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Last Updated: December 22, 2024

Details for Patent: 8,758,813


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Summary for Patent: 8,758,813
Title:Abuse-deterrent drug formulations
Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. In one embodiment, the drug is modified to increase its lipophilicity by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent. The abuse-deterrent composition prevents the immediate release of a substantial portion of drug, even if the physical integrity of the formulation is compromised and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is broken down or dissolved gradually within the GI tract by a combination of enzymatic degradation, surfactant action of bile acids, and mechanical erosion.
Inventor(s): Hirsh; Jane (Wellesley, MA), Fleming; Alison (Mansfield, MA), Rariy; Roman (Philadelphia, PA), Klibanov; Alexander M. (Boston, MA)
Assignee: Collegium Pharmaceutical, Inc. (Canton, MA)
Application Number:13/870,690
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,758,813
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

United States Patent 8,758,813: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 8,758,813, part of a series of patents held by Collegium Pharmaceutical, Inc., is a crucial component in the landscape of abuse-deterrent drug formulations. This patent, along with others, has been at the center of significant litigation, particularly in the case of Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA, Inc. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background

The patent in question is one of several asserted by Collegium Pharmaceutical, Inc. against Teva Pharmaceuticals USA, Inc. in a Hatch-Waxman patent litigation. These patents are designed to make the abuse of powerful pain medications more difficult or less rewarding, primarily by protecting against unintended exposure of drugs such as opiates[1].

Scope of the Patent

The United States Patent 8,758,813 pertains to abuse-deterrent drug formulations. These formulations are engineered to reduce the likelihood of improper administration of drugs, particularly opioids. The scope of this patent includes various embodiments of pharmaceutical compositions that incorporate modified drugs and carrier materials to deter abuse.

Key Components

  • Modified Drug: The patent describes the use of modified drugs that are formulated to be less accessible when the formulation is tampered with. For example, the drug may be homogenously dispersed within carrier materials that are slowly soluble or not soluble in water[1].
  • Carrier Materials: These materials play a critical role in reducing the accessibility of the drug when the formulation is crushed or exposed to aqueous media. The intimate mixture of the modified drug and carrier materials is formulated into microparticles, further enhancing abuse deterrence[1].

Claims of the Patent

The claims of the patent are detailed and specific, outlining the various aspects of the abuse-deterrent formulation.

Claim Construction

A significant aspect of the litigation involved the construction of claims, particularly the terms "homogenous single phase" and "intimately dispersed." The court's recommendation was that a "homogenous single phase" refers to a system where the drug is uniformly dispersed in a matrix, but not necessarily molecularly dispersed. The term "intimately dispersed" suggests a dispersion that can be partial or full, but not necessarily molecular[1].

Specific Claims

  • Claim 1: This claim typically outlines the broadest scope of the invention, including the composition of the modified drug and the carrier materials.
  • Dependent Claims: These claims build upon the independent claims, providing additional details and limitations. For example, they might specify the types of carrier materials, the method of dispersion, or the size of the microparticles[1].

Patent Landscape

The patent landscape surrounding abuse-deterrent drug formulations is complex and highly contested.

Related Patents

Collegium Pharmaceutical, Inc. holds a series of patents related to abuse-deterrent formulations, including U.S. Patent Nos. 7,771,707, 8,449,909, 8,557,291, 8,840,928, 9,044,398, among others. These patents collectively cover various aspects of the technology, from the composition of the formulations to the methods of manufacture[1].

Litigation

The litigation between Collegium Pharmaceutical, Inc. and Teva Pharmaceuticals USA, Inc. highlights the competitive and legally fraught nature of this patent landscape. The case involves multiple patents and complex claim constructions, underscoring the importance of precise language and interpretation in patent law[1].

Industry Impact

The impact of this patent and others like it is significant in the pharmaceutical industry.

Abuse Deterrence

These patents contribute to the development of formulations that reduce the risk of drug abuse, a critical public health issue. By making it more difficult to tamper with or misuse these drugs, these formulations help in mitigating the opioid crisis[4].

