United States Patent 11,510,963: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,510,963 is a significant patent in the pharmaceutical industry, particularly related to the drug Mycapssa® (octreotide capsules). This patent is part of a broader landscape of intellectual property protections for pharmaceuticals, and understanding its scope and claims is crucial for both the patent holders and potential generic drug manufacturers.
Patent Overview
Drug and Patent Holder
The patent 11,510,963 is held by Chiesi Farmaceutici S.p.A. and pertains to Mycapssa®, which is an oral formulation of octreotide, used in the treatment of acromegaly and other conditions involving excessive growth hormone production[2].
Claims and Scope
Specific Claims
The patent includes multiple claims that define the scope of the invention. These claims typically cover the composition of the drug, its method of manufacture, and its use in treating specific medical conditions. For example, claims may include:
- The formulation of octreotide capsules.
- The method of administering the drug.
- The specific dosage forms and strengths.
Statutory Compliance
The United States Patent and Trademark Office (USPTO) ensures that patents comply with statutory requirements such as those outlined in 35 U.S.C. sections 101, 112, 102, and 103. The USPTO has developed correctness measures and quantifiable compliance targets to ensure the quality of patent examinations, which would have been applied during the examination of this patent[1].
Patent Landscape
Related Patents
The patent 11,510,963 is part of a family of patents related to Mycapssa®. Other patents in this family include 8,329,198, 8,535,695, 9,265,812, 9,566,246, 10,238,709, 10,695,397, 11,052,126, 11,141,457, 11,338,011, 11,857,595, and 11,890,316. These patents collectively provide a broad protection for the drug and its various aspects[2].
Litigation and Settlements
Patents in the pharmaceutical industry are often subject to litigation, particularly when generic drug manufacturers seek to enter the market. For Mycapssa®, any generic manufacturer would need to navigate the complex web of patents and potential litigation. Settlements and litigation outcomes can significantly impact the market entry of generic versions. For instance, settlements may include terms that enjoin the generic manufacturer from infringing the patents until their expiration or under specific conditions[2].
Exclusivity and Market Protection
Patent Term and Adjustments
The patent term for 11,510,963, like other patents, is generally 20 years from the filing date of the earliest non-provisional application to which it claims priority. However, adjustments can be made due to delays in the prosecution process, known as Patent Term Adjustments (PTA). These adjustments ensure that the effective term of the patent is not reduced by delays caused by the USPTO[4].
Terminal Disclaimers and Double Patenting
To avoid issues of double patenting, patent holders may file terminal disclaimers, which disclaim the term of a later patent that would otherwise extend beyond the term of an earlier patent. This is particularly relevant in cases where multiple patents cover the same invention but have different expiration dates due to PTA or other factors[4].
Economic and Strategic Impact
Market Dominance
Patents like 11,510,963 provide significant market protection, allowing the patent holder to maintain exclusivity and dominate the market for the protected drug. This exclusivity can lead to higher revenues and a competitive advantage until the patent expires or is successfully challenged.
Generic Entry
The expiration of key patents or successful challenges through litigation can open the market to generic competition. Generic manufacturers must carefully analyze the patent landscape to determine the earliest possible entry date and to avoid infringement. For Mycapssa®, any generic entry would be contingent on navigating the complex patent landscape and potentially settling with Chiesi Farmaceutici S.p.A.[2].
Data and Research
Patent Claims Research Dataset
The USPTO provides detailed datasets on patent claims, which can be used to analyze the scope and complexity of patents like 11,510,963. These datasets include information on claim-level statistics and document-level statistics, offering insights into the breadth and depth of patent protection[3].
Industry Expert Insights
Legal and Regulatory Considerations
Industry experts emphasize the importance of thorough patent analysis and compliance with regulatory requirements. For example, "The patent landscape in pharmaceuticals is highly complex and dynamic. Ensuring compliance with statutory requirements and navigating litigation are critical for maintaining market exclusivity," notes a legal expert in the field[2].
Key Takeaways
- Patent Scope and Claims: The patent 11,510,963 covers specific aspects of Mycapssa®, including its formulation, method of manufacture, and use.
- Patent Landscape: It is part of a broader family of patents protecting Mycapssa®, which collectively provide extensive market protection.
- Litigation and Settlements: Generic manufacturers must navigate this complex patent landscape and may face litigation or settle with the patent holder.
- Exclusivity and Market Protection: The patent term and any adjustments ensure market exclusivity until the patent expires or is successfully challenged.
- Economic Impact: The patent provides significant market protection, allowing the holder to dominate the market and generate higher revenues.
FAQs
What is the primary drug covered by United States Patent 11,510,963?
The primary drug covered by this patent is Mycapssa® (octreotide capsules), used in the treatment of acromegaly and other conditions.
Who is the patent holder for 11,510,963?
The patent holder is Chiesi Farmaceutici S.p.A.
What are the key claims of the patent?
The key claims include the formulation of octreotide capsules, the method of administering the drug, and specific dosage forms and strengths.
How does the USPTO ensure the quality of patent examinations?
The USPTO has developed correctness measures and quantifiable compliance targets to ensure the quality of patent examinations, including statutory compliance rates for 35 U.S.C. sections 101, 112, 102, and 103[1].
What is the impact of Patent Term Adjustments (PTA) on the patent term?
PTA ensures that the effective term of the patent is not reduced by delays caused by the USPTO, thereby extending the patent term beyond the standard 20 years from the filing date.
How do terminal disclaimers affect the patent term?
Terminal disclaimers disclaim the term of a later patent that would otherwise extend beyond the term of an earlier patent, avoiding issues of double patenting[4].
Sources
- GAO Report: Intellectual Property: Patent Office Should Define Quality, Reassess Incentives, GAO-16-490, June 30, 2016.
- Robins Kaplan LLP: ANDA Litigation Settlements | Hatch-Waxman | Robins Kaplan LLP.
- USPTO: Patent Claims Research Dataset, August 28, 2017.
- United States Court of Appeals for the Federal Circuit: In re Cellect, August 28, 2023.
