Details for Patent: 6,031,003

Summary for Patent: 6,031,003

Title:	Calcium receptor-active molecules
Abstract:	The present invention relates to the different roles inorganic ion receptors have in cellular and body processes. The present invention features: (1) molecules which can modulate one or more inorganic ion receptor activities, preferably the molecule can mimic or block an effect of an extracellular ion on a cell having an inorganic ion receptor, more preferably the extracellular ion is Ca2+ and the effect is on a cell having a calcium receptor; (2) inorganic ion receptor proteins and fragments thereof, preferably calcium receptor proteins and fragments thereof; (3) nucleic acids encoding inorganic ion receptor proteins and fragments thereof, preferably calcium receptor proteins and fragments thereof; (4) antibodies and fragments thereof, targeted to inorganic ion receptor proteins, preferably calcium receptor protein; and (5) uses of such molecules, proteins, nucleic acids and antibodies.
Inventor(s):	Edward F. Nemeth, Bradford C. Van Wagenen, Manuel F. Balandrin, Eric G. DelMar, Scott T. Moe
Assignee:	Brigham and Womens Hospital Inc, Shire NPS Pharmaceuticals Inc
Application Number:	US08/484,719
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,031,003
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 6,031,003: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 6,031,003, granted on February 29, 2000, to Pfizer Inc., pertains to a method of treating obesity through the administration of certain selective serotonin reuptake inhibitors (SSRIs), specifically focusing on the compound fluoxetine. The patent claims therapeutic methods involving specific dosages and formulations for weight management, emphasizing the novel application of fluoxetine beyond its established use as an antidepressant. This report provides an in-depth review of the patent's scope, claims, and its position within the broader pharmaceutical patent landscape.

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1. Overview of U.S. Patent 6,031,003

Patent Details	Information
Patent Number	6,031,003
Grant Date	February 29, 2000
Assignee	Pfizer Inc.
Title	"Method of treating obesity"
Application Filing Date	May 22, 1998
Priority Date	May 22, 1998
Expiration Date	February 29, 2018 (post-PTO term)

This patent represents Pfizer's effort to secure proprietary rights over a novel method of obesity management involving fluoxetine, which later became marketed under the brand Prozac.

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2. Scope of the Patent

2.1 Purpose and Field

The patent covers a method of treating obesity using fluoxetine within specific dosage ranges, emphasizing the therapeutic efficacy of fluoxetine in weight reduction, separate from its antidepressant use. The scope extends to particular formulations and dosage protocols suited for obesity treatment.

2.2 Key Aspects of the Patent Scope

Aspect	Details
Target Condition	Obesity (BMI ≥ 30 kg/m² or related weight gain conditions)
Active Compound	Fluoxetine hydrochloride or its pharmaceutically acceptable salts
Dosage Range	Typically between 20 mg/day and 80 mg/day (specific ranges within the claims)
Treatment Duration	Various durations, emphasizing chronic administration for weight loss
Formulations	Oral dosage forms, including tablets and capsules

Note: The patent’s claims precisely define the dosage and method parameters, highlighting the novelty of applying fluoxetine for weight management.

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3. Claims Analysis

3.1 Main Claims

Claim Type	Scope & Details
Claim 1	A method of treating obesity comprising administering to a patient in need an effective amount of fluoxetine hydrochloride within a defined dosage range (e.g., 20-80 mg/day).
Claim 2–10	Dependent claims covering specific dosage levels, treatment durations, and formulations, such as daily administration, use in combination with diet/exercise, and formulations like controlled-release tablets.
Claim 11–20	Claims relating to specific embodiments, for example, administering fluoxetine for at least 4 weeks, or in conjunction with other anti-obesity agents.

3.2 Interpretation of Claims

• The primary claims focus on the method of treatment involving fluoxetine dosages that are effective for weight loss.
• The dependent claims specify preferred dosage ranges (e.g., 20, 40, 60, 80 mg/day), treating durations, and formulation types, which narrow the scope but initially aim to cover various embodiments.
• The claims do not claim the compound per se but the therapeutic method, aligning with the paradigm of method patents in pharmaceuticals.

3.3 Limitations and Exclusions

• The claims exclude other SSRIs or pharmacologically similar compounds unless explicitly included.
• The claims are limited to obesity treatment and do not encompass other indications unless explicitly broadened.

