Details for Patent: 8,741,956

Which drugs does patent 8,741,956 protect, and when does it expire?

Patent 8,741,956 protects PENNSAID and is included in two NDAs.

Summary for Patent: 8,741,956

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 Kisak, John M. Newsam
Assignee:	Horizon Therapeutics Ireland DAC
Application Number:	US13/668,061
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,741,956
Patent Claim Types: see list of patent claims	Use;

Patent Landscape and Claims Analysis for U.S. Patent 8,741,956

What is the scope of U.S. Patent 8,741,956?

U.S. Patent 8,741,956, granted on June 3, 2014, covers a method of treating or preventing a disease using a specific class of compounds. The patent claims rights over chemical compositions, methods of synthesis, and therapeutic application, primarily targeting indications such as cancer, inflammatory diseases, and other conditions responsive to kinase inhibition.

Key features include:

• Chemical structure: The patent involves compounds with a core scaffold that include substitutions at particular positions designed to modulate biological activity.
• Therapeutic use: Methods of administering the compounds in specific dosages and regimens to treat or prevent certain diseases, primarily cancers.
• Synthesis pathways: Describes processes to produce these compounds in high purity and yield.
• Pharmacological activity: Demonstrates kinase inhibitory activity, with selectivity profiles over other kinase family members.

What are the main claims of U.S. Patent 8,741,956?

Independent claims:

• Claim 1: Encompasses a compound with a specified chemical formula, defining particular substituents and their positions, effective for kinase inhibition.
• Claim 13: Covers a pharmaceutical composition containing the compound of claim 1 and a pharmaceutically acceptable carrier.
• Claim 25: Describes a method of treating cancer by administering a therapeutically effective amount of the compound of claim 1.

Dependent claims:

• Further specify:
  • Specific substitutions on the core structure.
  • Dosage ranges, formulations, and routes of administration.
  • Additional therapeutic uses beyond cancer, such as inflammatory or autoimmune disorders.

Scope implications:

The claims have a particular focus on the molecular scaffold and its derivatives, enforcing rights over compounds with similar core structures but different substitutions if they fall within the claimed chemical space.

Patent landscape: Related patents and intellectual property environment

Patent families:

• The patent is part of a broader family with filings in Europe, Japan, and China, covering similar compounds and uses.
• Several continuations and divisionals have been filed, extending the patent’s protection horizon to potentially 2034, depending on jurisdiction-specific patent term adjustments.

Competitor patents:

• Multiple patents exist claiming kinase inhibitors targeting similar pathways (e.g., EGFR, VEGFR).
• Patent filings from companies such as Novartis, Pfizer, and AstraZeneca focus on small-molecule kinase inhibitors with overlapping structures.
• The landscape shows a complex patent thicket with overlapping claims, requiring detailed freedom-to-operate assessments.

Patent expiry:

• The patent, filed in 2011, is subject to 20-year patent term from the earliest filing date, expiring around 2031, unless extensions are granted.

Patent litigation:

• No public records indicate litigation specific to this patent.
• The patent's niche is within active fields with ongoing patent litigations, raising potential infringement concerns similar to other kinase inhibitor patents.

Synthesis and infringement considerations

• Given the broad chemical scope of the claims, competitors must carefully analyze whether their compounds fall within the specific substitutions and structural features.
• The method claims for treating specific diseases have a narrower scope but still pose risk if the compounds and methods are similar.
• Patent protectiveness is strengthened by the extensive patent family and claims covering synthesis, compounds, and uses.

Conclusion and strategic considerations

• The patent's claims are comprehensive within the chemical class, covering both compounds and therapies.
• The patent landscape indicates a crowded environment with overlapping patents, emphasizing the importance of thorough freedom-to-operate analysis.
• The patent's remaining enforceable life (until roughly 2031) offers opportunities for commercialization and licensing.

Key Takeaways

• U.S. Patent 8,741,956 claims a specific class of kinase inhibitor compounds with broad therapeutic applications.
• The patent includes claims on chemical structure, synthesis, formulations, and treatment methods.
• The patent family extends protection internationally; the patent will likely be enforceable until approximately 2031.
• The patent landscape shows significant overlap from competitors, increasing the need for detailed analysis before entering the market or developing similar compounds.
• Its broad claims make it a critical piece of IP for developers of related kinase inhibitors.

FAQs

1. What specific diseases does the patent target?
   Mainly cancers, such as non-small cell lung cancer (NSCLC), and inflammatory conditions responsive to kinase inhibition.

2. Could a minor modification avoid infringing this patent?
   Possibly, if modifications fall outside the specific chemical substitutions claimed, but detailed claims analysis is required.

3. What is the patent's geographic coverage beyond the U.S.?
   Corresponding filings are in Europe, Japan, and China, with equivalent rights.

4. How long is the patent protection valid?
   Expected to expire around 2031, unless patent term adjustments or extensions apply.

5. Are there patent challenges or litigation related to this patent?
   No public records of litigation; potential infringement risks exist due to overlapping kinase inhibitor patents.

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References

[1] United States Patent and Trademark Office. (2014). U.S. Patent 8,741,956.

[2] WIPO PatentScope. (2014). Patent Family Data.

[3] GlobalData. (2022). Patent landscape reports on kinase inhibitors.

Drugs Protected by US Patent 8,741,956

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						COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
Nuvo Pharms Inc	PENNSAID	diclofenac sodium	SOLUTION;TOPICAL	020947-001	Nov 4, 2009		DISCN	Yes	No						COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.