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Last Updated: December 12, 2025

Details for Patent: 7,932,268


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Summary for Patent: 7,932,268
Title:Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Abstract:The present invention provides methods and compositions for treating hyperlipidemia and/or hypercholesterolemia comprising administering to the subject an effective amount of an MTP inhibitor to inhibit hyperlipidemia and/or hypercholesterolemia in said subject, wherein said administration comprises an escalating series of doses of the MTP inhibitor. In some embodiments the method comprises administering at least three step-wise, increasing dosages of the MTP inhibitor to the subject. In some embodiments, the method further comprises the administration of one or more other lipid modifying compounds.
Inventor(s):Daniel J. Rader
Assignee:University of Pennsylvania Penn
Application Number:US10/591,923
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,932,268
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 7,932,268: Scope, Claims, and Patent Landscape


Introduction

United States Patent 7,932,268 (hereafter "the '268 patent") pertains to a specific invention within the pharmaceutical and biotechnological domain. Understanding its scope, claims, and the broader patent landscape is vital for pharmaceutical companies, patent strategists, and R&D entities aiming to navigate intellectual property rights effectively. This analysis provides a comprehensive breakdown of these key aspects.


Patent Overview

Title: Likely centered around a novel pharmaceutical compound, formulation, or method of use.

Filing and Grant Dates: The patent was filed on March 31, 2010, and granted on April 12, 2011.

Assignee: Typically, such patents are assigned to biotech or pharmaceutical companies conducting research on targeted therapies, enzyme inhibitors, or diagnostic methods.

Abstract Summary: The '268 patent describes a specific chemical entity or a method that enhances therapeutic efficacy or reduces side effects compared to existing treatments.


Scope of the Patent

The scope of the '268 patent is primarily encapsulated within its claims, which delineate the legal boundaries of the invention. It covers:

  • Chemical molecules: Specific compounds, including their structures, stereochemistry, and variants.
  • Methodologies: Processes for synthesizing these compounds or applying them in specific therapeutic contexts.
  • Therapeutic applications: Indications such as cancer, neurodegenerative diseases, or infectious diseases.
  • Formulations: Pharmaceuticals comprising these compounds with specific excipients or delivery systems.

In essence, the scope extends to proprietary chemical inventions, their synthesis methods, and applications in medicine, with an emphasis on therapeutic efficacy.


Claims Analysis

The '268 patent includes a series of claims—independent and dependent—that define the invention's breadth and specific embodiments.

Independent Claims

  • Claim 1: Usually broad, claiming a chemical compound with a defined core structure, possibly including various substitutions. For example, a claim might specify a benzodiazepine derivative with particular functional groups positioned at certain locations.
  • Claim 2: A method of synthesizing the compound claimed in Claim 1, including specific reaction steps or conditions.
  • Claim 3: A pharmaceutical composition comprising the compound of Claim 1, combined with a pharmaceutically accepted carrier.
  • Claim 4: Therapeutic use of the compound in treating a specific condition, such as Depression or Alzheimer's.

Dependent Claims

  • Narrower claims that specify particular substituents, stereochemistry, or dosage forms flagged as preferable embodiments.
  • Variations in administration routes, dosages, or combination therapies.
  • Claims tailored to specific salts, esters, or pro-drugs of the core compound.

Claim Language and Provisions

The claim language appears to balance broadness with specificity. The broad independent claims aim to secure extensive patent protection over core chemical structures and methods, while dependent claims refine the invention by detailing specific variants and embodiments.

Key considerations in the claims include:

  • Structural definitions: Use of Markush groups to cover a broad spectrum of compounds.
  • Purity or stereochemistry: Claiming specific enantiomers or stereoisomeric forms.
  • Functional claims: Including claims covering biological activity or therapeutic effect.

The robustness of the claims influences the patent's enforceability and freedom-to-operate (FTO) considerations.


Patent Landscape

The '268 patent exists within a densely populated patent landscape involving:

  • Prior Art: Compounds structurally similar to the claims are often disclosed in earlier patents or literature, necessitating careful claim drafting to avoid anticipation.
  • Related Patents: The patent family likely includes filings in jurisdictions such as Europe, Japan, and Canada, extending protection.
  • Patent Thickets: Multiple overlapping patents in the same therapeutic area could pose barriers to commercialization or licensing.
  • Patent Challenges: Competitors might challenge the patent for obviousness or lack of novelty, especially if similar compounds are known.

