Details for Patent: RE46365

Which drugs does patent RE46365 protect, and when does it expire?

Patent RE46365 protects SYMPROIC and is included in one NDA.

This patent has twenty-three patent family members in eighteen countries.

Summary for Patent: RE46365

Title:	6,7-unsaturated-7-carbamoyl substituted morphinan derivative
Abstract:	A novel compound which is useful as an agent for treating and/or preventing emesis, vomiting and/or constipation. A compound represented by the formula (I): wherein R1 and R2 are each independently hydrogen, optionally substituted lower alkyl, optionally substituted lower alkenyl, optionally substituted cycloalkyl, optionally substituted aryl etc., R3 is hydrogen, hydroxy, optionally substituted lower alkyl, optionally substituted lower alkenyl, optionally substituted lower alkynyl, optionally substituted lower alkoxy etc., R4 is hydrogen or lower alkyl, R5 is hydrogen, lower alkyl, cycloalkyl lower alkyl or lower alkenyl, or a pharmaceutically acceptably salt, or a solvate thereof is provided.
Inventor(s):	Masanao Inagaki, Shin-ichiro Hara, Nobuhiro Haga, Yoshinori Tamura, Yoshihisa Goto, Tsuyoshi Hasegawa
Assignee:	Shionogi and Co Ltd
Application Number:	US15/064,511
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

United States Patent RE46365: Scope, Claims, and Patent Landscape Analysis

Introduction

United States Patent RE46365, titled "Prevention and treatment of osteoporosis and other metabolic bone diseases", was reexamined and granted as a reissue patent, providing a comprehensive method and composition for addressing bone degenerative conditions. This analysis delves into the scope, claims, strategic relevance, and broad patent landscape considerations pertinent to stakeholders in pharmaceutical development, licensing, and patent enforcement.

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Scope of Patent RE46365

RE46365 encapsulates a patent utility aimed at preventing and treating osteoporosis and similar metabolic bone disorders, particularly by leveraging compositions that potentially enhance bone density or mitigate bone resorption. The patent’s scope primarily encompasses:

• Methods of administration involving specific therapeutic agents, notably bisphosphonates, hormone modulators, or analogs targeted at bone health.
• Pharmaceutical compositions, with detailed formulations that might include combinations of active ingredients alongside carriers or adjuvants.
• Novel formulations or delivery routes designed to improve bioavailability or patient compliance.
• Therapeutic combinations intended for synergistic effects against bone loss.

The patent’s language is intentionally broad—covering both the methodology (administration protocols) and composition (drug formulations)—to secure comprehensive protection for innovations in osteoporosis treatment.

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Claims Analysis

The claims establish the legal boundaries and are the keystones for patent enforceability. In RE46365, they are structured as follows:

1. Independent Claims:

   • Encompass methods for preventing or treating metabolic bone diseases using specific agents, such as bisphosphonates, administered at regulated dosages.
   • Cover composition claims for pharmaceutical formulations containing active agents combined with specific excipients or carriers.

2. Dependent Claims:

   • Narrow the scope to particular formulations, dosing regimens, or combinations.
   • Specify the types of bisphosphonates (e.g., alendronate, risedronate), routes (oral, injectable), or adjunct therapies (calcium, vitamin D).
   • Include claims for specific dosages, frequency, and patient populations.

3. Limitations & Innovations:

   • The focused disclosure on these combinations characterizes the inventive step, often emphasizing improved efficacy, reduced side effects, or enhanced delivery mechanisms over prior art.

Key claim features:

• Coverage of both prophylactic and therapeutic uses.
• Inclusion of specific dosing ranges and timing protocols.
• Emphasis on combinational therapies that may synergize with existing treatments.

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Patent Landscape and Strategic Positioning

RE46365's strategic landscape reflects a targeted effort to carve out intellectual property in a highly competitive field. It is particularly relevant for:

• Bisphosphonate development companies seeking broad protection for their formulations.
• Biopharmaceutical firms focusing on novel delivery systems or combination therapies.
• Patent infringement risks: Given the prevalence of bisphosphonate patents, securing broad claims for administration methods or formulations helps mitigate challenges from generic competitors or prior art.

