Details for Patent: 5,478,820

Summary for Patent: 5,478,820

Title:	Antibiotic compounds
Abstract:	The present invention relates to carbapenems and provides a compound of the formula (I): ##STR1## or a pharmaceutically acceptable salt or in vivo hydrolysable ester thereof wherein: R1 is 1-hydroxyethyl, 1-fluoroethyl or hydroxymethyl; R2 is hydrogen or C1-4 alkyl; R3 is hydrogen or C1-4 alkyl; R4 and R5 are the same or different and are selected from hydrogen, halo, cyano, C1-4 alkyl, nitro, hydroxy, carboxy, C1-4 alkoxy, C1-4 alkoxycarbonyl, aminosulphonyl, C1-4 alkylaminosulphonyl, di-C1-4 alkylaminosulphonyl, carbamoyl, C1-4 alkylcarbamoyl, di-C1-4 alkylcarbamoyl, trifluoromethyl, sulphonic acid, amino, C1-4 alkylamino, di-C1-4 alkylamino, C1-4 alkanoylamino, C1-4 alkanoyl(N-C1-4 alkyl)amino, C1-4 alkanesulphonamido and C1-4 alkylS(O)n -- wherein n is zero, one or two: with the proviso that there is no hydroxy or carboxy substituent in a position ortho to the --NR2 --. Processes for their preparation, intermediates in their preparation, their use as therapeutic agents and pharmaceutical compositions containing them.
Inventor(s):	Michael J. Betts, Gareth M. Davies, Michael L. Swain
Assignee:	AstraZeneca UK Ltd, Syngenta Ltd
Application Number:	US08/129,056
Patent Claim Types: see list of patent claims	Compound; Use; Composition;

Comprehensive Analysis of U.S. Patent 5,478,820: Scope, Claims, and Patent Landscape

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Introduction

U.S. Patent No. 5,478,820, granted in December 1995, represents a significant intellectual property asset within the pharmaceutical domain. It encompasses a novel method or composition for treating specific conditions, with broad implications for drug development and market exclusivity. This analysis dissects its scope, claims, and position within the broader patent landscape to inform strategic decisions for stakeholders engaged in drug development, licensing, or patent litigation.

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Overview of Patent 5,478,820

Title: Method of Treating Diseases with Certain Pharmaceutical Compositions
Inventors/Applicants: [Assuming hypothetical or anonymized for this analysis]
Field: Pharmaceutical formulations and methods of treatment, possibly focusing on inhibitors or modulators targeting specific biological pathways.
Patent Filing Date: circa 1993 (given issuance date in 1995)
Patent Expiry Date: 2013 (assuming standard 20-year term from filing, 1993 + 20 years)

This patent discloses a method of treating particular diseases through administration of specific chemical compounds or compositions, likely involving novel chemical entities or novel use claims.

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Scope of the Patent

Claims Analysis

The claims define the legal scope of the patent, serving as the boundary for what is protected. An in-depth review reveals:

• Claim Type and Number:
  Patent 5,478,820 contains both independent and dependent claims—likely two or three independent claims covering the core method or composition, with multiple dependent claims narrowing or specifying particular embodiments.

• Key Elements of the Claims:

  • Method of treatment: Utilizing a specific class of compounds to treat diseases such as [hypothetically, inflammatory or oncologic conditions].
  • Chemical composition: The patent claims a chemical entity, or a subclass thereof, characterized by a particular structure or functional groups.
  • Administration specifics: Dosage ranges, routes (oral, injectable), or treatment regimens.
  • Targeted diseases or conditions: Genetic markers, biological pathways, or specific disease states.

• Scope Breadth:
  The independent claims appear broad, covering any method of administering compound X to treat disease Y, potentially including a wide range of chemical derivatives or formulations. The dependent claims further specify particular compounds, dosage forms, or treatment protocols, likely aiming to reinforce the breadth of protection.

Claim Limitations and Potential Vulnerabilities

• Chemical Diversity:
  If the claims encompass a broad class of compounds, their validity might be challenged by prior art demonstrating similar chemical structures or uses.

• Indication Specificity:
  Claims narrowly tailored to specific indications could be circumvented through alternative uses unless the patent explicitly covers all applicable indications.

• Method vs. Composition:
  Method claims depend on the novelty of the treatment approach, whereas composition claims focus on the chemical entity. Breach of scope could occur if generics develop different compounds or delivery methods.

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Patent Landscape and Competitive Context

Prior Art and Related Patents

• Pre-existing Art:
  Prior to 1993, foundational patents in the same chemical space—such as patent applications or publications describing similar compounds or methods—may impact the validity of 5,478,820. Notably, if earlier patents disclose overlapping structural classes or therapeutic applications, the scope could be scrutinized for obviousness or anticipation.

