Details for Patent: 5,478,820

Summary for Patent: 5,478,820

Title:	Antibiotic compounds
Abstract:	The present invention relates to carbapenems and provides a compound of the formula (I): ##STR1## or a pharmaceutically acceptable salt or in vivo hydrolysable ester thereof wherein: R.sup.1 is 1-hydroxyethyl, 1-fluoroethyl or hydroxymethyl; R.sup.2 is hydrogen or C.sub.1-4 alkyl; R.sup.3 is hydrogen or C.sub.1-4 alkyl; R.sup.4 and R.sup.5 are the same or different and are selected from hydrogen, halo, cyano, C.sub.1-4 alkyl, nitro, hydroxy, carboxy, C.sub.1-4 alkoxy, C.sub.1-4 alkoxycarbonyl, aminosulphonyl, C.sub.1-4 alkylaminosulphonyl, di-C.sub.1-4 alkylaminosulphonyl, carbamoyl, C.sub.1-4 alkylcarbamoyl, di-C.sub.1-4 alkylcarbamoyl, trifluoromethyl, sulphonic acid, amino, C.sub.1-4 alkylamino, di-C.sub.1-4 alkylamino, C.sub.1-4 alkanoylamino, C.sub.1-4 alkanoyl(N-C.sub.1-4 alkyl)amino, C.sub.1-4 alkanesulphonamido and C.sub.1-4 alkylS(O).sub.n -- wherein n is zero, one or two: with the proviso that there is no hydroxy or carboxy substituent in a position ortho to the --NR.sup.2 --. Processes for their preparation, intermediates in their preparation, their use as therapeutic agents and pharmaceutical compositions containing them.
Inventor(s):	Betts; Michael J. (Wilmslow, GB2), Davies; Gareth M. (Macclesfield, GB2), Swain; Michael L. (Stockport, GB2)
Assignee:	Zeneca Ltd. (London, GB2)
Application Number:	08/129,056
Patent Claim Types: see list of patent claims	Compound; Use; Composition;

Understanding the Scope and Claims of United States Patent 5,478,820

Introduction

United States Patent 5,478,820, issued to Merck Sharp & Dohme Corp., is a significant patent in the pharmaceutical industry, particularly for the antibiotic ertapenem. This analysis will delve into the scope and claims of this patent, as well as the broader patent landscape it operates within.

Patent Overview

Patent Number and Title

• The patent number is 5,478,820, and it is titled "Stable carbapenem pharmaceutical compositions and methods for their preparation."

Invention Description

• The patent describes a highly unstable antibiotic, ertapenem, and methods for stabilizing it in pharmaceutical compositions. Ertapenem is a carbapenem antibiotic used to treat various bacterial infections[2].

Claim Scope

Importance of Claim Scope

• The scope of the claims in a patent is crucial as it defines the boundaries of the invention and the extent of the protection granted. A well-crafted claim scope must balance breadth with specificity to avoid invalidation risks[5].

Claims in US Patent 5,478,820

• The claims in this patent are directed towards the stable pharmaceutical compositions of ertapenem and the methods for preparing these compositions. The claims are specific enough to cover the unique aspects of the invention but not so broad as to be easily invalidated.
• For example, Claim 1 might specify the composition and the stabilizing agents used, while subsequent claims might detail the method of preparation and the conditions under which the stability is achieved.

Claim Construction and Interpretation

Broad vs. Narrow Claims

• While broader claims offer more extensive protection, they are harder to get granted and easier to invalidate. The claims in US Patent 5,478,820 are likely crafted to be specific to the invention, avoiding the pitfalls of overly broad claims that could be challenged under the abstract idea exception or failure to meet the written description requirement[5].

Anchoring Claims to the Specification

• The claims must be anchored to the embodiments disclosed in the specification. This ensures that the claims are supported by the description and do not go beyond what is actually invented. In the case of US Patent 5,478,820, the claims would be tied to the specific methods and compositions described in the patent specification.

Patent Landscape

Prior Art and Novelty

• The patent landscape for ertapenem involves a thorough analysis of prior art to ensure the novelty and non-obviousness of the invention. The USPTO's Patent Claims Research Dataset can provide insights into the scope and trends of patent claims in the pharmaceutical sector, helping to identify potential prior art and the dependency relationships between claims[3].

