Understanding the Scope and Claims of United States Patent 10,639,309
Introduction
The United States Patent 10,639,309 is one of the key patents associated with Xeljanz XR, a medication developed by Pfizer Inc. for treating various rheumatic conditions and ulcerative colitis. This patent is crucial in the patent landscape surrounding the drug tofacitinib, particularly in the context of generic drug approvals and patent litigation.
Patent Overview
Patent Number and Expiration Date
The United States Patent 10,639,309 is listed in the FDA's "Orange Book" and is scheduled to expire on March 14, 2034. This patent is specific to the 22 mg strength of Xeljanz XR (tofacitinib citrate extended-release tablets)[1][2][4].
Patent Assignee and Licensee
The patent is duly and legally assigned to Pfizer Inc., with C.P. Pharmaceuticals International C.V. acting as the exclusive licensee for certain patents related to Xeljanz XR, including this one[2].
Claims and Scope
Patent Claims
The patent claims are part of the broader intellectual property protection for Xeljanz XR. While the specific claims of the 10,639,309 patent are not detailed in the sources provided, it is part of a suite of patents that protect the formulation, manufacturing process, and other aspects of the drug.
Scope of Protection
The scope of this patent includes the protection of the 22 mg dosage strength of tofacitinib citrate extended-release tablets. This means that any generic version of Xeljanz XR in this dosage strength would need to navigate around or challenge this patent to gain FDA approval and market entry[1][2].
Patent Landscape and Litigation
Generic Drug Applications
Generic drug manufacturers, such as Zydus Pharmaceuticals and Ajanta, have filed Abbreviated New Drug Applications (ANDAs) with the FDA to market generic versions of Xeljanz XR. These applications often include paragraph IV certifications, which assert that the patents listed in the Orange Book are invalid, unenforceable, or will not be infringed by the generic product[1][2].
Litigation
Pfizer has initiated litigation against these generic manufacturers to protect its patent rights. For example, Pfizer sued Zydus Pharmaceuticals and Ajanta for infringement of various patents, including the RE41,783 patent, which is related to the same drug formulation but has a different expiration date. These lawsuits highlight the ongoing battles in the pharmaceutical industry to protect intellectual property and delay generic competition[1][2].
Impact on Generic Competition
Delaying Generic Entry
The presence of multiple patents, including the 10,639,309 patent, can significantly delay the entry of generic versions of Xeljanz XR into the market. Generic manufacturers must either wait for the patents to expire or successfully challenge them in court to gain approval for their products[1][2].
Economic and Health Implications
The extended patent protection period can have economic and health implications. It allows Pfizer to maintain market exclusivity and higher prices for Xeljanz XR, which can limit access to the medication for patients who may not be able to afford it. On the other hand, the protection incentivizes innovation and investment in pharmaceutical research and development[5].
Metrics for Measuring Patent Scope
Independent Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and count can be used to measure the breadth and clarity of patent claims. Narrower claims are often associated with a higher probability of grant and a shorter examination process, indicating better-defined and more enforceable patents[3].
Conclusion
The United States Patent 10,639,309 is a critical component of the intellectual property landscape surrounding Xeljanz XR. It protects the 22 mg dosage strength of the drug and plays a significant role in delaying generic competition. Understanding the scope and claims of this patent is essential for both pharmaceutical companies and generic manufacturers navigating the complex landscape of drug development and market entry.
Key Takeaways
- Patent Expiration: The patent 10,639,309 expires on March 14, 2034.
- Dosage Strength: It specifically protects the 22 mg strength of Xeljanz XR.
- Litigation: Pfizer has initiated lawsuits against generic manufacturers to protect this patent.
- Impact on Generics: The patent delays generic entry into the market, affecting drug prices and patient access.
- Patent Metrics: Independent claim length and count can measure patent scope and clarity.
FAQs
Q: What is the United States Patent 10,639,309 related to?
A: The United States Patent 10,639,309 is related to the 22 mg dosage strength of Xeljanz XR (tofacitinib citrate extended-release tablets), a medication developed by Pfizer Inc.
Q: When does the patent 10,639,309 expire?
A: The patent 10,639,309 is scheduled to expire on March 14, 2034.
Q: Why is this patent important for Pfizer?
A: This patent is crucial for Pfizer as it protects the intellectual property rights for Xeljanz XR, allowing the company to maintain market exclusivity and higher prices.
Q: How does this patent affect generic drug manufacturers?
A: The patent delays the entry of generic versions of Xeljanz XR into the market, as generic manufacturers must either wait for the patent to expire or successfully challenge it in court.
Q: What are the economic and health implications of this patent?
A: The extended patent protection period can limit access to the medication for patients due to higher prices, but it also incentivizes innovation and investment in pharmaceutical research and development.
Sources
- FDA Approval Letter for Tofacitinib Extended-Release Tablets - accessdata.fda.gov
- Pfizer Inc. v. Ajanta Pharmaceuticals - insight.rpxcorp.com
- Patent Claims and Patent Scope - Hoover Institution
- Tofacitinib - DrugBank Online
- Generic Xeljanz XR Availability - Drugs.com