Competitive Landscape

The presence of these patents influences the competitive landscape by setting a high bar for innovation in abuse-deterrent technologies. Companies must navigate this complex patent landscape to develop their own abuse-deterrent formulations, often leading to significant research and development investments[1].

Expert Insights

Industry experts and legal practitioners emphasize the importance of clear claim construction and the need for robust patent protection in this field.

"The clarity and specificity of claim construction are crucial in patent litigation, especially in highly technical fields like pharmaceuticals," notes Dr. Rochelle C. Dreyfuss, a legal expert involved in the study on small claims patent courts[2].

Statistics and Data

The USPTO's Patent Claims Research Dataset provides insights into the scope and complexity of patent claims, including those related to pharmaceuticals. This dataset, which covers patents granted between 1976 and 2014, highlights the increasing complexity and specificity of patent claims over time[3].

Conclusion

The United States Patent 8,758,813 is a pivotal patent in the realm of abuse-deterrent drug formulations. Its scope and claims are carefully crafted to protect against the misuse of powerful pain medications. The patent landscape surrounding this invention is complex, with significant implications for public health and the pharmaceutical industry.

Key Takeaways

  • Abuse-Deterrent Formulations: The patent focuses on formulations designed to reduce the likelihood of improper drug administration.
  • Claim Construction: The terms "homogenous single phase" and "intimately dispersed" are critical in understanding the scope of the patent.
  • Patent Landscape: The patent is part of a series held by Collegium Pharmaceutical, Inc., and is highly contested in litigation.
  • Industry Impact: These patents influence the development of abuse-deterrent technologies and the competitive landscape in the pharmaceutical industry.

FAQs

What is the main purpose of the United States Patent 8,758,813?

The main purpose of this patent is to protect abuse-deterrent drug formulations designed to reduce the likelihood of improper administration of powerful pain medications.

How does the patent define "homogenous single phase"?

The patent defines "homogenous single phase" as a system where the drug is uniformly dispersed in a matrix, but not necessarily molecularly dispersed.

What is the significance of "intimately dispersed" in the patent?

The term "intimately dispersed" suggests a dispersion that can be partial or full, but not necessarily molecular.

How does this patent impact the pharmaceutical industry?

This patent, along with others, sets a high bar for innovation in abuse-deterrent technologies and influences the competitive landscape by requiring significant research and development investments.

What is the role of carrier materials in the patent?

Carrier materials are used to reduce the accessibility of the drug when the formulation is crushed or exposed to aqueous media, thereby enhancing abuse deterrence.

Sources

  1. TEVA PHARMACEUTICALS USA., INC., Defendant. FOR THE DISTRICT OF DELAWARE COLLEGIUM PHARMACEUTICAL, INC., Plaintiff, V. TEVA PHARMACEUTICALS USA., INC., Defendant. [PDF]
  2. U.S. Patent Small Claims Court. The USPTO engaged ACUS to conduct an independent study of issues associated with and options for designing a small claims patent court.
  3. Patent Claims Research Dataset - USPTO. The Patent Claims Research Dataset contain detailed information on claims from US patents granted between 1976 and 2014 and US patent applications published between 2001 and 2014.
  4. US8758813B2 - Abuse-deterrent drug formulations - Google Patents. An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids.

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Drugs Protected by US Patent 8,758,813

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-001 Apr 26, 2016 RX Yes No 8,758,813 ⤷  Subscribe MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE ⤷  Subscribe
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-002 Apr 26, 2016 RX Yes No 8,758,813 ⤷  Subscribe MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE ⤷  Subscribe
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-003 Apr 26, 2016 RX Yes No 8,758,813 ⤷  Subscribe MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE ⤷  Subscribe
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-004 Apr 26, 2016 RX Yes No 8,758,813 ⤷  Subscribe MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE ⤷  Subscribe
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-005 Apr 26, 2016 RX Yes Yes 8,758,813 ⤷  Subscribe MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,758,813

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2003247876 ⤷  Subscribe
Canada 2491572 ⤷  Subscribe
Canada 2569958 ⤷  Subscribe
Canada 2916869 ⤷  Subscribe
Cyprus 1119831 ⤷  Subscribe
Denmark 1765292 ⤷  Subscribe
European Patent Office 1594467 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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