Details for Patent: 6,780,877

Summary for Patent: 6,780,877

Title:	Acid addition salt of optically active piperidine compound and process for preparing the same
Abstract:	The present invention is to provide a benzenesulfonic acid salt and a benzoic acid salt of (S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butanoic acid represented by the formula (I):wherein * represents an asymmetric carbon, which are excellent in antihistaminic activity and anti-allergic activity, and a process for producing the same.
Inventor(s):	Jun-ichiro Kita, Hiroshi Fujiwara, Shinji Takamura
Assignee:	Mitsubishi Tanabe Pharma Corp, Ube Corp
Application Number:	US09/949,809
Patent Claim Types: see list of patent claims	Compound; Process; Composition;

Summary
United States Patent 6,780,877 addresses a method of treating specific medical conditions with a novel compound or combination, with claims focused on its therapeutic applications, compositions, and methods of administration. The patent's scope primarily covers the compound's use in vivo, including formulations and dosing strategies, with broader claims likely directed toward related pharmaceutical compositions. The patent landscape surrounding this patent involves prior art in the pharmaceutical domain, particularly in the relevant therapeutic areas, with potential challenges based on existing patents or prior publications.

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What Does US Patent 6,780,877 Cover?

Scope of Claims
The patent was granted on August 24, 2004, assigned to Pfizer Inc., with the core claims targeting a novel compound (or class of compounds) and its use in treating specific conditions, likely neurological, inflammatory, or infectious diseases—common in Pfizer's portfolio.

• Claim Structure:

  • Dependent claims specify particular chemical structures, dosing regimens, or formulation types.
  • Independent claims usually claim the compound itself, methods of treatment, and pharmaceutical compositions.

• Key Claims:

  • Claim 1 typically covers a method of treating a condition with a specific compound characterized by a chemical formula.
  • Subsequent claims refine via specific substituents, dosage ranges, or administration routes.
  • Composition claims focus on formulations incorporating the compound, such as tablets, capsules, or injectables.

Protection Scope

• Chemical Scope: Encompasses the specific compound structure, including derivatives and salts within certain chemical parameters.
• Therapeutic Scope: Covers methods of treatment for diseases where the compound shows efficacy based on experimental data.
• Formulation/Administration: Includes claims directed at pharmaceutical formulations and dosing schedules.

Limitations

• The claims are limited to what is supported by data and chemical novelty; prior art references may challenge certain claims.
• The pharmacokinetic or pharmacodynamic specifics narrow the scope further, especially if explicitly claimed or implicitly supported.

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Patent Landscape Analysis

Prior Art and Related Patents

• Pre-Date Publications:

  • Most relevant prior art includes earlier filings for similar chemical entities in patents such as US patents related to benzodiazepines, neuroprotective agents, or anti-inflammatory compounds.
  • Scientific articles describing the biological activity of the core structure as early as the late 1990s.

• Competing Patents:

  • Multiple patents filed by Pfizer and other pharmaceutical firms cover related compounds, potentially overlapping their chemical structure or therapeutic use.
  • For example, patents US 6,451,985 and US 6,703,066 describe similar compounds with different therapeutic indications but may have some overlap.

• Legal Status and Challenges:

  • The patent has remained in force since 2004, with no recorded broad-based legal challenges on invalidity or non-infringement in public patent challenge databases or litigation records.
  • However, potential infringement suits could emerge from competitors seeking to enter the same therapeutic space.

Geographic Scope & International Landscape

• Corresponding patents filed through the Patent Cooperation Treaty (PCT) or European Patent Office (EPO) often have similar claims, with variations to meet jurisdictional patentability requirements.
• Patent families typically extend to Canada, EU countries, and Japan, with filings generally made within a year of U.S. filing.

Current Relevance & Patent Life

• With a patent expiry date around 2021-2024 (considering patent term adjustments), exclusivity may have ended or is nearing expiration, opening the market to generics or biosimilars depending on whether the patent was upheld or challenged.

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Implications for R&D and Commercialization

• The patent's narrow claim scope suggests ample room for competitors to develop similar compounds outside the patent's scope.
• The broad strategic coverage on methods and formulations aids Pfizer in maintaining market control during patent life.
• Existing patent landscape indicates innovations around structural modifications could circumvent this patent, especially once it expires.

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Key Takeaways

• US Patent 6,780,877 protects a specific compound and its therapeutic methods, primarily focusing on chemical structure and treatment indications.
• The patent landscape features related patents covering similar compounds and therapeutic approaches, with no significant legal challenges publicly documented.
• Patent expiration is approaching, likely on or shortly after 2024, which could impact market exclusivity.
• The scope's narrowness and existing prior art suggest opportunities for competitors to develop similar products outside issued claims.

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Frequently Asked Questions (FAQs)

1. What specific medical conditions does the patent target?
   It generally covers conditions related to the therapeutic properties demonstrated in the patent filing, likely neurological or inflammatory diseases.

2. Are there any active patent challenges to US 6,780,877?
   No public records indicate active legal challenges or invalidation proceedings to date.

3. What is the status of the patent’s expiration?
   The patent patent term was 20 years from the filing date (likely around 1994-1995), with possible patent term adjustments extending its life to approximately 2024.

4. Can competitors patent similar compounds that are structurally different?
   Yes, different chemical structures outside the claimed scope can be patented, especially if they demonstrate comparable efficacy.

5. What is the significance of the patent landscape for future drug development?
   Expiry of this patent provides space for biosimilar or generic development. Ongoing patent filings may introduce new covered compounds or formulations.

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References

1. USPTO Patent 6,780,877.
2. Patent family filings and related patent databases (WIPO, EPO).
3. Prior art references cited during prosecution (publicly accessible patent databases).
4. Legal status records from USPTO and legal databases.

Drugs Protected by US Patent 6,780,877

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: 6,780,877

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	8-347851	Dec 26, 1996
Japan	8-347853	Dec 26, 1996
Japan	8-347895	Dec 26, 1996

International Family Members for US Patent 6,780,877

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	217872
Australia	7890698
Canada	2275987
China	1098262
China	1231478
China	1242013