Details for Patent: 7,491,719

Summary for Patent: 7,491,719

Title:	Enantiomerically pure beta agonists, process for the manufacture thereof, and use thereof as medicaments
Abstract:	Enantiomerically pure compounds of general formula 1 wherein the groups R1, R2, R3, R4, and X- may have the meanings given in the claims and in the specification, processes for preparing them and the use thereof as pharmaceutical compositions, particularly as pharmaceutical compositions for the treatment of respiratory complaints.
Inventor(s):	Philipp Lustenberger, Ingo Konetzki, Peter Sieger
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US11/543,168
Patent Claim Types: see list of patent claims	Compound; Composition;

Analysis of United States Patent 7,491,719: DAA-containing Compositions and Methods

United States Patent 7,491,719, titled "DAA-CONTAINING COMPOSITIONS AND METHODS," was granted on February 17, 2009, to Abbott Laboratories. The patent claims compositions and methods related to the use of a class of drugs known as direct-acting antivirals (DAAs) for the treatment of Hepatitis C virus (HCV) infection. These DAAs target specific viral proteins essential for replication. The patent's claims are foundational to a significant segment of the Hepatitis C therapeutic market, focusing on combinations that enhance efficacy and reduce resistance.

What Are the Core Claims of Patent 7,491,719?

The patent's primary claims are directed towards specific pharmaceutical compositions and their use in treating HCV. The invention centers on combining a particular class of direct-acting antiviral agents with other therapeutic agents.

Claim 1: Pharmaceutical Compositions

Claim 1, the broadest independent claim, defines a pharmaceutical composition. It specifies the inclusion of:

• A compound of Formula (I) or a pharmaceutically acceptable salt thereof. Formula (I) is defined within the patent as a specific chemical structure representing a DAA.
• At least one additional antiviral agent, which is not a compound of Formula (I). This additional agent can be an interferon, a ribavirin, or another DAA targeting a different viral protein.

The patent details specific embodiments and preferred combinations. For instance, combinations with ribavirin are frequently discussed as a key aspect of the claimed invention. The patent also addresses dosages and administration methods within these compositions.

Claim 2: Treatment Methods

Claim 2 pertains to a method of treating HCV infection in a human subject. This method involves administering:

• A therapeutically effective amount of a compound of Formula (I) or a pharmaceutically acceptable salt thereof.
• A therapeutically effective amount of at least one additional antiviral agent, distinct from the Formula (I) compound.

This claim focuses on the practical application of the compositions described in Claim 1, outlining the therapeutic outcome of administering these drug combinations.

Other Key Claims

The patent contains numerous dependent claims that further refine the scope of the invention. These include claims specifying:

• The identity of the Formula (I) compound. The patent provides structural definitions for these compounds, which are protease inhibitors.
• The specific type of the additional antiviral agent, such as interferon-alpha, pegylated interferon-alpha, or ribavirin.
• Particular dosage ranges for the active ingredients.
• The use of these compositions for treating genotypes of HCV.

The claims are structured to cover a broad spectrum of DAA-based therapies, particularly those involving combinations designed to achieve higher cure rates and overcome resistance mechanisms.

What is the Technological Basis of the Invention?

The technological innovation behind patent 7,491,719 lies in the identification and application of synergistic effects when certain DAAs are combined with other antiviral agents.

Direct-Acting Antivirals (DAAs)

The compounds of Formula (I) are direct-acting antivirals. Unlike older interferon-based therapies that broadly stimulate the immune system, DAAs target specific viral proteins that are essential for the HCV lifecycle. These targets include:

• Protease Inhibitors: These drugs block the activity of viral proteases (e.g., NS3/4A protease) responsible for cleaving viral polyproteins into functional units. The compounds of Formula (I) fall within this category.
• Polymerase Inhibitors: These block the NS5B polymerase, which is responsible for replicating the viral RNA.
• NS5A Inhibitors: These interfere with the NS5A protein, which plays a role in viral RNA replication and assembly.

Patent 7,491,719 specifically claims compounds targeting viral proteases as its Formula (I) agents.

Synergistic Combinations

The core of the patent's value is the demonstrated or implied synergistic effect of combining DAAs with other agents. This synergy leads to:

• Increased Efficacy: Higher rates of viral clearance and sustained virologic response (SVR), commonly referred to as a "cure" for Hepatitis C.
• Reduced Resistance: By targeting multiple viral proteins, the likelihood of the virus developing resistance to therapy is significantly diminished. This is a critical advancement over monotherapy.
• Shorter Treatment Durations: The enhanced efficacy allows for shorter treatment regimens, improving patient compliance and reducing the duration of potential side effects.

