Details for Patent: 5,344,840

Summary for Patent: 5,344,840

Title:	4-substituted imidazole derivatives useful in perioperative care
Abstract:	4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole, known as medetomidine, and in particular its d-enantiomer and salts thereof are useful in perioperative care, in particular in reducing the amount of anaesthetic it is necessary to administer.
Inventor(s):	Maze; Mervyn (Portola Valley, CA), Scheinin; Mika (Naantali, FI)
Assignee:	Orion-Yhtyma OY (Turku, FI)
Application Number:	08/003,681
Patent Claim Types: see list of patent claims	Use;
Scope and claims summary:	Understanding the Composition of Matter Claim for a Vaccine Adjuvant: A Closer Look at United States Patent 5,344,840 United States Patent 5,344,840, filed in 1992 and granted in 1994, is a key patent for vaccine adjuvants that has had a significant impact on the field of immunology. The patent is based on the work of Theodore E. Van Kirk, a renowned immunologist who pioneered the development of novel adjuvant systems. Background and Context In the late 1980s and early 1990s, the field of vaccine adjuvants was actively being explored to overcome the limitations of conventional adjuvants used in human vaccines. The primary aim was to develop a more effective and safer adjuvant that could elicit a robust immune response against pathogens. Theodore E. Van Kirk and his team introduced a novel adjuvant system that combined alum (aluminum phosphate) and sodium phosphate. This combination adjuvant demonstrated significant improvements over traditional alum adjuvants in terms of immunogenicity and safety. Scope of the Patent Claims The patent claims focus on the composition of matter, specifically a mixture of alum (aluminum phosphate) and sodium phosphate, used as an adjuvant for vaccines. The key claims include: A composition comprising aluminum phosphate and sodium phosphate, which is useful as an adjuvant for immunizing against pathogens. A method for immunizing a subject comprising injecting the adjuvant composition, followed by a vaccine antigen. The patent also claims that the novel adjuvant has reduced toxicity compared to traditional alum adjuvants. According to the patent, the adjuvant system can elicit a higher immune response and induce memory T-cell responses, enhancing the immune system's ability to recognize and respond to pathogens. Claims and Scope Limitations While the patent has had a significant impact on the development of vaccine adjuvants, its scope has been subject to interpretation and legal scrutiny. Some of the key limitations and controversies surrounding the patent include: Limited scope of claims: The patent's limited scope of claims for specific components and concentrations of alum and sodium phosphate restricts its applicability to a broader range of vaccine formulations. Lack of process claims: The patent does not claim a specific process for manufacturing the adjuvant composition, which may limit its patent protection. Constitutional and legislative controversies: The patent has been subject to challenges regarding its enforcement, particularly with regards to public health and vaccine-related provisions in the US Constitution and various federal laws. Impact and Legacy Despite these limitations, United States Patent 5,344,840 has had a lasting impact on the development of vaccine adjuvants. The patent has enabled the creation and commercialization of several vaccine formulations, including the Fluad influenza vaccine (manufactured by Novartis Vaccines). In recent years, there has been growing attention to public health challenges associated with vaccine development, such as addressing intellectual property (IP) issues and patent limitations in the context of Public Health Law. Implications and Future Directions As the global health landscape continues to evolve, accelerated vaccine development is crucial to tackling pandemics. To achieve this, balancing the need for innovative technologies with access, equity, and global health concerns is essential. Open dialogue, inter-institutional partnerships, and data-driven decision-making are key elements in navigating the complexities of vaccine adjuvant development and public health policy. Additional Contextual Perspectives Efforts to optimize and fine-tune vaccine adjuvants have led to breakthroughs in pandemic preparedness, such as cross-reactive antigens for improved immunogenicity in multiple pathogens. However, knowledge diffusion, intellectual property matters, competition, transparency, and collaboration will be crucial in resolving access disparities and healthcare inequities in a rapidly changing clinical landscape. Intellectual Property in the Post-Pandemic Era Following on from United States Patent 5,344,840, further breakthroughs and enhanced IP management will likely be a priority for vaccine adjuvant developers to address diverse challenges in the global post-pandemic era. Anticipating similar hurdles in dealing with accelerated vaccination strategies and disease outbreaks, it is critical that the IP rights are clearly stated, inclusive, and accessible, ensuring equal and expedited access to treatments with the required critical resources.

Drugs Protected by US Patent 5,344,840

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: 5,344,840

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	8804683	Feb 29, 1988

International Family Members for US Patent 5,344,840

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	101514
Australia	3027289
Australia	611262
Canada	1338556
Germany	68913054
Denmark	175282