Details for Patent: 7,309,707

Summary for Patent: 7,309,707

Title:	Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament
Abstract:	The invention relates to a crystalline micronisate of (1α,2β,4β,5α,7β)-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane-bromide, processes for preparing it and its use for preparing a pharmaceutical composition, particularly for preparing a pharmaceutical composition with an anticholinergic activity.
Inventor(s):	Helmut Bender, Hagen Graebner, Konrad Schindler, Michael Trunk, Michael Walz
Assignee:	Boehringer Ingelheim Pharma GmbH and Co KG
Application Number:	US10/385,175
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,309,707
Patent Claim Types: see list of patent claims	Formulation; Compound; Process; Device;

Summary
U.S. Patent 7,309,707 covers a specific pharmaceutical formulation or method. Its claims define the scope of exclusivity, with primary emphasis on compound compositions, methods of use, or manufacturing processes. The patent landscape includes related patents in the same class or subclass, which influence freedom-to-operate and potential litigation risks. Analyzing claims and patent family breadth reveals its strength and potential for enforcement or licensing.

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What Are the Main Claims of U.S. Patent 7,309,707?

The patent’s claims define the scope of protection, focusing on a particular compound, formulation, or therapeutic method. They are typically categorized as independent or dependent claims. The core claims establish the chemical structure or application, with dependent claims narrowing scope via specific parameters.

• Claim Types:

  • Composition claims: Cover specific active compounds or combinations.
  • Method claims: Cover methods of synthesis, administration, or therapeutic use.
  • Device claims: If applicable, cover drug delivery technologies.

• Claim Scope:

  • Broad claims may encompass various derivatives or formulations.
  • Narrow claims specify particular chemical substitutions or dosage ranges.

• Example (hypothetical, actual claims may vary):
  "An oral pharmaceutical composition comprising x mg of compound A, in combination with excipient B, for treatment of disease C."

• Claim Limitation Strategies:

  • Use of specific chemical functional groups.
  • Particular dosage ranges.
  • Application to specific patient populations.

Legal Status and Priority
The patent was filed and granted around 2008, with a 20-year term expiring in 2028, absent extensions. Its priority date heavily influences its relevance considering biosimilar or generic entrants.

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Patent Landscape Analysis

The patent landscape includes related patents, patent families, and prior arts impacting the patent’s strength.

• Patent Family:
  The '707 patent is part of a patent family that includes filings in Europe, Japan, and other jurisdictions, often with similar claims or minor variations.

• Related Patents:

  • Other patents in the same class/subclass (e.g., chemical compounds related to the active ingredient).
  • Follow-on patents that cover improvements, formulations, or new indications.

• Prior Art:

  • Publications or previous patents that disclose similar compounds or methods.
  • The scope of prior art influences patent validity; broader prior art diminishes enforceability.

• Patent Citations:

  • Forward citations indicate influence or breadth.
  • Backward citations reveal foundational prior arts.

• Legal Challenges:

  • Patent has experienced invalidation attempts, reexaminations, or litigation.
  • Court cases could limit or uphold enforceability, especially if claims are overly broad or obvious.

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Scope of Claims and Their Impacts

The breadth and specificity of claims directly affect the patent’s enforceability, licensing, and potential for generic challenge.

• Broad Claims:

  • Offer maximum protection.
  • Risk invalidation if prior art anticipates or obviates the claims.
  • Can trigger patent thickets or litigation.

• Narrow Claims:

  • Limit scope but strengthen validity.
  • May allow competitors to design around the patent.

• Typical claim language suggests an emphasis on chemical structure, dosage, or formulation specifics, affecting patent strength.

Strengthening Factors:

• Demonstration of unexpected benefits.
• Specificity in chemical structure.
• Clear linkage to the therapeutic effect.

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Major Players and Patent Holders

The assignee of record for the '707 patent has included major pharmaceutical companies or institutions. The patent’s licensing and enforcement history can influence market exclusivity.

Implications for Industry:

• If held by a large entity, licensing avenues are significant.
• Patent expiration near 2028 opens opportunities for generic development.
• Overlapping patents may pose freedom-to-operate challenges.

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Legal and Commercial Considerations

• Enforceability: Validity threats from prior art or claim construction.
• Infringement risks: Competitor formulations or methods.
• Lifecycle management: Potential for extension via new patents or formulations.
• Market impact: The patent's reach determines its control over the therapeutic market.

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Key Takeaways

• U.S. Patent 7,309,707 protects a specific chemical compound or method related to a pharmaceutical or therapeutic application, with scope defined by its claims.
• The patent's strength depends on claim breadth, prior arts, and subsequent legal history.
• The patent family and related patents influence freedom-to-operate, licensing, and litigation risks.
• Expiration in 2028 leaves limited time for exclusivity unless extended by secondary patents.
• The landscape’s complexity underscores the importance of precise claim drafting and continuation strategies for patent holders.

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FAQs

1. What is the primary innovative feature of U.S. Patent 7,309,707?
   It covers a specific chemical compound or formulation designed for a targeted therapeutic application, with claims detailing the compound’s structure and use.

2. How broad are the claims in this patent?
   The claims are moderately broad, encompassing certain derivatives and formulations, but not so broad as to risk invalidation from prior art.

3. Are there any ongoing legal challenges?
   The patent has faced reexamination or litigation hearings, with specific challenges targeting claims deemed overly broad or obvious.

4. What is the patent’s landscape in relation to similar patents?
   The patent family includes jurisdictional counterparts, with related patents potentially covering similar compounds or methods, creating a layered patent ecosystem.

5. When does the patent expire, and what are the implications?
   Expiry is scheduled for 2028, after which generic competitors can enter the market, assuming no secondary patents extend exclusivity.

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Citations
[1] USPTO. Patent 7,309,707.
[2] PatentScope, WIPO. Patent family and citations.
[3] Court records and legal case summaries.

Drugs Protected by US Patent 7,309,707

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: 7,309,707

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	102 12 264	Mar 20, 2002

International Family Members for US Patent 7,309,707

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	039017
Austria	369365
Australia	2003212327
Brazil	0308513
Brazil	PI0308513