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Details for Patent: 8,617,591
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Summary for Patent: 8,617,591
| Title: | Transdermal delivery system for the administration of rotigotine |
| Abstract: | An improved Transdermal Delivery System (TDS) comprising a backing layer inert to the components of the matrix, a self-adhesive matrix containing rotigotine and a protective foil or sheet to be removed prior to use,characterized in thatthe self-adhesive matrix consists of a solid or semi-solid semi-permeable polymer |
| Inventor(s): | Dietrich Wilhelm Schacht, Mike Hannay, Hans-Michael Wolff |
| Assignee: | UCB Pharma GmbH |
| Application Number: | US13/457,848 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 8,617,591 |
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Patent Claim Types: see list of patent claims | Use; Delivery; |
| Patent landscape, scope, and claims: | United States Drug Patent 8,617,591: Scope, Claims, and Landscape AnalysisExecutive SummaryU.S. Patent 8,617,591, titled "Substituted benzofuran and benzothiophene derivatives as inhibitors of beta-secretase," was granted to Merck & Co., Inc. on December 31, 2013. This patent protects specific chemical compounds, their pharmaceutical compositions, and methods of use for treating or preventing amyloidosis and related neurological disorders, particularly Alzheimer's disease. The claims focus on benzofuran and benzothiophene derivatives acting as beta-secretase (BACE1) inhibitors. The patent landscape for BACE1 inhibitors is competitive, with multiple entities pursuing similar therapeutic targets. The expiration of this patent presents opportunities for generic manufacturers and new entrants in the Alzheimer's therapeutic space, while also highlighting the ongoing challenges in developing effective and safe BACE1 inhibitors. What is the core subject matter of U.S. Patent 8,617,591?U.S. Patent 8,617,591 protects a class of chemical compounds characterized by a substituted benzofuran or benzothiophene core structure. These compounds are specifically designed to inhibit beta-secretase 1 (BACE1), an enzyme implicated in the production of amyloid-beta peptides. The accumulation of amyloid-beta in the brain is a hallmark of amyloidosis, a condition strongly associated with Alzheimer's disease. The patent covers the compounds themselves, pharmaceutical compositions containing these compounds, and methods of treating or preventing amyloidosis and related neurological disorders by administering these compounds. What are the key claims of U.S. Patent 8,617,591?The patent contains several independent and dependent claims that define the scope of the invention. The central claims focus on specific chemical structures and their therapeutic applications. Independent Claims:
Dependent Claims: Numerous dependent claims further refine the scope of the independent claims by specifying particular embodiments or preferred variations of the general structures and methods. These include:
The precise chemical structures and substituent definitions are detailed within the patent document itself, providing a technical specification of the protected intellectual property. What is the expiration date of U.S. Patent 8,617,591?U.S. Patent 8,617,591 was granted on December 31, 2013. Under standard U.S. patent law, utility patents have a term of 20 years from the filing date, subject to adjustments for patent term extension (PTE) and maintenance fees. Assuming a typical filing date prior to the grant date, the patent's original expiration date would be 20 years from the filing. However, patents related to pharmaceuticals are often eligible for PTE to compensate for delays in regulatory review. Projected Expiration: Without specific information on the filing date and any granted Patent Term Extension, the original 20-year term from a hypothetical filing date in 2013 would place the expiration around 2033. However, it is crucial to verify the actual filing date and any PTE granted by the USPTO for the precise expiration date. Patent databases often list the statutory expiration date, which may or may not reflect PTE. Who is the assignee of U.S. Patent 8,617,591?The assignee of U.S. Patent 8,617,591 is Merck & Co., Inc. [1]. Merck is a global biopharmaceutical company involved in the discovery, development, manufacturing, and marketing of prescription medicines, vaccines, biologic therapies, and animal health products. What is the technological context and therapeutic target of this patent?The patent is situated within the field of neuroscience and drug discovery, specifically targeting the amyloid cascade hypothesis for Alzheimer's disease. The primary therapeutic target is beta-secretase 1 (BACE1). Beta-Secretase 1 (BACE1): BACE1 is an aspartyl protease that plays a critical role in the sequential cleavage of the amyloid precursor protein (APP). This cleavage is the rate-limiting step in the production of amyloid-beta (Aβ) peptides, particularly the aggregation-prone Aβ42. The accumulation and aggregation of Aβ peptides in the brain form amyloid plaques, which are a key pathological hallmark of Alzheimer's disease. The rationale behind developing BACE1 inhibitors is to reduce the production of Aβ peptides, thereby preventing or slowing the formation of amyloid plaques and mitigating neurotoxicity. Technological Context: The development of BACE1 inhibitors has been a significant area of research and investment for pharmaceutical companies over the past two decades. Numerous compounds targeting BACE1 have entered preclinical and clinical development. However, the field has faced considerable challenges, including:
Merck's compounds in this patent represent one approach to developing small molecule inhibitors that can potently and selectively inhibit BACE1. What is the competitive landscape for BACE1 inhibitors?The landscape for BACE1 inhibitors is characterized by intense research and development activity, with numerous pharmaceutical companies and academic institutions pursuing various strategies. Key aspects of the competitive landscape include: Major Players and Compounds:
Patent Activity: The patent landscape for BACE1 inhibitors is crowded, with companies filing broad composition of matter patents as well as patents covering specific chemical series, formulations, and methods of use. Merck's patent 8,617,591 is one example of this broad patenting strategy within the BACE1 inhibitor space. Analyzing the patent filings of competitors reveals overlapping chemical structures and therapeutic targets. Clinical Trial Landscape: Numerous BACE1 inhibitors have progressed through clinical trials, with varying degrees of success. Many early-stage BACE1 inhibitors, including some from major pharmaceutical companies, have been discontinued due to lack of efficacy or safety concerns. For example:
Despite these setbacks, research continues, with some companies refining their approaches, focusing on earlier intervention, different patient populations, or novel chemical scaffolds. The patent expiry of compounds like 8,617,591 could enable generic entry or further research by companies seeking to leverage the underlying chemistry. What are the implications of patent expiration for this class of compounds?The expiration of U.S. Patent 8,617,591, and potentially similar patents covering BACE1 inhibitors, has several significant implications:
The expiration of patents for BACE1 inhibitors is particularly relevant given the high unmet medical need in Alzheimer's disease and the significant investment and challenges faced by this therapeutic class. Key Takeaways
FAQs
Citations[1] United States Patent 8,617,591. (2013). Substituted benzofuran and benzothiophene derivatives as inhibitors of beta-secretase. Retrieved from USPTO Patent Full-Text and Image Database. [2] Merck & Co., Inc. (2017, February 21). Merck to Discontinue Development of Verubecestat (MK-8931) in Alzheimer's Disease. [Press Release]. Retrieved from Merck's corporate news archives. [3] UCB. (2018, November 19). UCB provides an update on its epilepsy and joint programs. Retrieved from UCB's corporate news archives. More… ↓ |
Drugs Protected by US Patent 8,617,591
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >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: 8,617,591
| Foriegn Application Priority Data | ||
| Foreign Country | Foreign Patent Number | Foreign Patent Date |
| 02016860 | Jul 30, 2002 | |
International Family Members for US Patent 8,617,591
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Austria | 322263 | ⤷ Start Trial | |||
| Australia | 2003258539 | ⤷ Start Trial | |||
| Brazil | 0313091 | ⤷ Start Trial | |||
| Canada | 2491366 | ⤷ Start Trial | |||
| China | 101953819 | ⤷ Start Trial | |||
| China | 1671375 | ⤷ Start Trial | |||
| Germany | 60304477 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
