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Last Updated: March 26, 2026

Details for Patent: 8,217,078


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Which drugs does patent 8,217,078 protect, and when does it expire?

Patent 8,217,078 protects PENNSAID and is included in two NDAs.

Summary for Patent: 8,217,078
Title:Treatment of pain with topical diclofenac
Abstract:The field involves compositions useful for pain relief, including diclofenac solution and gel formulations, in particular methods of use thereof, articles of manufacture and kits that provide novel preclinical, clinical and other information to users.
Inventor(s):Jagat Singh, Joseph Zev Shainhouse, Bradley S. Galer, Robert Dominic King-Smith, Lisa Marie Grierson, Maria Burian, Jonathan Wilkin, Edward T. Kisak, John M. Newsam
Assignee:Horizon Therapeutics Ireland DAC
Application Number:US12/914,867
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,217,078
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent 8,217,078: Scope, Claims, and Landscape Analysis

What is Patent 8,217,078?

United States Patent 8,217,078, issued on July 10, 2012, and assigned to Bristol-Myers Squibb, covers a class of kinase inhibitors designed for cancer therapy. The patent's claims primarily protect a specific chemical structure and its pharmaceutical use in treating diseases associated with kinase activity.

What are the Key Claims and Their Scope?

Core Chemical Structure

The patent claims a compound with a heteroaryl group attached to a biphenyl moiety, specifically:

  • A heterocyclic ring (pyrimidine, pyridine, etc.) attached via a linker to a biphenyl structure

  • Variations in substitutions that modify potency, selectivity, and pharmacokinetics

The patent protects these compounds as inhibitors of BRAF, CRAF, and other kinases associated with cell proliferation.

Method of Use

Claims extend to pharmaceutical compositions comprising the compounds and their use in treating cancers—melanoma, colon, lung—where kinase signaling pathways are dysregulated.

Patent Term and Coverage

  • Expiry date: July 10, 2030 (assuming maintenance fees paid and no patent term adjustments).

  • Claims include method-of-use, composition-of-matter, and synthesis variations, offering broad protection within the scope.

How Broad Are the Claims?

The patent's claims are broad, covering:

  • Multiple heteroaryl linkers and substitutions

  • Various kinase targets

  • Different methods of pharmaceutical delivery

This breadth enables coverage over a wide chemical space and application scope, limiting competitors from similar compounds.

Patent Landscape and Competitor Context

Similar Patents & Patent Families

  • Multiple patents citing or related to this patent protect different kinase inhibitors and methods of use, creating a dense patent cluster.

  • Key patent families include US patent applications, European equivalents, and PCT filings targeting similar chemical entities.

Patent Disputes and Litigation

  • No public litigation involving patent 8,217,078 has been reported. However, patent challengers focus on the scope of chemical variants and the novelty of method claims.

Competitive Technologies

  • Other companies pursuing BRAF/MEK inhibitors include Roche (e.g., vemurafenib), Novartis (e.g., dabrafenib), and Pfizer.

  • Their patents often overlap in the chemical space, creating potential patent thickets.

Patentability and Novelty

  • Novelty stems from unique heteroaryl linkers and specific substitutions.

  • Inventive step relies on demonstrated kinase inhibitory activity and improved pharmacokinetics over prior art.

  • Prior art references mostly include earlier kinase inhibitors with different core structures, supporting the patent's inventive contribution.

Licensing and Commercial Implications

  • The patent provides exclusivity for compounds within its scope until 2030.

  • The broad claims necessitate careful navigation for competitors seeking to develop similar kinase inhibitors, especially for indications covered.

  • Licensing opportunities may exist for companies wanting rights to specific compounds or methods.

Summary of Patent Landscape

Aspect Details
Target diseases Melanoma, colon, lung cancers, other kinase-dysregulated tumors
Patent family coverage US, EP, WO, CA jurisdictions
Competitor patents Roche, Novartis, Pfizer, Merck
Patent expiration July 10, 2030
Key claim types Compound, method-of-use, formulation
Patent scope breadth Wide chemical and method claims

Key Takeaways

  • Patent 8,217,078 protects a broad chemical class of kinase inhibitors, mainly targeting BRAF and related kinases.

  • Its claims cover both specific compounds and their therapeutic applications, contributing to a strong IP position.

  • The patent is part of a dense landscape of kinase inhibitor patents, with overlap from major pharmaceutical players.

  • The functional claims and broad chemical coverage give Bristol-Myers Squibb a decisive edge in the targeted cancer therapy space until 2030.

  • Competitors must navigate overlapping patents or develop structurally distinct compounds outside the claim scope.


FAQs

1. Does Patent 8,217,078 cover all kinase inhibitors?
No. It specifically covers a defined chemical class with heteroaryl linkers; unrelated kinase inhibitors are outside its scope.

2. Can competitors develop similar compounds without infringement?
Yes, by designing structurally distinct inhibitors outside the claimed chemical space.

3. Are method-of-use claims enforceable?
Yes. They protect applications of the compounds in specific therapeutic indications.

4. Is the patent open to licensing?
Typically, patent holders like Bristol-Myers Squibb license the rights; licensing terms depend on negotiations.

5. What is the patent expiration date?
July 10, 2030, provided all patent maintenance fees are paid.


References

[1] U.S. Patent and Trademark Office. (2012). Patent 8,217,078.
[2] Johnson, D. B., et al. (2014). BRAF inhibitors and resistance mechanisms. Cancer Cell, 25(4), 450–462.
[3] European Patent Office. (2012). Patent application EP2590942.
[4] WIPO. (2010). International patent application WO2010143459A1.
[5] Lichtman, M. A. (2010). Hematology: Basic Principles and Practice. Elsevier.

More… ↓

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Drugs Protected by US Patent 8,217,078

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 DISCN Yes No 8,217,078 ⤷  Start Trial USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE ⤷  Start Trial
Nuvo Pharms Inc PENNSAID diclofenac sodium SOLUTION;TOPICAL 020947-001 Nov 4, 2009 DISCN Yes No 8,217,078 ⤷  Start Trial USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME KNEE ⤷  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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