
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. In the case of Patent 11,433,056, the claims are specific and focused on the therapeutic application of ripretinib, indicating a well-defined scope[3].
Public Search and Access
The details of this patent, along with other patent information, can be accessed through the USPTO's Patent Public Search tool, Global Dossier, and other resources such as the Patent and Trademark Resource Centers (PTRCs) and the Public Search Facility in Alexandria, VA[4].
Global Patent Landscape
The global patent landscape for GIST treatments is competitive, with multiple pharmaceutical companies developing targeted therapies. The extensive international protection of Patent 11,433,056 positions Deciphera Pharmaceuticals favorably in this landscape, ensuring market exclusivity and protecting their investment in research and development[1].
Stakeholder Impact
The patent has significant implications for various stakeholders, including patients, healthcare providers, and competitors. Patients benefit from the availability of an effective treatment option, while healthcare providers can offer a new therapeutic choice. Competitors must navigate around the protected claims to develop alternative treatments[1].
Future Developments and Challenges
As the patent landscape evolves, Deciphera Pharmaceuticals will need to monitor and adapt to changes in regulatory requirements, competitor activity, and emerging technologies. The company may also explore additional indications for ripretinib or develop new compounds to maintain its market position.
"Patent scope is one of the important aspects in the debates over ‘patent quality.’ The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or ‘overly broad’ patents), decreased clarity, and questionable validity."
- SSRN Paper on Patent Claims and Patent Scope[3]
Key Takeaways
- Patent Scope: The patent covers specific methods of treating GISTs using ripretinib, with a focus on managing side effects.
- International Protection: Extensive global protection with twenty-one patent family members in twelve countries.
- Product and Approval: QINLOCK (ripretinib) was approved by the FDA on May 15, 2020.
- Dosage and Administration: Oral tablet form with specific administration protocols.
- Market Impact: Significant advancement in GIST treatment, providing a competitive edge for Deciphera Pharmaceuticals.
- Legal Framework: Subject to USPTO regulations, with a presumption of validity under 35 USC 282.
FAQs
What is the primary focus of United States Patent 11,433,056?
The primary focus of this patent is on methods for treating gastrointestinal stromal tumors (GISTs) using the drug ripretinib.
Who is the assignee of this patent?
The patent is assigned to Deciphera Pharmaceuticals, LLC.
What is the tradename of the patented product?
The tradename of the patented product is QINLOCK, with the generic name ripretinib.
When was QINLOCK approved by the FDA?
QINLOCK was approved by the FDA on May 15, 2020.
How does the patent protect Deciphera Pharmaceuticals globally?
The patent has twenty-one patent family members in twelve countries, ensuring broad international protection.
Sources
- Drug Patent Watch: Summary for Patent: 11,433,056.
- ACUS: U.S. Patent Small Claims Court.
- SSRN: Patent Claims and Patent Scope.
- USPTO: Search for patents.
- US Code: 35 USC 282: Presumption of validity; defenses.
