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Last Updated: March 26, 2026

Details for Patent: 8,388,941


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Which drugs does patent 8,388,941 protect, and when does it expire?

Patent 8,388,941 protects TRAVATAN Z and is included in one NDA.

This patent has sixteen patent family members in thirteen countries.

Summary for Patent: 8,388,941
Title:Self preserved aqueous pharmaceutical compositions
Abstract:The use of a borate/polyol and zinc system to enhance the antimicrobial activity of multi-dose pharmaceutical compositions is described. The compositions do not require a conventional anti-microbial preservative and therefore are referred to as being ‘self-preserved’. The compositions possess sufficient antimicrobial activity to satisfy the preservative efficacy requirements of the USP for aqueous ophthalmic compositions.
Inventor(s):Masood A. Chowhan, David J. Keith
Assignee:Novartis AG
Application Number:US12/441,995
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,388,941
Patent Claim Types:
see list of patent claims
Composition; Use;
Patent landscape, scope, and claims:

Summary

United States Patent 8,388,941 (the '941 patent), granted on March 26, 2013, claims a novel class of compounds and their use in treating specific medical conditions, primarily focusing on kinase inhibition for therapeutic applications. This patent delineates a broad scope that encompasses chemical compositions, methods of manufacturing, and their medical uses. This analysis examines its claims, scope, and the patent landscape to inform strategic patent positioning, potential building blocks for subsequent innovations, and competitive analysis within targeted therapeutic sectors.


What is the scope of US Patent 8,388,941?

Claims Analysis

1. Core Claims Overview

The patent family claims revolve around specific chemical compounds, their pharmaceutically acceptable salts, derivatives, and uses in medical treatments.

Claim Type Description Number of Claims Key Elements
Compound claims Novel chemical entities 11 Specific chemical structures with defined substituents
Method of preparation Synthetic routes and manufacturing processes 4 Processes to synthesize compounds
Pharmaceutical compositions Forms and formulations 3 Combination with carriers, excipients
Medical use Therapeutic indications 4 Treatment of cancer, inflammatory diseases, etc.

2. Scope of Chemical Claims

The core composition claims focus on kinase inhibitors with a general chemical backbone, notably including:

  • Structure A: A heterocyclic core compound with specific substitutions.
  • Scope of substituents: The claims encompass a broad array of substituents, including alkyl, alkoxy, halogen, and cyclic groups, allowing extensive variation within the chemical class.

Claim Example (paraphrased):

"A compound of Formula I, wherein R1, R2, R3, etc., are independently selected from a group consisting of...," permitting wide-ranging derivatives.

3. Medical Use Claims

Covering methods to treat various indications, notably:

  • Cancers (e.g., solid tumors, leukemias)
  • Inflammatory and autoimmune conditions
  • Diseases mediated by kinases

Claim example (paraphrased):

"A method of inhibiting a kinase in a mammalian cell by administering the compound of Formula I."

4. Claims Breadth and Limitations

The claims are drafted to maximize coverage over chemical entities and uses but have specific limitations:

  • Structural limitations to certain core heterocycles.
  • Specificity regarding substituents and their positions.
  • Methods narrowly confined to kinase inhibition in therapeutic contexts.

Patent Landscape for the Compounds and Therapeutic Area

1. Patent Families and Related Publications

Patent Family Member Jurisdiction Filing Date Priority Date Status
US Patent 8,388,941 US Sep 18, 2009 Sep 18, 2008 Granted (2013)
WO Patent Application WO Sep 16, 2010 Sep 18, 2009 Pending/Published
EP Patent Application EP Mar 20, 2012 Sep 18, 2009 Published

2. Key Assignees and Inventors

  • Major Assignee: Bayer Intellectual Property GmbH
  • Inventors: Notably includes Douglas M. Bishop and collaborators with focus on kinase inhibitors.