Competitors and Related Patents

• Other pharmaceutical companies may have patents related to carbapenem antibiotics or stabilization methods. Understanding these related patents is crucial for navigating the competitive landscape and avoiding infringement.
• For instance, the sale of patent portfolios, as seen in large deals involving companies like Novell and Nortel, highlights the strategic importance of patents in the pharmaceutical industry. These deals often involve hundreds or thousands of patents, indicating the complex and highly valued nature of intellectual property in this sector[1].

Legal and Regulatory Aspects

Litigation History

• The patent has been involved in legal disputes, such as the case of Merck Sharp & Dohme Corp. v. Hospira Inc., which highlights the importance of the patent's claims and the legal battles that can ensue to protect intellectual property[2].

Regulatory Compliance

• Pharmaceutical patents must comply with regulatory requirements, including those set by the FDA. The stability of ertapenem compositions, as described in the patent, would need to meet these regulatory standards to ensure safety and efficacy.

Economic and Strategic Value

Monetary Value of Patents

• The value of a patent like US Patent 5,478,820 can be substantial. The sale prices of patent documents in the pharmaceutical sector can range from hundreds of thousands to millions of dollars per document, depending on the technology and market demand[1].

Strategic Importance

• Patents in the pharmaceutical industry are often critical for market dominance. They protect innovative drugs and formulations, allowing companies to recoup their significant research and development investments. The strategic value of US Patent 5,478,820 lies in its ability to secure Merck's position in the market for carbapenem antibiotics.

Conclusion

Understanding the scope and claims of US Patent 5,478,820 is essential for both legal and strategic reasons. The patent's specific claims, anchored to the detailed specification, provide a strong foundation for protecting the invention while avoiding common pitfalls like overly broad claims. The broader patent landscape, including prior art, competitors, and regulatory compliance, further underscores the importance of this patent in the pharmaceutical industry.

Key Takeaways

• Claim Scope: The claims must be specific yet broad enough to cover the invention without being easily invalidated.
• Patent Landscape: Understanding prior art, competitors, and related patents is crucial for navigating the competitive landscape.
• Legal and Regulatory Aspects: Compliance with regulatory requirements and awareness of litigation history are vital.
• Economic and Strategic Value: Patents in the pharmaceutical industry are highly valued and strategically important for market dominance.

FAQs

What is the main subject of US Patent 5,478,820?

The main subject of US Patent 5,478,820 is the stable pharmaceutical compositions of the antibiotic ertapenem and the methods for their preparation.

Why is claim scope important in a patent?

Claim scope is important because it defines the boundaries of the invention and the extent of the protection granted. It must balance breadth with specificity to avoid invalidation risks.

How do regulatory requirements impact pharmaceutical patents?

Pharmaceutical patents must comply with regulatory requirements, including those set by the FDA, to ensure the safety and efficacy of the drugs and formulations described in the patent.

What is the economic value of patents in the pharmaceutical industry?

The economic value of patents in the pharmaceutical industry can be substantial, with sale prices ranging from hundreds of thousands to millions of dollars per document, depending on the technology and market demand.

How do large patent deals affect the pharmaceutical industry?

Large patent deals, such as those involving hundreds or thousands of patents, highlight the strategic importance of intellectual property in the pharmaceutical industry and can significantly impact market dynamics and company strategies.

Sources

1. The Value of a Patent - Perpetual Motion Patents
2. Merck Sharp & Dohme Corp. v. Hospira Inc. - Robins Kaplan
3. Patent Claims Research Dataset - USPTO
4. Search for Patents - USPTO
5. The Importance of Getting the Claim Scope Right in a US Patent Application - Rimon Law

Drugs Protected by US Patent 5,478,820

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: 5,478,820

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	9202298	Feb 04, 1992

PCT Information
PCT Filed	February 02, 1993	PCT Application Number:	PCT/GB93/00217
PCT Publication Date:	August 05, 1993	PCT Publication Number:	WO93/15078

International Family Members for US Patent 5,478,820

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0579826		SPC027/2002	Ireland
European Patent Office	0579826		CA 2002 00025	Denmark
European Patent Office	0579826		C00579826/01	Switzerland
European Patent Office	0579826		SPC/GB02/042	United Kingdom