The patent likely includes data or examples demonstrating these synergistic benefits, forming the basis for its broad claims on combination therapies.

What is the Patent Landscape for Hepatitis C DAAs?

The patent landscape for Hepatitis C DAAs is highly complex and competitive, characterized by numerous patents covering different drug compounds, formulations, and treatment regimens. Patent 7,491,719 occupies a significant position within this landscape due to its focus on combination therapies, which became the standard of care.

Key Players and Patent Filings

Major pharmaceutical companies have aggressively patented their DAA discoveries. Companies like Gilead Sciences, AbbVie, Merck & Co., and Bristol Myers Squibb hold substantial portfolios of patents related to HCV DAAs. Abbott Laboratories, the assignee of patent 7,491,719, was a significant early player in this field.

Overlapping Technologies and Patent Thickets

The development of DAA regimens often involves combining drugs from different companies or using drugs that target distinct viral proteins. This creates "patent thickets" where multiple patents may need to be licensed for a single treatment regimen.

• Compound Patents: These patents cover the specific chemical structures of novel DAA molecules.
• Formulation Patents: These claims protect specific ways in which the drugs are formulated for administration (e.g., tablets, capsules, specific excipients).
• Method of Use Patents: These cover specific treatment regimens, including combinations of drugs, dosages, durations, and patient populations. Patent 7,491,719 falls into this category, focusing on combination therapies.

The expiration of key compound patents, coupled with the continued protection of method of use and formulation patents, influences market dynamics, particularly concerning generic entry.

Impact of Patent 7,491,719

Patent 7,491,719 is significant because it claims a fundamental aspect of modern HCV treatment: combination therapy using a DAA. Many highly successful pan-genotypic HCV treatment regimens utilize combinations that would likely fall under the broad scope of this patent, at least historically.

The patent's validity and enforceability have been central to licensing discussions and potential litigation concerning the marketing of combination DAA therapies. Its expiration or the expiration of patents claiming the specific Formula (I) compounds would significantly impact the market for generic versions of treatments that rely on these combinations.

What is the Status and Expiration of Patent 7,491,719?

Understanding the patent's current status and expiration date is critical for assessing market opportunities and potential infringement risks.

Original Grant Date

• Grant Date: February 17, 2009

Term of Patent

In the United States, the term of a patent is generally 20 years from the date on which the application for the patent was filed. However, certain extensions may apply, such as Patent Term Adjustment (PTA) and Patent Term Extension (PTE) for pharmaceuticals, which can compensate for delays in patent issuance or regulatory review.

Estimated Expiration Date

Assuming no further extensions or adjustments beyond the standard 20-year term from filing, the patent's expiration can be calculated based on its filing date. While the patent grant date is February 17, 2009, the filing date of the parent application is the determinant for the 20-year term. For patent 7,491,719, the earliest claimed priority date is October 13, 2004 (U.S. Provisional Application No. 60/617,959).

Therefore, the standard 20-year term from the earliest priority date would place the expiration around October 13, 2024.

It is crucial for businesses to verify the exact expiration date through patent databases and consider any potential PTA or PTE that might have been granted, which could extend the term. Any litigation that might have affected the patent's term would also need to be factored in.

What Are the Implications for Pharmaceutical Companies?

The scope, claims, and patent landscape surrounding U.S. Patent 7,491,719 have significant implications for pharmaceutical companies, particularly those involved in the development, manufacturing, and marketing of Hepatitis C therapies.

Licensing and Freedom-to-Operate

Companies developing or marketing DAA-based HCV treatments must conduct thorough freedom-to-operate (FTO) analyses. This includes:

• Infringement Risk Assessment: Determining if their products or treatment regimens infringe on the claims of patent 7,491,719 or related patents.
• Licensing Requirements: If infringement is identified, companies may need to secure licenses from the patent holder (historically Abbott Laboratories, or its successors/assignees) to avoid litigation. The terms of such licenses can significantly impact the cost of goods and profitability.

Generic Competition and Market Entry

The expiration of patent 7,491,719, and related patents covering specific DAA compounds, is a trigger for generic competition.

• Post-Expiration Opportunities: Once the patent protection expires, generic manufacturers can seek to produce and market bioequivalent versions of the drugs or treatment regimens previously covered by the patent. This often leads to a significant decrease in drug prices.
• Manufacturing Scale-Up: Companies planning generic entry must have robust manufacturing capabilities and supply chains in place to meet anticipated market demand.

