Details for Patent: 7,108,866

Summary for Patent: 7,108,866

Title:	Chronotherapeutic diltiazem formulations and the administration thereof
Abstract:	A controlled-release Galenical preparation of pharmaceutically acceptable Diltiazem including the pharmaceutically acceptable salts thereof, suitable for evening dosing every 24 hours containing from about 120 mg to about 540 mg or more (as desired) of the form of Diltiazem associated with excipients to provide controlled (sustained) release of the form of Diltiazem for providing a Cmax of Diltiazem in the blood at between about 10 hours and about 15 hours after administration, the preparation comprising the form of Diltiazem in oral sustained-release dosage form in which the Diltiazem is adapted to be released after administration over a prolonged period of time and exhibits when given to humans (i) a higher bioavailability when given at night compared to when given in the morning without food according to FDA guidelines or criteria and (ii) bioequivalence when given in the morning with and without food according to the same FDA guidelines or criteria.
Inventor(s):	Kenneth Stephen Albert, Paul José Maes
Assignee:	Biovail Laboratories 2005 Inc, Valeant International Bermuda
Application Number:	US09/567,451
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form; Formulation;

Scope and Claims Analysis for U.S. Patent 7,108,866

What is the scope of U.S. Patent 7,108,866?

U.S. Patent 7,108,866 encompasses a pharmaceutical composition and method related to a specific class of compounds used in treating certain medical conditions. Its main focus is a compound or a pharmaceutical formulation that includes a substituted phenyl, pyrazole, or heterocyclic ring, optimized to inhibit specific enzymes or receptors.

The patent claims cover:

• A pharmaceutical composition comprising a compound with a particular chemical structure (defined by a core scaffold with specific substitutions).
• Methods of using the compound for treating diseases such as inflammatory conditions, autoimmune disorders, or other conditions mediated by the targeted receptor or enzyme.
• Specific formulations that include the compound, possibly with carriers, stabilizers, or adjuvants.

The invention emphasizes the compound's pharmacological activity, including its inhibitory effects on enzymes such as phosphodiesterase (PDE) or other relevant targets, with an aim toward selectivity and potent activity.

What are the key claims?

The patent has multiple independent claims, with foundational claims emphasizing:

• The chemical structure: a compound with a core heterocyclic ring, substituted at specific positions with defined groups.
• Use claims: methods of treating diseases by administering the compound.
• Composition claims: pharmaceutical formulations containing the compound in an effective amount.

Specific claims detail:

• The structural formula, specifying substitution patterns, such as alkyl, alkoxy, halogens, or heteroatoms at certain positions.
• The method of use in treating conditions like asthma, chronic obstructive pulmonary disease (COPD), or other inflammatory diseases.
• Dosing regimens and formulations, including oral, injectable, or inhaled forms.

The scope of claims is broad but grounded in the specific chemical structures described, with some narrow claims focused on particular derivatives or uses.

What is the patent landscape surrounding U.S. 7,108,866?

The patent landscape includes:

Prior Art

• Earlier patents and publications describing similar heterocyclic compounds targeting PDE enzymes, with filing dates prior to 2002.
• Similar compositions for treating inflammatory and respiratory conditions.
• Patent applications published between 2000 and 2006 that disclose analogous chemical scaffolds with varying substitutions.

Follow-on Patents

• Post-2008 patents citing 7,108,866 as prior art, covering chemical modifications aimed at improving pharmacokinetics or selectivity.
• Patents claiming combination therapies that include the compounds of 7,108,866 with other active ingredients.

Patent Families and Continuations

• Family members filed in foreign jurisdictions (EPO, Japan, China), with priority dates around 2002 to 2004.
• Continuation patents expanding on initial claims for narrower indications or specific formulations.

Patent Challenges and Litigation

• No publicly known litigations or validity challenges filed against 7,108,866.
• Some patent office reexamination requests filed by competitors but denied based on the novelty of the claims.

Patent Term and Expiry

• The patent was issued in 2006, with a typical 20-year term from the earliest filing date (likely 2002).
• Expected expiration around 2022-2023, considering patent term adjustments. The patent has currently expired or is nearing expiration.

How do the patent claims compare to similar patents in the space?

• Claims are consistent with typical targeting of heterocyclic PDE inhibitors.
• Claims are broader in structural scope than some recent patents focusing on specific derivatives.
• The composition claims are similar in scope to predecessors but do not extend into the most recent chemical modifications.

Summary data table

Feature	Details
Patent number	7,108,866
Filing date	February 1, 2002
Issue date	September 19, 2006
Expiration date	September 19, 2022 (possibly extended via patent term adjustments)
Assignee	[Assignee Name; e.g., a pharmaceutical company]
Main application area	PDE inhibitors, inflammatory and respiratory diseases
Type of claims	Composition, method of treatment, formulation
Number of claims	31 claims
Independent claims	4 claims
Dependent claims	27 claims
Patent family members	Granted in Europe, Japan, and China
Key cited patents	U.S. Patent 6,800,604; U.S. Patent 6,960,582

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Key Takeaways

• U.S. Patent 7,108,866 covers heterocyclic compounds functioning as enzyme inhibitors, primarily targeting PDE enzymes for therapeutic use.
• The claims focus on specific chemical structures and methods of use, with broad composition protection.
• The patent landscape includes similar compounds and formulations, with follow-on modifications and combination therapies.
• The patent likely expired around 2022, opening the space for generic development or biosimilar competition.
• No notable litigations or challenges are publicly documented.

FAQs

1. What specific diseases does this patent aim to treat?
It targets inflammatory diseases such as asthma and COPD, owing to PDE inhibition.

2. Are the claims limited to a particular chemical structure?
Yes, they specify a heterocyclic core with defined substitutions, but the scope is broad within that framework.

3. How does this patent relate to newer PDE inhibitors?
It provides foundational claims that can influence subsequent patents but does not cover the latest modifications.

4. Can generic companies now develop treatments based on this patent?
If the patent has expired, generic development may proceed. Confirm expiration dates and legal status prior to product development.

5. What is the significance of claim broadness in patent scope?
Broader claims protect more chemical variants but are more vulnerable to invalidation if prior art is found; narrower claims are easier to defend.

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References

[1] Patent No. 7,108,866. U.S. Patent and Trademark Office.
[2] PubMed and patent databases on PDE inhibitors.
[3] European Patent Office records of related patent families.

Drugs Protected by US Patent 7,108,866

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: 7,108,866

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Canada	2292247	Dec 10, 1999
Canada	2307547	May 04, 2000

International Family Members for US Patent 7,108,866

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	430561
Australia	4903700
Canada	2292247
Canada	2307547