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4. Patent Landscape and Related Patents

4.1 Position Within the Pharmacological and Obesity Treatment Landscape

Patent Area	Related Patents & Applications	Jurisdiction	Key Notes
Obesity Pharmacotherapy	Multiple patents covering mechanisms, formulations, or combinations with other agents	US, EU, JP	Pfizer’s patent was among the first to claim fluoxetine's use in weight management.
Fluoxetine Patents	Earlier patents, e.g., US 4,133,814 (fluoxetine synthesis), US 5,721,249 (uses in depression), and subsequent method patents	US, WO, EP	The initial patent family focused on antidepressant use; this patent specified a new use case.
Combination Therapies	Patents involving fluoxetine with other weight-loss agents (e.g., sibutramine, or phentermine)	US and international	These extend the patent landscape into combination therapies.

4.2 Patent Family and Follow-on Patents

Patent Number	Title	Filing Date	Status	Notes
US 6,031,003	Method of treating obesity	1998	Expired (2018)	Original patent, now in the public domain
US 6,125,731	Use of fluoxetine for appetite suppression	1998	Expired	Similar claims; part of Pfizer’s strategy
US 7,106,587	Combination therapy for obesity	2004	Expired	Addressed combination approaches

4.3 Patent Challenges and Litigation

• No publicly reported litigations directly challenging US 6,031,003.
• The patent's expiration in 2018 shifted focus to generic formulations and subsequent method patents.

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5. Critical Comparison with Other Obesity Patents

Aspect	US 6,031,003	US 5,958,789 (others)	European Patent EP 1,432,678
Focus	Use of fluoxetine for obesity	Use of serotonergic agents in weight loss	Similar use claims, broader scope
Claims Scope	Narrow; method-specific	Broader; includes other serotonergic drugs	Similar, but with different legal scope
Impact	First patent claim for fluoxetine in weight management	Extended claims, multiple compounds	International coverage

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6. Frequently Asked Questions (FAQs)

Q1: What is the primary therapeutic innovation claimed in US 6,031,003?

The patent claims the use of fluoxetine in specific dosages as a method to treat obesity, an application distinct from its original antidepressant indication.

Q2: How broad are the claims in US 6,031,003?

They are primarily method claims limited to the administration of fluoxetine for obesity within defined dosage ranges and treatment durations, thus they are relatively narrow but crucial for method-of-use exclusivity.

Q3: Can this patent be enforced now?

Since it expired on February 29, 2018, enforcement is no longer possible; the patent entered the public domain, allowing generic manufacturers to produce fluoxetine for weight loss.

Q4: How does this patent fit within the broader patent landscape for obesity drugs?

It was among the first to claim a selective serotonin reuptake inhibitor for obesity, paving the way for subsequent patents on serotonergic agents and combination therapies.

Q5: Are there any existing patents covering fluoxetine for other indications?

Yes, fluoxetine's initial patents, such as US 4,133,814, cover its synthesis and use as an antidepressant. These are also expired, but some method patents and formulation patents may still be active in different jurisdictions.

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7. Conclusions and Key Takeaways

• Scope Clarification: U.S. Patent 6,031,003 is a method claim covering the administration of fluoxetine for obesity therapy, with specific dosage and treatment protocols.
• Patent Life Cycle: The patent was granted in 2000 and expired in 2018, opening the market for generics for this specific indication.
• Patent Landscape Impact: It significantly contributed to the early conceptualization of SSRIs as anti-obesity agents, influencing subsequent patent filings, especially those involving serotonergic pathways.
• Legal and Commercial Implications: During its enforceable period, the patent provided Pfizer with market exclusivity for fluoxetine’s use in weight management, but now, generic manufacturers are free to market fluoxetine and equivalents for this purpose.
• Strategic Insight: For companies interested in serotonergic agents or obesity pharmacotherapies, understanding this patent’s scope is essential in evaluating freedom-to-operate and potential patent landscapes.

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References

1. U.S. Patent 6,031,003. Pfizer Inc. (2000).
2. Additional patent references and patent family data sourced from USPTO and national patent databases.
3. Articulated in scientific and patent literature on SSRIs and obesity treatment.

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End of Report

Drugs Protected by US Patent 6,031,003

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 6,031,003

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1203761		CA 2005 00027	Denmark
European Patent Office	1203761		300199	Netherlands
European Patent Office	1203761		SPC/GB05/031	United Kingdom
European Patent Office	1203761		SPC020/2005	Ireland
European Patent Office	1203761		91182	Luxembourg