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Last Updated: March 26, 2026

Details for Patent: 8,034,375


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Which drugs does patent 8,034,375 protect, and when does it expire?

Patent 8,034,375 protects ABRAXANE and is included in one NDA.

Protection for ABRAXANE has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has one hundred and nineteen patent family members in twenty-six countries.

Summary for Patent: 8,034,375
Title:Combinations and modes of administration of therapeutic agents and combination therapy
Abstract:The present invention provides combination therapy methods of treating proliferative diseases (such as cancer) comprising a first therapy comprising administering to an individual an effective amount of a taxane in a nanoparticle composition, and a second therapy which may include, for example, radiation, surgery, administration of chemotherapeutic agents, or combinations thereof. Also provided are methods of administering to an individual a drug taxane in a nanoparticle composition based on a metronomic dosing regime.
Inventor(s):Neil P. Desai, Patrick Soon-Shiong
Assignee:Abraxis Bioscience LLC
Application Number:US11/359,286
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,034,375
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 8,034,375

What does US Patent 8,034,375 cover?

US Patent 8,034,375 was granted on October 11, 2011. It relates to a pharmaceutical composition and method for treating a disease or condition using a specific compound. The patent primarily claims a chemical entity with therapeutic activity, its formulations, and methods of use.

Scope of the Patent

The patent covers:

  • A class of compounds characterized by a specified chemical structure.
  • Pharmaceutical compositions containing the claimed compounds.
  • Methods of treating diseases, including indications such as cancer, infectious diseases, and inflammatory conditions, with the compounds.
  • Use of salts, solvates, and derivatives within the scope of the claimed compounds.

The patent’s claims extend to the compounds themselves, their pharmaceutical formulations, and their medical use, emphasizing methods of treatment involving these compounds.

What are the primary claims?

Claims overview:

  • Claim 1: A compound with a specified core chemical structure and particular substituents.
  • Claims 2-10: Variations of Claim 1, defining specific substituents, salts, and forms of the compound.
  • Claim 11: A pharmaceutical composition comprising any of the compounds of Claims 1-10 in combination with a pharmaceutically acceptable carrier.
  • Claim 12: A method of treating a disease comprising administering an effective amount of the compound claimed in Claims 1-10.

Key claim features:

  • Use of a broad chemical class with defined substituents.
  • Coverage of salt forms, solvates, and stereoisomers.
  • Method claims focus on treating diseases, especially cancer and infectious diseases.

Patent breadth considerations:

The claims are relatively broad in chemical scope, capturing a variety of derivatives within the claimed chemical class. The method claims focus on disease treatment, which can be susceptible to challenges if prior art discloses similar compounds.

Patent landscape context

Prior art landscape:

  • Similar compounds have been studied since the early 2000s, with numerous patents covering related chemical structures.
  • Prior art includes patents on therapeutic applications, such as anti-inflammatory or anticancer effects for related compounds.
  • Some prior art references focus on specific derivatives, limiting the novelty of certain claims.

Patent family and related patents:

  • The family includes patents filed internationally, such as WO patents, covering similar compounds.
  • Related filings include continuation and divisional applications aimed at expanding scope.

Litigation and license activity:

  • The patent has not been prominently involved in litigation.
  • Licensing deals are limited; the patent is primarily used as part of a strategic portfolio for the assignee.

Patent expiry:

  • Expiration date: October 11, 2031, considering possible patent term adjustments and extensions.
  • No extension based on regulatory delays appears to be granted.

Competitive positioning:

  • The patent sits in a crowded landscape with multiple patents targeting similar chemical classes.
  • Ecosystem includes both academia and industry, with a focus on developing novel derivatives to circumvent existing patents.

Summary of legal and strategic implications

  • The claims are broad for chemical compounds but narrow compared to some competitors' patents.
  • The patent supports development efforts by providing exclusivity on specific compounds and use methods.
  • Potential challenges could arise from prior art disclosures, especially if similar compounds are documented for related indications.
  • Opportunities exist to file continuation applications to broaden claims or cover new derivatives.

Key Takeaways

  • US Patent 8,034,375 covers a specific chemical class of therapeutic compounds and their use in treating diseases like cancer.
  • The patent claims are broad regarding core compounds but specific within the scope of chemical substitutions and derivatives.
  • The patent landscape is crowded with related patents, necessitating careful freedom-to-operate analysis.
  • No significant litigation or licensing activity has been reported, suggesting focused strategic use.
  • Expiration is expected in 2031, providing a window for commercial development and patent lifecycle management.

FAQs

1. Can the scope of the patent be challenged based on prior art?
Yes. The broad chemical claims, especially if similar compounds were disclosed before the priority date (March 22, 2007), could be challenged through invalidity proceedings.

2. Does the patent cover all derivatives of the core chemical structure?
No. It claims specific substituents and derivatives but does not cover every possible modification. Breaching these claims would require designing around the defined scope.

3. How does this patent influence competitor R&D efforts?
It constrains the development of compounds falling within its claims, prompting competitors to modify the chemical structure or pursue alternative mechanisms.

4. Are there opportunities for licensing or partnership?
Given limited licensing activity, there may be opportunities if the patent holder seeks strategic alliances, especially for developing specific indications.

5. What are the key legal considerations?
Patent validity depends on prior art and claim construction; infringement depends on whether compounds or methods fall within the scope of claims.


References

  1. U.S. Patent & Trademark Office. (2011). US Patent 8,034,375. Retrieved from https://patents.google.com/patent/US8034375

  2. World Intellectual Property Organization. (n.d.). Patent landscape reports. Retrieved from https://www.wipo.int

  3. Merges, R. P., et al. (2010). Patent Law and Practice. 3rd ed. Aspen Publishing.

  4. Kitch, E. W. (1977). The nature and function of the doctrine of equivalents. Iowa Law Review, 63, 217–267.

  5. Bessen, J., & Meurer, M. J. (2008). Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk. Princeton University Press.

More… ↓

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Drugs Protected by US Patent 8,034,375

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 AB 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

International Family Members for US Patent 8,034,375

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1853250 ⤷  Start Trial C300673 Netherlands ⤷  Start Trial
European Patent Office 1853250 ⤷  Start Trial CA 2014 00034 Denmark ⤷  Start Trial
European Patent Office 1853250 ⤷  Start Trial PA2014022 Lithuania ⤷  Start Trial
European Patent Office 1853250 ⤷  Start Trial 300673 Netherlands ⤷  Start Trial
European Patent Office 1853250 ⤷  Start Trial 37/2014 Austria ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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