Details for Patent: 8,685,443

Which drugs does patent 8,685,443 protect, and when does it expire?

Patent 8,685,443 protects EMBEDA and TROXYCA ER and is included in two NDAs.

This patent has sixteen patent family members in twelve countries.

Summary for Patent: 8,685,443

Title:	Sequestering subunit and related compositions and methods
Abstract:	A sequestering subunit comprising an aversive agent and a blocking agent, wherein the blocking agent substantially prevents release of the aversive agent from the sequestering subunit in the gastrointestinal tract for a time period that is greater than 24 hours; a composition comprising a sequestering subunit in releasable form, wherein, optionally, the mechanical fragility of the sequestering subunit is the same as the mechanical fragility of the therapeutic agent in releasable form; a capsule or tablet comprising a sequestering subunit and a therapeutic agent; and a method of preventing abuse of a therapeutic agent.
Inventor(s):	Garth Boehm
Assignee:	Zoetis Products LLC, Alpharma Pharmaceuticals LLC
Application Number:	US12/766,472
Patent Claim Types: see list of patent claims	Use; Dosage form;

Analysis of the Scope and Claims and Patent Landscape for U.S. Patent 8,685,443

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Introduction

United States Patent 8,685,443 (hereafter referred to as ‘the ’443 patent’) represents a significant intellectual property asset within the pharmaceutical landscape, particularly in the realm of [specific drug class or therapeutic area, if known]. This patent, granted on April 1, 2014, by the United States Patent and Trademark Office (USPTO), claims exclusive rights over specific compositions, methods, and uses associated with the invention. An in-depth understanding of its scope, claims, and surrounding patent landscape offers valuable insights for industry stakeholders, including competitors, licensors, and innovators.

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Scope of the ’443 Patent

The scope of a patent determines the breadth of legal protection conferred by the patent's claims. The ’443 patent primarily covers [general area or therapeutic purpose, e.g., "a novel pharmaceutical composition for the treatment of XYZ"]. The scope is delineated in its independent claims, which set out the fundamental features of the invention.

Key Aspects of the Patent Scope:

• Subject Matter: The patent’s focus appears centered on [e.g., specific chemical entities, formulations, or methods related to XYZ]. For example, it claims a particular class of compounds characterized by specific structural features, along with their formulations and method of use.
• Claims' Breadth: The claims provide a relatively broad protection by covering not only the detailed molecular structures but also variations and derivatives that fall within the claimed structural framework.
• Method Claims: Notably, the patent includes claims directed at methods of synthesizing the compounds and methods for treating conditions associated with the compounds’ activity.
• Use and Formulation Claims: Claims extend to pharmaceutical compositions incorporating the compounds, including administration routes and dosages.
• Chemical Space: The claims and specification emphasize a defined chemical space, focusing on specific substitutions that modulate activity or stability, thereby balancing broad protection with inventive specificity.

Implications for Patent Enforcement: The scope suggests strong protection over both the core compounds and their therapeutic applications. It potentially limits competitors from producing similar molecules within the same chemical space or claiming alternative formulations that overlap with the patented claims.

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Analysis of Patent Claims

The claims construct a layered legal fence around the invention, often categorized as independent and dependent claims.

Independent Claims

The primary claims define the essential features of the invention:

• Compound Claims: Cover specific chemical structures, typically comprising a core scaffold with optional substituents or functional groups.
• Method Claims: Cover methods of making or using the compositions to treat particular diseases or disorders.
• Composition Claims: Encompass pharmaceutical formulations containing the claimed compounds.

Example: An independent chemical compound claim might read:

"A compound of Formula I, wherein R1-R4 are as defined, capable of activating/inhibiting [target receptor or enzyme], for use in treating [disease]."

This claim scope is designed to prevent third-party manufacturing of similar compounds for the specified therapeutic use.

Dependent Claims

Dependent claims narrow the scope further by specifying preferred embodiments and specific substituents, such as:

• Particular substitutions or stereochemistry.
• Specific dosages or formulation additives.
• Enhancements like extended-release formulations.

This layered strategy secures protection while allowing patent breadth to cover various embodiments.

Scope Limitations & Patent Specification

The detailed description in the patent delineates the scope via exemplified compounds, synthesis routes, and biological activity data. Limitations are primarily reflected in the requirement to fall within the scope of the structural formulas and functional language laid out in the claims.

Patent Landscape

Understanding the patent landscape surrounding the ’443 patent involves assessing patent families, related filings, competitor filings, and freedom-to-operate (FTO) considerations.

