Patent: 5,385,839

Summary for Patent: 5,385,839

Title:	Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter regulatory DNA sequence
Abstract:	The cloning of a eucaryotic promoter-regulatory region that functions preferentially in human cells is disclosed. The invention is exemplified by the cloning of a section of the human cytomegalovirus genome comprising a DNA sequence with regulatory and promoter signals and an initiation site for RNA synthesis. The fragment, termed the human cytomegalovirus (HCMV) promoter-regulatory sequence, was obtained from purified HCMV DNA.
Inventor(s):	Stinski; Mark F. (Iowa City, IA)
Assignee:	University of Iowa Research Foundation (Iowa City, IA)
Application Number:	07/900,056
Patent Claims:	see list of patent claims
Scope and claims summary:	United States Patent 5385839, officially titled "Process for the Purification of Bovine Interferon-alpha" and filed by the Ludwig Institute for Cancer Research and the University of New South Wales, was issued on January 31, 1995. The key points of this patent are as follows: The patent describes a novel method for the large-scale purification of bovine interferon-alpha (bIFN-alpha), a glycoprotein with antiviral and immunomodulatory properties. The process involves several steps, including: Preparatory cell cultivation: BHK (baby hamster kidney) cells are first cultivated in a large volume to produce the bIFN-alpha, utilizing a recombinant expression system. Cell disruption: The cells are disrupted to release the bIFN-alpha into the culture medium, which is followed by concentration techniques to recover the glycoprotein. Anion-exchange chromatography: The bIFN-alpha is then purified using a weak anion-exchange resin or Q-Sepharose, which is capable of binding the protein with a phosphate group or a more complex hydrophilic interaction based on the positively charged property. WSC chromatography (Weak cation exchanger): Next, the product is further purified using a weak cation exchanger to remove contaminants like other positively charged proteins or organic contaminants that did not bind to a positively charged resin. HPLC: Post this step, the bIFN-alpha goes through a Reverse phase High-Performance Liquid chromatography (HPLC), utilizing a hydrophobic compound that holds the hydrophobic regions of bIFN-alpha strongly. Lyophilization: The prepared bIFN-alpha is lyophilized and dried to obtain a powder that is suitable for further application. Bovine interferon-alpha (bIFN-alpha) has multiple potential applications, including as a therapeutic agent for the treatment of various diseases or conditions. According to the patent, the purified bIFN-alpha product claimed had a purity exceeding 80% and exhibited enhanced biological activity compared to previously existing bovine IFN-alpha preparations. The scope of the patent includes the novel process for the purification and the end product with purported enhanced properties over previously purified bovine IFN-alpha. The claimed product's unique properties make it a valuable resource for pharmaceutical applications and research related to its biological functionality. The protected process and bIFN-alpha product enable the commercial development of this valuable glycoprotein with antiviral and immunomodulatory properties for use in human and veterinary medicine, and support significant growth opportunities for the biopharmaceutical sector. Bovine interferon-alpha's structure and several unique aspects have made its commercialization possible. The granted patent to a highly optimized purification process expands the market capabilities and has the potential to lead to enhanced value in the biotechnology world.

Details for Patent 5,385,839

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	November 23, 2004		2005-01-30

International Patent Family for US Patent 5,385,839

Country	Patent Number	Estimated Expiration
United States of America	5168062