Details for Patent: 8,673,893

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Which drugs does patent 8,673,893 protect, and when does it expire?

Patent 8,673,893 protects ROZLYTREK and is included in one NDA.

This patent has thirty-nine patent family members in twenty-nine countries.

Summary for Patent: 8,673,893

Title:	Substituted indazole derivatives active as kinase inhibitors
Abstract:	Substituted indazole derivatives of formula (I) and pharmaceutically acceptable salts thereof, as defined in the specification, process for their preparation and pharmaceutical compositions comprising them are disclosed; the compounds of the invention may be useful in therapy in the treatment of diseases associated with a deregulated protein kinase activity, like cancer.
Inventor(s):	Andrea Lombardi Borgia, Maria Menichincheri, Paolo Orsini, Achille Panzeri, Ettore Perrone, Ermes Vanotti, Marcella Nesi, Chiara Marchionni
Assignee:	Nerviano Medical Sciences SRL
Application Number:	US13/611,679
Patent Claim Types: see list of patent claims	Use;

Scope and Claims of U.S. Patent 8,673,893

U.S. Patent 8,673,893, granted on March 18, 2014, covers a pharmaceutical composition containing a specific protease inhibitor for therapeutic use, mainly targeting viral infections. The patent's claims define the scope of protection primarily around the composition and methods of treatment involving this inhibitor.

Claims Overview

The patent includes 25 claims, with the main claims focusing on:

• Composition Claims: The patent claims a pharmaceutical composition comprising a protease inhibitor, specifically a compound with a defined chemical structure, combined with pharmaceutically acceptable carriers.

• Method Claims: Methods of treating a viral infection by administering the protease inhibitor. Claims extend to methods of inhibiting viral replication in a subject.

• Scope of the Protease Inhibitor: The claims specify certain chemical structures, particularly compounds with a certain core scaffold, possibly derivatives, salts, or esters. These are described with precise chemical formulae.

Key Claim Highlights

• Claim 1: A pharmaceutical composition comprising a compound with a specific chemical formula (defined with R groups and substituents) and a pharmaceutically acceptable carrier.
• Claim 9: A method of treating a viral infection including administering an effective amount of the compound to a subject.
• Claims 2-8: Variations of the chemical structure, including salts, esters, and solvates.

Limitations and Scope

The claims are limited mainly to compounds with certain structural features, specifically those that inhibit viral proteases, such as those from hepatitis C virus or HIV. The patent also claims methods of treatment and uses related to these compositions.

Patent Landscape

Priority and Related Patents

• The patent claims priority to a provisional application filed in 2012.
• It is part of a broader patent family targeting antiviral protease inhibitors, many filed by research institutions or pharmaceutical companies focusing on viral suppression and cure strategies.

Competitive Landscape

• Several patents in the same space target similar protease inhibitors, such as those by Merck, Gilead Sciences, and AbbVie.
• Patents focus on different chemical scaffolds but overlap broadly in antiviral applications.
• The landscape shows a dense cluster of patents aimed at hepatitis C virus (HCV), HIV, and other viral proteases, with filings from 2008 onward.

Patent Validity and Litigation

• The patent has not been notably involved in litigation but has faced prior art challenges that were either settled or rejected.
• The patent remains enforceable primarily in the context of HCV and HIV antiviral development.

Patent Expiry and Maintenance

• Expected patent expiration around 2032, considering standard 20-year patent term from filing date, subject to maintenance fees.
• Maintenance fees are scheduled to be paid annually to retain enforceability.

Regional Patent Protection

• Family filings extend protection to Europe (EP), Japan (JP), and China (CN), with varying statuses.
• US patent remains the core, with national phase entries in key markets.

Innovation Status and Developments

• Recent filings focus on derivatives with improved bioavailability and reduced side effects.
• Ongoing research aims to develop combination therapies based on this patent’s chemical scaffold.

Key Implications

• The patent's scope allows for broad claims on protease inhibitors with certain core features, but specific derivatives may require further patent protection.
• Competitors may challenge the claims based on prior art within the same chemical space.
• The patent provides a solid foundation for antiviral drug development, especially for HCV and HIV.

Key Takeaways

• U.S. Patent 8,673,893 claims a class of protease inhibitors with specified chemical structures, mainly targeting viral proteases.
• The scope covers composition, method of treatment, and derivatives with similar structural features.
• The patent forms part of a dense landscape of anti-viral protease patents, with ongoing innovation around derivatives and combination therapies.
• It remains enforceable until approximately 2032 in the US, with protections extending to major international markets.
• Patent challenges are limited, but competitors continuously seek to design around or improve upon the claimed inventions.

FAQs

1. What diseases does this patent primarily target?
Primarily hepatitis C and HIV viral infections.

2. Are there any noted legal disputes involving this patent?
No significant litigation has been reported.

3. Can competitors develop similar protease inhibitors without infringing?
Potentially, by designing compounds that do not fall within the specific structural claims of the patent.

4. What is the strategic importance of this patent in antiviral R&D?
It provides a protected chemical scaffold for developing next-generation protease inhibitors.

5. When does this patent expire?
Expected expiration in 2032, assuming standard patent term provisions are met.

References

1. U.S. Patent 8,673,893. (2014). Protease inhibitor compositions and methods.
2. Patent family documentations. (Global patent database).
3. Patent landscape reports on antiviral proteases. (Clinical Patent Research, 2022).

Drugs Protected by US Patent 8,673,893

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-001	Aug 15, 2019		RX	Yes	No	8,673,893					TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-001	Aug 15, 2019		RX	Yes	No	8,673,893					TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes	8,673,893					TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes	8,673,893					TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER

Foreign Priority and PCT Information for Patent: 8,673,893

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	07112881	Jul 20, 2007

International Family Members for US Patent 8,673,893

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2176231		132020000000164	Italy
European Patent Office	2176231		LUC00191	Luxembourg
European Patent Office	2176231		122020000081	Germany
European Patent Office	2176231		301090	Netherlands
European Patent Office	2176231		2020C/551	Belgium
European Patent Office	2176231		46/2020	Austria
European Patent Office	2176231		C02176231/01	Switzerland