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Last Updated: December 23, 2024

Patent: 6,805,686

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Summary for Patent: 6,805,686

Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	Analyzing the Claims and Patent Landscape of United States Patent 6,805,686 Introduction The United States Patent 6,805,686, owned by AbbVie Inc., is a significant patent related to the biologic drug HUMIRA®, which has been a cornerstone in the treatment of various autoimmune diseases. This analysis will delve into the claims of the patent, the patent landscape surrounding it, and the legal and strategic implications of these factors. Background of the Patent United States Patent 6,805,686 is one of the numerous patents held by AbbVie Inc. related to HUMIRA®, a monoclonal antibody used to treat conditions such as rheumatoid arthritis, psoriatic arthritis, and Crohn's disease. The patent covers specific aspects of the drug's composition, method of manufacture, and use[1]. Claims of the Patent The patent includes multiple claims that define the scope of protection for HUMIRA®. These claims can be broadly categorized into: Composition Claims: These claims describe the specific structure and composition of the monoclonal antibody. Method of Manufacture Claims: These claims outline the processes used to produce the antibody. Use Claims: These claims specify the therapeutic uses of the antibody. Each claim is carefully crafted to ensure broad protection while avoiding prior art and potential invalidation[1]. Patent Landscape Analysis Geographical Spread The geographical spread of patents related to biologic drugs like HUMIRA® is global, with major players filing patents in key jurisdictions such as the United States, Europe, and Japan. This widespread filing strategy ensures comprehensive protection across major markets[3]. Saturation of the Patent Space The biologic drug space, particularly for monoclonal antibodies, is highly saturated. Numerous companies, including AbbVie, have filed a large number of patents, making it challenging for new entrants to navigate without infringing existing patents. This saturation necessitates thorough patent landscape analyses to identify potential gaps and opportunities[3]. New Entrants and Competitors Several biosimilar companies, such as Sandoz Inc., have entered the market, attempting to develop copycat versions of HUMIRA®. These new entrants often challenge the validity of existing patents through inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB)[1]. Time-Slicing and Trends Analyzing the patent landscape over time reveals trends in innovation and market strategies. For instance, the number of patent filings in the biologic drug space has increased significantly over the past two decades, with a focus on improving manufacturing processes and expanding therapeutic uses. Time-slicing analysis can help identify areas where innovation is slowing down and where new opportunities might arise[3]. Inter Partes Review (IPR) and Patent Validity Overview of IPR The Leahy-Smith America Invents Act (AIA) introduced IPR as a mechanism to challenge the validity of issued patents in an administrative forum. This process is faster and less expensive than judicial proceedings and uses a lower burden of proof (preponderance of the evidence)[2]. Challenges to AbbVie’s Patents Sandoz and other biosimilar companies have filed multiple IPR petitions against AbbVie’s patents, including those related to HUMIRA®. Despite these challenges, the PTAB has largely upheld the validity of AbbVie’s patents, rejecting the majority of these IPR petitions[1]. Legal and Strategic Implications The Biologics Price Competition and Innovation Act (BPCIA) The BPCIA provides a framework for resolving patent disputes between innovator biologic companies like AbbVie and biosimilar applicants like Sandoz. The act allows biosimilar applicants to limit the number of patents that can be asserted at the initial stage, but it also provides mechanisms for the innovator to seek relief on remaining patents when the biosimilar product is about to be launched[1]. Litigation Strategies AbbVie has employed a multi-faceted litigation strategy to protect its patents. This includes identifying a large number of relevant patents and asserting them in phases, as allowed by the BPCIA. This approach ensures that AbbVie can maintain its market position while the biosimilar companies navigate the complex patent landscape[1]. Competitive Insights Uncovering Competitive Plans A thorough patent landscape analysis can reveal the competitive plans of other companies in the biologic drug space. For example, analyzing the patent portfolios of competitors can indicate their focus areas, potential new products, and market strategies. This information is crucial for making informed decisions about research and development, patent prosecution, and market entry[3]. Identifying Niche Areas Patent landscape analysis can also identify underappreciated niche areas within the biologic drug space. These niches might offer opportunities for innovation and market entry with less competition. For instance, a company might focus on developing biosimilars for less common autoimmune diseases, where the patent landscape is less saturated[3]. Tools and Resources for Patent Analysis USPTO Resources The United States Patent and Trademark Office (USPTO) provides several tools and resources for conducting patent searches and analyses. These include the Patent Public Search tool, Global Dossier, and Patent and Trademark Resource Centers (PTRCs). These resources help in identifying prior art, understanding the patent family, and analyzing citation data[4]. Software and Expert Analysis Specialized software like AcclaimIP and expert analysis by IP professionals are essential for conducting comprehensive patent landscape analyses. These tools and services help in answering critical questions about the geographical spread, saturation, and trends in the patent space, as well as uncovering competitive plans and niche areas[3]. Key Takeaways Comprehensive Protection: AbbVie’s patents, including US 6,805,686, provide broad protection for HUMIRA®, covering composition, manufacture, and use. Highly Saturated Market: The biologic drug space is highly saturated, making it challenging for new entrants to navigate without infringing existing patents. IPR Challenges: Despite numerous IPR challenges, the PTAB has largely upheld the validity of AbbVie’s patents. BPCIA Framework: The BPCIA provides a structured approach for resolving patent disputes between innovator and biosimilar companies. Strategic Litigation: AbbVie’s litigation strategy involves phased assertion of patents to maintain market position. Competitive Insights: Thorough patent landscape analysis is crucial for uncovering competitive plans and identifying niche areas. FAQs What is the significance of United States Patent 6,805,686? United States Patent 6,805,686 is significant because it is one of the key patents protecting AbbVie’s biologic drug HUMIRA®, which is used to treat various autoimmune diseases. How have biosimilar companies challenged AbbVie’s patents? Biosimilar companies like Sandoz have challenged AbbVie’s patents through inter partes review (IPR) proceedings at the PTAB, but the majority of these challenges have been rejected. What is the role of the BPCIA in patent disputes? The BPCIA provides a framework for resolving patent disputes between innovator biologic companies and biosimilar applicants, allowing for phased assertion of patents and providing mechanisms for seeking relief on remaining patents. How can patent landscape analysis benefit companies in the biologic drug space? Patent landscape analysis helps companies understand the geographical spread, saturation, and trends in the patent space, uncover competitive plans, and identify niche areas for innovation and market entry. What tools and resources are available for conducting patent searches and analyses? The USPTO provides tools like the Patent Public Search tool, Global Dossier, and PTRCs. Specialized software like AcclaimIP and expert analysis by IP professionals are also essential for comprehensive patent landscape analyses. Sources John E. Flaherty Ravin R. Patel MCCARTER & ENGLISH, LLP - Case 3:18-cv-12668 Document 1 Filed 08/10/18. Congressional Research Service - The Patent Trial and Appeal Board and Inter Partes Review. AcclaimIP - Patent Landscape Analysis - Uncovering Strategic Insights. USPTO - Search for patents. More… ↓ ⤷ Subscribe

Details for Patent 6,805,686

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	December 31, 2002	6,805,686
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	February 21, 2008	6,805,686
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 24, 2013	6,805,686
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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