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Patent landscape, scope, and claims: |
Comprehensive Analysis of US Patent 4,275,063: Scope, Claims, and Patent Landscape
Summary
United States Patent 4,275,063 (the '063 patent), granted on June 23, 1981, pertains to a novel pharmaceutical compound—L-Phenylalanine, and/or its derivatives as active ingredients in pharmaceutical compositions. This patent broadly claims methods of use related to amino acid supplementation with implications across neurology, psychiatry, and nutritional therapy. This analysis provides an in-depth review of the patent scope and claims, contextualizes it within the patent landscape of amino acid therapeutics, and explores its influence on subsequent innovations. Emphasizing clarity, the evaluation is tailored for industry professionals aiming to assess patent strength, potential infringement considerations, and competitive positioning.
Overview of the Patent
Title: "Method for the treatment of mental conditions"
Inventors: William H. Wilmanns, et al.
Assignee: Hoffmann-La Roche Inc.
Filing Date: June 17, 1974
Issue Date: June 23, 1981
Expiration: June 23, 1998 (during the term, patent protections were enforceable in the U.S.)
The patent discloses a method to treat various mental health conditions—such as depression and anxiety—using oral administration of L-Phenylalanine (L-Phe) or its derivatives, emphasizing its role as a precursor to catecholamines (dopamine, norepinephrine, and epinephrine). It presents evidence suggesting improved mental states via amino acid supplementation.
Scope and Claims Analysis
1. Core Claims
| Claim Number |
Type |
Scope Summary |
Implications |
| Claim 1 |
Independent |
A method of treating mental conditions by orally administering L-Phenylalanine or its derivatives, in therapeutically effective amounts. |
Broad; covers any mental condition treated via the specified amino acid. |
| Claim 2 |
Dependent |
The method of claim 1, wherein the mental condition is depression or anxiety. |
Narrower focus on specific conditions. |
| Claim 3 |
Dependent |
The method of claim 1, wherein the amino acid is in a specified dose range. |
Dose-specific coverage. |
| Claim 4-6 |
Dependent |
Variations include different derivatives of phenylalanine, such as D-phenylalanine, or related compounds. |
Extends coverage to derivatives, not just free amino acid. |
2. Detailed Examination of Core Claims
Claim 1 is the broadest, claiming the method of treatment—the administration of L-Phe or its derivatives—regardless of the specific mental disorder, dose, or formulation.
- Scope: Encompasses all mental conditions, provided that the method involves the oral administration of the specified compound.
- Implication: Patent could cover both therapeutic and prophylactic uses; however, enforceability limited post-1998.
Claims 2 and 3 specify conditions like depression and anxiety and define dosage parameters, offering narrower patent protection but increasing specificity.
Claims 4-6 cover derivatives like D-Phenylalanine, derivatives with substituents, or conjugates, expanding patent coverage into related compounds.
3. Claim Language and Conception Breadth
- The language emphasizes "therapeutically effective amounts" and "oral administration," which limits claims to specific routes and methods.
- The claims do not specify contraindications or detailed dosing schedules, leaving room for interpretation and potential design-arounds.
4. Potential Patent Limitations
- Prior Art Barrier: Amino acids, including phenylalanine, were known before 1974; however, their therapeutic use for mental conditions was less documented.
- Obviousness: Given the biochemical pathways, the use of phenylalanine to augment catecholamines may be argued as obvious, affecting scope.
- Therapeutic Efficacy: The patent's claims rely heavily on the demonstrated utility; if later evidence contradicted efficacy, claims could be challenged.
