Details for Patent: 6,352,684

Summary for Patent: 6,352,684

Title:	CRC-free medicinal aerosol formulations of 1,1,1,2-tetrafluoroethane (134A) with polar adjuvant
Abstract:	A medicinal aerosol formulation including 0.01-5% medicament, at least 50% by weight 1,1,1,2-tetrafluoroethane (134a), less than 5% surface active agent, and at least one compound having higher polarity than 1,1,1,2-tetrafluoroethane, and which is free of chlorofluorocarbons and propellants CHClF.sub.2, CH.sub.2 F.sub.2 and CF.sub.3 CH.sub.3.
Inventor(s):	Purewal; Tarlochan S. (Leamington Spa, GB), Greenleaf; David J. (Loughborough, GB)
Assignee:	Riker Laboratories Inc. (St. Paul, MN)
Application Number:	09/067,346
Patent Claim Types: see list of patent claims	Formulation; Compound;

Understanding the Scope and Claims of United States Patent 6,352,684

Introduction

United States Patent 6,352,684, assigned to Riker Laboratories Inc., is a significant patent in the pharmaceutical industry. To analyze its scope and claims, it is essential to delve into the details of the patent, the patent landscape, and the relevant regulations.

Patent Overview

The patent in question, US 6,352,684 B1, was granted on March 5, 2002. Here is a brief overview of what the patent entails:

Inventors and Assignees

• The patent was assigned to Riker Laboratories Inc., which is now part of other pharmaceutical companies due to mergers and acquisitions.
• The inventors listed on the patent are key individuals who contributed to the development of the technology or product described in the patent[5].

Claims Analysis

Types of Claims

• Drug Substance Patents: These claims cover the active ingredient(s) of the drug.
• Drug Product Patents: These include formulation and composition patents, which protect the specific way the drug is formulated and composed.
• Use Patents: These claims cover specific uses or indications of the drug product[2].

Claim Scope

• The claims in US 6,352,684 B1 would typically include detailed descriptions of the invention, such as the chemical structure of the active ingredient, the method of preparation, and any specific uses or indications.
• For example, if the patent is related to a pharmaceutical product, the claims might cover the active moiety, its salts, esters, or derivatives, as well as the dosage form and strength[1].

Patent Landscape

Regulatory Framework

• The patent is governed by the Drug Price Competition and Patent Term Restoration Act of 1984 (Waxman-Hatch Act), which provides periods of exclusivity for new drug applications and certain supplements to these applications.
• This act allows for exclusivity periods where abbreviated new drug applications (ANDAs) cannot be submitted or made effective for a specified period, typically five years for new molecular entities or three years for new clinical investigations[2].

Exclusivity and Patent Term

• The patent term for U.S. patents issued on or after June 8, 1995, was extended from 17 years from the date of issue to 20 years from the date of filing due to the Uruguay Round Agreements Act (URAA)[2].
• Exclusivity information, such as the date upon which the exclusivity expires, is crucial for understanding when generic versions of the drug can be approved[1].

Patent Analytics and Claim Coverage

Claim Coverage Matrix

• To understand the full scope of the patent, a Claim Coverage Matrix can be used. This tool categorizes patents by claims and overarching scope concepts, helping to identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[3].

Claim Charts

• Interactive claim charts generated by tools like ClaimScape® software can help technical experts review patent coverage. These charts are useful for determining whether a particular scope concept is applicable to a target product or method and for identifying gaps in current coverage[3].

Practical Implications

Market Impact

• The exclusivity period granted by the patent can significantly impact the market by preventing the entry of generic competitors, thereby allowing the patent holder to maintain market dominance for a specified period.
• This exclusivity can also influence pricing strategies and revenue projections for the patented drug product[2].

Competitive Landscape

• Understanding the patent landscape is crucial for competitors who may be considering developing generic versions of the drug. They must wait until the exclusivity period expires or challenge the patent through certification that the patent is invalid or will not be infringed[2].

Data Integrity and Verification

FDA Sources

• The FDA’s Orange Book, which lists approved drug products with therapeutic equivalence evaluations, is a key source for verifying patent and exclusivity information. However, discrepancies can occur due to data integrity issues, and further verification is often necessary[1][2].

Verification Challenges

• Harmonization of GATT and U.S. patent regulations can lead to changes in patent expiration dates, which may not always be accurately reflected in FDA databases. Therefore, it is important to address any discrepancies through the FDA's Division of Data Management & Services[2].

Key Takeaways

• Patent Claims: Detailed analysis of the claims in US 6,352,684 B1 is essential to understand the scope of protection.
• Regulatory Framework: The patent is governed by the Waxman-Hatch Act and URAA, which affect exclusivity periods and patent terms.
• Patent Analytics: Tools like Claim Coverage Matrix and claim charts are vital for analyzing the patent landscape and identifying gaps or opportunities.
• Market Impact: The exclusivity period can significantly influence market dynamics and competitive strategies.
• Data Integrity: Verification of patent and exclusivity information through reliable sources like the FDA’s Orange Book is crucial.

FAQs

1. What is the significance of the Waxman-Hatch Act in relation to pharmaceutical patents?

   • The Waxman-Hatch Act provides periods of exclusivity for new drug applications and certain supplements, preventing the submission or approval of generic versions for a specified period.

2. How does the URAA affect patent terms for pharmaceuticals?

   • The URAA extended the term of patents issued on or after June 8, 1995, from 17 years from the date of issue to 20 years from the date of filing.

3. What is the purpose of a Claim Coverage Matrix in patent analytics?

   • A Claim Coverage Matrix helps categorize patents by claims and scope concepts, identifying which patents and claims are actively protecting intellectual property and where gaps or opportunities exist.

4. Why is data verification important for pharmaceutical patents?

   • Data verification is crucial due to potential discrepancies in FDA databases and the need to ensure accuracy in patent expiration dates and exclusivity periods.

5. How do exclusivity periods impact the market for patented pharmaceuticals?

   • Exclusivity periods prevent the entry of generic competitors, allowing the patent holder to maintain market dominance and influence pricing strategies and revenue projections.

Sources

1. FDA Orange Book Cumulative Supplement - DrugPatentWatch
2. Drugs Under Patent 2006 Sample Page - FOI Services
3. Patent Analytics - Schwegman, Lundberg & Woessner, P.A.
4. Albuterol: Uses, Interactions, Mechanism of Action - DrugBank Online
5. Untitled - Googleapis.com - Patent Images Storage

Drugs Protected by US Patent 6,352,684

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

Foreign Priority and PCT Information for Patent: 6,352,684

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	88284773	Dec 06, 1988

International Family Members for US Patent 6,352,684

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	4595689
Australia	631155
Canada	2004598
Canada	2303601
Germany	68904300
Germany	68924540
Denmark	595789