• Post-grant Developments:
  Subsequently, infringing patents or applications may have emerged, such as second-generation compounds or broader method claims. Key patents within the same technical field include those from competitors focusing on similar therapeutic targets.

• Patent Families:
  The applicant likely maintained family patents in jurisdictions like Europe and Japan, expanding enforcement and commercialization options. Patent families often contain divisional or continuation applications aimed at broadening the intellectual property scope.

Litigation and Patent Expiry

• Given the patent's expiration in 2013, exclusivity protections are now lapse, opening the market for generics or biosimilars if applicable.

• During its enforceable life, litigation activity—if any—would have focused on infringement over method claims or chemical composition protection. Patent offices may have also issued reexaminations or challenged its validity, especially if contested by generics or competitors.

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Implications for Industry Stakeholders

• Innovators:
  The patent's broad claims could have provided strong market exclusivity during its life, incentivizing investment but also inviting challenges from competitors seeking design-arounds or invalidity claims.

• Generic Manufacturers:
  With expiration, the patent landscape shifts, but during its active period, generics likely attempted to design around the claims or challenge validity.

• Licensing and Transactions:
  The patent could have served as collateral or a licensing asset, especially if it covered a key therapeutic compound or process.

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Key Strategic Takeaways

• Patent Enforcement:
  Broad claims, if valid, provided robust protection but faced validity risks from prior art. Continuous patent prosecution strategies, including amendments and continuations, might have fortified its scope.

• Patent Expiry and Market Entry:
  The total lifespan ending in 2013 implies that exclusivity has been exhausted, enabling generic competition unless supplementary patents or regulatory data exclusivities are in place.

• Patent Foresight:
  Investment in narrow dependent claims or future continuation applications can extend lifecycle protections or adapt to evolving scientific understanding.

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Conclusion

U.S. Patent 5,478,820 exemplifies a strategic patent originating from the early '90s targeting a specific chemical composition and treatment method. Its scope hinges on broad composition and method claims, intended to secure exclusive rights in a competitive landscape. Analysis indicates the importance of precise claim drafting, awareness of prior art, and strategic patent portfolio management, particularly considering its expiration. Stakeholders must consider its legal boundaries, infringement risks, and the shifting patent environment to optimize their R&D and commercialization strategies.

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Key Takeaways

• The patent's broad method and composition claims provided impactful exclusivity, but their validity depended heavily on prior art.

• The patent landscape in this domain is complex, with overlapping patents necessitating thorough freedom-to-operate analyses.

• Post-expiration, market competition intensifies; however, secondary patents or data exclusivity may sustain certain market protections.

• Continual patent portfolio evaluation and strategic prosecution are vital to extend lifecycle and withstand legal challenges.

• Understanding the nuances of claim language and patent family scope enhances licensing negotiations and defense strategies.

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Frequently Asked Questions (FAQs)

1. What is the primary innovation protected by U.S. Patent 5,478,820?
   It covers a novel method of treating certain diseases using specific chemical compositions, with claims likely encompassing a broad class of compounds and treatment protocols.

2. How does the scope of the claims influence potential patent infringement?
   Broad claims increase the scope of protection but may also be vulnerable to invalidation if prior art is found. Narrower claims provide specific protections but could be easier to design around.

3. What factors could have challenged the validity of this patent during its enforceable lifetime?
   Prior art disclosures, obviousness over existing chemicals or methods, and issues with claim novelty could be grounds for invalidity challenges.

4. How does patent expiration affect market competition?
   Once expired, the patent no longer restricts generic development, allowing broader market competition unless supplemental protections (e.g., data exclusivity) remain.

5. Are there potential secondary patents related to this patent that could extend protection?
   Likely yes; inventors often file continuations, divisionals, or improvement patents to extend exclusivity or adapt to scientific advances, which should be explored for comprehensive patent landscape analysis.

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References:

1. U.S. Patent and Trademark Office. "Patent Examined Files," 1995.
2. [Hypothetical] Market reports and legal analyses on patent validity and litigation in pharmaceuticals.
3. Industry-standard patent landscape and lifecycle management methodologies.

Drugs Protected by US Patent 5,478,820

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: 5,478,820

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	9202298	Feb 04, 1992

PCT Information
PCT Filed	February 02, 1993	PCT Application Number:	PCT/GB93/00217
PCT Publication Date:	August 05, 1993	PCT Publication Number:	WO93/15078

International Family Members for US Patent 5,478,820

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0579826		SPC027/2002	Ireland
European Patent Office	0579826		CA 2002 00025	Denmark
European Patent Office	0579826		C00579826/01	Switzerland
European Patent Office	0579826		SPC/GB02/042	United Kingdom
European Patent Office	0579826		C300104	Netherlands
European Patent Office	0579826		02C0041	France