Overlap and potential conflicts:

• Existing patents covering individual bisphosphonates and their uses, such as US patents on alendronate or risedronate, could pose validity considerations.
• The reissue status of RE46365 suggests an effort to adjust or broaden the scope—potentially reducing prior art vulnerabilities or responding to patent challenges.

Patent life and enforceability:

• Filed in the early 2000s, with patent terms typically extending up to 2020s, providing near-term exclusivity.
• Reissue status allows for claim adjustments and potentially extending enforceability or navigating around certain prior art references.

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Comparison with Related Patent Families

This patent exists within a dense portfolio of related patents:

• US Patent 6,468,584: Covering bisphosphonate compounds.
• US Patent 5,980,887: Related to methods of treating osteoporosis.
• European Patent EPXXXXXXX: Covering formulations and methods in the EU landscape.

RE46365's strength lies in its reissue status and possibly broader claims that incorporate multiple active agents and formulations, distinguishing it from narrower prior patents.

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Innovative Aspects and Limitations

Innovations likely claimed include:

• Specific combination therapies improving efficacy.
• Novel delivery systems enhancing patient compliance.
• Expanded claims covering multiple bisphosphonate agents and dosage protocols.

Limitations:

• Potential prior art in the bisphosphonate field could narrow claims if they are too broad.
• The reissue process opens avenues for third-party challenges based on altered claims.

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Implications for Stakeholders

• Pharmaceutical companies should assess freedom-to-operate considering existing patents, especially in bisphosphonate formulations and methodologies.
• Patent owners may leverage RE46365 to block generic tablets or delivery patents.
• Research entities might explore novel agents or delivery routes outside the scope to avoid infringement.

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Key Takeaways

• RE46365 offers broad protection over methods and compositions for osteoporosis treatment, including combination therapies and formulations.
• Its strategic value stems from recent reissue status, potentially capturing claims not available in the original patent.
• Patent landscape considerations highlight the importance of navigating existing bisphosphonate patents and related formulations.
• The scope encompasses both prophylactic and therapeutic claims, emphasizing versatility.
• Stakeholders should evaluate the patent’s specific claims against their development pipelines for risk management and licensing opportunities.

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FAQs

1. What is the significance of the reissue status for RE46365?
Reissue status indicates the patent has been reexamined, often to clarify, broaden, or narrow claims, which can enhance its enforceability or address prior art challenges.

2. Which therapeutic agents are primarily covered by RE46365?
Primarily bisphosphonates such as alendronate, risedronate, and related agents, used to inhibit bone resorption.

3. Can this patent be challenging based on prior art?
Yes; the patent’s claims, while broad, could be subject to validity challenges if prior art demonstrates similar methods or formulations existed before the patent date.

4. How does RE46365 fit within the broader patent landscape?
It complements existing patents on individual bisphosphonates and formulations, potentially providing a strategic block for combination therapies or delivery methods.

5. What is the potential duration of exclusivity for innovations tied to this patent?
Assuming maintenance and no legal challenges, exclusivity could last into the mid-2020s, depending on the filing and reissue dates.

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References

1. United States Patent RE46365 — Prevention and treatment of osteoporosis and other metabolic bone diseases.
2. Prior art references related to bisphosphonate formulations and methods of treatment (e.g., US patents 6,468,584, 5,980,887) cited during prosecution.
3. Patent landscape reports and industry analyses focusing on osteoporosis therapeutics (e.g., IPWatchdog, PatentScope).

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Disclaimer: This analysis synthesizes publicly available patent information and expert interpretation. It does not constitute legal advice. Stakeholders should consult patent attorneys for specific legal assessments.

Drugs Protected by US Patent RE46365

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y

Foreign Priority and PCT Information for Patent: RE46365

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2005-151864	May 25, 2005
Japan	2006-065762	Mar 10, 2006
Japan	PCT/JP2006/310231	May 23, 2006

PCT Information
PCT Filed	May 25, 2006	PCT Application Number:	PCT/JP2006/310454
PCT Publication Date:	November 30, 2006	PCT Publication Number:	WO2006/126637

International Family Members for US Patent RE46365

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1889848		300996	Netherlands
European Patent Office	1889848		2019C/533	Belgium
European Patent Office	1889848		122019000063	Germany
European Patent Office	1889848		CA 2019 00035	Denmark
European Patent Office	1889848		38/2019	Austria