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Last Updated: December 23, 2024

Details for Patent: 9,856,265

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Which drugs does patent 9,856,265 protect, and when does it expire?

Patent 9,856,265 protects OLYSIO and is included in one NDA.

This patent has sixty-two patent family members in forty-one countries.

Summary for Patent: 9,856,265

Title:	Macrocyclic inhibitors of hepatitis C virus
Abstract:	Inhibitors of HCV replication of formula (I) ##STR00001## and the N-oxides, salts, and stereoisomers, wherein each dashed line represents an optional double bond; X is N, CH and where X bears a double bond it is C; R.sup.1 is --OR.sup.7, --NH--SO.sub.2R.sup.8; R.sup.2 is hydrogen, and where X is C or CH, R.sup.2 may also be C.sub.1-6alkyl; R.sup.3 is hydrogen, C.sub.1-6alkyl, C.sub.1-6alkoxyC.sub.1-6alkyl, C.sub.3-7cycloalkyl; R.sup.4 is aryl or Het; n is 3, 4, 5, or 6; R.sup.5 is halo, C.sub.1-6alkyl, hydroxy, C.sub.1-6alkoxy, phenyl, or Het; R.sup.6 is C.sub.1-6alkoxy, or dimethylamino; R.sup.7 is hydrogen; aryl; Het; C.sub.3-7cycloalkyl optionally substituted with C.sub.1-6alkyl; or C.sub.1-6alkyl optionally substituted with C.sub.3-7cycloalkyl, aryl or with Het; R.sup.8 is aryl; Het; C.sub.3-7cycloalkyl optionally substituted with C.sub.1-6alkyl; or C.sub.1-6alkyl optionally substituted with C.sub.3-7cycloalkyl, aryl or with Het; aryl is phenyl optionally substituted with one, two or three substituents; Het is a 5 or 6 membered saturated, partially unsaturated or completely unsaturated heterocyclic ring containing 1 to 4 heteroatoms selected from nitrogen, oxygen and sulfur, and being optionally substituted with one, two or three substituents; pharmaceutical compositions containing compounds (I) and processes for preparing compounds (I). Bioavailable combinations of the inhibitors of HCV of formula (I) with ritonavir are also provided.
Inventor(s):	Simmen; Kenneth Alan (Tervuren, BE), De Kock; Herman Augustinus (Arendonk, BE), Raboisson; Pierre Jean-Marie Bernard (Sterrebeek, BE), Hu; Lili (Mechelen, BE), Tahri; Abdellah (Anderlecht, BE), Surleraux; Dominique Louis Nestor Ghislain (Braine-le-chateau, BE), Nilsson; Karl Magnus (Gothenburg, SE), Samuelsson; Bengt Bertil (Skarholmen, SE), Rosenquist; Asa Annica Kristina (Huddinge, SE), Ivanov; Vladimir (Moscow, RU), Pelcman; Mikael (Alvsjo, SE), Belfrage; Anna Karin Gertrud Linnea (Uppsala, SE), Johansson; Per-Ola Mikael (Huddinge, SE), Vendeville; Sandrine Marie Helene (Etterbeek, BE)
Assignee:	Janssen Sciences Ireland UC (Little Island, Co. Cork, IE) Medivir AB (Huddinge, SE)
Application Number:	15/454,911
Patent Claim Types: see list of patent claims	Use; Composition; Compound;
Patent landscape, scope, and claims:	United States Patent 9,856,265: A Detailed Analysis of Scope, Claims, and Patent Landscape Introduction United States Patent 9,856,265, hereafter referred to as US9856265, is a patent that protects the pharmaceutical drug OLYSIO (simeprevir), a treatment for hepatitis C. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent. Patent Overview Patent Number and Title US9856265 is titled "Macrocyclic compounds and their use in therapy," and it was granted to protect specific macrocyclic compounds, including simeprevir, which is used in the treatment of hepatitis C virus (HCV) infection[2]. Patent Assignee The patent is assigned to Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, which developed and markets OLYSIO. Scope of the Patent Protected Compounds The patent protects a class of macrocyclic compounds, specifically those with a particular chemical structure that inhibits the NS3/4A protease of the hepatitis C virus. This inhibition is crucial for the therapeutic effect of the drug[2]. Therapeutic Use The scope of the patent includes the use of these compounds in the treatment of HCV infection. This encompasses various aspects of therapy, including the administration of the drug alone or in combination with other antiviral agents. Claims of the Patent Independent and Dependent Claims The patent includes a series of independent and dependent claims that define the scope of protection. Independent claims typically describe the broadest aspects of the invention, while dependent claims narrow down the scope by adding additional features or limitations. Claim Examples For instance, Claim 1 might describe a broad class of macrocyclic compounds, while dependent claims (e.g., Claims 2-10) might specify particular substituents, ring structures, or pharmaceutical compositions that include these compounds[2]. Patent Family and International Protection Global Patent Family US9856265 is part of a large patent family with sixty-two patent family members in forty-one countries. This extensive global coverage ensures broad protection for the invention across multiple jurisdictions[2]. International Patent Offices The protection of this patent is not limited to the United States. It is also protected through various international patent offices, including the European Patent Office (EPO), Japan Patent Office (JPO), and others, providing a comprehensive global patent landscape[1]. Patent Landscape Prior Art and Citation Data To