United States Patent 9,629,852: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,629,852, issued on April 25, 2017, is a significant patent in the field of ophthalmic pharmaceuticals. This patent, assigned to SUN PHARMA ADVANCED RESEARCH COMPANY LTD., pertains to a pharmaceutical composition designed for ophthalmic use, specifically involving prostaglandin derivatives or salts.
Inventors and Assignees
The patent was invented by Khopade Ajay Jaysingh, Halder Arindam, and Bhowmick Subhas Balaram, and is assigned to SUN PHARMA ADVANCED RESEARCH COMPANY LTD., a leading pharmaceutical company[2].
Patent Scope
The patent scope is defined by the claims and the detailed description of the invention. Here, the patent covers a pharmaceutical composition suitable for ophthalmic use, which includes:
- Prostaglandin Derivatives or Salts: The composition is centered around one or more prostaglandin derivatives or salts, which are known for their therapeutic effects in ophthalmic treatments.
- Stabilizing Agents: The composition includes a stabilizing amount of polyethylene glycol hydroxystearate, which helps in maintaining the stability of the prostaglandin derivatives.
- Pharmaceutically Acceptable Vehicle: The composition also includes a pharmaceutically acceptable vehicle, which ensures the safe and effective delivery of the active ingredients to the eye[2][5].
Claims
The patent claims are crucial as they define the legal boundaries of the invention. Here are some key claims:
- Claim 1: This claim specifies the composition comprising one or more prostaglandin derivatives or salts, a stabilizing amount of polyethylene glycol hydroxystearate, and a pharmaceutically acceptable vehicle.
- Subsequent Claims: These claims further detail the specific components, their proportions, and the methods of preparation, ensuring that the composition meets the required standards for ophthalmic use[2].
Patent Expiration Date
The patent is set to expire on September 12, 2029. This expiration date is significant as it marks the end of the exclusive rights granted to the patent holder, after which the composition can be manufactured and marketed by other companies[2].
Related Patents
There are other related patents that cover similar compositions and methods. For example, Patent 9,539,262, also issued to SUN PHARMA ADVANCED RESEARCH COMPANY LTD., covers a similar ophthalmic composition with slightly different claims and expiration dates. These related patents collectively protect the intellectual property of the company in the ophthalmic pharmaceutical sector[2].
Patent Landscape
The patent landscape in the ophthalmic pharmaceutical sector is complex and highly competitive. Here are some key aspects:
- Competitive Environment: Companies like Allergan plc have also been active in this sector, with patents like those for RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%, which have been subject to various legal and strategic maneuvers to protect their intellectual property[4].
- Legal Strategies: The use of sovereign immunity by entities like the Saint Regis Mohawk Tribe to protect patents from inter partes review (IPR) challenges is an example of the innovative legal strategies employed in this landscape[4].
Impact on Generic Availability
The expiration of this patent and related ones will have a significant impact on the availability of generic versions of these ophthalmic compositions. Once the patent expires, other pharmaceutical companies can file Abbreviated New Drug Applications (ANDAs) to market generic versions, potentially reducing costs and increasing accessibility for patients[2].
Metrics for Patent Scope
The scope of this patent can be analyzed using metrics such as independent claim length and independent claim count. Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process, which could be relevant in understanding the strategic approach taken by the inventors and the patent office[3].
Economic and Social Implications
The economic implications of this patent include the potential for significant revenue generation for SUN PHARMA ADVANCED RESEARCH COMPANY LTD. during the patent term. Socially, the availability of these ophthalmic compositions can improve eye health outcomes, particularly for conditions treated by prostaglandin derivatives.
Key Takeaways
- Patent Scope and Claims: The patent covers a specific ophthalmic composition with prostaglandin derivatives or salts, stabilized by polyethylene glycol hydroxystearate.
- Expiration Date: The patent expires on September 12, 2029.
- Related Patents: Other patents by SUN PHARMA ADVANCED RESEARCH COMPANY LTD. protect similar compositions.
- Patent Landscape: The sector is competitive with various legal strategies to protect intellectual property.
- Generic Availability: Expiration will lead to the potential for generic versions.
FAQs
What is the main composition covered by United States Patent 9,629,852?
The main composition covered by this patent is a pharmaceutical composition suitable for ophthalmic use, comprising one or more prostaglandin derivatives or salts, a stabilizing amount of polyethylene glycol hydroxystearate, and a pharmaceutically acceptable vehicle.
Who are the inventors of this patent?
The inventors are Khopade Ajay Jaysingh, Halder Arindam, and Bhowmick Subhas Balaram.
What is the expiration date of this patent?
The patent is set to expire on September 12, 2029.
How does this patent impact the availability of generic ophthalmic compositions?
Once the patent expires, other companies can file ANDAs to market generic versions of the composition, potentially reducing costs and increasing accessibility.
What is the significance of the stabilizing agent in this composition?
The stabilizing agent, polyethylene glycol hydroxystearate, helps maintain the stability of the prostaglandin derivatives, ensuring the composition remains effective and safe for ophthalmic use.
How does the patent landscape in ophthalmic pharmaceuticals affect this patent?
The competitive and legally complex landscape means that companies must employ various strategies to protect their intellectual property, such as using sovereign immunity or engaging in patent litigations.
Cited Sources
- US9629852B2 - Ophthalmic composition comprising a prostaglandin - Google Patents
- Generic Xelpros Availability - Drugs.com
- Patent Claims and Patent Scope - SSRN
- Allergan and Saint Regis Mohawk Tribe Announce Agreements Regarding RESTASIS Patents - srmt-nsn.gov
- MX-2010004211-A - Unified Patents Portal
