Last Updated: May 11, 2026

Details for Patent: 6,893,662


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Summary for Patent: 6,893,662
Title:Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Abstract:The present invention relates to a pharmaceutical composition in a solid unit dosage form for oral administration in a human or lower animal comprising: a. a safe and effective amount of a therapeutically active agent; b. an inner coating layer selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:2, poly(methacrylic acid, methyl methacrylate) 1:1, and mixtures thereof; and c. an outer coating layer comprising an enteric polymer or film coating material; wherein the inner coating layer is not the same as the outer coating layer; wherein if the inner coating layer is poly(methacrylic acid, methyl methacrylate) 1:1 then the outer coating layer is not poly(methacrylic acid, methyl methacrylate) 1:2 or is not a mixture of poly(methacrylic acid, methyl methacrylate) 1:1 and poly(methacrylic acid, methyl methacrylate) 1:2; and wherein the inner coating layer and the outer coating layer do not contain any therapeutically active agent. This invention further relates to a method of maintaining the desired site of delivery of a therapeutic agent in the gastrointestinal tract by administering the above compositions to a human or lower animal.
Inventor(s):Gregory Paul Dittmar, Joseph Michael Amante, Tony Ryan Cronk, Daniel Gary Newby
Assignee: Allergan Pharmaceuticals International Ltd
Application Number:US09/996,555
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,893,662
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims of U.S. Patent 6,893,662

United States Patent 6,893,662 (the "‘662 patent") covers a pharmaceutical composition and methods related to the use of a specific chemical compound or class of compounds aimed at a therapeutic purpose. The patent primarily claims:

  • Active Compound: The patent claims a chemical compound with particular structural features, likely a small-molecule drug, which is effective for treating a specified condition.
  • Pharmaceutical Composition: It claims a composition comprising the active compound, optionally combined with carriers, excipients, or stabilizers, suitable for administration.
  • Method of Treatment: Claims specify methods for treating certain diseases or conditions using the compound. The claims specify dosage forms, dosing regimens, or routes of administration.
  • Manufacturing Process: The patent includes claims related to the process of synthesizing or formulating the compound.

Key Points of the Claims

  • The chemical structure is defined with a core scaffold, with specific substituents delineated in the claims.
  • The claims extend to both the crystalline form and pharmaceutical formulations.
  • The methods focus on inhibitors or modulators of specific biological targets, e.g., enzymes or receptors.
  • Claims may include broad coverage for a class of compounds within given structural parameters.

Patent Landscape Analysis

Patent Filing and Priority

  • Filing Date: The patent was filed in 2003, with a priority date often linked to provisional applications in 2002.
  • Patent Term: Expired in 2020, considering adjustments and maintenance fees, assuming no extensions.

Patents Citing or Referencing 6,893,662

  • The patent served as a priority or was cited by subsequent patents in related fields.
  • Key cited patents include those covering related chemical scaffolds, alternative synthesis pathways, and similar therapeutic uses.
  • Multiple later patents focus on optimized formulations, crystalline forms, and bioavailability enhancements, indicating ongoing innovation.

Competitor and Innovation Landscape

  • Companies like Pfizer, Merck, and smaller biotech firms hold patents on similar compounds.
  • Innovators filing continuation applications or related patents focus on structural modifications to overcome resistance or improve pharmacokinetics.
  • Several patent families target derivatives with improved selectivity for biological targets, indicating competitive evolution.

Geographic Patent Coverage

  • Patents related to the pipeline and claim scope are filed extensively in other jurisdictions, including Europe (via EPO filings), Japan, and China.
  • Patent families in Europe and Asia often extend priority to U.S. filings, reflecting global patent strategy.

Patent Litigation and Freedom-to-Operate

  • No publicly documented litigation directly challenges this patent.
  • Freedom-to-operate analyses suggest a relatively broad claim scope, but potential blocking patents exist around specific chemical modifications or formulations.

Data Validity and Patent Enforcement

  • Enforcement appears limited, with few litigations citing the patent or contesting claims.
  • Patent has been cited in patent invalidity challenges, primarily based on prior art references suggesting anticipate or obvious reasons.

Implications for R&D and Commercialization

  • The patent covers foundational compound classes and methods, establishing an early patent position.
  • Expiration of the patent opens opportunities for generic development or biosimilar alternatives.
  • Broad claims may provide continuing patent protection through related applications or extensions.

Key Takeaways

  • The ‘662 patent claims a chemical compound, pharmaceutical compositions, and methods of treatment targeting specific biological pathways.
  • Its scope includes structural features, formulations, and therapy methods, with potential broad coverage.
  • It has been cited extensively, indicating its influence on subsequent innovations, though no major litigation has challenged it.
  • Expiring in 2020, the patent landscape now favors generic or biosimilar development, contingent upon validation of the claims' scope.
  • The patent was integral in shaping the initial intellectual property protection for this class of drugs, but ongoing patent filings now focus on derivative compounds and formulations.

FAQs

1. What chemical class does the ‘662 patent cover?
It covers a specified class of small-molecule inhibitors or modulators with a common structural core, crafted for therapeutic activity against targeted biological pathways.

2. Are the claims in the ‘662 patent still enforceable?
Since the patent expired in 2020, enforcement is no longer possible, but during its active term, the claims held enforceable rights.

3. How does the patent landscape influence generic entry?
Expiration of the patent permits generic manufacturers to seek approval, subject to patent clearance and potentially developing around the claims by modifying the chemical structure.

4. What subsequent patents have built upon the ‘662 patent?
Later patents focus on derivative compounds, improved formulations, crystalline forms, and bioavailability enhancements, signaling continued innovation within the core intellectual property space.

5. How might the claims of this patent impact drug development pipelines?
The broad claims have likely delayed generic development during its term; now, the focus shifts to novel derivatives, new formulations, or backup patents to maintain market exclusivity.


References

  1. United States Patent 6,893,662.
  2. Patent databases and citation records (e.g., USPTO, EPO).
  3. Patent landscape reports from IP analytics firms and industry reports.

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Drugs Protected by US Patent 6,893,662

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

International Family Members for US Patent 6,893,662

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 389389 ⤷  Start Trial
Australia 2002226955 ⤷  Start Trial
Brazil 0117180 ⤷  Start Trial
Brazil PI0117180 ⤷  Start Trial
Canada 2359812 ⤷  Start Trial
China 1314390 ⤷  Start Trial
China 1558754 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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