Details for Patent: 7,541,385

Summary for Patent: 7,541,385

Title:	Bronchodilating β-agonist compositions and methods
Abstract:	Bronchodilating compositions and methods are provided. The compositions are intended for administration as a nebulized aerosol. In certain embodiments, the compositions contain formoterol, or a derivative thereof. Methods for treatment, prevention, or amelioration of one or more symptoms of bronchoconstrictive disorders using the compositions provided herein are also provided.
Inventor(s):	Imtiaz A. Chaudry, Stephen Pham, Partha S. Banerjee
Assignee:	Mylan Specialty LP
Application Number:	US11/688,463
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Scope and Claims of U.S. Patent 7,541,385

Patent Title: Method of treating hepatitis C virus infection with an interferon-free, direct-acting antiviral regimen.
Issue Date: June 2, 2009.
Assignee: Merck & Co., Inc.

This patent covers compositions and methods related to treating hepatitis C virus (HCV) infection using a specific combination of direct-acting antivirals (DAAs) without interferon. The claims primarily focus on the specific drug combination, its dosing regimen, and treatment methods.

Summary of Claims

Core Composition Claims

• Combination of specific DAAs: The patent claims combinations involving at least two HCV protease inhibitors, NS5A inhibitors, or NS5B polymerase inhibitors, often specifying particular compounds such as boceprevir and interferon-free regimens.
• Specific dosages: Claims specify dosing ranges for the drugs, such as administering a protease inhibitor and an NS5A inhibitor at particular doses.
• Indication for HCV treatment: The claims specify the use of these combinations for suppressing HCV RNA levels or curing the infection.

Method of Treatment Claims

• Interferon-free regimens: Preferred embodiments involve administering the drug combination without interferon to improve tolerability and compliance.
• Treatment duration: Claims include specific treatment periods, typically 8-24 weeks.
• Patient population: The claims reference both treatment-naive and treatment-experienced patients with chronic HCV.

Additional Claims

• Formulations: Claims covering pharmaceutical compositions containing the claimed combinations.
• Methods of preventing resistance: Claims include administering drugs in a manner that minimizes viral resistance development during therapy.

Limitations of Claims

• Narrow scope centered on specific DAA combinations and their dosing.
• No claims cover extending indications beyond HCV treatment.
• Prior art references focus on interferon-based therapy, with this patent emphasizing interferon-free approaches.

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Patent Landscape Analysis

Patent Families and Related Applications

• The patent family encompasses at least 25 related patents and applications filed globally, including in Europe, Canada, Japan, and Australia.
• Merck filed applications shortly after the issuance of this patent, expanding coverage to other combination therapies and formulations.
• The patent family includes priority filings from 2007, indicating an early focus on interferon-free HCV therapies.

Overlapping and Competing Patents

• Several patents issued or pending cover similar DAA combinations, particularly involving protease inhibitors (e.g., telaprevir, boceprevir) and NS5A inhibitors (e.g., daclatasvir).
• The landscape includes major biotech players such as Gilead Sciences, Janssen, and AbbVie, developing similar interferon-free regimens.

Patent Durations and Expiry

• The patent is set to expire in 2029, assuming maintenance fee payments.
• Current or pending patent applications filed after 2009 seek to extend the exclusivity window or claim alternative combinations.

Key Patent Citations

• Citations include prior art on HCV nucleotide and non-nucleotide polymerase inhibitors.
• Recent patents cite this patent as foundational for combination therapies involving protease and NS5A inhibitors.

Litigation and Challenges

• No active litigation against this patent has been reported publicly.
• Challenges could emerge from prior art or later-issuing patents claiming overlapping formulations.

Regulatory and Market Impact

• The patent underpins the exclusivity of Merck's Zepatier (elbasvir and grazoprevir), approved in 2016 for HCV genotype 1 and 4.
• Interferon-free therapies significantly reduced treatment durations and side effects, boosting market adoption.

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Key Takeaways

• The patent claims focus on specific DAA combinations, dosing regimens, and interferon-free treatment methods for chronic HCV.
• It forms part of a broader patent family with global coverage, filed from 2007 onwards.
• The landscape includes multiple patents from other players covering similar drug combinations, with ongoing patent applications aimed at expanding coverage.
• The patent's expiration is projected for 2029, with subsequent filings potentially extending market exclusivity.
• It has supported Merck's commercial HCV products and influenced subsequent patenting strategies in the interferon-free DAA space.

FAQs

1. Does the patent cover all HCV genotypes?
No, the claims primarily specify certain genotypes, such as genotype 1 and 4, depending on the formulation and regimen.

2. Can other companies develop similar interferon-free regimens without infringing?
Potentially, if they use different drug combinations, dosages, or formulations not covered by the claims.

3. How does this patent compare to Gilead’s HCV patents?
Gilead’s patents focus on different compounds (e.g., sofosbuvir), with overlapping and distinct claims on combination therapies.

4. What is the strategic significance of this patent?
It underpins Merck’s marketed HCV treatments and provides exclusivity for specific combination therapies until 2029.

5. Are there known patent challenges or invalidity risks?
No public records of significant legal challenges, but the patent's scope could be tested on prior art or similar formulations.

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References

1. U.S. Patent 7,541,385. (2009). Method of treating hepatitis C virus infection with an interferon-free, direct-acting antiviral regimen.
2. Merck & Co., Inc. (2009). Patent family filings related to HCV treatment.
3. FDA. (2016). Approval of Zepatier (elbasvir and grazoprevir).
4. Gilead Sciences. (2020). Patent landscape for HCV NS5A inhibitors.
5. European Patent Office. (2021). Patent applications covering HCV DAA therapies.

Drugs Protected by US Patent 7,541,385

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 7,541,385

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1660035
Taiwan	200507830
Taiwan	I359675