United States Patent 9,539,262: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,539,262, titled "Ophthalmic composition comprising a prostaglandin," is a significant patent in the field of ophthalmic pharmaceuticals. This patent, owned by Sun Pharmaceutical Industries Ltd., protects a specific formulation of an ophthalmic composition that includes prostaglandin derivatives or salts. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Patent Title and Number
- Patent Title: Ophthalmic composition comprising a prostaglandin
- Patent Number: US9539262B2
Publication and Issue Dates
- Publication Date: April 25, 2017
- Issue Date: April 25, 2017[2].
Scope of the Patent
Invention Description
The patent describes an ophthalmic composition that includes one or more prostaglandin derivatives or salts. These compositions are designed for the treatment of ophthalmic conditions, such as elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The formulation may include various excipients, such as polyethylene glycol, hydroxystearate, and other stabilizers to enhance the stability and efficacy of the prostaglandin[1].
Key Components
- Prostaglandin Derivatives: The patent specifies various prostaglandin derivatives, including but not limited to, latanoprost and its analogs.
- Excipients: The composition may include polyethylene glycol, hydroxystearate, and other additives to improve the formulation's stability and patient compliance[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically outline the essential features of the ophthalmic composition, such as:
- The presence of one or more prostaglandin derivatives or salts.
- The specific excipients used in the formulation.
- The concentration and pH range of the composition[1].
Dependent Claims
Dependent claims further specify the invention by detailing particular aspects of the composition, such as the type of prostaglandin used, the concentration of excipients, and the method of administration.
Patent Landscape
Patent Expiration
The patent US9539262B2 is set to expire on October 15, 2028. This expiration date is crucial for generic manufacturers who may be planning to enter the market with their own versions of the drug[2][5].
Related Patents
There are other patents related to the same drug, Xelpros, which also protect different aspects of the formulation and administration. For example, US9629852, another patent for Xelpros, expires on September 12, 2029. Understanding the full scope of these related patents is essential for navigating the intellectual property landscape[2][5].
Litigation History
Xelpros has been subject to various legal proceedings, including patent litigations. One notable case was initiated on June 6, 2013, challenging the validity of patent US9629852. Such litigations can impact the exclusivity period and the potential for early generic entry[2].
Global Patent Protection
International Patents
The protection of Xelpros is not limited to the United States. The drug is protected by patents in multiple countries, which is crucial for strategizing market entry on a global scale. Understanding the broader patent landscape helps in identifying markets with weaker patent protection, which could be ideal entry points for generic versions[2].
Metrics for Measuring Patent Scope
Claim Length and Count
Research has shown that the scope of a patent can be measured using metrics such as independent claim length and count. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process. This is relevant as the examination process tends to narrow the scope of patent claims over time[3].
Impact on Innovation and Market Entry
Innovation Incentives
The breadth and clarity of patent claims can significantly impact innovation incentives. Overly broad or unclear claims can lead to increased licensing and litigation costs, potentially diminishing the incentives for innovation. The specificity and clarity of the claims in US9539262B2 are crucial in this context[3].
Generic Entry
The expiration of the patent in 2028 will open the door for generic versions of the drug. Companies like Apotex Inc and Eugia Pharma Specialities Ltd have already filed for generic versions of similar prostaglandin-based drugs, indicating a competitive market post-patent expiration[5].
Key Takeaways
- Patent Scope: The patent protects a specific ophthalmic composition containing prostaglandin derivatives or salts.
- Claims: Independent and dependent claims define the essential features of the composition.
- Expiration: The patent expires on October 15, 2028.
- Related Patents: Other patents protect different aspects of the drug, such as dosage and administration.
- Global Protection: The drug is protected by patents in multiple countries.
- Innovation and Market Entry: The patent's expiration will facilitate generic entry, potentially increasing market competition.
FAQs
Q: What is the main subject of United States Patent 9,539,262?
A: The main subject is an ophthalmic composition comprising one or more prostaglandin derivatives or salts.
Q: Who owns the patent US9539262B2?
A: The patent is owned by Sun Pharmaceutical Industries Ltd.
Q: When does the patent US9539262B2 expire?
A: The patent expires on October 15, 2028.
Q: What are the key components of the ophthalmic composition described in the patent?
A: The key components include prostaglandin derivatives or salts and excipients such as polyethylene glycol and hydroxystearate.
Q: How does the patent landscape impact generic entry?
A: The expiration of the patent and related patents will allow generic manufacturers to enter the market, increasing competition.
Sources
- US9539262B2 - Ophthalmic composition comprising a prostaglandin - Google Patents
- Xelpros patent expiration - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- Search for patents - USPTO
- Drug Patents containing Latanoprost - Pharsight
