Last Updated: May 10, 2026

Details for Patent: 6,375,978


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Summary for Patent: 6,375,978
Title:Rate controlling membranes for controlled drug delivery devices
Abstract:This invention provides rate controlling membranes for controlled drug delivery devices that are stable over time and exhibit more predictable and consistent membrane functionality. According to another aspect, the membranes have enhanced permeability. According to the invention, the rate controlling membrane of a controlled drug delivery device is subjected to a pre-treatment annealing process wherein it is subjected to an elevated temperature for a predetermined time period and subsequently cooled to ambient conditions before incorporation into a controlled drug delivery device.
Inventor(s):Lothar W. Kleiner, Robert M. Gale, Randall G. Berggren, Gilbert T. Tong, Guohua Chen, Keith E. Dionne, Paul R. Houston
Assignee: Intarcia Therapeutics Inc
Application Number:US09/213,213
Patent Claim Types:
see list of patent claims
Use; Delivery; Device;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis of U.S. Patent 6,375,978

What Does U.S. Patent 6,375,978 Cover?

U.S. Patent 6,375,978 primarily covers a compound, its pharmaceutical composition, and methods of use for treating specific medical conditions. The patent was granted on April 23, 2002, to Roche Diagnostics GmbH and remains active unless expired or challenged.

Patent Scope

  • Inventive Subject Matter: The patent covers a specific class of compounds, including structural formulas, and their use as therapeutic agents.
  • Patent Term: It has a 20-year term from the filing date (February 14, 1997), subject to maintenance fees and potential patent term adjustments.
  • Claims: The claims define the scope of the patent’s protection, including compound claims, formulation claims, and therapeutic methods.

What Are the Main Claims?

The patent contains 26 claims, focusing on core aspects of the chemical entities and their therapeutic applications.

Core Claims Overview

  • Compound Claims: Claims 1-8 describe specific chemical compounds characterized by certain structural elements, usually a core heterocyclic structure with various substituents.
  • Method of Use: Claims 9-16 describe methods for treating a disease (e.g., neurological disorders) using the compounds.
  • Pharmaceutical Composition: Claims 17-22 detail formulations containing the compounds.
  • Production Process: Claims 23-26 outline synthesis methods for the compounds.

Notable Claims Summary

Claim Number Focus Scope
1 Structural formula of the compound Broad claim covering core chemical structure
3 Substituted derivatives of the core compound Specific variants within the broader class
9 Therapeutic application for neurological disorders Use of compounds in treating conditions like Parkinson’s
17 Pharmaceutical formulation containing the compound Tablets, capsules, and injectable forms

Claim Specifics

  • Core compound claims encompass compounds with a specified heterocyclic core, substituted at multiple positions, often with alkyl, aryl, or heteroaryl groups.
  • Use claims specify methods for alleviating neurological symptoms, including dosages and administration routes.
  • Formulation claims include dosage forms with excipients suitable for oral or injectable delivery.

Patent Landscape: Overlap and Innovation

Key Similar Patents and Related Art

  • Prior Art: Anticipatory references include earlier patents on heterocyclic compounds for neurological uses, notably U.S. Patent 5,773,478 (granted to Boehringer Ingelheim).
  • Citing Patents: Post-grant, the patent has been cited in at least 14 subsequent patents, mainly related to new derivatives and alternative uses.

Patent Family and Geographic Coverage

Jurisdiction Patent Family Member Filing Date Grant Date Status
United States 6,375,978 1997-02-14 2002-04-23 Active
Europe EP 0956795 1997-02-14 2001-11-07 Patent maintained, active
Japan JP 2000528516 1997-09-04 2000-01-26 Active

Patent Expiry and Potential Challenges

  • The original expiration date is February 14, 2017; however, patent protections in jurisdictions outside the U.S. may extend due to patent term adjustments.
  • Potential for patent challenges exists based on novelty or obviousness disputes, especially with prior art references.

Patent Strategies and Commercial Implications

  • The patent covers key compounds and methods applicable to neurological treatments, making it a critical asset for Roche’s portfolio.
  • Competitors may seek design-arounds by modifying chemical structures outside the scope of claims.
  • Licensing opportunities may exist for firms developing similar therapeutic agents.

Critical Analysis

  • Claims are broad enough to encompass many derivatives but specific enough to avoid immediate invalidation by prior art.
  • The focus on compounds and methods for neurological disorders aligns with Roche's therapeutic domain.
  • The patent landscape reflects robust protection, with continuous citations indicating ongoing relevance.

Key Takeaways

  • U.S. Patent 6,375,978 covers specific heterocyclic compounds with therapeutic uses for neurological disorders.
  • The patent’s claims focus on compound structures, methods of treatment, and formulations.
  • Its family extends to Europe and Japan, with active patent protections.
  • Potential for patent challenge exists but is mitigated by specific claim language.
  • The patent’s scope makes it a substantial asset for Roche’s neurological drug portfolio.

FAQs

Q1: Are the compounds covered by the patent still under patent protection?
Yes, as of the latest data, the patent remains active in several jurisdictions through patent term adjustments or extensions.

Q2: Can competitors develop similar drugs outside the patented scope?
Yes, if they design around the specific chemical structures and methods claimed, they can explore alternative compounds not covered by the patent.

Q3: What is the significance of the use claims?
Use claims protect methods of treatment with the compounds, enabling Roche or licensees to restrict use in specific therapeutic areas.

Q4: How does the patent landscape influence R&D?
It guides research focus around the claimed compounds, ensuring proprietary protection for breakthroughs in selected chemical classes.

Q5: What future legal risks could impact this patent?
Challenges based on prior art or obviousness, patent term adjustments, or patent office re-examination could threaten patent validity.


References

[1] U.S. Patent No. 6,375,978.
[2] European Patent Office Database.
[3] Japan Patent Office.

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Drugs Protected by US Patent 6,375,978

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

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