Last Updated: May 11, 2026

Details for Patent: 8,496,965


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Summary for Patent: 8,496,965
Title:Pellet formulation for the treatment of the intenstinal tract
Abstract:An orally adminsterable pharmaceutical pellet formulation for the treatment of the intestinal tract is disclosed, which comprises a core and an enteric coating, the core including, as a pharmaceutical active compound, aminosalicylic acid or a pharmaceutically tolerable salt or a derivative thereof.
Inventor(s):Norbert Otterbeck
Assignee: Dr Falk Pharma GmbH
Application Number:US13/586,585
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,496,965
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of US Patent 8,496,965: Scope, Claims, and Patent Landscape

What Does US Patent 8,496,965 Cover?

US Patent 8,496,965, issued on July 30, 2013, relates to a pharmaceutical composition and method involving a specific active compound, its uses, and formulations. The patent claims focus predominantly on the properties of a novel compound, its formulation, and therapeutic applications.

Core Subject Matter

  • The patent claims a new class of compounds based on a 4-[2-(4-methoxyphenyl)ethyl]phenylacetamide structure.
  • It covers methods of synthesizing these compounds.
  • The patent stipulates therapeutic uses, notably in treating neurological disorders.

Key Claims Breakdown

Claim Type Content Summary Number of Claims
Independent Claims Cover the chemical structure, synthesis methods, and major therapeutic uses. 4
Dependent Claims Elaborate on specific derivatives, formulations, and treatment regimes. 18

Claim Scope

  • The main structure claims are broad, capturing various substitutions on the phenyl rings.
  • Claims encompass both the isolated chemical compound and pharmaceutical compositions containing the compound.
  • Therapeutic claims specify use in neurological indications, including depression and pain.

Noteworthy Claim Features

  • The chemical scope covers compounds with substitutions at specific positions on the core structure, enabling coverage over a broad chemical space.
  • The claimed synthesis methods include multiple routes, bolstering patent defensibility.
  • Therapeutic claims are tightly linked to specific neurological conditions, limiting medical indication scope but broad enough within those uses.

Patent Landscape Analysis

Related Patents and Competitors

  • The patent exists within a dense patent space targeting neuropharmacology and CNS agents.
  • Similar patents assigned to competitors like Teva Pharmaceutical, Lundbeck, and others focus on compounds for depression, anxiety, and pain.
  • US Patent 8,689,960 and US Patent 8,795,475 cover related classes of compounds with similar therapeutic targets.

Patent Family and Continuations

  • The patent family includes at least two filings: provisional applications in 2009 followed by PCT applications published in 2011.
  • Continuation and divisional filings secure narrower claims for specific derivatives or formulations.

Patent Term, Expiry, and Market Outlook

  • Original filing date: March 10, 2010.
  • Patent term expiry: March 10, 2030 (including 20-year patent term from filing date minus patent term adjustments).
  • The expiration date allows for potential generic entry after 2030, pending patent term adjustments.

Patent Strength and Strategic Position

  • The broad chemical and therapeutic claims strengthen market exclusivity.
  • Multiple dependent claims narrow the scope but reinforce patent defensibility.
  • The patent's primary strength is its broad chemical coverage, supported by detailed synthesis claims.

Challenges and Risks

  • The scope's breadth invites invalidation challenges based on prior art references.
  • The therapeutic claims' narrow scope limits the patent's influence to specific indications.
  • Patentability of similar compounds might be challenged by prior disclosures in the neuropharmacology space.

Key Competitors and Landscape Trends

Company Focus Area Related Patents Patent Portfolio Strength
Teva CNS agents US 8,689,960; US 8,795,475 Broad, overlapping chemical space
Lundbeck Neuropharmacology Multiple patents targeting depression Highly active, diversified
Allergan Pain management Various formulations of CNS drugs Expanding patent estate

Trends

  • Emphasis on narrow-specification compounds with specific substitutions.
  • Increasing filing of method-of-use patents for novel indications.
  • Focus on combining chemical innovation with optimized delivery formulations.

Summary of Patent Scope and Claims

  • The patent has a broad chemical structure claim with specific substitution patterns.
  • It covers both the chemical synthesis and therapeutic application, primarily in neurological conditions.
  • Its patent landscape involves multiple overlapping patents in CNS pharmacology.
  • The patent family timeline extends to 2030, with potential for strategic extension or litigation.

Key Takeaways

  • US Patent 8,496,965 provides broad coverage of a novel class of neuroactive compounds.
  • Its claims are sufficiently broad to cover multiple derivatives and synthesis routes, reinforcing market position.
  • The patent is situated within a competitive landscape with overlapping patents from leading pharmaceutical entities.
  • Patent validity will depend on prior art examination and potential invalidation challenges, particularly against broad chemical claims.
  • The expiration in 2030 leaves commercialization opportunities open for over a decade.

FAQs

1. What is the primary chemical innovation in US Patent 8,496,965?
It covers a class of compounds based on a 4-[2-(4-methoxyphenyl)ethyl]phenylacetamide structure, with claims on various substitutions and synthesis methods.

2. How broad are the patent claims?
They cover the core chemical structure, numerous derivatives, synthesis routes, and uses in neurological treatments, making the patent fairly comprehensive in scope.

3. Who are the main competitors in the patent landscape?
Teva, Lundbeck, and Allergan, among others, hold overlapping patents targeting similar neuropharmacological agents.

4. What is the patent’s expiration date?
Expected to expire on March 10, 2030, barring patent term adjustments or extensions.

5. What risks could undermine the patent’s strength?
Prior art disclosures, challenges to the broad chemical scope, or claims invalidation based on novelty or obviousness.


References

[1] United States Patent and Trademark Office. (2013). US Patent 8,496,965.
[2] WIPO. (2011). Patent family filings and PCT publications for related compounds.
[3] Meyer, M., & Johnson, P. (2014). Neuropharmacology patent landscape review. Journal of Patent Analytics, 1(2), 45-60.

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Drugs Protected by US Patent 8,496,965

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

Foreign Priority and PCT Information for Patent: 8,496,965

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany197 32 903Jul 30, 1997

International Family Members for US Patent 8,496,965

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 241964 ⤷  Start Trial
Canada 2297832 ⤷  Start Trial
Germany 19732903 ⤷  Start Trial
Germany 59808642 ⤷  Start Trial
Denmark 0977557 ⤷  Start Trial
European Patent Office 0977557 ⤷  Start Trial
Spain 2196556 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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