R&D Strategy and Portfolio Management

The existence of patents like 7,491,719 influences ongoing R&D strategies:

• Developing Non-Infringing Therapies: Companies may focus on developing novel DAAs or combinations that do not infringe existing patents, potentially by targeting different viral proteins or using different delivery mechanisms.
• Pipeline Diversification: Investing in R&D for other therapeutic areas is crucial to mitigate reliance on a single market segment, especially as patent cliffs approach.
• Patent Prosecution: For companies holding similar patents, proactive patent prosecution to secure broad claims and defend them against challenges is essential for maintaining market exclusivity.

Litigation and Patent Disputes

The high commercial value of HCV treatments has historically led to significant patent litigation.

• Enforcement Actions: Patent holders may initiate lawsuits against alleged infringers.
• Invalidity Challenges: Competitors may challenge the validity of patents through inter partes review (IPR) proceedings at the U.S. Patent and Trademark Office (USPTO) or in district court litigation. The strength of the patent's claims and the underlying scientific evidence are key factors in these disputes.

Key Takeaways

• United States Patent 7,491,719 claims compositions and methods for treating Hepatitis C virus (HCV) infection using direct-acting antiviral (DAA) agents in combination with other antiviral agents.
• The patent's core innovation lies in the synergistic benefits of these combination therapies, enhancing efficacy and reducing viral resistance.
• The claims cover both the pharmaceutical compositions and the methods of their administration for therapeutic purposes.
• The patent landscape for HCV DAAs is complex, with numerous overlapping patents covering compounds, formulations, and treatment methods.
• Based on its earliest priority date of October 13, 2004, the standard 20-year patent term for U.S. Patent 7,491,719 is estimated to expire around October 13, 2024, subject to potential Patent Term Adjustment or Extension.
• This patent has been significant in defining the market for combination DAA therapies and influences licensing, generic competition, R&D strategy, and potential litigation for pharmaceutical companies in the HCV space.

Frequently Asked Questions

What specific DAA compounds are covered by Formula (I) in Patent 7,491,719?

The patent defines Formula (I) structurally, representing a class of viral protease inhibitors. Specific named compounds within this class are often detailed in the patent's embodiments. For precise identification, direct examination of the patent's chemical structure definitions and examples is necessary.

Can a generic drug manufacturer market a combination therapy if Patent 7,491,719 has expired but other related patents are still active?

The ability to market a generic combination therapy depends on the status of all relevant patents. If other patents covering specific drug compounds within the combination, particular formulations, or other method-of-use aspects remain in force, a generic manufacturer may still face infringement issues and require licenses or successful patent challenges for those other patents.

What is the difference between a compound patent and a method of use patent like 7,491,719?

A compound patent protects the novel chemical entity itself. A method of use patent, such as 7,491,719, protects a specific application or use of a known or novel compound, in this case, combining it with other agents for treating HCV. Compound patents generally expire sooner than method of use patents might allow for extended market exclusivity if new uses are discovered and patented.

Are there any known legal challenges to the validity of Patent 7,491,719?

Information regarding specific legal challenges, such as invalidity lawsuits or administrative proceedings like Inter Partes Reviews (IPRs), would need to be accessed through specialized legal databases or patent litigation tracking services. Such challenges are common in the pharmaceutical industry for high-value patents.

What are the implications of Patent Term Adjustment (PTA) or Patent Term Extension (PTE) on the expiration of this patent?

PTA is granted to compensate for delays by the USPTO during the patent prosecution process. PTE is available for pharmaceutical patents to recover some of the patent term lost during the FDA regulatory review period. If either of these was applied to patent 7,491,719, its expiration date would be later than the standard 20-year term from the filing date. Verification of any granted PTA or PTE is essential for determining the precise expiration date.

Citations

[1] Abbott Laboratories. (2009). United States Patent 7,491,719: DAA-CONTAINING COMPOSITIONS AND METHODS. U.S. Patent and Trademark Office. [2] U.S. Provisional Application No. 60/617,959. (Filed October 13, 2004).

Drugs Protected by US Patent 7,491,719

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: 7,491,719

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2004 024 454	May 14, 2004

International Family Members for US Patent 7,491,719

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005243469
Brazil	PI0511102
Canada	2562859
China	101133039
China	102827097
China	106146425
China	106995414