United States Patent 10,058,536: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,058,536, assigned to Astellas Pharma Inc., is a crucial patent in the pharmaceutical industry, particularly for the drug Myrbetriq, which is used to treat overactive bladder. This patent protects a specific pharmaceutical composition containing mirabegron, a key active ingredient in Myrbetriq.
Patent Overview
Issuance and Assignee
The patent was issued on August 28, 2018, to Astellas Pharma Inc. The inventors listed include Takae Seiji, Sakai Toshiro, Kasashima Yuki, Ansei Yurina, and Kiyota Tsuyoshi[4].
Patent Claims
The patent claims cover several aspects of the pharmaceutical composition:
- A modified release liquid (suspension) containing mirabegron.
- A ready-to-suspend pharmaceutical composition containing mirabegron.
- A mirabegron-containing pharmaceutical composition that does not generate undissolved lumps when suspended at the time of use.
- The composition includes a complex of mirabegron or a pharmaceutically acceptable salt thereof with sodium polystyrene sulfonate[4].
Scope of the Patent
Technical Details
The patent describes a pharmaceutical composition designed to improve the delivery of mirabegron. The composition ensures that the drug is released in a controlled manner, addressing issues such as the formation of undissolved lumps when the drug is suspended. This is achieved through the use of specific additives and a hydrogel-forming polymer, which enhance the solubility and stability of the drug[4].
Innovations and Advantages
The innovations covered by this patent are significant because they address critical formulation challenges. The use of sodium polystyrene sulfonate and other specified components ensures that the mirabegron is delivered consistently, regardless of the patient's dietary state. This consistency is crucial for maintaining the drug's efficacy and reducing side effects.
Patent Landscape
Related Patents
Myrbetriq is protected by a series of patents, each covering different aspects of the drug and its formulations. Here are some key related patents:
- U.S. Patent 10,842,780: This patent, also owned by Astellas Pharma, covers a pharmaceutical composition for modified release, specifically addressing the issue of food effect on the drug's effectiveness[1][4].
- Other Patents: There are several other patents related to Myrbetriq, including those that have expired and those that are still active. For example, patents like US7342117 and US6346532 have expired, while others like US10058536 and US10842780 remain active[2][4].
Patent Expiration Dates
The patent in question, US10,058,536, has two expiration dates based on different claims:
- March 31, 2036: For certain claims related to the pharmaceutical composition.
- September 30, 2036: For other claims, including those related to pediatric formulations[2][4].
Litigation and Challenges
The patents protecting Myrbetriq have been subject to various legal challenges. Companies like Sandoz and Lupin have sought to produce generic versions of Myrbetriq by challenging the validity of Astellas Pharma's patents. However, the Federal Circuit has upheld the validity of these patents, particularly the '780 patent, which is crucial for the extended-release formulation of Myrbetriq[1].
Impact on Generic Launches
Delayed Generic Entry
The upholding of these patents by the Federal Circuit has significant implications for the pharmaceutical industry. It delays the entry of generic versions of Myrbetriq into the market, as generic manufacturers cannot launch their products until the patents expire or are invalidated. The estimated generic launch date for Myrbetriq is September 30, 2036, based on the current patent landscape[2].
Industry Implications
The ruling in favor of Astellas Pharma reinforces the importance of patent protection in the pharmaceutical industry. It highlights the ongoing debates over patent eligibility, particularly for complex drug formulations. Courts must balance the need to incentivize innovation with concerns about overly broad patent claims that might stifle competition[1].
Patent Quality and Scope
Metrics for Patent Scope
The scope of a patent, such as US10,058,536, can be measured using various metrics, including independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of patent claims, which are critical for determining patent quality. Narrower claims tend to have a higher probability of grant and a shorter examination process compared to broader claims[3].
Clarity and Validity
The clarity and validity of patent claims are essential for maintaining the integrity of the patent system. The Federal Circuit's decision to uphold the '780 patent emphasizes the importance of adhering to established legal grounds and the presumption of validity for all grounds of validity, including those under 35 U.S.C. ยง 101[1].
Conclusion
The United States Patent 10,058,536 is a pivotal patent in the pharmaceutical industry, protecting a critical formulation of mirabegron used in Myrbetriq. The patent's scope and claims are designed to ensure the consistent delivery of the drug, addressing key formulation challenges. The patent landscape, including related patents and litigation, highlights the complex and often contentious nature of patent protection in the pharmaceutical sector.
Key Takeaways
- Patent Protection: The patent protects a modified release pharmaceutical composition containing mirabegron.
- Expiration Dates: The patent expires on March 31, 2036, and September 30, 2036, for different claims.
- Litigation: The patent has been subject to legal challenges, but the Federal Circuit has upheld its validity.
- Industry Impact: The ruling delays the entry of generic versions of Myrbetriq into the market.
- Patent Quality: The patent's scope and clarity are critical for determining its validity and impact on innovation.
FAQs
Q: What is the main subject of United States Patent 10,058,536?
A: The patent covers a pharmaceutical composition containing mirabegron, specifically designed for modified release to treat overactive bladder.
Q: Who is the assignee of this patent?
A: The assignee is Astellas Pharma Inc.
Q: What are the expiration dates for this patent?
A: The patent expires on March 31, 2036, and September 30, 2036, for different claims.
Q: How does this patent impact generic drug launches?
A: The patent's validity delays the entry of generic versions of Myrbetriq into the market until the patent expires.
Q: What are some of the key challenges faced by this patent?
A: The patent has faced legal challenges from companies seeking to produce generic versions of Myrbetriq, but the Federal Circuit has upheld its validity.
Sources
- Federal Circuit upholds Myrbetriq patent, hinders generic launches - Asia IP Law
- Myrbetriq Granules patent expiration - Pharsight - GreyB
- Patent Claims and Patent Scope - Hoover Institution
- Generic Myrbetriq Availability - Drugs.com
- Pharmaceutical composition for modified release - PubChem
