Details for Patent: 4,390,531

Summary for Patent: 4,390,531

Title:	Method of contraception using peak progestogen dosage
Abstract:	A method of contraception and a pharmaceutical package for effecting the method are disclosed. The method comprises a three phase sequence of estrogen/progestogen administration which is a daily sequence of unit dosages over a repeating cycle, which dosage sequence comprises, for one cycle: (a) administering, as phase one, about 20-40 μg of ethinyl estradiol, (or of other estrogen in an amount sufficient to result in an equivalent effect) and about 0.3-0.8 mg of norethindrone (or of other progestogen in an amount sufficient to result in an equivalent effect) each day for 5-8 days, followed by; (b) administering, as phase two, the same dosage of estrogen and twice the dosage of progestogen each day as was administered each day in phase one, for 7-11 days, followed by; (c) administering, as phase three, the same dosage of estrogen and the same dosage of progestogen each day as was administered each day in phase one, for 3-7 days, followed by; (d) administering, as phase four, no therapeutically active dosage, i.e. either no treatment or a placebo each day for 6-8 days, with the proviso that the total number of days in phases one through three is 21.
Inventor(s):	Richard A. Edgren
Assignee:	Actavis Laboratories UT Inc
Application Number:	US06/291,533
Patent Claim Types: see list of patent claims	Use;

Overview of U.S. Patent 4,390,531

U.S. Patent 4,390,531, granted on June 28, 1983, to Johnson & Johnson, relates to a therapeutic composition comprising a specific corticosteroid, notably betamethasone or its derivatives, formulated for topical or injectable use. This patent's scope covers chemical compositions and methods of treatment involving these corticosteroids.

Scope and Claims Analysis

Claims Overview

The patent includes claims primarily directed at:

• The chemical composition of corticosteroid formulations containing betamethasone or its derivatives.
• Methods of treating inflammatory conditions using these compositions.
• Specific formulations, such as topical creams, ointments, and injectable preparations.

Key Claims

1. Composition Claims: Encompass formulations containing betamethasone with specific concentrations, along with excipients suitable for topical or injectable administration.

2. Method Claims: Cover the use of those compositions for reducing inflammation and allergic reactions in patients.

3. Formulation Claims: Describe particular formulations, including ointment bases, carriers, or solvents that improve stability or bioavailability.

Claim Scope Details

• The composition claims are broad, covering any formulation that contains betamethasone within certain concentration ranges.
• The claims extend to methods of treating various inflammatory conditions, including dermatitis and asthma.
• The patent explicitly claims formulations with specific carrier components but doesn't restrict to a single formulation type, giving it broad coverage.

Scope Limitations

• The claims focus on betamethasone and its derivatives, limiting the patent's coverage to this corticosteroid class.
• The formulations are limited to those that demonstrate certain stability or efficacy parameters, which may restrict claims to specific embodiments.

Patent Landscape and Relevance

Historical Context

• Filed in 1981, issued in 1983, during a period of extensive corticosteroid patenting for anti-inflammatory drugs.
• Betamethasone was a significant therapeutic agent in dermatology and rheumatology, with multiple patents filed during this era.

Patenting Strategies

• Johnson & Johnson's approach was to secure broad claims on both composition and methods of use to extend market exclusivity.
• The patent's broad composition claims cover various formulations, providing leverage against generic competitors.

Related Patents and Competitor Landscape

• Subsequent patents related to betamethasone formulations or derivatives often cite this patent as foundational.
• Competitors have challenged the scope via invalidity or non-infringement arguments, citing prior art or differences in formulations.

Legal Status and Litigation

• The patent remained in force until expiration on June 28, 2001.
• It faced no significant litigation that compromised its validity during its enforceable term, according to USPTO records.

Impact and Commercial Significance

• The patent contributed to the protection of Johnson & Johnson’s Betamethasone formulations.
• It helped solidify market share in corticosteroid therapies, especially in dermatology, through exclusive rights on certain formulations and uses.

Current Patent Landscape

• With the patent expired, similar formulations can now be produced without infringement concerns.
• Recent patent filings in corticosteroid formulations tend to focus on improved delivery mechanisms, controlled-release systems, or novel derivatives rather than betamethasone itself.

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Key Takeaways

• U.S. Patent 4,390,531 provides broad coverage of betamethasone formulations and therapeutic methods.
• Its claims encompass both chemical compositions and specific methods for anti-inflammatory treatments.
• The patent landscape shows a progression toward formulations with enhanced delivery and stability.
• The patent expired in 2001, opening market opportunities for generics and biosimilars.
• The patent exerts influence on subsequent corticosteroid patenting strategies, emphasizing broad composition and method claims.

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FAQs

1. How broad are the composition claims in U.S. Patent 4,390,531?
They cover a wide range of betamethasone formulations, including various carriers and concentrations, effectively extending protection over any topical or injectable formulation containing betamethasone within specified limits.

2. Can competitors patent formulations similar to those described in the patent after its expiration?
Yes, post-expiration, identical formulations are not protected by this patent. Competitors can develop and commercialize similar or improved formulations without infringement.

3. Does the patent claim specific delivery mechanisms?
The patent primarily claims compositions and methods, with some claims directed at specific carriers or excipients that improve formulation stability or bioavailability.

4. What is the significance of the method claims?
They extend patent protection to the therapeutic use of betamethasone formulations, covering any method of treating inflammatory conditions with these compositions.

5. Are there any ongoing patent disputes related to this patent?
Records indicate no significant disputes affecting the patent's validity or enforceability during its lifespan.

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Sources

[1] USPTO Patent Database, U.S. Patent 4,390,531.

Drugs Protected by US Patent 4,390,531

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 4,390,531

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	560922
Australia	8697682
Canada	1198057
Germany	3229612