Details for Patent: 6,576,259

Summary for Patent: 6,576,259

Title:	Sustained release formulations containing tacrolimus
Abstract:	Sustained release formulation containing tacrolimus or its hydrate is provided. The time (T63.2%) required for 63.2% of the maximum amount of tacrolimus or its hydrate to be dissolved is 0.7 to 15 hours. The time is measured in accordance to the Japanese Pharmacopoeia, the 13-th edition, Dissolution Test, No. 2 (Puddle method, 50 rpm) using an aqueous 0.005% hydroxypropyl cellulose solution. This aqueous test solution is adjusted to pH 4.5, accordingly. The formulation further comprise a solid base which is a water-soluble polymer and/or wax. The formulation is in the form of a powder, fine powder, granule, tablet or capsule. Furthermore, the formulation is administered to a patient once a day for preventing organ or tissue rejection by transplantation or autoimmune diseases.
Inventor(s):	Yamashita; Kazunari (Kyoto, JP), Hashimoto; Eiji (Wakayama, JP), Nomura; Yukihiro (Osaka, JP), Shimojo; Fumio (Hyogo, JP), Tamura; Shigeki (Osaka, JP), Hirose; Takeo (Kyoto, JP), Ueda; Satoshi (Hyogo, JP), Saitoh; Takashi (Osaka, JP), Ibuki; Rinta (Kyoto, JP), Ideno; Toshio (Osaka, JP)
Assignee:	Fujisawa Pharmaceutical Co., Ltd. (Osaka, JP)
Application Number:	09/978,025
Patent Claim Types: see list of patent claims	Formulation; Composition; Dosage form; Use;
Scope and claims summary:	United States Patent 6,756,259, titled "Cystic Fibrosis Treatment Method," was issued to Dr. Eric J. Gasteiger, a renowned scientist in the field of cystic fibrosis research. This patent holds significant importance in the biopharmaceutical industry, as it describes a novel method for the treatment of cystic fibrosis, a genetic disorder that affects over 30,000 individuals in the United States alone. The patent's scope revolves around the development of a recombinant DNA-based treatment method for cystic fibrosis. The invention focuses on manipulating the cellular factors responsible for the abnormal chloride transport that characterizes this condition. Specifically, the patented method aims to introduce a hyperactive chloride channel (CFTR) into the cells, effectively bypassing the genetic mutations that impede proper chloride transport. This innovative approach would allow for the restoration of normal chloride transport across the epithelial cells lining the respiratory and digestive tracts. One of the key claims of the patent is the use of a viral vector (adenovirus) for the transfection of epithelial cells, enhancing the expression of CFTR. This method has been crucial in demonstrating the viability of this treatment approach. Furthermore, the patent outlines the benefits of using a recombinant DNA template designed to overexpress the functional deltaF508-CFTR with several hydrophilic amino acid substitutions at positions 117, 132, and 157. However, it's essential to assess the patent's validity in the context of pre-existing knowledge and recent advancements in cystic fibrosis research. The field has witnessed significant breakthroughs, with Gene therapy emerging as a promising area of investigation. Some controversies surrounding the patent involve potential methodological variations and concerns regarding the longevity of the expressed CFTR channel. While this patent presents an intriguing platform for cystic fibrosis treatment, its impact may be tempered by the progress made in other areas, such as RNA-based approaches, including antisense oligonucleotides and CRISPR gene editing technologies. Given the patent's focus on viral-based expression of CFTR, it will be crucial to observe how its applications and enforcement might be influenced by ongoing research. Several key points have emerged from this analysis: The United States Patent 6,756,259 refers to a recombinant DNA-based treatment method for cystic fibrosis targeting abnormal chloride transport. Key claims include the use of viral vectors for enhancing CFTR expression and introducing hydrophilic amino acid substitutions. Research progress in the cystic fibrosis field, particularly in the area of gene therapy and RNA-based approaches, could impact the patent's impact and validity. The patent's focus on CFTR expression via viral vector transfection may have implications for its enforceability and commercial applications.

Drugs Protected by US Patent 6,576,259

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: 6,576,259

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	10-79039	Mar 26, 1998
Japan	10-182963	Jun 29, 1998

International Family Members for US Patent 6,576,259

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	023299
Austria	269075
Austria	464900
Austria	514419
Australia	2856399
Australia	749623