Details for Patent: 8,753,665

Which drugs does patent 8,753,665 protect, and when does it expire?

Patent 8,753,665 protects POSIMIR and is included in one NDA.

This patent has fifty-four patent family members in twenty-nine countries.

Summary for Patent: 8,753,665

Title:	Controlled delivery system
Abstract:	The present invention relates to novel anesthetic compositions containing a non-polymeric carrier material and an anesthetic, where the compositions are suitable for providing a sustained local anesthesia without an initial burst and having a duration for about 24 hours or longer. Certain compositions are also provided that include a first anesthetic and a second anesthetic. In such compositions, the second anesthetic is a solvent for the first anesthetic and provides an initial anesthetic effect upon administration to a subject. The non-polymeric carrier may optionally be a high viscosity liquid carrier material such as a suitable sugar ester. The compositions can further include one or more additional ingredients including active and inactive materials. Methods of using the compositions of the invention to produce a sustained anesthetic effect at a site in a subject are also provided. Preferably the composition contains bupivacaine and a sugar ester such as saib.
Inventor(s):	Verity; A. Neil (Sunnyvale, CA)
Assignee:	Durect Corporation (Cupertino, CA)
Application Number:	11/663,125
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Dosage form;

Understanding the Scope and Claims of United States Patent 8,753,665

Introduction

United States Patent 8,753,665, titled "Controlled Delivery System," is a patent that revolves around novel anesthetic compositions and their delivery mechanisms. To delve into the specifics of this patent, it is crucial to analyze its scope, claims, and the broader patent landscape it operates within.

Patent Overview

Patent Number and Title

• The patent number is US8753665B2, and the title is "Controlled Delivery System."

Publication and Prior Art

• The patent was published on June 3, 2014, with a prior art date of October 27, 2006[4].

Scope of the Patent

Invention Description

• The patent describes a controlled delivery system for anesthetic compositions. This system involves non-polymeric carrier materials and anesthetics, designed to provide a controlled release of the anesthetic over a specified period. The composition is intended to improve the administration and efficacy of anesthetics, such as bupivacaine, by maintaining therapeutic levels for extended hours[4].

Technical Details

• The patent specifies the components of the anesthetic composition, including the non-polymeric carrier material and the anesthetic agent. It also details the method of administration and the benefits of the controlled delivery system, such as reduced side effects and improved patient comfort.

Claims of the Patent

Independent and Dependent Claims

• The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific details or limitations.
  • For example, an independent claim might describe the general composition of the anesthetic delivery system, while a dependent claim could specify the type of non-polymeric carrier material used or the method of preparing the composition[4].

Claim Structure

• The claims are structured to cover various aspects of the invention, including the composition itself, the method of preparation, and the method of use. This ensures comprehensive protection for the inventors by covering different potential infringements.

Patent Landscape

Technology Field

• This patent falls under the "Drugs and Medical Instruments" field, one of the six broad technology fields categorized by the USPTO. This field has seen significant activity and scrutiny, with a notable decrease in the allowance rate of patent applications over time[1].

Allowance Rate

• According to a study by Carley, Hegde, and Marco, the allowance rate for patent applications in the "Drugs and Medical Instruments" field has decreased substantially. Only about 55.8% of patent applications in this field are eventually granted without using continuation procedures[1].

Continuation Procedures

• The use of continuation procedures, such as Requests for Continued Examination (RCEs), is common in this field. These procedures allow applicants to continue the prosecution of their applications, which can be particularly relevant for complex medical inventions[1].

Economic and Legal Implications

Economic Impact

• Patents like US8753665B2 can have significant economic implications, particularly in the pharmaceutical and medical device industries. They can influence market competition, innovation, and the availability of new treatments.

Legal Considerations

• For any administrative claim of patent infringement related to this patent, the claim must be in writing and include specific details such as an allegation of infringement, a request for compensation, and a citation of the patent. The claim must also identify the alleged infringing item or process and provide detailed documentation[5].

Industry Expert Insights

• Industry experts often highlight the importance of robust patent protection in the medical field. For example, Alan Marco, former Chief Economist at the USPTO, has discussed the critical role of patent claims in defining the scope of protection and encouraging innovation[3].

Statistics and Trends

• The USPTO's Patent Claims Research Dataset provides insights into patent scope and claims trends. For instance, the dataset shows that patents in the medical field often have complex claim structures to ensure broad protection[3].

Key Takeaways

• Patent Scope: The patent covers a controlled delivery system for anesthetic compositions, including non-polymeric carrier materials and anesthetics.
• Claims Structure: The patent includes independent and dependent claims to ensure comprehensive protection.
• Patent Landscape: The patent falls within the "Drugs and Medical Instruments" field, which has seen a decrease in allowance rates.
• Economic and Legal Implications: The patent can significantly impact the pharmaceutical and medical device industries and requires detailed documentation for any infringement claims.

FAQs

1. What is the main invention described in US Patent 8,753,665?

   • The main invention is a controlled delivery system for anesthetic compositions using non-polymeric carrier materials.

2. Which technology field does this patent belong to?

   • This patent belongs to the "Drugs and Medical Instruments" field.

3. What is the significance of continuation procedures in patent applications?

   • Continuation procedures, such as RCEs, allow applicants to continue the prosecution of their applications, which is particularly relevant for complex medical inventions.

4. How do patent claims impact the scope of protection for an invention?

   • Patent claims define the scope of protection by specifying the exact features and limitations of the invention, ensuring that the inventors have comprehensive protection against infringement.

5. What are the requirements for filing an administrative claim for patent infringement?

   • The claim must be in writing, include an allegation of infringement, a request for compensation, and detailed documentation identifying the alleged infringing item or process.

Sources

1. Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203.
2. U.S. Patent and Trademark Office (USPTO). (n.d.). U.S. Patent and Trademark Office (USPTO). Retrieved from https://www.usa.gov/agencies/u-s-patent-and-trademark-office
3. USPTO. (2017). Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
4. Google Patents. (2014). US8753665B2 - Controlled delivery system. Retrieved from https://patents.google.com/patent/US8753665B2/en
5. Acquisition.gov. (n.d.). Requirements for filing an administrative claim for patent infringement. Retrieved from https://www.acquisition.gov/dfars/227.7004-requirements-filing-administrative-claim-patent-infringement

Drugs Protected by US Patent 8,753,665

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021		DISCN	Yes	No			Y			METHOD FOR PROVIDING SUSTAINED LOCAL ANESTHESIA FOR AT LEAST 24 HOURS

Foreign Priority and PCT Information for Patent: 8,753,665

PCT Information
PCT Filed	September 15, 2005	PCT Application Number:	PCT/US2005/032863
PCT Publication Date:	March 30, 2006	PCT Publication Number:	WO2006/033948

International Family Members for US Patent 8,753,665

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005287175
Austria	E537844
Brazil	PI0515372