understand the patent landscape, it is crucial to analyze prior art and citation data. Tools like the Common Citation Document (CCD) and the Patent Public Search tool provided by the USPTO can help consolidate citation data from multiple patent offices, giving a clearer picture of the prior art and the novelty of the invention[1]. Competitor Patents The patent landscape for HCV treatments is highly competitive, with numerous patents held by other pharmaceutical companies. Analyzing these competitor patents can provide insights into the technological advancements and the competitive environment in the field. Search and Analysis Tools USPTO Resources The USPTO offers several resources for searching and analyzing patents, including the Patent Public Search tool, Global Dossier, and the Patent Examination Data System (PEDS). These tools can be used to search for related patents, view file histories, and download bibliographic data[1]. International Databases Databases such as esp@cenet from the European Patent Office, PATENTSCOPE from the World Intellectual Property Organization (WIPO), and others provide access to international patent collections, enabling a comprehensive search of prior art and related patents[1]. Economic and Strategic Implications Market Impact The protection afforded by US9856265 and its global counterparts has significant market implications. It allows Janssen Pharmaceuticals to maintain market exclusivity for OLYSIO, influencing the pricing and availability of HCV treatments. Research and Development The patent also impacts research and development in the field of HCV treatments. Other companies may need to navigate around the protected compounds and methods, driving innovation in alternative treatments. Expiration and Future Considerations Patent Expiration Patents typically expire 20 years from the filing date. Understanding the expiration date of US9856265 and its family members is crucial for planning future strategies, whether it be the development of generic versions or the pursuit of new therapeutic approaches. Post-Expiration Strategies After the patent expires, generic versions of simeprevir may enter the market, potentially changing the competitive landscape. Companies may also focus on developing new drugs or improving existing treatments to maintain market share. Key Takeaways Patent Protection: US9856265 protects specific macrocyclic compounds used in HCV treatment. Global Coverage: The patent has extensive global protection with 62 family members in 41 countries. Competitive Landscape: The HCV treatment market is highly competitive, with numerous patents from various pharmaceutical companies. Search and Analysis: Utilize USPTO and international databases for comprehensive patent searches. Economic Impact: The patent significantly influences market exclusivity and pricing of HCV treatments. Future Strategies: Companies must plan for post-expiration strategies, including generic versions and new therapeutic developments. FAQs Q: What is the main compound protected by US9856265? A: The main compound protected is simeprevir, a macrocyclic compound used in the treatment of hepatitis C virus (HCV) infection. Q: How many countries have patent family members for US9856265? A: There are 62 patent family members in 41 countries. Q: What tools can be used to search for related patents? A: Tools such as the USPTO's Patent Public Search, Global Dossier, and international databases like esp@cenet and PATENTSCOPE can be used. Q: What is the significance of the Common Citation Document (CCD)? A: The CCD consolidates citation data from multiple patent offices, providing a single point of access to prior art citations for a patent family. Q: When do patents typically expire? A: Patents typically expire 20 years from the filing date. Sources USPTO - Search for patents: https://www.uspto.gov/patents/search DrugPatentWatch - Patent 9,856,265: https://www.drugpatentwatch.com/p/patent/9856265 USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset Duke University Libraries - Finding Patents Online: https://guides.library.duke.edu/c.php?g=289276&p=1929213 PubChem - Patent US-2010113440-A1: https://pubchem.ncbi.nlm.nih.gov/patent/US-2010113440-A1 More… ↓ ⤷ Subscribe

Drugs Protected by US Patent 9,856,265

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	9,856,265	⤷ Subscribe	Y	Y		METHOD OF TREATING HEPATITIS C	⤷ Subscribe
>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: 9,856,265

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	05107074	Jul 29, 2005
	05107417	Aug 11, 2005
	06101280	Feb 3, 2006

International Family Members for US Patent 9,856,265

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Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1912999	⤷ Subscribe	CA 2014 00053	Denmark	⤷ Subscribe
European Patent Office	1912999	⤷ Subscribe	C300697	Netherlands	⤷ Subscribe
European Patent Office	1912999	⤷ Subscribe	PA2014036	Lithuania	⤷ Subscribe
European Patent Office	1912999	⤷ Subscribe	1490062-5	Sweden	⤷ Subscribe
European Patent Office	1912999	⤷ Subscribe	14C0076	France	⤷ Subscribe
European Patent Office	1912999	⤷ Subscribe	C20140034 00151	Estonia	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.