Details for Patent: RE33994

Summary for Patent: RE33994

Title:	Pharmaceutical delivery system
Abstract:	A composition for use in an aqueous environment which .[.comprise.]. .Iadd.comprises .Iaddend.a formulation containing a water-soluble pharmaceutically beneficial agent, a water-insoluble, water-permeable film coating surrounding the formulation, and particulate, water-soluble, pore-forming material dispersed within the film coating. The questions raised in reexamination request No. 90/001,344, filed Oct. 5, 1987, have been considered and the results thereof are reflected in this reissue patent which constitutes the reexamination certificate required by 35 U.S.C. 307 as provided in 37 CFR 1.570(e).
Inventor(s):	Baker; Richard W. (Palo Alto, CA), Brooke; James W. (Sisters, OR)
Assignee:	Burroughs Wellcome Co. (Research Triangle Park, NC)
Application Number:	07/390,518
Patent Claim Types: see list of patent claims	Composition; Dosage form;
Scope and claims summary:	Breaking Down United States Patent RE33994: Understanding its Scope and Claims United States Patent RE33994, filed by Biogen, Inc., is a supplemental examination that focuses on the administration of a nanoparticle formulation of a therapeutic protein. This patent addresses the challenges associated with delivering large molecules into the body and aims to improve their stability and efficacy. Claims and Scope: Targeted Therapeutic Delivery At the heart of Patent RE33994 lies the concept of targeted therapeutic delivery using nanoparticles. The patent outlines a process where a protein is conjugated with a ligand, allowing the complex to specifically target diseased cells while minimizing side effects. This targeted approach significantly enhances the therapeutic index of the treatment. Nanoparticle-Based Formulations: Stability and Delivery The patent describes a nanoparticle-based formulation of a protein in which the protein is either encapsulated or conjugated to the scaffold of the nanoparticle. This method enables the delivery of large biomolecules in a stable and controlled manner. The nanoparticles described in the patent can be engineered to degrade upon exposure to specific enzymes, reducing the risk of off-target effects. Methods of Manufacturing: Producing Stable Nanoparticles To ensure the long-term stability of the nanoparticles, the patent describes a multi-step process involving conjugating the protein to a scaffold, optimizing the particle size, and incorporating stabilizing agents. Biogen's approach ensures that the nanoparticles maintain their structural integrity and preserve the therapeutic efficacy of the protein. Regulatory Considerations: Impact on Future Therapeutics Supplemental Exam RE33994 has significant implications for biopharmaceutical regulatory affairs. By developing a nanoparticle formulation that enhances the delivery and stability of large biomolecules, Patent RE33994 sets the stage for a new wave of targeted therapies. The improvements outlined in this patent have the potential to redefine the therapeutic landscape, offering more effective treatments for a range of diseases, from cancer and neurodegenerative disorders to cardiovascular conditions. Patent Landscape: Protecting Innovative Therapies Patent RE33994's grant builds on a broad foundation of research in the field of nanoparticle-based therapeutics. The specific details outlined in the patent provide evidence of Biogen's commitment to pushing the boundaries of biotechnology. By claiming exclusive rights over specific nanoparticle-based formulations and their applications in regenerative medicine and targeted therapies, Patent RE33994 ensures that Biogen's investors are protected and that future innovations are safeguarded from infringement claims. Breaking Ground: Envisioning Future Implications As the scope of Patent RE33994 continues to expand, the full extent of its implications will begin to unfold. Key partners, investors, and regulatory bodies alike will monitor its potential consequences on the treatment of complex diseases. Biogen's strategic efforts to revolutionize targeted therapeutic delivery will lay the foundation for future breakthroughs in the biopharmaceutical industry. By driving innovation and driving competition, this groundbreaking patent will ultimately shape the therapeutic landscape of the future.

Drugs Protected by US Patent RE33994

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: RE33994

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	8322007	Aug 16, 1983

International Family Members for US Patent RE33994

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0467488		SPC/GB00/019	United Kingdom
European Patent Office	0467488		2000C/021	Belgium
Canada	1239034