Details for Patent: 8,128,960

Which drugs does patent 8,128,960 protect, and when does it expire?

Patent 8,128,960 protects TRIESENCE and is included in one NDA.

This patent has twenty-five patent family members in twenty-one countries.

Summary for Patent: 8,128,960

Title:	Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection
Abstract:	Triamcinolone acetonide suspension compositions are disclosed. The suspension compositions have a relatively low viscosity and are easy to extrude through a 27- or 30-gauge needle but are highly flocculated and easily redispersed. The compositions are particularly suitable for intravitreal injection.
Inventor(s):	Kabra; Bhagwati P. (Euless, TX), Sarkar; Ruma (Fort Worth, TX)
Assignee:	Alcon Research, Ltd. (Fort Worth, TX)
Application Number:	12/401,168
Patent Claim Types: see list of patent claims	Composition; Compound; Formulation;

Analyzing the Scope and Claims of United States Patent 8,128,960

Introduction

United States Patent 8,128,960, titled "Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection," is a significant patent in the field of ophthalmology. This patent, granted to inventors for their innovative formulation, is crucial for understanding the patent landscape in pharmaceuticals, particularly in eye treatments.

Patent Overview

Patent Number and Title

• The patent number is US8128960B2, and the title is "Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection"[4].

Inventors and Assignees

• While the specific inventors and assignees are not detailed here, it is common for such patents to be assigned to pharmaceutical companies or research institutions.

Publication and Priority Dates

• The patent was published on March 6, 2012, with a priority date that reflects the initial filing of the patent application.

Claims Analysis

Independent and Dependent Claims

• The patent includes both independent and dependent claims. Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations.
  • For example, Claim 1 might describe the general composition of the triamcinolone acetonide suspension, while dependent claims might specify particular concentrations, particle sizes, or methods of preparation[4].

Claim Scope and Limitations

• The claims in this patent are designed to protect the specific formulation and method of preparing low viscosity, highly flocculated triamcinolone acetonide suspensions. This includes the composition, the process of flocculation, and the characteristics of the final product.
  • The scope of these claims is critical in determining what constitutes infringement and what variations are allowed without infringing the patent.

Patent Landscape

Prior Art and Novelty

• The patent examiner would have reviewed prior art to ensure the invention was novel and nonobvious. This involves comparing the claimed invention against existing patents, publications, and other known technologies in the field.
  • The prior art keywords listed in the patent, such as "sediment," "suspension composition," and "chloride," indicate the areas where the examiner looked for similar inventions[4].

Competitors and Related Patents

• The patent landscape in ophthalmic pharmaceuticals is highly competitive, with numerous patents covering various aspects of eye treatments.
  • Companies like Allergan, Novartis, and Pfizer have significant portfolios in this area, and understanding their patents is crucial for navigating the landscape.

Technical Details

Composition and Preparation

• The patent describes a specific formulation of triamcinolone acetonide, which is a corticosteroid used for treating various eye conditions.
  • The formulation involves creating a low viscosity suspension with highly flocculated particles, which is critical for intravitreal injections.
  • The technical details include the concentration of triamcinolone acetonide, the type of suspending agents used, and the method of flocculation[4].

Clinical Significance

• The invention is significant because it provides a formulation that is easier to administer and potentially more effective due to its low viscosity and high flocculation characteristics.
  • This can improve patient outcomes by reducing the risk of complications associated with higher viscosity suspensions.

Economic and Commercial Impact

Costs and Commercialization

• The cost of developing and maintaining a patent like this can be substantial. According to the University of Kansas, drafting and filing a non-provisional patent application can cost between $8,000 and $20,000, with additional costs incurred during patent prosecution and maintenance[5].
  • Commercial partners often play a crucial role in covering these costs, especially if there is a high likelihood of recovering these expenses through future commercialization.

Market Competition

• The commercial impact of this patent is significant, as it can provide a competitive edge in the market for ophthalmic treatments.
  • Companies holding such patents can leverage them to secure market share and negotiate better terms with partners and competitors.

Legal and Regulatory Aspects

Patent Prosecution and Examination

• The patent prosecution process involves a detailed examination by the USPTO to ensure the invention meets the criteria of novelty, nonobviousness, and utility.
  • If the patent examiner does not accept the initial claims, the applicant must present arguments and amended claims to overcome any objections[5].

Appeals and Litigation

• If the patent examiner issues a final rejection, the applicant can appeal to the Patent Trial and Appeal Board (PTAB) or the U.S. court system.
  • Successful appeals can lead to claim allowance and the granting of the patent, while unsuccessful appeals may result in the abandonment of the patent application[5].

International Considerations

Global Patent Protection

• Patent protection is not limited to the United States; inventors often seek protection in multiple jurisdictions.
  • The process for international patent protection involves filing under the Patent Cooperation Treaty (PCT) or directly in individual countries, which can significantly increase the costs and complexity of patenting[1][5].

Future Developments and Trends

Advancements in Ophthalmic Treatments

• The field of ophthalmology is rapidly evolving, with new technologies and formulations being developed continuously.
  • Future developments may include improved delivery systems, new active ingredients, or enhanced formulations that build upon the innovations protected by this patent.

Impact of Emerging Technologies

• Emerging technologies such as gene therapy, stem cell therapy, and advanced biomaterials may also influence the patent landscape in ophthalmology.
  • These technologies could lead to new patent filings and potentially challenge existing patents, including US8128960B2.

Key Takeaways

• Patent Scope: The patent protects a specific formulation of triamcinolone acetonide suspension for intravitreal injection.
• Claims Analysis: Independent and dependent claims define the scope of the invention, including composition, preparation, and characteristics.
• Patent Landscape: The patent is part of a competitive landscape in ophthalmic pharmaceuticals, with numerous related patents and competitors.
• Technical Details: The formulation involves low viscosity and high flocculation, which is clinically significant for patient outcomes.
• Economic Impact: The patent has substantial commercial value, with significant costs associated with development and maintenance.
• Legal and Regulatory: The patent underwent rigorous examination and could be subject to appeals and litigation.

FAQs

Q: What is the main invention protected by US Patent 8,128,960?

• The main invention is a low viscosity, highly flocculated triamcinolone acetonide suspension for intravitreal injection.

Q: How does the patent prosecution process work for this type of patent?

• The process involves filing a patent application, examination by the USPTO, potential amendments and arguments, and possible appeals if the application is rejected.

Q: What are the costs associated with filing and maintaining a patent like US8128960B2?

• The costs can range from $8,000 to $20,000 for drafting and filing, with additional costs during prosecution and maintenance, potentially totaling over $30,000.

Q: How does this patent impact the market for ophthalmic treatments?

• The patent provides a competitive edge in the market, allowing the holder to secure market share and negotiate better terms with partners and competitors.

Q: Can this patent be protected internationally?

• Yes, the patent can be protected internationally through the Patent Cooperation Treaty (PCT) or direct filings in individual countries.

Sources

1. Clemson University Libraries - Research and Course Guides: Patent Searching, Advanced[1].
2. USA.gov - U.S. Patent and Trademark Office (USPTO)[2].
3. USPTO - Patent Claims Research Dataset[3].
4. Google Patents - US8128960B2 - Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection[4].
5. University of Kansas - Intellectual Property Protection[5].

Drugs Protected by US Patent 8,128,960

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Harrow Eye	TRIESENCE	triamcinolone acetonide	INJECTABLE;INTRAVITREAL	022048-001	Nov 29, 2007		RX	Yes	Yes	8,128,960		Y

International Family Members for US Patent 8,128,960

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	070824
Australia	2009223649
Brazil	PI0909630