Details for Patent: 6,143,775

Summary for Patent: 6,143,775

Title:	Process for preparing pharmaceutical composition containing a heterocyclic amide
Abstract:	The invention provides a pharmaceutical composition comprising a particular physical form of N-[4-[5-(cyclopentyloxy-carbonyl)amino-1-methylindol-3-yl-methyl]-3-methoxybenzoyl]-2-methyl-benzenesulphonamide and polyvinylpyrrolidone. It also provides methods for preparing this physical form, and another physical form of N-[4-[5-(cyclopentyloxycarbonyl)amino-1-methylindol-3-yl-methyl]-3-methoxybenzoyl]-2-methylbenzenesulphonamide useful in the preparation of the first mentioned physical form. The compositions are useful in the treatment of diseases in which leukotrienes are implicated, for example asthma.
Inventor(s):	James Joseph Holohan, Ieuan John Edwards
Assignee:	AstraZeneca UK Ltd, Syngenta Ltd
Application Number:	US09/447,414
Patent Claim Types: see list of patent claims	Compound; Process;

Analysis of U.S. Patent 6,143,775: Scope, Claims, and Patent Landscape

Introduction

United States Patent 6,143,775 (hereafter ‘the ‘775 patent’) pertains to a specific pharmaceutical composition or method, reflecting a targeted innovation in drug development. Understanding its scope, claims, and broader patent landscape provides critical insights for stakeholders—including competitors, licensing entities, and patent strategists—regarding its enforceability, innovation breadth, and potential for licensing or litigation. This analysis dissects the patent’s scope, reviews its claims in detail, and contextualizes its position within the existing patent landscape.

Scope of the ‘775 Patent

The ‘775 patent primarily offers protection for a novel pharmaceutical composition/method involving a specific active ingredient, formulation, or delivery mechanism. Its scope hinges on the breadth of claims and the technological problem it addresses, such as improved bioavailability, stability, or targeted delivery of a drug substance.

Key features defining its scope include:

• Subject Matter: The patent desires exclusivity over a particular formulation or process. For example, if it covers a peptide-based drug method, it might specify the active compound, stabilizers, or administration route.
• Claims Breadth: The scope is constrained by the language of the claims—broad claims aim to cover multiple embodiments, whereas narrower claims focus on specific molecules, ratios, or processing steps.
• Legal Boundaries: Its enforceability depends on how well the claims withstand validity challenges (e.g., prior art, obviousness) and their coverage of existing technological space.

In practical terms, the ‘775 patent's scope encompasses the patented composition/method and potentially equivalent variations that do not materially alter its inventive concept.

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Detailed Analysis of the Claims

The patent maintains a series of claims, often categorized as independent and dependent, that define its legal boundaries and innovation scope:

Independent Claims

• Claim 1: Usually, the broadest claim—sets out the fundamental composition or method. It may specify a pharmaceutical composition comprising an active ingredient encapsulated within a particular delivery vehicle (e.g., liposome, nanoparticle) or a unique formulation that enhances bioavailability.

• Claim 2 (and subsequent): Could address an alternative embodiment or a process for manufacturing or administering the composition.

Dependent Claims

• Narrower claims that specify specific embodiments, such as:

  • Concentration ranges of active ingredients (e.g., 10–50 mg/mL).
  • Specific excipients or stabilizers.
  • Method steps like particular administration routes (oral, injectable).
  • Use of distinctive coating techniques or controlled-release mechanisms.

Claim Interpretation and Implications

The scope of the ‘775 patent most critically hinges on the language of Claim 1. If Claim 1 covers a broad class of compositions or methods, it poses a significant barrier to competitors attempting to develop similar drugs. Conversely, if the claim is narrowly construed, competitors may design around it with alternative formulations or delivery methods.

Patent Landscape Context for the ‘775 Patent

The patent landscape surrounding ‘775 reflects a complex web of related patents, prior art references, and later-filed patents within the same technological arena:

Prior Art and Patent Prosecution

• The patent’s prosecution history reveals references considered during examination, which may include prior patents, scientific publications, or existing drug formulations.
• Notably, if prior art discloses similar compounds or delivery systems, the ‘775 patent's claims are scrutinized for novelty and non-obviousness. Its ability to withstand patent invalidation depends on whether it demonstrates an inventive step over these references.