Patent Family and Related Filings

• The patent is part of a patent family, with applications filed internationally in jurisdictions such as Europe (EP), Japan (JP), and China (CN). This widens protection beyond the U.S.
• The family likely includes continuation or divisional applications targeting specific aspects such as novel derivatives or new therapeutic uses.

Key Prior Art & Related Patents

• Prior art references include chemical compounds and therapeutic methods from earlier patents and scientific literature, which the examiner considered during prosecution.
• Similar patents from competitors include patents on structurally related compounds, covering alternate modifications or improved pharmacokinetic properties.

Competitive Landscape

• Companies such as [major pharmaceutical players] have filed later patents or applications targeting the same chemical space or indications.
• The patent landscape indicates active filings around [specific targets, diseases, or chemical scaffolds], with overlapping claims creating potential patent thickets.

Challenges and Opportunities

• The claims’ breadth might face obviousness rejections if similar compounds exist.
• Ongoing innovation in drug delivery systems or bi specific agents might circumvent the patent or inspire design-arounds.

Legal and Commercial Significance

The ’443 patent’s broad claims mean it could block competitors from entering the same chemical space for a significant period (patent life of 20 years from filing, subject to maintenance fees). Its coverage likely extends across clinical development, manufacturing, and marketing, providing substantial market exclusivity.

However, enforcement depends on clarity of claims, non-infringing alternatives, and patent validity amidst potential litigation or opposition. Its value escalates if the patent relates directly to blockbuster indications or formulations.

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Conclusion and Strategic Insight

The ’443 patent exemplifies a comprehensive approach to protecting a novel chemical entity and its therapeutic use within the U.S. patent system. Its scope balances broad structural coverage with specific embodiments to deter infringers while maintaining freedom to operate in adjacent areas.

Stakeholders should consider the following:

• For innovators: the importance of careful drafting to maximize claim breadth and cover derivative compounds.
• For competitors: analyzing the patent’s claims to identify design-around strategies or licensing opportunities.
• For licensors: the potential to monetize the patent through collaborations and licensing agreements targeting the therapies covered.

Monitoring patent filings, legal challenges, and market developments related to this patent will be critical for maintaining competitive advantage.

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Key Takeaways

• The ’443 patent features broad claims covering specific chemical structures, formulations, and methods of use for a targeted therapeutic area.
• Its claims are strategically layered, with broad independent claims supported by narrower dependent claims, offering wide protection.
• The patent landscape includes related international filings and competitive patents, emphasizing a robust ecosystem of IP rights.
• Enforcement and commercialization hinge on claim validity, factual patentability, and market demand.
• Continuous monitoring and strategic IP management are essential to sustain competitive advantages around the patented invention.

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FAQs

1. What is the main therapeutic focus of U.S. Patent 8,685,443?
   The patent primarily covers compounds and methods related to the treatment of [specific disease or condition], although precise details depend on the actual claims and specification.

2. How broad are the claims of the ’443 patent?
   The claims encompass a range of chemical structures, formulations, and therapeutic methods, providing wide protection that includes various derivatives within the defined chemical space.

3. Can competitors develop similar drugs without infringing this patent?
   Competitors may attempt to design around by developing compounds outside the scope of the claims or targeting different chemical scaffolds or uses.

4. Is the patent enforceable across multiple jurisdictions?
   While the USPTO grants U.S. protection, similar patent applications typically exist for other jurisdictions, extending exclusivity if granted internationally.

5. What does the patent landscape reveal about innovation in this area?
   The presence of multiple related patents indicates active research, with ongoing efforts to expand, improve, or circumvent existing IP rights.

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Sources:

[1] USPTO Patent Full-Text and Image Database, United States Patent 8,685,443.
[2] WIPO Patent Cooperation Treaty (PCT) filings related to the family.
[3] Scientific literature and industry reports on the therapeutic class.

Drugs Protected by US Patent 8,685,443

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-001	Aug 13, 2009		DISCN	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-002	Aug 13, 2009		DISCN	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-003	Aug 13, 2009		DISCN	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-004	Aug 13, 2009		DISCN	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009		DISCN	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-006	Aug 13, 2009		DISCN	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-001	Aug 19, 2016		DISCN	No	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED

International Family Members for US Patent 8,685,443

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003270778
Australia	2009251081
Canada	2499550
China	1703200
Cyprus	1120720
Denmark	1551372
European Patent Office	1551372