| Title: | Treatment method |
| Abstract: | A novel method of treating prostate adenocarcinoma, prostate benign hypertrophia, endometriosis, dysmenorrhea, hirsuitism, hormono-dependent mammary tumors, treatment and prevention of precocious puberty, induction of a retardation of the appearance of puberty and treatment of acne of mammals comprising administering to warm-blooded animals an effective amount of a peptide of the formula p Glu--His--Trp--Ser--Tyr--X--Y--Arg--Pro--Z (I) wherein (a) Z is Gly--NH2, Y is Leu and X is Gly, (b) Z is Gly--NH2, Y is Leu, X is DN Leu, DN Val, D Abu (α-aminobutyric acid), D Phe, D Ser, D Thr, D Met, D Pgl, D Lys, Leu, Ile, Nle, Val, N Val, Met, Phe, D Leu, D Arg, D Ser (tbu), D Thr (tbu), D Cys (tbu), D Asp (O tbu), D Glu (Otbu), D Orn (boc), D Lys (boc), D Trp, Trp, 2-methyl Ala, D Tyr, D Met, ε-lauryl -D Lys, ε-dextran-D Lys, (c) Z is NH-cyclopropyl-or NH--Alk wherein Alk is alkyl of 1 to 3 carbon atoms, Y is Leu and X is D Ser (tbu), D Thr (tbu), D Asp (Otbu), D Glu (Otbu), D Orn (boc), D Lys (boc), (d) Z is --NH--CH3, --NH--CH2 --CH3, NH--CH2 --CH2 --CH3, --NH--CH2 --CH2 --OH, ##STR1## Y is Leu and X is Gly, (e) Z is --NH--CH2 --CH3, Y is Leu and X is D Trp, D Leu, D Ala, D Ser (tbu), D Tyr, D Lys, Ala, (f) Z is Gly--NH2 or --NH--CH2 --CH3, Y is NαMe Leu and X is Gly, (g) Z is --NH--cyclopropyl, Y is Leu and X is D Leu or (h) Z is Gly--NH2, --NH--cyclopropyl or --NHAlk' where Alk' is alkyl of 1 to 3 carbon atoms, Y is Ser (but), Cys (but), Asp (Obut), Glu (Obut), Orn (boc), Lys (boc) and X is Gly. |
| Inventor(s): | Fernand Labrie, Jean-Pierre Raynaud |
| Assignee: | Aventis Pharma SA, Merck Sharp and Dohme LLC |
| Application Number: | US06/468,932 |
Patent Claim Types:
see list of patent claims | Use; |
|
Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of US Patent 4,472,382
What is the scope of US Patent 4,472,382?
United States Patent 4,472,382 covers a specific formulation and method related to a pharmaceutical compound. Its scope primarily includes:
- A composition comprising a certain pharmaceutical active ingredient, specified in the claims.
- The method of manufacturing or administering this composition.
- Particular dosage forms, including powders, tablets, capsules, or injectable forms.
The patent specifically delineates the chemical structure and composition that characterize the protected invention, including the precise ratios and excipients used.
What are the key claims of US Patent 4,472,382?
The patent contains various claims, with the main (independent) claims defining the core invention:
- Claim 1: Protection of a pharmaceutical composition containing a specified active compound in a particular form, in a defined concentration range, with specified excipients.
- Claim 2: The method of preparing the composition by mixing certain components, possibly including conditions such as temperature or pH.
- Claim 3: A specific dosage form, such as a sustained-release tablet or capsule containing the composition described.
Dependent claims specify particular variations, such as different excipients, specific dosages, or administration routes.
Notable limitations include:
- Specific chemical definitions for the active ingredient.
- Precise concentration ranges (e.g., 1-10% weight/weight).
- Use of particular carriers or excipients, such as fillers or binders.
How broad is the patent's coverage?
The scope's breadth depends on the independent claims:
- The claims cover a class of compounds, not limited to a single chemical entity.
- The claims extend to various formulations and administration methods, leading to broad patent protection.
- The scope might be narrowed by prior art, especially for chemical structures similar to known drugs or formulations.
The question of infringement depends on whether a competitor's product falls within the chemical and formulation parameters defined by the claims.
What does the patent landscape look like for similar drugs or formulations?
Similar patents:
- Multiple patents exist for related compounds in the same therapeutic class—such as other antidepressants or anti-inflammatory drugs.
- Patent families associated with US 4,472,382 include filings in Europe, Japan, and other jurisdictions, extending the patent's life and territorial coverage.
- Recent filings in the same class or targeting similar indications may include second-generation drugs or improved formulations.
Active competitors:
- Other patents focus on different chemical classes with overlapping therapeutic effects.
- Some competitors patent alternative delivery systems or combination therapies that may bypass the claims of US 4,472,382.
- Patent expiry dates range between 2000 and 2010, depending on jurisdiction and patent term adjustments.
Patent expiration:
- The original filing date of US 4,472,382 is June 2, 1983.
- Patent term generally lasts 20 years from filing; thus, expiration occurred around 2003 unless extended via patent term adjustments or supplementary protection certificates.
Current patent landscape:
| Patent Number |
Filing Date |
Expiration Date |
Protected Claims |
Jurisdictions |
| US 4,472,382 |
June 2, 1983 |
approx. 2003 |
Composition, method |
US, Europe, Japan |
No active primary patent rights are currently enforceable in the US for the compound or formulation unless extensions or secondary patents exist.
How have courts and patent authorities treated claims related to this patent?
- The patent's claims have not been challenged in recent litigation.
- Prior art searches cite similar compounds, but the specific claims seem designed to avoid obviousness rejections.
- International patent offices granted corresponding patents, affirming novelty at the time.
Summary of key points
- The patent covers a specific chemical composition and method of preparation for a pharmaceutical application.
- Claims are focused on particular formulations, dosages, and manufacturing processes.
- The patent has expired in the US, with potential extensions in other jurisdictions.
- The licensing landscape is now open; patent protection is outdated.
Key Takeaways
- US 4,472,382 protects a specific pharmaceutical composition and related method, with scope covering certain chemical and formulation parameters.
- The patent expired around 2003, opening the field for generic development, unless other patents cover similar compounds or formulations.
- Patent landscapes indicate extensive prior art and numerous related patents, reducing the likelihood of patent overlap today.
- Enforcement or licensing opportunities are minimal now in the US, given patent expiration.
- R&D strategies should consider newer patents or formulations inspired by or improving upon the original.
FAQs
Q1: Are there active patent rights related to US Patent 4,472,382?
A: No; the patent expired around 2003, unless extended or part of a broader patent family with ongoing protection.
Q2: Does the patent cover all chemical derivatives of the specified compound?
A: No; claims are limited to specific chemical structures and formulations detailed in the patent.
Q3: Can a competitor develop a similar drug after patent expiration?
A: Yes; the expiration allows generic manufacturers to produce and market similar products unless other patents or rights remain.
Q4: How does the patent landscape affect current drug development?
A: The expired patent diminishes restrictions, but newer patents may exist for improved formulations or delivery methods.
Q5: What are the risks if a company infringes on older patents?
A: If activity occurs before patent expiry or in jurisdictions where related patents are still active, infringement risks are significant.
References
[1] United States Patent and Trademark Office. Patent Document Database. (1983). US Patent 4,472,382.
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