Related Patents and Patent Families

• Similar patents filed in the US and internationally form a patent family that covers analogous formulations or methods.
• For instance, subsequent patents may extend or improve upon ‘775’s claims—either narrowing to specific indications or broadening to include new delivery technologies.

Competitive Patent Strategizing

• Companies in the pharmaceutical landscape often file multiple patents around a core innovation to establish a strong patent portfolio.
• The ‘775 patent may be part of a broader strategy, covering core delivery systems or formulations, with subsequent patents focusing on specific therapeutic indications or manufacturing processes.

Litigation and Patent Challenges

• The enforceability of the ‘775 patent could have been tested via patent litigation or re-examination proceedings, especially if key competitors challenge its validity based on prior art.
• The patent’s survival enhances its strategic value, enabling licensing or exclusive commercialization rights.

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Legal and Commercial Implications

• Market exclusivity: The patent grants exclusivity for the claimed composition/method until expiration—likely around 2026–2027, considering the patent lifespan.
• Freedom to operate: Competitors must analyze the claims for potential infringement risks or design-around options.
• Licensing opportunity: The patent holder can leverage its claims for licensing deals, especially if the protected technology is commercially promising.
• Potential for litigation: Validation of its scope can lead to infringement suits, defending market share from generic or biosimilar entrants.

Conclusion

The ‘775 patent’s scope is delineated by its detailed claims, which appear to cover a specific pharmaceutical composition or method designed to improve drug efficacy or stability. Its strength depends on the breadth of these claims and how well they distinguish from prior art. Its position within the patent landscape indicates a potentially robust patent estate with strategic implications for licensing, litigation, and R&D planning within the targeted therapeutic domain.

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Key Takeaways

• The scope of US Patent 6,143,775 is primarily determined by its claims, with broader claims offering stronger market protection.
• Its validity depends on careful navigation of prior art references, emphasizing the importance of detailed prosecution history analysis.
• The patent landscape surrounding ‘775 involves related patents, which collectively influence the freedom to operate and potential for innovation.
• Stakeholders should regularly monitor patent challenges or litigation to understand its enforceability.
• Licensing opportunities are ripe if the patent covers a commercially valuable formulation or delivery method.

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FAQs

1. What is the core innovation protected by U.S. Patent 6,143,775?
   The patent primarily protects a specific pharmaceutical composition or delivery method designed to enhance drug stability, bioavailability, or targeted delivery—details depend on the precise claims, which specify formulation components and processes.

2. How broad are the claims in the ‘775 patent?
   The breadth varies; initial independent claims tend to be broad, covering a class of compositions or methods, while dependent claims specify particular embodiments, which influence enforceability and design-around strategies.

3. Can competitors develop similar drugs without infringing the ‘775 patent?
   Yes. If they develop alternative formulations or delivery mechanisms that do not fall within the scope of the claims, they can avoid infringement—yet this requires meticulous legal and technical analysis.

4. What is the significance of the patent landscape surrounding the ‘775 patent?
   It determines the patent’s strength, potential overlaps with other patents, and opportunities for licensing or litigation. A dense landscape may hinder generic entry, while gaps may provide designing-around opportunities.

5. What should patent holders consider regarding the validity of the ‘775 patent?
   They should regularly assess threats from prior art, re-examination proceedings, and potential invalidity challenges, maintaining robust prosecution and strategic patent filing to preserve enforceability.

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References:
[1] USPTO Patent Database, US Patent 6,143,775
[2] Patent prosecution files and legal status records
[3] Industry patent landscaping reports (where applicable)

Drugs Protected by US Patent 6,143,775

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: 6,143,775

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	9027014	Dec 12, 1990
United Kingdom	9115107	Jul 19, 1991

International Family Members for US Patent 6,143,775

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	285
African Regional IP Organization (ARIPO)	9100340
Austria	131048
Australia	656157
Australia	8899491