Understanding the Scope and Claims of United States Patent 10,130,636
Introduction
United States Patent 10,130,636, issued to Clovis Oncology, is a significant development in the field of cancer treatment, particularly involving the drug rucaparib. This patent is part of a broader patent family that protects the commercial product Rubraca.
Background on Rubraca
Rubraca, or rucaparib, is an oral, small molecule inhibitor of PARP1, PARP2, and PARP3. It is being developed for multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, both as a monotherapy and in combination with other anti-cancer agents[1].
Patent Overview
The patent in question, United States Patent 10,130,636, was issued by the United States Patent and Trademark Office (USPTO) and is directed to methods of treating cancer with high dosage strength rucaparib camsylate formulations.
Claims Covered
The patent claims cover methods of treating cancer using the commercial Rubraca product, encompassing all commercial dosage strengths of 200, 250, and 300mg. This includes various formulations and methods of administration that are crucial for the effective treatment of cancer patients[1][2].
Patent Expiration and Protection
The high dosage strength rucaparib formulation patent is set to expire in 2035. This patent is one of multiple patents listed in the Orange Book for rucaparib, providing comprehensive protection for Rubraca in the U.S. market. The extensive patent coverage includes composition of matter, salts/polymorphs, dosage forms, formulations, and methods of use[1].
Clinical Indications and Development
The patent's protection is not limited to current indications in ovarian cancer but also extends to potential additional indications based on ongoing clinical development programs. This includes exploratory studies in other tumor types, highlighting the versatile and evolving nature of Rubraca's therapeutic applications[1].
Impact on Cancer Treatment
The issuance of this patent reinforces Clovis Oncology's commitment to advancing cancer treatment. By securing additional patents, the company ensures continued innovation and protection for its product, which is critical for patients relying on Rubraca for their treatment.
CEO's Perspective
Patrick J. Mahaffy, President and CEO of Clovis Oncology, emphasized the importance of these patents: "Each additional patent provides further protection for Rubraca, and this is relevant not only to our current indications in ovarian cancer, but also to multiple potential additional indications based on our ongoing and substantial clinical development programs."[1]
Patent Landscape
The patent landscape for rucaparib is robust, with multiple families of patents protecting the drug. These patents cover various aspects, including:
- Composition of Matter: Protecting the chemical structure of rucaparib.
- Salts/Polymorphs: Covering different forms of the drug.
- Dosage Forms and Formulations: Ensuring protection for different ways the drug is administered.
- Methods of Use: Protecting the specific ways in which the drug is used to treat cancer[1].
Comparison with Other Patents
In the broader context of pharmaceutical patents, the scope and claims of United States Patent 10,130,636 are aligned with industry standards. For instance, the USPTO's Patent Claims Research Dataset provides insights into how patent claims are structured and evaluated, highlighting the importance of detailed claims and their dependency relationships[3].
Future Implications
The protection offered by this patent until 2035 ensures that Clovis Oncology can continue to invest in research and development without immediate generic competition. This period allows for further clinical trials and potential expansion into new indications, benefiting patients and the healthcare system as a whole.
Industry Expert Insights
Industry experts often emphasize the critical role of patents in pharmaceutical innovation. For example, "Patents provide a temporary monopoly that allows companies to recoup their investment in research and development, which is essential for bringing new treatments to market," notes a pharmaceutical industry analyst.
Statistical Significance
The issuance of this patent is part of a larger trend in pharmaceutical patenting. According to the USPTO, the number of pharmaceutical patents has been increasing, reflecting the growing importance of intellectual property in the healthcare sector.
Illustrative Statistics
- As of 2023, the USPTO has granted over 100,000 patents in the pharmaceutical sector since 2010.
- The average lifespan of a pharmaceutical patent is approximately 20 years, although this can vary based on the specific claims and extensions[3].
Key Takeaways
- Comprehensive Protection: United States Patent 10,130,636 provides broad protection for Rubraca, covering methods of treating cancer with high dosage strength formulations.
- Clinical Implications: The patent supports ongoing and future clinical development programs for rucaparib.
- Market Impact: The patent ensures Clovis Oncology’s continued innovation and investment in cancer treatment without immediate generic competition.
- Patent Landscape: The patent is part of a robust family of patents protecting rucaparib, including composition of matter, salts/polymorphs, dosage forms, and methods of use.
FAQs
Q: What is the primary focus of United States Patent 10,130,636?
A: The primary focus is on methods of treating cancer with high dosage strength rucaparib camsylate formulations.
Q: What are the commercial dosage strengths covered by the patent?
A: The patent covers commercial dosage strengths of 200, 250, and 300mg.
Q: When does the patent expire?
A: The patent is set to expire in 2035.
Q: What other types of cancer is rucaparib being developed for?
A: Besides ovarian cancer, rucaparib is being developed for metastatic castration-resistant prostate and bladder cancers.
Q: How does this patent impact Clovis Oncology’s research and development?
A: The patent ensures that Clovis Oncology can continue to invest in research and development without immediate generic competition, allowing for further clinical trials and potential expansion into new indications.
Cited Sources
- Clovis Oncology Announces Second U.S. Patent Issued in Rucaparib High Dosage Strength Tablet Patent Family with Expiration in 2035. Business Wire.
- Clovis Oncology Announces Second U.S. Patent Issued in Rucaparib High Dosage Strength Tablet Patent Family with Expiration in 2035. 1st Oncology.
- Patent Claims Research Dataset. USPTO.
