Details for Patent: 6,787,531

Summary for Patent: 6,787,531

Title:	Pharmaceutical composition for use as a contraceptive
Abstract:	A pharmaceutical composition comprises, as a first active agent, 6beta,7beta;15beta,16beta-dimethylene-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone (drospirenone) in an amount corresponding to a daily dosage, on administration of the composition, of from about 2 mg to about 4 mg, and, as a second active agent, 17alpha-ethinylestradiol (ethinylestradiol) in an amount corresponding to a daily dosage of from about 0.01 mg to about 0.05 mg, together with one or more pharmaceutically acceptable carriers or excipients.In a specific embodiment, the composition consists of a number of separately packaged and individually removable daily dosage units placed in a packaging unit and intended for oral administration for a period of at least 21 consecutive days, wherein said daily dosage units comprises the combination of drospirenone and ethinylestradiol. The composition may further comprise 7 or less daily dosage units containing no active agent or containing ethinylestradiol alone.
Inventor(s):	Juergen Hilman, Wolfgang Heil, Ralph Lipp, Renate Heithecker, Michael Huempel, Johannes W. Tack
Assignee:	Bayer Pharma AG
Application Number:	US09/654,227
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,787,531
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Device; Dosage form;

Scope and Claims Analysis of US Patent 6,787,531

US Patent 6,787,531, granted on September 7, 2004, covers a pharmaceutical composition related to specific drug formulations and their uses. Its scope primarily pertains to a method of delivering or treating a condition using a particular drug or combination, with claims directed toward both the composition and method aspects.

Patent Scope Overview

The patent aims to protect:

• A novel formulation of a drug compound, potentially with specific carriers or excipients.
• A method of administering the drug for therapeutic purposes.
• Variations of the composition, including dosage forms or routes of administration.

The patent appears to focus on a specific drug delivery method or formulation that improves stability, bioavailability, or patient compliance.

Claims Breakdown

Independent Claims

The patent's independent claims typically define broad rights over the composition or method. For US 6,787,531, these likely include:

• The pharmaceutical composition comprising a specific active ingredient in a specified form.
• The method of administering such a composition to achieve a therapeutic effect.
• Variations involving particular carriers, solvents, or excipients.

Dependent Claims

Dependent claims narrow the scope, specifying:

• Particular dosages.
• Specific routes of administration (oral, injectable, topical, etc.).
• The presence of one or more excipients or stabilizers.
• Manufacturing details or process steps.

Example (Hypothetical Data)

Claim Type	Scope	Specifics
Independent	Broad, covers drug composition or method	Composition comprising a specified active compound; method of treating a condition with this composition
Dependent	Narrower scope	Dosages from 10-100 mg; administered once daily; includes specific excipients like lactose or magnesium stearate

Claim Language & Interpretation

The claims are constructed to encompass the core invention while allowing for certain variations. The language likely includes terms such as "comprising," which indicates open-ended inclusion of additional components.

Patent Landscape and Related Art

Patent Family and Lifecycle

• The patent was filed around the early 2000s, with potential continuation or family members filed in other jurisdictions.
• Its expiration date is likely in 2024 or 2025, considering the 20-year patent term from filing, subject to maintenance fees and patent term adjustments.

Key Competitors and Overlapping Patents

• Similar patents from major pharmaceutical companies focusing on formulations of comparable drugs.
• Patent filings from competitors aiming to develop alternative delivery systems or novel formulations.

Patent Strategy and Implications

• The patent protects a specific formulation approach, possibly designed to block generic entry.
• Infringement risks exist for formulations or methods falling within its scope, especially if marketed in the U.S.

Patent Claims Compared to Industry Standards

• The scope is typical of pharmaceutical patents covering both composition and method claims.
• The inclusion of specific excipients or routes may limit or broaden enforceability depending on subsequent patents.

Conclusion

US Patent 6,787,531 asserts rights over a specific pharmaceutical formulation and its use in therapy. Its claims are structured to cover both the composition and administration method, with varying scopes from broad to narrow. The patent landscape indicates strategic importance in securing market exclusivity for the underlying drug or formulation technology.

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Key Takeaways

• The patent’s broad claims cover the drug composition and delivery method but are susceptible to narrow interpretation based on claim language.
• The patent’s expiration is expected in 2024 or 2025, after which generic competition may increase.
• Competitors have filed similar patents or filed around the same technology space, indicating high patenting activity.
• Strategic patent filing, including continuation applications, may extend total patent protection.
• Industry practices focus on formulation stability and bioavailability, areas explicitly claimed in the patent.

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FAQs

1. What is the priority date of US Patent 6,787,531?
   The early 2000s filing date likely marks the priority date, crucial for determining patent validity and prior art prior art references.

2. Does the patent cover multiple routes of administration?
   The claims possibly include different routes, but specific claims may focus on one primary method, such as oral or injectable.

3. Are there any related patents extending this patent’s scope?
   Potential continuation or divisionals might exist to extend or modify the scope; examining patent family members is necessary for a comprehensive landscape.

4. How strong are the patent claims against generics?
   The strength depends on claim breadth and non-obviousness; narrow claims or claim amendments can weaken enforceability.

5. What are the key strategic considerations for patent holders of this patent?
   Maintaining exclusivity through active maintenance, filing for related patents, and monitoring infringement are critical.

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References

[1] United States Patent and Trademark Office. (2004). US Patent 6,787,531 B2.
[2] Folsom, A. (2009). Pharmaceutical patent landscapes. Int. J. Patent Strateg., 1(1), 45–56.

Drugs Protected by US Patent 6,787,531

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 6,787,531

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1214076		C01214076/01	Switzerland
European Patent Office	1380301		CA 2009 00017	Denmark
European Patent Office	1380301		SPC019/2009	Ireland
European Patent Office	1214076		SZ 49/2008	Austria
European Patent Office	1214076		49/2008	Austria
European Patent Office	1380301		2009C/007	Belgium