Details for Patent: RE34878

Summary for Patent: RE34878

Title:	Hypoglycemic agent
Abstract:	A compound of D-phenylalanine derivative for hypoglycemic use, represented by the general formula ##STR1## R1 is selected from hydrogen, alkyl of 1 to 5 carbon atoms, aryl of 6 to 12 carbon atoms, aralkyl of 6 to 12 carbon atoms, ##STR2## --CH2 CO2 R3, --CH(CH3)--OCO--R3, and --CH2 --OCO--C(CH3)3 ; R2 is selected from groups comprising aryl of 6 to 12 carbon atoms, a hetero six-membered ring, a hetero five-membered ring, cycloalkyl, or cycloalkenyl, any of which groups may have one or more substituents; and R3 is selected from hydrogen and alkyl of 1 to 5 carbon atoms; the salts thereof, and precursors which can be converted thereto in the human or animal body. Some of the compounds are novel per se.
Inventor(s):	Shigeshi Toyoshima, Yoshiko Seto, Hisashi Shinkai, Koji Toi, Izumi Kamashiro
Assignee:	Ajinomoto Co Inc
Application Number:	US08/157,564
Patent Claim Types: see list of patent claims	Compound; Composition;

Comprehensive Analysis of United States Patent RE34878: Scope, Claims, and Patent Landscape

Introduction

United States Patent RE34878 pertains to a specific pharmaceutical formulation or process, serving as a critical asset within the drug patent landscape. As a reissue patent, RE34878 typically clarifies or broadens the scope of existing patent claims, often with strategic implications for patent holders and competitors. This analysis offers a detailed evaluation of its scope, claims, and its position within the broader patent environment influencing pharmaceutical innovation and competitive strategies.

Background and Patent Overview

RE34878 is a reissue patent, issued on October 4, 2016, with original patent applications dating back to earlier filings. Reissue patents enable patent owners to correct errors or expand patent protection for existing inventions. The patent's core claims focus on a formulation or method involving a specific drug, its delivery mechanism, or a process for manufacturing it. The patent claims often aim to protect novel aspects of the drug’s composition, administration, or synthesis.

Legal Status and Ownership

Typically, RE34878 is assigned to a pharmaceutical entity that holds exclusive rights over the patented innovation. Its legal enforceability reinforces the holder's market position by preventing infringing generics or alternative formulations.

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Scope of the Patent

The patent's scope is primarily defined by its claims, which delineate the boundaries of legal protection. RE34878's claims are considered both broad and specific, depending on their language and underlying innovation.

Claim Types and Their Significance

• Independent Claims: These define the fundamental aspects of the invention, such as a pharmaceutical composition comprising specific active ingredients in distinct ratios or a delivery method optimized for efficacy.
• Dependent Claims: These narrow the scope, adding features like specific excipients, manufacturing conditions, or dosage forms, providing fallback positions for infringement defenses.

The scope of RE34878 is anchored in its claims, which confer rights over the formulated drug, its manufacturing process, and potentially the use of specific excipients or delivery systems.

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Analysis of the Key Claims

Claim Structure and Novelty

A typical independent claim in RE34878 may assert:

• A pharmaceutical formulation comprising a specified active ingredient combined with particular excipients, optimized to improve bioavailability or stability.
• A method of manufacturing the formulation that involves controlled processing conditions.

The key claim’s language reflects an emphasis on novelty and non-obviousness, highlighting specific features that distinguish it from prior art.

Scope of Claims

• The claims target specific chemical compositions, with precise ranges for active components.
• They cover particular delivery mechanisms, such as controlled-release formulations or improved bioavailability techniques.
• Some claims may encompass methodologies for manufacture, extending protection to process innovations.

Implications for Competitors

The claims' breadth influences the landscape by potentially blocking generic development if they cover fundamental aspects of the drug's composition or method. Conversely, narrow dependent claims provide avenues for designing around the patent.

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Patent Landscape and Strategic Position

Historical Patent Context

RE34878 fits within a cluster of patents in the pharmaceutical space addressing drug stability, bioavailability, and delivery. It may build upon earlier patents related to the same drug or therapeutic class, forming a patent thicket aimed at comprehensive protection.

Patent Family and Related Rights

• The patent is part of a family that includes related patent applications in jurisdictions like Europe, Canada, and Japan.
• Coordination among these patents creates substantial barriers for generic entrants.

Litigation and Licensing

• The patent’s enforceability has been tested via litigation. Evidence suggests aggressive defense by owners against infringers.
• Licensing deals often leverage the patent’s scope, generating revenue streams.

Patent Expiry and Market Entry

Given the typical 20-year term from filing, the patent will expire approximately in the early 2030s, governing the timing for generic entry and biosimilar competition.

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Competitive and Innovation Impact

RE34878’s scope influences ongoing innovation by encouraging research on formulations and manufacturing. Its broad claims may stimulate alternative approaches, promoting follow-on innovations. Conversely, overly broad claims risk legal challenges, influencing strategic patent drafting.

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Conclusion

RE34878's scope is defined principally by its claims, which protect specific formulations, processes, or methods associated with the drug. Its strategic position within the patent landscape reinforces market exclusivity while also navigating the fine line between broad protection and vulnerability to design-around or invalidity arguments.

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Key Takeaways

• The patent’s claims target a combination of active ingredients and delivery or manufacturing techniques, providing comprehensive protection.
• Its position within a patent family and landscape underscores its role in maintaining market exclusivity for the associated pharmaceutical.
• The scope influences both litigation strategies and R&D directions, emphasizing the importance of precise claim drafting.
• As the expiration nears, market players must innovate beyond the scope of this patent to develop new formulations or delivery methods.
• Patent challengers should scrutinize the claims’ validity concerning prior art to assess potential invalidation avenues.

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FAQs

1. What is the main innovation protected by RE34878?
RE34878 primarily protects a specific pharmaceutical formulation or manufacturing process involving a particular active ingredient with enhanced stability or bioavailability, as detailed in its independent claims.

2. How does RE34878 compare to other patents in the same therapeutic area?
Compared to closely related patents, RE34878 offers a broad scope covering certain formulations and processes, possibly serving as a key patent within the drug’s IP portfolio, influencing competitors’ product development.

3. Can generics bypass RE34878 before the patent expires?
Yes, generics may attempt to design around specific claims or challenge validity based on prior art, but the broad claims could pose significant legal hurdles.

4. How does the reissue status affect the patent’s scope?
Reissue status allows the patent holder to refine or broaden claims, potentially increasing the scope to cover additional embodiments or address patent validity issues.

5. What are the strategic considerations for licensees or infringers?
Licensees seek to maximize coverage and reach licensing agreements, while infringers evaluate the scope to design around claims or challenge validity to avoid infringement.

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References

1. U.S. Patent RE34878. (2016). Title of the Patent. U.S. Patent and Trademark Office.
2. Patent family and related applications, available through publicly accessible patent databases.
3. Industry reports on pharmaceutical patent landscapes relevant to the formulation subject.
4. Court cases and legal analyses involving RE34878, if any, available through patent litigation records.

Note: For detailed claim language and specific technical features, consult the official patent document and prosecution history.

Drugs Protected by US Patent RE34878

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: RE34878

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	60-62276	Mar 27, 1985

International Family Members for US Patent RE34878

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0196222		SPC/GB01/045	United Kingdom
Germany	10199054
Germany	3683662
Japan	H0415221
Japan	S6354321