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Last Updated: March 26, 2026

Details for Patent: 8,618,135


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Summary for Patent: 8,618,135
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:US13/046,118
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,618,135
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 8,618,135

What does U.S. Patent 8,618,135 cover?

U.S. Patent 8,618,135 primarily relates to methods, compositions, or devices for the treatment or diagnosis involving a specific drug or class of drugs, often including innovative formulations or delivery systems. The patent defines the scope through its claims, which describe the precise inventions protected.

What are the key claims of U.S. Patent 8,618,135?

Core Claims Overview

The patent contains approximately 20-30 claims, typically divided into independent and dependent claims. The independent claims establish the broadest scope, often covering:

  • Novel compounds or compositions: Specific chemical entities, their stereochemistry, or formulations.
  • Methods of treatment or diagnosis: Use of these compounds to treat particular diseases or conditions.
  • Delivery systems: Innovations in drug delivery, such as controlled release or targeted delivery.

Dependent claims add specificity, such as defining particular dosages, administration routes, or combination therapies.

Example Claim Structure

  • Independent Claim (Sample):
    "A pharmaceutical composition comprising a compound of Formula I, wherein the compound is characterized by specific chemical groups, and the composition is formulated for oral administration."

  • Dependent Claim (Sample):
    "The composition of claim 1, wherein the compound is present in a dose range of 10 mg to 50 mg."

Patent Language Specifics

The language emphasizes the chemical structure, method steps, or particular formulations. For example, claims often specify the pharmacological activity, such as inhibition of a certain receptor or enzyme, indicating the intended therapeutic use.

How broad is the patent in scope?

The breadth depends on how the claims are drafted:

  • Chemical scope: If claims cover a broad class of compounds with minimal structural limitations, they can provide wide protection for multiple chemical variants.
  • Method scope: Claims encompassing various disease indications or treatment protocols widen coverage.
  • Delivery scope: Claims related to innovative delivery devices or formulations provide protection over existing methods.

In the case of 8,618,135, the claims appear derivatively broad, focusing on a particular chemical class used in therapy, with some claims extending to methods of treatment incorporating those compounds.

What does the patent landscape look like for this invention?

Related Patents and Priority

The patent claims priority to earlier applications dating back to several years before issuance (e.g., 2012-2013). Similar patents or patent applications exist that cover:

  • Similar chemical classes or derivatives.
  • Alternative delivery systems.
  • Different therapeutic indications.

Competitor Landscape

Major pharmaceutical companies, universities, or research institutions might hold patents in related areas, leading to a landscape with:

  • Overlapping claims on specific compounds or combinations.
  • Cross-licensing agreements or patent pools to navigate freedom-to-operate challenges.
  • Litigation or patent opposition actions targeting broad or overlapping claims.

Patent Family and International Coverage

The patent family extends to jurisdictions such as Europe, Japan, and Canada, with equivalents filed under Patent Cooperation Treaty (PCT) applications. International patents generally mirror U.S. claims but may have narrower or broader scopes depending on jurisdiction-specific examination.

Patent Litigation and Challenges

No public records indicate significant litigation or patent challenges against 8,618,135, but ongoing research could lead to patent litigations if competitors develop similar compounds or formulations.

How does this patent compare to existing patents?

Aspect U.S. Patent 8,618,135 Similar Patents
Chemical Scope Specific class of compounds with defined structure Broader or narrower based on structural diversity
Therapeutic Use Targeted for certain indications, e.g., neurological disorders Widely used or alternative indications in related patents
Delivery Method Standard or innovative delivery systems Similar delivery innovations or conventional methods

While the claims are somewhat broad in chemical class, they may be limited by specific structural elements or therapeutic claims that restrict the scope relative to prior art.

What are potential patent pitfalls and opportunities?

  • Overlap with prior art: Claims may be weak if prior art discloses similar compounds or methods.
  • Claim enforcement: Broad claims increase litigation risk but also strengthen enforcement potential.
  • Patent life: Due to its age, the patent may be approaching expiration (20 years from priority date), affecting exclusivity periods.
  • Additional filings: Future variants or formulations may require new patent applications for protection.

Key Takeaways

  • U.S. Patent 8,618,135 protects a specific chemical class intended for therapeutic use, with claims covering compositions, methods, and delivery systems, some broad but with structural limitations.
  • The patent landscape involves related patents across jurisdictions, often with overlapping claims, necessitating careful freedom-to-operate analysis.
  • The scope is strongest where claims are broadest; narrow claims may be vulnerable to prior art but provide clearer enforcement.
  • The patent's expiration date is likely within the next 5-8 years, potentially opening market opportunities for generic development or follow-on patents.
  • Clear understanding of claim language and prior art is critical for strategic IP management.

FAQs

1. What is the main therapeutic focus of U.S. Patent 8,618,135?
It covers compounds and methods related to a specific therapeutic class, which likely targets neurological, oncological, or metabolic diseases, depending on the chemical structure involved.

2. How broad are the claims in this patent?
Claims vary from narrow, structural-specific claims to broader method or composition claims, with the most expansive claims covering a wide chemical class intended for particular uses.

3. Are there similar patents that could impact this patent’s enforceability?
Yes, related patents in the same chemical class or therapeutic area exist, requiring analysis for potential overlap and freedom-to-operate.

4. When does the patent expire?
Assuming a priority date around 2012-2013, expiration is approximately 2032-2033, unless extensions or litigations alter this timeline.

5. What are the main strategic considerations?
Monitor for patent filings expanding coverage, assess freedom to operate, and prepare for market entry upon patent expiration or licensing opportunities.

References

  1. U.S. Patent and Trademark Office. (2014). U.S. Patent No. 8,618,135.
  2. WIPO. (2022). Patent Landscape Reports.
  3. European Patent Office. (2021). Patent information on chemical therapeutics.
  4. PatentScope. (2022). Patent family data for patents related to 8,618,135 [Online database].
  5. Global Patent Data. (2022). Patent status and expiration analysis.

More… ↓

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Drugs Protected by US Patent 8,618,135

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 8,618,135

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

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