Details for Patent: 5,210,085

Summary for Patent: 5,210,085

Title:	Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds
Abstract:	The present invention relates to a method of preparing the antiviral compounds 2'-deoxy-5-fluoro-3'thiacytidine (FTC) and various prodrug analogues of FTC from inexpensive precursors with the option of introducing functionality as needed; methods of using these compounds, particularly in the prevention and treatment of AIDS; and the compounds themselves. This synthetic route allows the stereoselective preparation of the biologically active isomer of these compounds and related compounds.
Inventor(s):	Liotta; Dennis C. (Stone Mountain, GA), Schinazi; Raymond F. (Decatur, GA), Choi; Woo-Baeg (North Brunswick, NJ)
Assignee:	Emory University (Atlanta, GA)
Application Number:	07/659,760
Patent Claim Types: see list of patent claims	Use; Composition;

Understanding the Scope and Claims of United States Patent 5,210,085

Introduction

United States Patent 5,210,085, held by Gilead Sciences, is a significant patent in the pharmaceutical industry, particularly in the treatment of HIV. This patent, along with others, has been at the center of various legal and regulatory discussions. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape it operates within.

Patent Overview

Patent Number and Title

• The patent number is 5,210,085, and it pertains to the use of a specific compound for treating HIV.

Issuance and Expiration

• The patent was issued on May 11, 1993, and it expired in 2015, marking the end of Gilead's exclusive rights to the invention[2].

Claims and Scope

Claim Structure

• The claims in a patent define the scope of the invention and are crucial for determining what is protected. For U.S. Patent 5,210,085, the claims are directed towards the use of a specific compound, B-FTC (a nucleoside analog), for the treatment of HIV. These claims must be anchored to the embodiments disclosed in the specification to avoid invalidation[5].

Specific Embodiments

• The patent claims are not just limited to the compound itself but also include methods of using the compound to treat HIV. This specificity is important because overly broad claims can be more easily invalidated due to failure to meet the written description requirement or falling under the abstract idea exception[5].

Prior Art and Patentability

Prior Art Considerations

• When filing a patent, it is essential to consider prior art to ensure the invention is novel and non-obvious. For U.S. Patent 5,210,085, the prior art landscape would have included other treatments and compounds known at the time of filing. The patent office would have evaluated whether the claimed invention was significantly different from existing knowledge[5].

Patentability Requirements

• To be patentable, an invention must meet the requirements of novelty, non-obviousness, and utility. The claims in U.S. Patent 5,210,085 would have been scrutinized to ensure they met these criteria. The specificity of the claims helps in navigating these requirements effectively[5].

Patent Litigation and Settlements

Reverse Payment Settlements

• U.S. Patent 5,210,085 has been involved in several patent litigation cases, particularly with generic manufacturers seeking to enter the market. Gilead has been accused of using reverse payment settlements to delay the entry of generic versions of their drugs. These settlements involve payments from the brand-name manufacturer to the generic manufacturer to stay out of the market, which can have significant anticompetitive effects[2].

Hatch-Waxman Act

• The Hatch-Waxman Act plays a crucial role in resolving patent disputes between brand-name and generic drug manufacturers. When a generic manufacturer files an Abbreviated New Drug Application (ANDA) with a paragraph IV certification, it certifies that the relevant patent is invalid or will not be infringed. This triggers a lawsuit from the brand-name manufacturer, which can delay FDA approval of the generic drug for up to 30 months[2].

Global Patent Landscape

International Patent Cooperation

• Patents like U.S. Patent 5,210,085 are often part of a global patent family. The Patent Cooperation Treaty (PCT) allows for international patent applications, facilitating the protection of inventions across multiple countries. This global landscape is crucial for pharmaceutical companies like Gilead, which operate in a highly regulated and competitive international market[4].

Global Dossier and Common Citation Document

• Tools like the Global Dossier and the Common Citation Document (CCD) help in managing and analyzing patent applications across different jurisdictions. These tools provide access to file histories, citation data, and other relevant information, making it easier to navigate the complex global patent system[1].

Economic and Regulatory Impact

Market Competition

• The expiration of U.S. Patent 5,210,085 in 2015 opened the market to generic versions of the drug, increasing competition and potentially reducing prices. This is in line with the goals of the Hatch-Waxman Act, which aims to balance the incentives for innovation with the need for affordable drugs[2].

Regulatory Scrutiny

• Patents and their settlements are under constant regulatory scrutiny. The FTC and other antitrust authorities monitor reverse payment settlements to ensure they do not stifle competition. The Supreme Court's decision in FTC v. Activis, Inc. highlights the importance of scrutinizing these settlements for anticompetitive effects[2].

Key Takeaways

• Specificity in Claims: The scope of the claims in U.S. Patent 5,210,085 is critical for its validity and enforceability.
• Patent Litigation: The patent has been involved in significant litigation, including reverse payment settlements that have anticompetitive implications.
• Global Patent System: The patent is part of a broader global patent landscape, managed through tools like the Global Dossier and CCD.
• Regulatory Impact: The expiration of the patent and the entry of generics have significant implications for market competition and drug prices.

FAQs

1. What is the significance of U.S. Patent 5,210,085?

   • U.S. Patent 5,210,085 is significant because it pertains to the use of a specific compound for treating HIV, a critical area in pharmaceutical research.

2. Why are the claims in a patent important?

   • The claims define the scope of the invention and determine what is protected. Overly broad claims can be more easily invalidated.

3. What is a reverse payment settlement in patent litigation?

   • A reverse payment settlement involves a payment from a brand-name manufacturer to a generic manufacturer to stay out of the market, which can have anticompetitive effects.

4. How does the Hatch-Waxman Act impact patent disputes in the pharmaceutical industry?

   • The Hatch-Waxman Act provides procedures for resolving patent disputes between brand-name and generic drug manufacturers, balancing innovation incentives with the need for affordable drugs.

5. What tools are available for managing global patent applications?

   • Tools like the Global Dossier and the Common Citation Document help in managing and analyzing patent applications across different jurisdictions.

Sources

1. USPTO - Search for patents
2. Jacksonville Police Officers & Fire Fighters Health Ins. Tr. v. Gilead Sciences
3. USPTO - Patent Claims Research Dataset
4. Canadian Patents Database - Patent 2348948 Summary
5. Rimon Law - The Importance of Getting the Claim Scope Right in a US Patent Application

Drugs Protected by US Patent 5,210,085

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 5,210,085

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0513200		91073	Luxembourg
European Patent Office	0513200		300148	Netherlands
European Patent Office	0513200		SPC/GB04/016	United Kingdom
European Patent Office	0513200		SZ 7/2004	Austria
European Patent Office	0513200		C00513200/01	Switzerland