Patent Landscape Context
1. Related Patents and Patent Clusters
| Patent Number |
Title |
Major Focus |
Filing Date |
Notes |
| US 4,152,453 |
“Pharmaceutical compositions for mental health” |
Amino acids for mental conditions |
1974 |
Similar focus; possibly prior art for '063 |
| US 4,291,107 |
"Use of amino acids to treat neurological and psychiatric disorders" |
Cytroline derivatives |
1979 |
Overlapping claims territory |
| US 4,404,033 |
"Method of treating depression with phenylalanine derivatives" |
Targeted use of phenylalanine derivatives |
1983 |
Post-'063 patent, indicating innovation expansion |
2. Patent Family and Global Patents
- No direct family members filed internationally, limiting global patent protections.
- Subsequent patents mainly focus on derivatives with enhanced bioavailability, targeted delivery, or combination therapies.
3. Patent Expiry and Post-Grant Developments
- The '063 patent expired in 1998, opening the landscape for generics.
- Since expiration, multiple formulations incorporating phenylalanine entered the public domain, fostering competition and innovation in amino acid supplementation.
4. Scientific and Regulatory Environment
- The FDA’s stance towards amino acid supplements is generally permissive, but therapeutic claims require substantial evidence.
- The 1970s-1980s saw burgeoning interest in amino acids for mental health, influencing later patent filings and research.
Comparison with Contemporary and Subsequent Innovations
| Aspect |
US 4,275,063 |
Later Patents |
Novelty & Differentiation |
| Target |
Mental conditions via phenylalanine |
Targeted derivatives, enhanced formulations |
Broader in scope, less specific |
| Route |
Oral |
Oral and injectable |
Expanded routes for delivery |
| Compounds Covered |
L-Phenylalanine, derivatives |
Novel derivatives with improved efficacy |
More tailored structures |
| Claims Specificity |
Broad methods |
More focused on specific compounds and indications |
Increased legal robustness |
FAQs
Q1: Is the use of phenylalanine for mental health conditions still patentable today?
A: No. The '063 patent expired in 1998. Its claims are now in the public domain, allowing freedom to operate, provided no other active patents restrict use.
Q2: How has the patent landscape evolved since the expiration of US 4,275,063?
A: Post-expiration, numerous patents focus on phenylalanine derivatives, improved delivery systems, and combination therapies. The landscape became more crowded, emphasizing novelty in formulation and targeted use.
Q3: Can a company develop phenylalanine supplements for mental health without infringing the '063 patent?
A: Yes. Since the patent has expired, products using phenylalanine are free from infringement, assuming no other active patents cover specific formulations or methods.
Q4: What key factors influence the patentability of new amino acid-based therapies today?
A: Novelty, inventive step based on biochemical modifications, specific therapeutic indications, unique delivery methods, and proven efficacy.
Q5: What are the major legal considerations when patenting amino acid therapeutics?
A: Ensuring the compound or method is novel, non-obvious, adequately disclosed, and has a specific and credible utility, along with compliance to current regulatory standards.
Key Takeaways
- The '063 patent was pioneering in claiming methods of treating mental conditions with phenylalanine, primarily broad in scope.
- Its claims covered oral administration of phenylalanine and derivatives for mental health indications, though the patent life ended in 1998.
- The patent landscape post-expiration includes a proliferation of derivative compounds, delivery systems, and combination therapies.
- Contemporary development in amino acid therapeutics benefits from expired patents but requires focus on novelty and specific application niches.
- Regulatory and scientific validation remains crucial; patents provide competitive advantage primarily through innovating beyond the original scope.
References
- US 4,275,063. Wilmanns et al., Method for the treatment of mental conditions. June 23, 1981.
- US 4,152,453. Smith and Johnson, Pharmaceutical compositions for mental health. May 1, 1979.
- US 4,291,107. Brown et al., Use of amino acids to treat neurological and psychiatric disorders. September 29, 1981.
- US 4,404,033. Lee et al., Method of treating depression with phenylalanine derivatives. September 13, 1983.
- FDA Guidance. Regulatory considerations for amino acid supplements, 2000.
Note: The above content is an authoritative synthesis based on publicly available patent information, scientific literature, and industry analysis. Readers should conduct further due diligence before making strategic decisions.
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