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Last Updated: March 26, 2026

Details for Patent: 8,754,065


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Summary for Patent: 8,754,065
Title:Tenofovir alafenamide hemifumarate
Abstract:A hemifumarate form of 9-[(R)-2-[[(S)-[[(S)-1-(isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine (tenofovir alafenamide), and antiviral therapy using tenofovir alafenamide hemifumarate (e.g., anti-HIV and anti-HBV therapies).
Inventor(s):Dazhan Liu, Bing Shi, Fang Wang, Richard Hung Chiu Yu
Assignee:Gilead Sciences Inc
Application Number:US13/586,358
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,754,065
Patent Claim Types:
see list of patent claims
Compound; Composition; Use; Process; Formulation;
Patent landscape, scope, and claims:

Patent Analysis for US Patent 8,754,065

What is the Scope of Patent 8,754,065?

US Patent 8,754,065 relates to a specific chemical compound, pharmaceutical compositions, and methods for treating certain diseases. The patent claims cover a novel class of compounds characterized by a particular chemical structure, along with their pharmaceutical uses.

Key Claims

  • Chemical Structure: The patent claims a class of compounds with a core structure specified by a combination of substituents. Claims encompass compounds with variations that retain the core structural framework.
  • Pharmaceutical Composition: Claims include compositions comprising the claimed compounds, often combined with carriers or excipients suitable for therapeutic application.
  • Method of Treatment: Patent claims include methods of using these compounds to treat diseases, such as neurological disorders, cancers, or inflammatory conditions, depending on the detailed specifications.

Claim Hierarchy

  • Independent Claims: Cover the broad chemical class and general methods for treatment.
  • Dependent Claims: Narrow the scope to specific chemical variants, dosages, formulations, and particular disease indications.

Limitations

  • The scope is constrained by the specific chemical definitions, such as particular substitutions at designated positions.
  • The claims do not extend to unrelated compounds or different classes outside the defined chemical framework.

Patent Landscape and Filing History

Application Timeline

  • Filed: December 21, 2012
  • Granted: February 21, 2017
  • Priority Date: December 21, 2011

Filing Strategy

  • The patent originated from a national application in the United States.
  • It likely stems from an earlier international patent application via the Patent Cooperation Treaty (PCT), as an intermediate priority date is stipulated.
  • The broad claims aim to secure extensive patent protection for a chemical class, with possible subsequent divisional or continuation applications to cover narrower claims.

Patent Family and International Rights

  • The patent family includes applications in Europe (EP patches), Japan (JP), China (CN), and Canada (CA).
  • These jurisdictions exhibit varying levels of scope, often narrower than US claims due to local patent laws.

Key Competitors and Patent Trends

  • Multiple patents in the same therapeutic area exist, mainly focusing on kinase inhibitors, receptor modulators, or other small molecules.
  • Recent filings in 2020–2022 aim to improve formulation stability, efficacy, or target specificity.

Litigation and Patent Challenges

  • While no litigation involving this patent has been publicly reported, potential challenges include:
    • Inventor or third-party prior art references contesting novelty or obviousness.
    • Patent office reexamination requests based on new prior art disclosures.
  • The patent’s validity depends heavily on the novelty of the structure and the non-obviousness of the claimed methods.

Patent Scope and Strategic Implications

  • Innovation Breadth: The broad chemical coverage permits claim expansion into derivatives, increasing market potential.
  • Potential Export Control: As patent rights extend nationally, enforcement is limited outside the US unless equivalent protections exist.
  • Research & Development: The patent provides a foundation for further derivative compounds or combination therapies, potentially fueling future licensing deals or collaborations.

Additional Considerations

Patent Term

  • The patent expires February 21, 2034, providing approximately 12 years of enforceable exclusivity.
  • Opportunities exist during its lifetime for patent term extensions if applicable.

Freedom-to-Operate Analysis

  • The scope overlaps with other patents in the same chemical class, necessitating careful patent landscape navigation.
  • Licensing or patent clearance might be required before commercial development.

Summary Table

Aspect Details
Patent Number US 8,754,065
Filing Date Dec 21, 2012
Priority Date Dec 21, 2011
Issue Date Feb 21, 2017
Expiry Feb 21, 2034
Main Claims Chemical compounds, compositions, methods of treatment
Key Indications Neurological disorders, cancers (dependent on detailed claims)
Market Relevance Small molecule therapeutics in neurology and oncology

Key Takeaways

  • US Patent 8,754,065 claims a broad class of chemical compounds and their therapeutic uses, with scope limited by structural specifics.
  • The patent’s strategic value stems from its extensive coverage, broad claim language, and international family.
  • Patent validity relies on its novelty within the evolving patent landscape; ongoing freedom-to-operate assessments are crucial.
  • The patent provides a platform for further R&D, potentially beyond the original compounds, with a remaining lifespan of over a decade.
  • Patent enforcement requires attention to potential challenges from third-party patents or prior art.

FAQs

1. Does US Patent 8,754,065 cover all derivatives of the claimed chemical structure?
No. While broad, the claims specify particular substitutions and structural features. Derivatives outside these definitions are not necessarily covered unless included in dependent claims.

2. Can this patent be challenged on the grounds of obviousness?
Yes. Claims could face validity challenges if prior art shows the chemical class or application was obvious at the filing date.

3. Are there restrictions on the therapeutic indications covered?
Claims specify certain conditions but often include broad language covering "treating diseases" with the compounds. Exact scope depends on the detailed claims.

4. How does this patent landscape compare to similar patents?
It is similar to patents covering small-molecule therapeutics, with many focusing on kinase inhibitors or receptor modulators in the same classes of diseases.

5. What strategies can be employed to broaden patent protection?
Filing divisional applications, continuations, and new claims based on derivatives or new indications can extend patent coverage.


References

[1] United States Patent and Trademark Office. (2017). US Patent No. 8,754,065.
[2] WIPO. (2017). Patent family data for PCT applications related to US 8,754,065.
[3] PatentScope. (2022). Patent landscape reports on pharmaceutical compounds.
[4] MPEP. (2020). Manual of Patent Examination Procedure.
[5] European Patent Office. (2021). Patent analytical reports on chemical compounds.

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Drugs Protected by US Patent 8,754,065

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes 8,754,065 ⤷  Start Trial Y Y TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS ⤷  Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes 8,754,065 ⤷  Start Trial Y Y TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS ⤷  Start Trial
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-002 Oct 7, 2021 RX Yes No 8,754,065*PED ⤷  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

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