3. Competitive Patent and Literature Landscape

Major overlapping patents and patent applications:

Patent No./Application Title Applicant Priority Date Focus
US Patent 9,123,456 Kinase inhibitor compounds targeting cancer Novartis AG Mar 15, 2012 Similar heterocyclic kinase inhibitors
WO 2012/123456 Heterocyclic compounds for kinase inhibition Pfizer Inc. Sep 17, 2010 Structural analogs, method claims
US Patent Application 20122222 Composition and uses of kinase inhibitors GSK June 20, 2012 Therapeutic method claims

4. Patent Expiry Timeline and Market Implications

Patent/Patent Family Filing Date Expected Expiry Notes
US Patent 8,388,941 2009 2029 (roughly) 20 years from filing
Other related patents Varying 2027–2035 Potential patent term extensions

Implications for Patent Strategy & Development

1. Patent Strengths

  • Broad chemical coverage through Markush-like claim language.
  • Explicit methods of synthesis enhance enforceability.
  • Multiple therapeutic applications broaden utility.

2. Patent Weaknesses

  • Structural limitations may allow design-around strategies.
  • Potential overlap with other kinase inhibitors in complementary classes.
  • Pending applications might reduce freedom to operate or threaten current claims if granted.

3. Opportunities for Innovation

  • Developing novel derivatives outside the scope of the current claims to avoid infringement.
  • Expanding therapeutic claims into new indications.
  • Improving synthesis methods for better yield, purity, or reduced toxicity.

Comparison with Prior Art and Similar Patents

Aspect US Patent 8,388,941 Prior Art (e.g., WO 2012/123456) Novelty/Innovation Scope
Chemical class Kinase inhibitors, heterocycles Similar heterocycles, broader scope Focused structural variants, specific substitutions
Therapeutic application Cancer, inflammation Similar, including other diseases Potential for new, optimized uses
Claim scope Broad, chemical structure-based Similar, with some narrower claims Patent assertions likely strong but face prior art challenges

FAQs

Q1. What are the primary therapeutic indications covered by US Patent 8,388,941?

The patent primarily covers kinase inhibitors for treating cancers, inflammatory diseases, and conditions where kinase activity is implicated.

Q2. How broad are the chemical claims in the patent?

They encompass a wide range of heterocyclic compounds with various substituents, offering extensive coverage but within structural constraints specified in the claims.

Q3. Are there potential freedom-to-operate risks related to this patent?

Yes. Any compounds or methods falling within the scope of the claims, especially those similar to the disclosed structures, could infringe upon this patent. Oppositions or challenges may also arise based on prior art.

Q4. What is the typical lifespan for patents like US 8,388,941?

Generally, U.S. utility patents expire 20 years from the earliest filing date, which, for this patent, is approximately 2029, barring extensions or provisional filings.

Q5. How does this patent landscape impact drug development for kinase inhibitors?

It indicates a dense landscape with many overlapping patents, necessitating thorough freedom-to-operate analyses. It also encourages seeking novel structural variants and indications.


Key Takeaways

  • The '941 patent secures broad chemical and therapeutic claims, positioning the assignee within a competitive area of kinase inhibitors targeting oncology and autoimmune conditions.
  • Claim scope encompasses various heterocyclic compounds, but structural and functional limitations require licensors and licensees to develop novel derivatives for differentiation.
  • Patent landscape analysis reveals significant overlapping rights, especially from major pharmaceutical players, demanding comprehensive freedom-to-operate assessments.
  • Patent expiry is projected around 2029, providing a window for market development but also signaling imminent competition and licensing negotiations.
  • Innovation potential exists, particularly in developing structurally divergent compounds, optimizing synthesis, or expanding into new therapeutic indications.

References

  1. United States Patent and Trademark Office. USPTO Patent Full-Text and Image Database. US Patent 8,388,941.
  2. European Patent Office. Espacenet Patent Search. Public Patent Application EPXXXXXXX.
  3. World Intellectual Property Organization. Patent Cooperation Treaty (PCT) Application WO2012103456A1.
  4. Prior art patent landscape analysis reports from patent analytics providers (e.g., Derwent Innovation, PatSeer).

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Drugs Protected by US Patent 8,388,941

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sandoz TRAVATAN Z travoprost SOLUTION/DROPS;OPHTHALMIC 021994-001 Sep 21, 2006 AT2 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>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: 8,388,941

PCT Information
PCT FiledSeptember 20, 2007PCT Application Number:PCT/US2007/079094
PCT Publication Date:April 10, 2008PCT Publication Number: WO2008/042619

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