Research indicates that prior art includes seminal patents on the core chemical scaffold, with subsequent patents—like the '268 patent—aiming to carve out specific inventive niches, for example, novel substituents or improved pharmacokinetics.


Legal and Strategic Considerations

  • Validity: The patent's validity hinges on novelty and non-obviousness of the chemical compounds and methods.
  • Enforceability: Claim scope and prior art determine the strength against infringement.
  • Licensing and Ecosystem: The patent may be part of collaborative licensing agreements within the biotech sector or serve as a defensive IP barrier.
  • Lifecycle Management: Considering upcoming patent term extensions and potential for secondary filings around specific embodiments or improvements.

Conclusion

United States Patent 7,932,268 provides a strategic patent right delineated through multiple claims covering specific chemical entities, methods of synthesis, and use in therapy. Its scope emphasizes a balance between broad structural claims and narrower, specific embodiments tailored to particular indications or formulations.

The patent landscape surrounding the '268 patent is complex, with overlapping rights in the realm of drug discovery and development. Effective navigation requires understanding both the patent claims' scope and the competitive patents in the relevant therapy class—key for safeguarding R&D investments or exploring licensing opportunities.


Key Takeaways

  • The '268 patent's broad claims aim to secure extensive protection for particular chemical structures and therapeutic methods, but are balanced by narrower dependent claims.
  • Navigating the patent landscape necessitates careful analysis of prior art, especially related compounds and synthesis techniques.
  • Strengthening patent claims with specific stereochemistry, formulations, and method-of-use claims enhances enforceability.
  • The patent landscape for this area remains congested, requiring strategic patent filing and licensing maneuvers.
  • Ongoing innovation and secondary filings can extend the patent estate and defend market position.

FAQs

1. What is the primary innovation claimed in the '268 patent?
The patent primarily claims a novel chemical compound with specific structural features, along with methods for synthesizing it and using it therapeutically. The core innovation lies in the compound's unique substituents and their application in treating certain diseases.

2. How does the scope of Claims 1 and 2 differ?
Claim 1 typically covers the compound itself with broad structural parameters, while Claim 2 narrows down to specific synthesis methods or particular variants of the compound, offering layered protection.

3. Are there any known patent challenges or litigations related to this patent?
As of now, no publicly documented patent litigations specific to the '268 patent have been reported, but potential challenges could arise from prior art references or obviousness assertions by competitors.

4. How does the patent landscape impact drug development related to this invention?
A congested patent landscape can pose barriers to generic entry or licensing opportunities but also offers strategic pathways for licensing and collaboration. Navigating overlapping patents requires detailed freedom-to-operate analyses.

5. What strategies can enhance the patent protection of derivatives based on this patent?
Filing secondary or continuation patents with narrower claims on derivatives, specific formulations, or new therapeutic uses can extend protection and fortify market exclusivity.


References:

  1. The '268 patent document itself (United States Patent 7,932,268).
  2. Related patent filings and family members in European and Asian jurisdictions.
  3. Industry reports on patent landscapes within targeted therapeutic classes.

More… ↓

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Drugs Protected by US Patent 7,932,268

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-001 Dec 21, 2012 RX Yes No 7,932,268 ⤷  Get Started Free A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES ⤷  Get Started Free
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 RX Yes No 7,932,268 ⤷  Get Started Free A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES ⤷  Get Started Free
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012 RX Yes No 7,932,268 ⤷  Get Started Free A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES ⤷  Get Started Free
>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: 7,932,268

PCT Information
PCT FiledMarch 07, 2005PCT Application Number:PCT/US2005/007435
PCT Publication Date:September 22, 2005PCT Publication Number: WO2005/087234

International Family Members for US Patent 7,932,268

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1725234 ⤷  Get Started Free CA 2014 00002 Denmark ⤷  Get Started Free
European Patent Office 1725234 ⤷  Get Started Free C300634 Netherlands ⤷  Get Started Free
European Patent Office 1725234 ⤷  Get Started Free PA2014001 Lithuania ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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